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Running head: NONINVASIVE POSITIVE PRESSURE VENTILATION 1 Noninvasive Positive Pressure Ventilation Compared to Noninvasive Mechanical Ventilation in Respiratory Failure Patients Alice Pinyan Maryville University

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Running head: NONINVASIVE POSITIVE PRESSURE VENTILATION 1

Noninvasive Positive Pressure Ventilation Compared to

Noninvasive Mechanical Ventilation in Respiratory Failure Patients

Alice Pinyan

Maryville University

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2NONINVASIVE POSITIVE PRESSURE VENTILATION

Chapter I

Introduction

Chronic obstructive pulmonary disease (COPD) is a severe and debilitating disease

characterized by the progression of an individual’s inability to have normal breathing related to

the obstruction of airflow and is not fully reversible (World Health Organization, 2016).

According to the World Health Organization (2017), 65 million people have COPD. The

prevalence of chronic obstructive pulmonary disease is astounding. According to the Centers for

Disease Control and Prevention (2017a), 15.7 million Americans are diagnosed with COPD.

There are approximately eight per 100,000 individuals in Tennessee who have COPD (Centers

for Disease Control and Prevention, 2017b).

Chronic obstructive pulmonary disease patients often develop high carbon dioxide (CO2)

levels and low oxygen (O2) levels that are diagnosed as hypercapnic respiratory failure with

hypoxia. The clinic where the data will be collected, East Tennessee Pulmonary and Sleep

Medicine, serves patients with pulmonary and sleep disorders. Education and treatment provided

at the author’s clinical practice site provide a holistic approach to using education, counseling,

and treatment regimens to prevent deterioration of symptoms in COPD patients with hypercapnic

respiratory failure (HRF).

This disease affects individuals, families, communities, and the economy emotionally,

physically and financially. According to estimates from the World Health Organization (2017),

“65 million people have moderate to severe chronic obstructive pulmonary disease” and “more

than 3 million people died of COPD in 2005.” According to the Centers for Disease Control and

Prevention (CDC), “Almost 15.7 million Americans (6.4%) reported that they had been

diagnosed with COPD.” The CDC (2017) also reported that COPD “was the third leading cause

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3NONINVASIVE POSITIVE PRESSURE VENTILATION

of death in the United States in 2014.” There are 7.06-9.29 per 100,000 individuals in Tennessee

that are reported to have COPD (Centers for Disease Control and Prevention, 2011). The 2012

hospitalization rates for COPD were higher for women, and the age range for those hospitalized

most was 70-79 years (Tennessee Department of Health, 2017). As the disease progresses, the

patient can develop hypercapnic respiratory failure (HRF).  Hypercapnia is having high carbon

dioxide (CO2) levels in the arterial blood. This study will explore the effectiveness of

noninvasive positive pressure (NIPPV) compared to noninvasive mechanical ventilation (NMV)

in respiratory patients.

The incidence of COPD is high and using oral and nebulized medications are not always

enough. Chronic obstructive pulmonary disease patients are put on noninvasive positive air

pressure devices to assist in keeping airways open, but a newer device is the noninvasive

mechanical ventilator (NMV) (e.g., Trilogy and Astral). The devices work differently, and the

effects of the two types of devices warrant a comparison in the treatment of HRF patients.

There are two types of noninvasive positive pressure modes. The continuous positive air

pressure (CPAP) device has one setting for the continuous inspiratory pressure that the patient

breathes and the bilevel positive air pressure (BiPAP) device has an inspiratory and an expiratory

(I/E) pressure. In more advanced noninvasive positive pressure ventilation (NIPPV) devices,

there are more settings that can be used to better support the hypercapnic respiratory failure

patients. One of these devices is the bilevel positive air pressure with spontaneous timed

(BiPAP-ST) mode. This device automatically senses when spontaneous respiration does not

occur, and a forced breath is triggered after a specified amount of time. The average volume

assured pressure support (AVAPS) has the same modes as the BiPAP but has volume cycled

positive pressure or tidal volume control (Hyzy, 2017). This setting ensures that the lungs fill

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with a specific volume of air during inspiration. Noninvasive mechanical ventilation (NMV) can

provide any of the mentioned modes, separately, or in combination as in a mechanical ventilator

(Hyzy, 2017). This project aims to improve patient outcomes by comparing the results of the

NIPPV and noninvasive mechanical ventilation (NMV) and determining which device will be

most effective in the treatment of COPD patients with hypercapnic respiratory failure. Then,

advanced practice nurses will have the knowledge to select the device most appropriate for their

patients.

Purpose

The use of noninvasive positive pressure ventilation (NIPPV) and noninvasive mechanical

ventilation (NMV) have positive effects on patients. The purpose of this project is to answer the

question: In respiratory patients, what is the effect of utilizing traditional noninvasive positive

pressure ventilation devices (CPAP, BiPAP, BiPAP-ST) compared to newer noninvasive positive

pressure ventilation devices (Trilogy, Astral)? The project will take place in an office setting at

East Tennessee Pulmonary and Sleep Medicine clinic in Tennessee, and will compare traditional

noninvasive positive pressure devices to the new noninvasive mechanical ventilation devices in

patients with hypercapnic respiratory failure (HRF) due to chronic obstructive pulmonary disease

(COPD). Pulmonary function test (PFT) and arterial blood gas (ABG) results will be used as

quality indicators to compare the effectiveness of the devices.

Background

The idea for this project came about by the recurring denials of coverage for noninvasive

positive pressure ventilation devices (BiPAP, AVAPS) and mainly the noninvasive mechanical

ventilation devices (Trilogy, Astral). The primary researcher observed that patients started on

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the noninvasive mechanical ventilation devices had an overall improvement in health status, and

when the devices were denied, the therapy was stopped, and the patients deteriorated.

Noninvasive positive pressure ventilation is controversial. Literature is limited on the effects

of NIPPV in HRF and literature is also limited on noninvasive mechanical ventilation devices.

The use of the acronym NIPPV is often used in the literature to describe all types of ventilation

support devices. The NMV provides continuous or intermittent ventilatory support and has

multiple modes like a mechanical ventilator.

Patients with COPD who develop hypercapnic respiratory failure benefit from using NIPPV

and NMV. Using NIPPV improves respiratory status by decreasing CO2 levels, stabilizing or

improving lung function, and exercise tolerance. A systematic review and meta-analysis by

Struik, Lacasse, Goldstein, Kerstjens, and Wijkstra (2013) reported improvement in partial

arterial carbon dioxide (PaCO2) and an increase in walking distance. Zamzam, Azab, El Wahsh,

Ragab, and Allum (2013) indicated that activity is affected by the severity of COPD.

Patients that were previously on the noninvasive positive pressure ventilation had a decline in

respiratory status when the device was not used. Oscroft, Quinnell, Shneerson, and Smith

(2010b) stated that stopping NIPPV at night made breathing worse. They reported that the

patient had an increase in CO2 levels.

