COMPARATIVE STUDY ON THE OUTCOME OF EARLY

TRACHEOSTOMY VS LATE TRACHEOSTOMY IN PATIENTS WHO

ARE ON PROLONGED MECHANICAL VENTILATION IN INTENSIVE

CARE UNIT

S. No Table of Content Page No

1 INTRODUCTION

2 REVIEW OF LITERATURE

3 AIMS & OBJECTIVES

4 MATERIALS & METHODS

5 RESULTS

6 DISCUSSION

7 CONSULATION

8 LIMITATIONS

9 BIBLIOGRAPHY

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Glossary Abbreviations

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INTRODUCTION

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INTRODUCTION

Tracheostomy is a procedure generally suggested for patients who are critically ill and require

prolonged mechanical ventilation. Tracheostomy is a surgical procedure where an alternate

airway is created for the patients. This procedure plays a crucial role reducing co-morbid

conditions like duration of stay at the hospital, pneumonia1 which occurs due to the assisted

ventilation and also bringing down the mortality rates. There are two major techniques for

tracheostomy, including open surgical tracheostomy (ST) and percutaneous dilatational

tracheostomy (PDT).

Other forms of assisted ventilation during emergencies and when the patients are critically ill and

unable to maintain the normal respiration is endotracheal intubation. On the other hand extended

tracheal tube intubation time may lead to serious complications involving damage to the trachea

and larynx.2 Tracheostomy can practically be an advantageous alternative3 for intubation, by

reducing the airway resistance and requirement of sedatives, on the same time tracheostomy is

also not without any complications. Complications like vocal cord dysfunction, stomal

granulation, persistent tracheal fistula, and scarring are persistent for the patients undergoing

tracheostomy4.

There is a huge number of tracheostomies performed on patients with mechanical ventilation. A

study from the UK have reported an estimate of 15000 tracheostomy procedures annually5. The

median time taken to perform of a tracheostomy was found to be 10 to 11 days after admitting I

the ICU, but on the other hand, upto 13% of the tracheostomies were placed within 2 days of

admission6. Even after tracheostomy being a crucial decision, that is to be taken during the

emergencies, there is a lack of definite and robust set of guidelines for the procedure.

Recommendations have been made at a consensus conference that, translaryngeal intubation for

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patients need of the artificial airway up to 10 days and performing tracheostomy after 21 days of

intubation7. But the timing of tracheostomy is still disputed.There lies an ambiguity on when

exactly to carry out the procedure and the factors that are to be taken into consideration. The

appropriate timing to carry out tracheostomy can affect various parameters like cost of

admission, duration of stay in the hospital, morbidity and mortality.

When assessed for the secondary outcomes, studies have reported a significant decrease in

average days spent in the intensive care unit with early tracheostomies. There was no evidence

suggesting that either treatment led to a lower likelihood of pneumonia8. In a similar study9,

which tried to address the controversy had indicated that early tracheostomy had no influence on

mortality, pneumonia, or laryngotracheal pathology rates in trauma patients

Studies10-12 conducted on the timing of tracheostomy in adult subjects undergoing mechanical

ventilation have documented no difference in mortality or hospital-acquired pneumonia, but

early tracheostomy was associated with significantly decreased duration of mechanical

ventilation and shorter stay in the intensive care unit.

A study carried out for analyzing the cost incurred had demonstrated that across multiple centers,

early tracheostomy, defined as tracheostomy performed within 10 days of tracheal intubation,

considerably has reduced hospital costs based on LOS alone and these results were consistent.

There are studies, which have reported that early tracheostomy offers considerable economic

benefit, and have demonstrated early tracheostomy reduce long term mortality, ventilator

dependent days and ICU stay13. This could be possibly be a result of early tracheostomy

improving lung mechanics and oral hygiene, decreasing pain, decreasing need for sedatives and

improving communication when compared to a ventilator13. Through these studies,

7

recommendations were made for a robust cost effectiveness study that would guide the

procedure in future.

Most importantly in cases of trauma patients with severe head or chest injury who need

intubation and mechanical ventilation for a long time often undergo tracheostomy. Physicians

have a responsibility to balance benefits with risks of complications such as bleeding, infection,

nerve injury, and tracheal damage. Furthermore, evidence on the benefits of tracheotomy despite

risks is necessary to influence both the patient’s family and medical providers who are uncertain

about invasive procedures

As in the recent times, there are large number of studies that are being carried out on the current

issue, but are mostly presented with inconclusive results. Through this current study, an attempt

is being made to compare the benefits and adverse effects of early and late tracheostomy and to

possibly ascertain an appropriate time for carrying out the procedure in critically ill patients and

also during emergencies.

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AIMS & OBJECTIVES

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AIMS AND OBJECTIVES:

Aim:

To evaluate and compare the benefits and adverse effects of early and late tracheostomy

in patients who are on mechanical ventilation in ICU setup.

To highlight the benefits of effective post-operative tracheostomy care.

Objectives:

To evaluate the indications and outcome of patients requiring tracheostomy in intubated

patients who are in intensive care unit.

To compare the complications in patients undergoing early and delayed tracheostomy.

To prove the advantages of doing tracheostomy at the appropriate time.

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REVIEW OF LITERATURE

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REVIEW OF LITERATURE

Increasing number of critically ill patients and need for mechanical ventilation

Nazir I Lone and Timothy S Walsh14 have carried out a retrospective cohort study to establish the

incidence and outcomes of prolonged mechanical ventilation in a UK.Out of 8290 ICU

admission episodes, 7848 were included in the analysis. PMV patients used 29.1% of all general

ICU bed days, spent longer in hospital after ICU discharge than non-PMV patients (median 17 vs

7 days, P < 0.001) and had higher hospital mortality (40.3% vs 33.8%, p value = 0.02). For the

region, in which about 70 PMV patients were treated each year, a weaning unit with a capacity

of three beds appeared most cost efficient. From the findings, authors have conclude that,

establishing a weaning unit would potentially reduce acute bed occupancy by 8-10% and could

reduce overall treatment costs.

To determine the characteristics, the frequency and the mortality rates of patients needing

mechanical ventilation and to identify the risk factors, a prospective cohort study was carried out

by Léa Fialkow et al15., among 1,115 patients admitted to the ICU who needed mechanical

ventilation. The mean Acute Physiology and Chronic Health Evaluation II (APACHE II) score

was 22.6±8.3. Independently associated factors were the conditions present at the beginning of

mechanical ventilation, age, acute respiratory distress syndrome, sepsis and chronic obstructive

pulmonary disease. The other conditions that were associated during the course of mechanical

ventilation were acute respiratory distress syndrome, sepsis, and renal, cardiovascular, and

hepatic failures. Based on the findings, authors have concluded that, it was evident that mortality

13

rate of patients who required mechanical ventilation was higher, which may have been related to

the severity of illness of the patients admitted to the ICU.

Role of tracheostomy in mechanical ventilation

Marchese S et al16., have reported results of their study one-year survey which evaluated clinical

characteristics, types of tracheostomy and complications in patients. Major complications after

tracheostomy were 2%. 427 tracheostomies were evaluated for de-cannulation, 96 (22.5%) were

closed, 175 patients (41%) were discharged with home mechanical ventilation, 114 patients

(26.5%) maintained the tracheostomy despite weaning from mechanical ventilation and 42

patients (10%) were dead