Even with the controversy about using NIPPV/NMV for the treatment of HRF in COPD

patients, studies showed there is an improvement in CO2 levels, patient symptoms, and exercise

endurance with the use of these devices. The research findings will compare the effects of the

noninvasive treatment modalities in respiratory failure patients who have severe or very severe

COPD.

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Significance

Nursing

The role of nurses is crucial in the care of respiratory patients, namely COPD and respiratory

failure patients. Knowledge about COPD exacerbations and types of respiratory failure is the

key to prompt and adequate care. Chronic obstructive pulmonary disease decreases airflow in

patients, and the reduction of airflow leads to Type 1 respiratory failure. Type 1 respiratory

failure is a decrease in oxygenation. Type 2 respiratory failure is a decrease in ventilation which

causes increased CO2 and low oxygen (Hunter 2009). Nurses play a vital role in this study

because they are responsible for patient assessments and communicating the findings to the

physician or nurse practitioners in order to implement the best interventions for the patient. The

use of NIPPV has also been reported to prolong survival in patients with COPD and hypercapnic

respiratory failure (Hanna, Dominelli, Chen, Reid, & Road, 2013).

Advanced Practice Nursing

The significance of this project for advanced practice nursing comes from the tertiary level of

care. Advanced practice nurses (APN) have advanced knowledge to care for patients at this

level. Tertiary care is the level of care where the APN has the knowledge to diagnose and treat

disease and disabilities. With proper education, the APN can diagnose COPD, COPD

exacerbations, respiratory failure, and provide care to improve patient outcomes. APN’s starting

the NIPPV or NMV as a treatment in COPD patients with respiratory failure can improve patient

outcomes and possible decrease mortality rates. Galli et al. (2014) indicated findings of

increased survival in patients with NIPPV use compared to patients with no NIPPV (µ2 = 23.8, p

< 0.0001) and found a reduction in hospitalizations (40% vs. 75%, p < 0.0001) through 180 days.

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Advanced practice nurses use all levels of care for the patients, but using NIPPV at the tertiary

level can provide a benefit for the COPD patients who have hypercapnic respiratory failure.

Healthcare

Chronic obstructive pulmonary disease affects healthcare, and one significant burden to

healthcare is the costs for treatment of COPD patients. According to the Centers for Disease

Control and Prevention (2017a), by 2020 the cost of medical care for COPD patients will be

more than $90 billion. The use of NIPPV decreases the cost of hospital stays and does not

increase cost when used at home (Clini, Magni, Crisafulli, Viaggi, & Ambrosino, 2009). There

needs to be more studies to determine if home use of NIPPV and NMV decreases hospitalization

rates in COPD hypercapnic respiratory patients and benefits healthcare.

Practice Support

The pulmonary practice where the project will be completed will provide excellent support.

The supervising physician and the staff understand the importance of this project on a

professional and personal level. The supervising physician is a committee member who is

willing to provide guidance for the project. The office manager has agreed to access of the

charts with the understanding that permission is required from the facility officials and the

Institutional Review Board before the data is extracted by the primary investigator. The

supervising physician and the office manager have approved weekend visits to the office for the

investigator to review the charts and obtain information. Having internal support increases

confidence that the project on the effects of NIPPV compared to NMV in COPD patients with

hypercapnic respiratory failure can be accomplished.

Benefit of Project to Practice

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The benefit of this project will assist in determining the most effective ventilation methods for

COPD hypercapnic respiratory patients. Trying to determine the appropriate device to use for

patients and the process for approval is time-consuming. Having more knowledge about the

effects of the NIPPV and the NMV will decrease the paperwork, stress, and time to get approval

for the appropriate devices. The greatest benefit of this project to practice is practitioners will

know the patients will be receiving the treatment that is most beneficial for them.

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Chapter II

Literature Review

Chronic obstructive pulmonary disease (COPD) is a progressive disease that causes

dysfunction in respiratory gas exchange. Many patients with COPD progress to develop

respiratory failure. The treatments for COPD patients are limited to medications in pill, inhaler,

and nebulizer form. Patients with respiratory failure are also treated with noninvasive positive

pressure ventilation. Noninvasive positive pressure ventilation (NIPPV) and noninvasive

mechanical ventilators (NMV) are controversial. The purpose of this research study is to answer

the question: In patients with COPD, what is the effect of utilizing traditional noninvasive

positive pressure ventilation compared to newer noninvasive mechanical ventilation devices.

This project aims to determine if newer NMVcompared to traditional NIPPV treatment

modalities provide improved patient outcomes as measured by pulmonary function testing (PFT)

and arterial blood gas carbon dioxide (CO2) levels.

A comprehensive review of the literature identified articles on noninvasive positive pressure

ventilation and noninvasive mechanical ventilation in COPD, acute respiratory failure (ARF),

chronic respiratory failure (CRF), and exercise capacity. This chapter will explore literature on

the effects of noninvasive ventilation devices on lung function. Also, a comparison of traditional

and newer NIPPV treatment modalities will be presented.

Search History

A computerized search of several electronic databases was utilized to identify published

research articles. These databases included the Cochrane, Medline, and Cumulative Index to

Nursing and Allied Health Literature (CINAHL). The search terms included: chronic obstructive

pulmonary disease, acute respiratory failure, chronic respiratory failure, hypercapnia, exercise

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capacity, noninvasive positive pressure ventilation, and noninvasive mechanical ventilation. The

search was restricted to articles in English from January 1995 to July 2018. Articles that

contained reports on pulmonary function test (PFT), arterial blood gases (ABG) and exercise

capacity were included in the review. The studies that were included in the search centered on a

diagnosis of COPD, acute respiratory failure, chronic respiratory failure, hypoxia, and exercise

tolerance with the use of NIPPV devices. Articles that focused on educational information and

did not include PFT and ABG measurements or were specific to quality of life were excluded.

Relevant information from 38 articles from 2006-2018 was included in the literature review.

COPD

An explanation of COPD, acute respiratory failure, and chronic respiratory failure is

important for understanding the use of noninvasive positive pressure ventilation in respiratory

failure. Using NIPPV assists in keeping small airways open, maintaining tidal volume, and

maintaining CO2 and oxygen levels.

The abnormalities that occur in COPD affect the airways, lung parenchyma, and pulmonary

vasculature. According to Han, Dransfield, and Martinez (2017), changes in the airway include

inflammation, increased size of goblet cells, fibrosis, and airway collapse. The problem with air

exchange relates to permanent dilation of the lung parenchyma, hyperplasia of the pulmonary

vasculature, and smooth muscle hypertrophy. These pathological changes with COPD also

affect the alveolar structures and disrupt gas exchange (Han, Dransfield, and Martinez, 2017)

Acute Respiratory Failure

Patients with chronic obstructive pulmonary disease can develop acute respiratory failure.

Acute respiratory failure is the sudden onset of elevated partial pressure of arterial carbon

dioxide (PaCO2) and low partial pressure arterial oxygen (PaO2). Researchers suggest that the

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use of NIPPV lowers the risk of mechanical ventilation and decreases the risk of death (Liu,

Zhao & Tang, 2016). Information is presented on the effects of using noninvasive positive

pressure ventilation in out-of-hospital patients and according to Mal, McLeod, Iansavichene,

Dukelow, and Lewell (2014), using NIPPV during emergency medical service transport of

respiratory failure patients revealed a decreased risk of death and intubation. The patients also

have a better event-free survival rate (Galli et al., 2014). Vasquez et al. (2017) reported that

large numbers of COPD patients had not been prescribed positive air pressure devices for

respiratory failure. The risk of changes in gas exchange and serious complications are increased

as the disease progresses (Liao et al., 2017).

Acute hypercapnic respiratory failure can recur in chronic hypercapnic respiratory failure

(HRF) patients. The process of gas exchange malfunction causes the oxygen level to drop and

the carbon dioxide level to increase. Although acute respiratory failure is a severe form of

respiratory malfunction, mechanical ventilation is not always the first-line treatment (Liu et al.

2016). Patients stabilized with noninvasive positive pressure ventilation or noninvasive

mechanical ventilation for severe respiratory distress have decreased use of invasive mechanical

ventilation and decreased mortality (Mal et al. 2014). Patients who use NIPPV at home are

reported to have fewer readmissions for exacerbations of COPD and respiratory failure (Galli et

al., 2005). Everyone with chronic obstructive pulmonary disease is at risk for developing

chronic hypercapnic respiratory failure.

Chronic Hypercapnic Respiratory Failure

Chronic hypercapnic respiratory failure is a consistent elevation in the patient’s carbon

dioxide level that has occurred over time. Patients adapt to the elevated CO2 levels and are

asymptomatic of acute respiratory failure symptoms. Chronic obstructive pulmonary disease

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patients with hypercapnic respiratory failure are still at risk for acute HRF. There is an increased

risk of respiratory acidosis which decreases the central drive of respirations and could be reduced

with the use of noninvasive devices in the home (Zhou et al. 2017). A decrease in carbon

dioxide levels and improved patient survival is also supported (Liao et al., 2017).

Lung Function

Using noninvasive positive pressure ventilation in respiratory disease patients is important to

the health of the patient. According to Kolodziej, Jensen, Rowe, and Sin (2007), using bilevel

NIPPV shows a carbon dioxide reduction, but no improvement in lung function, work of

breathing, or exercise capacity. The studies on chronic respiratory failure in COPD patients

provide different information. Struik et al. (2013) found that after using the NIPPV for three

months, CO2 levels improved. There is an indication that improvement in CO2 levels, lung

function, work of breathing, and exercise capacity correlates to higher pressure levels on the

bilevel NIPPV and longer use time on the NIPPV (Kolodziej et al., 2007).

Not all studies indicated improvements in patients using the NIPPV. The study by Dretzke et

al. (2016) did not show significant changes in CO2, lung function, or exercise capacity. Hanna,

Dominelli, Chen, Reid, and Road (2013) did not indicate positive findings in other chronic

respiratory diseases namely amyotrophic lateral sclerosis, Duchenne muscular dystrophy,

restrictive thoracic disease, and obesity hypoventilation syndrome. Hanna et al. (2013) did

indicate the use of NIPPV in COPD patients was successful in past studies. There is an

indication of some improvement in CO2 levels in regards to better patient compliance with

NIPPV therapy (Bhatt, Peterson, Wilson, & Durairaj, 2013).

Patients who have severe stable COPD with hypercapnic respiratory failure (HRF) and use

the NIPPV have a reduction in exacerbations with decreasing costs from hospitalizations and

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13NONINVASIVE POSITIVE PRESSURE VENTILATION

intubations (Clini, Magni, Cristafulli, Viaggi, & Ambrosino, 2008). Clini et al. (2008) also

determined in a cost comparison that there was a reduction in the cost of hospital stay with the

implementations of NIPPV therapy.

The use of NIPPV can have a positive effect on patients in several ways. Decreases in CO2

levels, stabilized lung function, and decreased work of breathing, are positives of the NIPPV.

Another use of NIPPV is to increase exercise capacity for patients with respiratory failure.

Another consideration is in the past ten years; it has been recognized that inflammatory

responses can lead to comorbidities. These comorbidities include “ischemic heart disease, heart

failure, diabetes mellitus (DM), metabolic syndrome, osteoporosis, anemia and depression” and

improvement was seen in COPD patients with hypercapnic respiratory failure who used the

NIPPV (Dimoulis et al., 2015).

Studies on the use of noninvasive bilevel positive pressure interventions at night in stable

hypercapnic COPD patients are limited. One study by Struik et al. (2013) showed no significant

change with nocturnal NIPPV until three months and then it is recommended for higher pressure

usage whereas, McEvoy et al., (2009) found there may be an improvement in survival. Another

study found that the use of nighttime NIPPV in patients receiving pulmonary rehabilitation has

been shown to improve CO2 levels, maintain PaO2 levels, and improve the amount of gases

inhaled or exhaled in a minute (Duiverman et al. 2008).

Another study by Ciftci et al. (2017) reported increased mortality in older adults on NIPPV in

the hospital but accredited this to increased comorbidities. Patients who had an admission to the

hospital for acute respiratory failure and were discharged home on the NIPPV on oxygen had a

prolonged time until an exacerbation or death (Murphy et al., 2017). Moreover, Jaber et al.

(2016) stated that NIPPV is proven to be effective in acute exacerbations of COPD. Even

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14NONINVASIVE POSITIVE PRESSURE VENTILATION

though most of the studies in the literature are about the use and effectiveness of NIPPV in acute

hypercapnic respiratory failure, home NIPPV is commonly indicated for COPD (Crimi et al.,

2016). The evidence reports that the use of NIPPV in COPD patients with hypercapnic

respiratory failure is beneficial for decreasing carbon dioxide levels, decreasing readmissions for

exacerbations, and decreasing mortality. Further research comparing NIPPV to NMV in COPD

patients with hypercapnic respiratory failure would provide evidence on the statistical

significance of one device over the other.

Exercise Capacity

Activity in patients with COPD is limited by shortness of breath from pathophysiological

factors. Respiratory failure patients gradually adapt to worsening shortness of breath by

decreasing activity levels (Lahaije, Van Helvoort, Dekhuijzen, & Heijdra, 2010). Activity

limitations in patients with COPD lead to decreased ability to perform activities of daily living

due to physiological changes in COPD. Lahaije et al. (2010) showed that exercise is limited for

various reasons such as lack of energy, motor dysfunction, and hyperinflation. Oscroft et al.

(2010b) indicated there is a significant improvement in exercise capacity, gas exchange, and

improved survival with use of the NIPPV and Salturk et al. (2015) stated the use of noninvasive

mechanical ventilation at home improved exercise capacity in the six-minute walk test.

On further review of the literature, there is information on improvement in respiratory failure

patients using hi intensity NIPPV. A study by Dreher, Storre, & Windisch (2007) indicated that

the use of hi intensity NIPPV with activity increases oxygen levels, yields less shortness of

breath, and increases exercise capacity. The ability of patients to ambulate and use lung function

to its fullest capacity is important to survival and decreasing complications. The use of NIPPV

with activity helped patients not only with gas exchange and lung function, but also improved

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health-related quality of life, mood, dyspnea, and exercise tolerance (Duiverman et al., 2011).

One negative indication on the use of NIPPV in COPD patients was no change in oxygen levels

with the device during ambulation (Walker et al., 2015). The use of specific devices in research

studies is limited, but research is necessary for showing the effect of the devices on COPD and

hypercapnic respiratory failure.

Device Comparison

The findings in the literature for comparisons of standard NIPPV devices and NMV are

limited. This study will help to fill the gaps in the literature. The comparisons are related to

continuous positive air pressure (CPAP), bilevel positive air pressure (BPAP), and volume-

assured pressure support (VAPS) devices (Pluym, Kabir, & Gohar, 2015). Studies indicated the

use of NIPPV could improve survival, reduce hypercapnia, and improve gas exchange (Bhatt,

Peterson, Wilson, & Durairaj 2013; Kolodziej, Jensen, Rowe, & Sin 2007). Shebl and

Abderaboh (2015) stated that the use of noninvasive positive pressure ventilation could assist

COPD patients with breathing at night by decreasing end-expiratory lung volume and improving

CO2 levels by the enhancement of respiratory functions. A further consideration for NIPPV is

the use of high-intensity devices for improvement in respiratory function, exercise capacity, and

gas exchange (Altintas, 2016).

Although noninvasive positive pressure ventilation continues to be controversial in treating

COPD, the NIPPV is efficiently used for patients with COPD that experience respiratory failure

in hospital settings but is controversial in regards to the effectiveness of in-home use (Altintas,

2016). NIPPV indicates improvement in pulmonary function and arterial blood gases with the

goal of lowering PaCO2 levels and increasing survival related to improvement in hypercapnia

(Bhatt, Peterson, Wilson, & Durairaj, 2013).

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In a randomized crossover trial by Oscroft et al. (2010a) on the use of volume-assured

compared to pressure preset devices, the results did not indicate any difference in the effects on

respiratory failure between the two devices as they were equally effective in each group, but

further studies with different inspiratory ventilation settings may be useful. Windisch, Haenel,

Storre, & Dreher (2009) found that high-intensity NIPPV improved CO2 levels, lung function,

and exacerbation rates as evidenced by decreased hospitalizations for exacerbation in the first

year with using the device compared to previous studies with lower inspiratory settings. The use

of positive air pressure devices namely CPAP, BiPAP, and NIPPV showed a reduction in

hospitalization of COPD patients (Vasquez et al., 2017). In a newer device, that is an NIPPV

with built-in software; there is a reduction in PaCO2 and improved exercise tolerance and

compliance with therapy (Zhou et al., 2017).

The use of mechanical ventilation increases a patient’s risk of complications such as

baroreceptor damage, ventilator-associated pneumonia, tracheal damage, and death (Liu et al.

2016). The use of NIPPV can decrease these risk factors. Carbon dioxide levels are reported to

be significantly lower with noninvasive mechanical devices (Ekkernkamp, Storre, Windisch, &

Dreher, 2014). According to Tsai, Lee, Delcos, Hanania, & Camargo, 2013), the guidelines

recommended early use of NIPPV, but use is limited for various reasons. These reasons include

lack of knowledge, insufficient training, lack of equipment, and set up time. An important

finding in the literature was how withdrawing long-term nighttime NIPPV affects COPD

patients. Long-term withdrawal of the NIPPV caused a progressive elevation in CO2, and these

findings were associated with increased mortality (Oscroft, Quinnell, Shneerson & Smith,

2010b).

Literature Critique

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17NONINVASIVE POSITIVE PRESSURE VENTILATION

The articles reviewed suggest negative and positive findings, and this information is

important to this project. This project will attempt to fill the gap in the literature that exists in

making the decision of which device is more beneficial to the patient. This project will

hopefully contribute to the body of knowledge about COPD and how it can be managed

effectively.

Strengths

The literature on noninvasive positive pressure ventilation is vast and varies greatly on

obstructive pulmonary diseases. The literature provided information on HRF in COPD patients

and the effects of the NIPPV on CO2 levels, lung function, and exercise capacity. The use of

NIPPV is beneficial with some patients (Dretzke et al. 2016). Hanna et al. (2013) stated that

NIPPV has been used and is effective in patients with hypercapnic respiratory failure. The

primary researcher supports that research that has been done on the positive effects of using the

NIPPV and the NMV in the treatment and maintenance of symptoms in hypercapnic respiratory

failure patients.

Weaknesses

The weaknesses in the literature were many. One weakness was the lack of studies on

specific devices. Several of the researchers discussed COPD and NIPPV, but did not mention

the stages of COPD. According to the Global Strategy for the Diagnosis, Management, and

Prevention of COPD (2017), the Global Initiative for Chronic Obstructive Lung Disease

(GOLD) (2017) categories are labeled one through four and include mild, moderate, severe, and

very severe stages. Most of the researchers described studies done on NIPPV and did not specify

BiPAP, BiPAP-ST, or NMV. The distinction in the devices could provide evidence-based

information on which device is most effective in the different stages of COPD and could identify

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18NONINVASIVE POSITIVE PRESSURE VENTILATION

which devices and pressures are needed for treatment of the symptoms of COPD, respiratory

failure, and hypercapnia.

Gaps

Gaps in the literature include the lack of inclusion criteria for comorbidities. This gap makes

the information seem incomplete because the comorbidities along with an established diagnosis

of COPD might impact the results of the intervention. A COPD patient with HRF can have

worsening symptoms related to heart disease, bronchiectasis, diabetes and other diseases.

Another gap in the literature was the use of patients with a diagnosis of alpha-1 antitrypsin

(A1A) deficiency COPD. Alpha-1 antitrypsin is a protease inhibitor. The deficiency of alpha-1

antitrypsin is an inherited disorder and can cause problems with the lungs including chronic

obstructive pulmonary disease which can lead to respiratory failure. Patients with A1A are

classified by the severity of the COPD and should be included if they are treated with NIPPV or

another device. Another gap in the literature are studies that focus on specific devices. This

project will add to the body of knowledge on respiratory devices used to treat COPD. This

project will hopefully help to decrease the gaps in the literature.

Limitations

The articles assessed in this review of literature pointed out several limitations. One of the

limitations is the risk of selection bias with randomized control trials (Hannan et al. 2013).

Selection of participants who are at high risk of acquiring a disease is an example of selection

risk bias. Enrolling patients and not using them in the study is a limitation (Kahan, Rehal & Cro,

2015). Patients who are enrolled in a study and meet inclusion criteria should be used in the

study so that the population can be represented through all participants. The lack of similarities

in patients and the design of studies is a significant limitation according to Liu et al. (2016).

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Patients used in studies should have similar qualities for the study to be accurate and the design

must be appropriate for the aim of the study. Oscroft et al. (2010) stated that the lack of

participants is a limitation as the number of patients should be large enough to represent the

population.

Concepts and Definitions

Chronic Obstructive Pulmonary Disease is described in many ways, but Dretzke et al. (2016)

described it as a “progressive lung disease, characterized by nonreversible airflow obstruction

and intermittent exacerbations” (p. 2269). One important factor with COPD is the nonreversible

factor. The nonreversible factor makes the point that no device repairs the damage to the lungs,

but could improve and maintain the current lung function. Using NIPPV as a treatment for

COPD HRF can assist with lowering carbon dioxide levels and improving exercise tolerance

(Zhou et al., 2017). Management to keep the CO2 levels in a safe range decreases the risks of

exacerbations or acute respiratory failure. COPD has several stages of severity. The severity of

COPD is determined by the forced expiratory volume in one second (FEV1) that is below a

normal range of 80% to 120%. In the Global Initiative for Chronic Obstructive Lung Disease

(GOLD), there are four stages of COPD. This study will center on the third and fourth stages of

COPD. GOLD 3 (severe) COPD with an FEV1 that is 30% of the predicted lung function and in

GOLD 4 (very severe), less than 30% predicted lung function (Global Initiative for Chronic

Obstructive Lung Disease, 2016).

“Respiratory failure is a syndrome in which the respiratory system fails in one or both of its

gas exchange functions” (Liu et al. 2016, p. 514). Patients can have respiratory failure in which

the oxygen level is critically low, or the CO2 level is critically high with low oxygen levels.

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Noninvasive positive pressure ventilation is initiated as a treatment modality for patients

“with or at risk of chronic hypercapnic respiratory failure” (Hannan et al. 2013, p. 230). The use

of the term noninvasive positive pressure ventilation is confusing. The term is used to describe

all devices such as CPAP, BiPAP, BiPAP-ST, VAPS, and NMV when the modes and use of the

devices are different. For example, the CPAP and BiPAP are used to treat sleep apnea and

BiPAP, BiPAP-ST, and VAPS are used to treat central apnea events and COPD. The NMV is

used to treat hypercapnic respiratory failure in patients who need pressure support and tidal

volume control.

Theoretical Framework

Betty Neuman’s Systems Model of Nursing

The Neuman’s Systems Model of Nursing is a mid-range open system-based theory and will

be the theoretical framework guiding this research study. Neuman’s model can be used

holistically and serves as a guide to holistic care (Neuman, 2017). Neuman’s theory focuses on

the client/client system that includes the individual, family, group/aggregate, and community

(Neuman, 2017). Neuman’s model includes physiological, psychological, sociocultural,

developmental, and spiritual variables. Neuman’s model also includes internal, external, and

created environments, and intra-personal, inter-personal, and extra-personal stressors.

The Neuman System Model will assist nurse practitioners in making informed decisions on

treatment modalities for COPD patients with HRF. Understanding the progression of and the

treatments for chronic obstructive pulmonary disease with hypercapnic respiratory failure is

important for health care providers involved with patients.

The interacting variables of Neuman’s model help health care providers and others to

understand the effect the disease can have on the patient. The patient experiences physical

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changes such as shortness of breath, coughing, sputum production, fatigue, and decreased

exercise capacity. They also have psychological problems like anxiety from the increased

shortness of breath, and depression from the changes in their social life. The developmental

stages of COPD patients with HRF are also affected. The detrimental factors of the disease on

some patients bring a positive spiritual outlook or hope, and others have a negative spiritual

outlook or show despair. The model centers on the environments and stressors of the patient.

The environments in this model are internal, external, and created and the stressors are intra-

personal, inter-personal, and extra-personal. This model is important to this project because the

environment and stressors relate to the variables associated with the patient. The variables

include: (a) physiological, (b) psychological, (c) sociocultural, (d) developmental, and (e)

spiritual. The nurse practitioner must have an understanding of the patient’s environment and

stressors. Recognition of problems and the variables will prompt the nurse practitioner to order

appropriate interventions. These interventions include counseling, access to support programs,

further education on the disease, and access to spiritual leaders. Using the information from

Neuman’s model can assist the nurse practitioner to understand the issues that may arise with the

patient and how to intervene when needed.

Neuman also discusses the normal line of defense for the patient (client), the lines of

resistance, and optimal system stability. If the nurse practitioners are knowledgeable about the

disease and the effect it can have on patients, they can assist the patient in reaching the highest

level of health possible. This model uses the three dimensions of primary, secondary, and

tertiary prevention, and this is important to the evidence-based care and management of COPD

HRF patients, so they can maintain the highest level of health possible.

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Chapter III

Methodology

The purpose of the methods chapter is to describe the research plan for this study. This

chapter will describe the steps that were used to address the research question. The research

question is as follows: What is the effectiveness of the NIPPV compared to NMV in respiratory

patients? This study will also address the needs assessment, resources needed, the project

budget, timeline and the protection of human subjects.

Research Design

A descriptive correlational design was utilized for this study in order to gain a better

understanding of the respiratory devices that would be best suited for COPD HRF patients. The

study was conducted using a retrospective chart review for obtaining the data. The data for this

project was extracted from the electronic medical records (EMR) of adult patients with COPD,

hypercapnia, hypoxia, and respiratory failure at the author’s clinic, East Tennessee Pulmonary

and Sleep Medicine. (See Appendix A – Approval Letter from Office Manager and the

Physician). The charts from all patients from January 1, 2008 to July 24, 2018 who received

treatment with NIPPV and NMV were reviewed by the primary investigator for potential

inclusion in the retrospective medical record review.

Sample and Setting

The sample was determined based on a power analysis which indicated the number of

subjects to utilize in the study, which were 128 subjects. The inclusion criteria: (a) 18 to 80

years of age, (b) any gender, (c) any ethnic background, (d) documented diagnosis of COPD

(stages Gold 3 or Gold 4), (e) documented diagnosis of hypercapnia, (f) documented diagnosis of

hypoxia, (g) documented diagnosis of respiratory failure, (h) documented baseline FEV1, PaCO2,

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and PaO2, (i) documented post-treatment FEV1, PaCO2, and PaO2, and (j) documented use of

NIPPV or NMV. The setting, East Tennessee Pulmonary and Sleep Medicine, was founded in

2006 with the purpose of caring for patients from 12 years of age and older with pulmonary and

sleep disorders. The office was started by a physician, and in 2011 a nurse practitioner was added

to the practice. The practitioners see approximately 150 patients a week. The mission of the

clinic is to provide high quality, evidence-based care to all patients seen in the practice.

Measurement

The instrument used in the data collection procedure was a demographic survey that was

created by the primary investigator to collect pertinent data about the subjects. (see Appendix B

Data Collection Sheet). The data included age, gender, diagnosis, device, and pre-device PaO2,

FEV1 and CO2, and post-device PaO2, FEV1 and CO2. The demographic survey was utilized to

create the spreadsheet to assist with data analysis.

Data Collection Procedure

The primary investigator obtained approval from the IRB at Maryville University and

permission from the officials at East Tennessee Pulmonary and Sleep Medicine clinic to conduct

the study (see Appendix A – Approval Letter from Office Manager and the Physician). After

approval from the IRB was granted for the study, the primary investigator accessed the electronic

medical records and there were 39 patients who met the inclusion criteria. The data collected

from the archival charts included age and diagnoses of COPD, hypercapnia, hypoxia, and

respiratory failure. The data collected also included the type of devices, FEV1, PaCO2, and O2

levels. The data was manually exported to the spreadsheet and the primary investigator de-

identified the collected information into numerical codes that will not link the chart to any

participant (see Appendix B – Data Collection Sheet). This information was kept on an

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encrypted computer in which the primary investigator was the only person who was familiar with

the password.

This research study was conducted through a retrospective chart review. There were no active

participants. A descriptive correlational study was utilized for this project. Electronic medical

records were obtained on-site from the clinic for data collection (See Appendix A - Approval

Letter from Office Manager and the Physician). The researcher recorded the selected data for

this project, which included: gender, device, pre- and post FEV1, pre- and post CO2, and pre- and

post O2 levels. (See Appendix B Data Collection Sheet). All potential patient identifiers were

removed, and the data were cleaned and coded for analysis.

Data Analysis

Following data collection and prior to data analysis, all data were cleaned and coded. All

statistical analysis was conducted using SPSS version 25 statistical package. The SPSS

statistical package allowed the researcher to reduce the data. The data were reported using

frequencies and percentages and displayed in tables. Descriptive statistics were calculated for

age, gender, diagnosis, respiratory devices, pre-device and post-device use for O2, CO2, and

FEV1 levels. Independent samples t-tests were utilized to compare the different devices by

assessing means of the O2, CO2, and FEV1 variables.

Needs Assessment

According to the World Health Organization (2017), 65 million people have COPD. The

prevalence of chronic obstructive pulmonary disease is astounding. According to the Centers for

Disease Control and Prevention (2017a), 15.7 million Americans are diagnosed with COPD.

There are approximately eight per 100,000 individuals in Tennessee who have COPD (Centers

for Disease Control and Prevention, 2017b). Patients with COPD hypercapnic respiratory

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failure need more than medications to control disease symptoms. The elevation of carbon

dioxide can lead to death and needs to be controlled. The uses of NIPPV and NMV devices have

been shown to aid in decreasing the CO2 levels. Determining if the effectiveness of one device

compared to the other is statistically significant will aid in the selection of the most appropriate

device to use for the COPD HRF patients.

Resources

One resource for this project was the electronic medical record that was used on-site at the

clinic for the collection of demographics and data by the primary investigator. The specifically

designed spreadsheet was used for documenting the data that was collected from the EMR.

Other resources included a pulmonologist as a reference person for consultation on diagnosis,

PFT, and ABG results, and a statistician for questions regarding data analysis.

Project Budget

The financial resources needed for this project included personal use resources such as gas for

vehicle use and cost of office supplies. The time and travel to the office location were minimal.

There is no cost for access to the office, consultations with the pulmonologist, statistician, or

office manager. The cost of the project will be estimated at 25 dollars or less.

Timeline

A timeline is necessary for completion of the project. The steps in the timeline included

approval from the IRB and officials at the setting utilized for the project. The timeline also

included the implementation, analysis of the data results, and dissemination of the results into a

final written project and oral presentation. The analysis of the findings was completed in three to

four weeks. Finalizing the chapters and completion of the program will take place until August

26, 2018.

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Protection of Human Subjects

The primary investigator obtained approval from the IRB at Maryville University and

permission from the officials at East Tennessee Pulmonary and Sleep Medicine clinic to conduct

the study (see Appendix A – Approval Letter from Office Manager and the Physician).

There were no foreseen risks for physical, psychological, social/economic, or legal risks that

would result from this study. One identified risk was a breach of confidentiality; however, this

risk is minimal as every effort was taken to maintain confidentiality. All data had all potential

identifiers removed. All data is presented in the aggregate. To minimize the risk of breach of

confidentiality, consent and HIPAA forms from the participating facility were obtained and

signed by the principal investigator. To keep the obtained data safe and confidential, it was

stored on a password protected computer within a secure personal location to which only the

principal investigator is aware and possesses access. The location where the computer was

located was locked inside a personal space with the key residing with the principal investigator

only. After the data was statistically analyzed, it was returned to the participating facility and

shredded in accordance with the facility policy that is already in place to destroy confidential

medical records

The data was recorded and stored on the principal investigator’s personal laptop that is

protected with a secure passcode and stored in a private secure locked location with only the

principal investigator having access to the data obtained. All data was de-identified. The data

was reported and shared during a professional presentation with the instructors and peers in the

DNP (Doctor of Nursing Practice) program at Maryville University, as well as, in a written

scholarly paper. The data will be shared with the East Tennessee Pulmonary and Sleep Medicine

physician, Dr. Mandeep Bakshi, and possibly in a written publication. All data stored on the

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password protected computer was manually deleted after data analysis by the primary

investigator.

Conclusion

Chronic obstructive pulmonary disease with hypercapnic respiratory failure is a respiratory

disease that requires more than traditional treatment. The need for this research project is

important to COPD patients with hypercapnic respiratory failure. The data will be used to

determine the comparisons between noninvasive positive pressure ventilation and noninvasive

mechanical ventilation devices. The data provided will aid in determining if the differences

between the devices are statistically significant, so the proper device can be used to treat

respiratory patients. These findings will add to the current literature on the evidence-based care

of patients with COPD and HRF and explore the potential for further research.

This knowledge will hopefully contribute to improved care, patient outcomes, and increased

patient compliance with visits for health maintenance instead of secondary or tertiary visits. The

results of the project can lead to practice changes for respiratory patients. Changes may provide

the COPD patient with hypercapnic respiratory failure with the most effective noninvasive

treatment for correction or stabilization of hypercapnic respiratory failure.

Chapter IV

Results

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28NONINVASIVE POSITIVE PRESSURE VENTILATION

The purpose of this chapter is to present the findings of this research study. The findings are

presented by describing the sample and addressing the research question. The research goal is to

compare the effectiveness of a noninvasive positive pressure ventilator to a noninvasive

mechanical ventilator in respiratory patients. The comparison between the devices will provide

statistical information on the effect of each device on oxygen, forced expiratory volume in one

second, and carbon dioxide levels.

Statistical Analysis

Data was analyzed using SPSS version 25. The study results were expressed as a percentage

or mean plus or minus standard deviation. The statistical tests utilized for this study was a

descriptive analysis of variables and independent samples t-tests. Descriptive statistics were

calculated for age, gender, diagnosis, respiratory devices, pre-device and post-device use for O2,

CO2, and FEV1 levels. Independent samples t-tests were utilized to compare the different

devices to determine if one device indicated a statistical significance to the other device in

effectiveness on the O2, CO2, and FEV1 variables.

Results

Demographic Characteristics of COPD Patients

The sample consisted of 39 charts with patients having a respiratory diagnosis based on

International Classification of Diseases (ICD) ten codes. The patient charts met the following

inclusion criteria: (a) 18 to 80 years of age, (b) any gender, (c) any ethnic background, (d)

documented diagnosis of COPD (stages Gold 3 or Gold 4), (e) documented diagnosis of

hypercapnia, (f) documented diagnosis of hypoxia, (g) documented diagnosis of respiratory

failure, (h) documented baseline FEV1, PaCO2, and PaO2, (i) documented post FEV1, PaCO2,

and PaO2, and (j) documented use of NIPPV or NMV.

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Descriptive Statistics

The mean age was 67.31 years, and there were 26 females and 13 males. The average age of

females is 68 years of age and males average age was 66 years. The ethnicity of the 39 subjects

was white, non-Hispanic. The number of NIPPV devices was 15 and NMV was 24. The

descriptive analysis of pre and post oxygen levels showed the mean difference of -6.38 mm hg.

The pre and post FEV1 levels have a mean difference of 20.18%. The difference between the

pre and post CO2 level had a mean difference of -4.86 mm hg. (See Table 1).

Table 1Descriptive Statistics

N Minimum Maximum Mean Std. DeviationGENDER 39 1 2 1.67 .47

AGE 39 46 80 67.31 8.76DX 39 1 4 3.13 .92

DEVICE 39 1 2 1.23 .98PRE-O2 39 41.60 130.0 75.4 23.9

POST-O2 39 38.4 124.0 69.0 16.93DIFF O2 39 -72.90 47.64 -6.38 25.71

PRE-FEV1 39 .0 72.0 37.33 18.53POST-FEV1 39 .0 64.0 17.14 19.63DIFF FEV1 39 -16.00 72.00 20.18 23.25PRE-CO2 39 35.0 101.0 61.34 13.92

POST-CO2 39 39.4 98.1 56.79 14.75DIFF CO2 39 -57.40 46.90 -4.86 18.99

Valid N (listwise) 39

Statistical Analysis

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An independent samples t-test was calculated to compare the mean difference in O2 levels for

the noninvasive positive pressure ventilation (NIPPV) device (m = - 3.07 %) and the noninvasive

mechanical ventilation (NMV) device (m = -8.45 %). No significant difference was found (p

= .532) (See Table 3). This finding indicated that oxygen levels with both devices were lower

and that neither device was effective in maintaining oxygen levels in the patients. This finding

could be related to the severity of the disease and the need for supplemental oxygen.

The independent samples t-test was calculated to compare the mean difference for forced

expiratory volume in one second (FEV1) for the noninvasive positive pressure ventilation device

(m = 27.29 %), and the noninvasive mechanical ventilation device (m = 15.74). No difference

was found (p = .133). (See Table 3). The findings indicate low FEV1 levels that are the result of

excess mucus production, tissue death, destruction of bronchioles, inflammation, and fibrosis

(Berg & Wright, 2016).

An independent samples t-test was calculated for comparison of the mean difference in CO2

levels with NIPPV device (m = 3.91mm Hg) and the NMV (m = -10.34 mm Hg). There was a

significant difference found (p = .021) (See Table 3). This significant difference indicated that

CO2 levels of patients on the NMV device are improved compared to CO2 levels of patients on

NIPPV.

Table 3Independent Samples Test

Levene's Test for Equality

of Variances t-test for Equality of Means

F Sig. t df Sig. (2-tailed)

Mean Difference

Std. Error Difference

95% Confidence Interval of the

Difference

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Lower Upper

DIFF O2

Equal variances assumed

.019 .890 .631 37 .53 5.38 8.53 -11.90 22.67

Equal variances

not assumed

.619 28.02 .541 5.38 8.69 -12.42 23.19

DIFF FEV

1

Equal variances assumed

.256 .616 1.536 37 .133 11.55 7.5222180

-3.6844899

26.79 778233

Equal variances

not assumed

1.493 27.17 .147 11.55666668

7.73658002

-4.3123017

27.42756354

DIFF CO2

Equal variances assumed

.084 .774 2.420 37 .021 14.24333334

5.8878550

2.3127534

26.17 339133

Equal variances

not assumed

2.461 31.49 .020 14.24333334

5.7880520

2.4402864

26.04 763804

In summary, this chapter has addressed the research question: What is the effectiveness of

noninvasive positive pressure ventilation compared to noninvasive mechanical ventilation in

respiratory patients. This chapter has described the sample of respiratory patients at the clinic.

The study found that there was no statistical difference in oxygen levels or FEV1 levels between

the two devices. However, the study did indicate an improvement in the carbon dioxide levels of

patients on the noninvasive mechanical ventilator. The information from the data analysis

indicated that patients on the NMV have a significant decrease in levels compared to the NIPPV.

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Chapter V

Discussion

Noninvasive positive pressure ventilation compared to noninvasive mechanical ventilation

was assessed to determine if one device was more effective than the other in the treatment of

patients with COPD and hypercapnic respiratory failure. Lowering carbon dioxide levels in

COPD HRF patients is imperative in slowing the progression of the disease. Using NIPPV

improves respiratory status by decreasing CO2 levels, stabilizing lung function, and increasing

exercise tolerance (Struik, Lacasse, Goldstein, Kerstjens, & Wijkstra, 2013). It is reported that

activity is affected by the progressive stages of COPD (Zamzam, Azab, El Wahsh, Ragab, &

Allum, 2013).

Comorbidities

Another consideration was the effect of comorbidities. The literature indicated that

comorbidities are usually present with the diagnosis of COPD and can increase the risk of

exacerbations. Comorbidities such as cardiovascular disease, bronchiectasis, chronic bronchitis,

and depression are indicators for worsening respiratory symptoms (Westerik et al., 2017).

Although data was not collected on comorbidities, there could be a correlation related to the

findings. Comorbidities such as cardiovascular disease are frequently present in COPD patients

and correlates to the common inflammatory process in both diseases (Gunay, Sariaydin, & Acay,

2016). Westerik et al. (2017) stated that patients are more at risk for COPD exacerbation related

to the impact of comorbidities. Keeping in mind the impact that comorbidities can have on

COPD, it is important to recognize that “almost 50% of the COPD patients have 3 or more

comorbidities” (Dursunoglu et al., 2016). The development of hypercapnic respiratory failure

increases the risk of mortality (Liao et al. 2017). The two year rate of death after hypercapnea

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develops is 30-40% (Galli, et al., 2014). Two significant comorbidities that occur in COPD

patients are musculoskeletal decline and cardiovascular disease and they can affect the patient’s

ability to breath properly (Dursuboglu et al., 2016).

Demographic Variables

The more data and understanding of the effectiveness of the devices will help increase

knowledge and ultimately aid in improving COPD HRF patients respiratory status. Descriptive

analysis was used to describe the demographics of the sample and independent t-tests were

performed to compare the effectiveness of the devices.

The descriptive analysis revealed a mean age of 67 years. A study by Westerik et al. (2017)

on COPD exacerbations indicated a mean age (M = 66.5 years) and the mean age (m = 65 years)

was reported in a study by Shebl and Aberaboh (2015). “The prevalence of COPD increases

with age” (Criner & Han, 2018, p. 593). The ethnicity of the 39 subjects was Caucasian and this

is likely because the population of Greene County Tennessee is 68,615 and 93 percent of the

population is Caucasian (Census Reporter, 2016).

NIPPV vs. NMV

The independent samples t-test indicated low oxygen levels with both devices. This finding is

related to the severity of the disease. As COPD progresses the airflow is more limited, and the

capillary bed is destroyed, causing disruption in gas exchange, and the potential for the

development of pulmonary hypertension and right heart failure (Kent, Mitchell, & McNicholas,

2011). Liao et al. (2017) indicated that use of the NIPPV did not improve oxygen levels. The

evidence indicates that the NIPPV and NMV do not improve oxygenation in COPD HRF

patients due to the pathophysiologic change in the lungs.

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The independent samples t-test was calculated to compare the means between devices for

differences in forced expiratory volume in one second (FEV1). The findings suggest a low

FEV1 level. Galli et al., (2014) indicated that there is not a significant change in FEV1 between

patients on the NIPPV compared to those not on a device. This can be explained by

understanding that the damage to the lungs is not reversible and the FEV1 indicates the

percentage of lung capacity and determines the severity of the disease (Lung Institute, 2016).

The main finding in the study was improvement in carbon dioxide levels. The independent

samples t-test was calculated to compare the mean difference in CO2 levels with NIPPV device

(m = 3.91mm Hg) and the NMV (m = -10.34 mm Hg) (see Table 2). There is a significant

difference found (p = .021) (See Table 3). This significant difference indicates that CO2 levels of

patients who use the NMV device were improved compared to CO2 levels of patients on NIPPV.

The damage to the lungs from COPD causes ventilation and perfusion difficulties. This

disruption in gas exchange occurs in COPD HRF patients and is related to a decrease in alveolar

function. The oxygen can get in to the lungs, but the exhalation of carbon dioxide is limited.

This pathology can occur with rapid shallow breathing, over inflation of the lungs, or destruction

of pulmonary capillaries. Patients needing more respiratory support can use the NMV devices at

home. The patients using NMV have decreased carbon dioxide levels and improved survival

rates, improved exercise capacity, and improved quality of life (Duiverman, 2018).

Chronic obstructive pulmonary disease is not only a severe and debilitating disease; it is a

complicated disease. The damage in the lungs is caused by several mechanisms including

inflammation that affects the alveolar, changes in the airways, and inflammatory changes in

vasculature. Patients with COPD have emphysema, chronic bronchitis, or both of them. The

combination of emphysema and chronic bronchitis can make treatment more difficult, and

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patients that develop hypercapnia have a higher risk of death (Nilius, Katamadze, Domanski,

Schroeder & Franke, 2017). The research showed that keeping the carbon dioxide levels down is

imperative to survival of COPD HRF patients.

Limitations

Several limitations are associated with this study. First, this is a retrospective pre and post

comparison study and “is subject to inherent bias” (Coughlin, Liang &, Parthasarathy, 2015) as

this researcher must assume that the information in the electronic medical records is accurate

(Terry, 2015). Next, the devices were not separated by specific modes, comorbidities and

oxygen use were not taken into consideration. The researcher had to assume the data was

correctly recorded in the EMR. The literature did not separate the devices by specific type, and

the researcher did not consider oxygen usage or comorbidities. These limitations must be takent

into consideration with the findings of the study; however, the study can be used in future, larger

studies for better representation of a larger population.

Application to Practice

Nurse practitioners should stay up to date on guidelines for the care of COPD patients

(Bostock-Cox, 2017). The information gathered from this study and the literature has increased

this researcher’s knowledge and the new-found knowledge needs to be shared. The information

from this study will be used in practice to develop a protocol for treatment of COPD HRF

patients with a noninvasive mechanical ventilation device. The data analysis and the literature

suggest improvement in CO2 levels in COPD HRF patients. The findings of the study will be

shared with the clinic physician and initiation of the protocol will begin.

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36NONINVASIVE POSITIVE PRESSURE VENTILATION

Another implication to practice is having increased evidence on the efficacy of NMV on

COPD HRF. The findings can be used to strengthen the appeal for NMV through insurance

companies. Providing the information from this study and the literature will be compelling for

the use of this device.

This study can be replicated by other researchers with larger groups to be more representative

of a larger population of COPD patients. It is recommended that further studies be conducted to

include age, gender, ethnicity, diagnosis, device types, and pre-device and post-device levels of

O2, CO2, and FEV1 levels, along with using separate device types, and comorbidities. This would

likely provide stronger evidence for the use of the noninvasive mechanical ventilators in patients

with COPD HRF.

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Appendix A

Approval Letter from Clinic Manager and the Physician

1404 Tusculum Blvd. Suite 2200 Greeneville, TN 37745

EAST TENNESSEE Tel: 423-798-8052 PULMONARY AND SLEEP MEDICINE Fax: 423-798-8055

July 31, 2017

Re: DNP Candidate / Alice M. Pinyan

To: Whom it may concern

It is to our understanding that our current Nurse Practitioner, Alice M. Pinyan, is a DNP candidate and is working on a scholarly project. We have granted Alice permission to review our patient's charts for use in gaining valuable information to assist her in the completion of her project.

These charts are to be reviewed for clinical information only and the identity of the patients are to remain confidential and unidentifiable in her project.

Sincerely,

Shirley Ball, Office Manager

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Appendix B

Data Collection Sheet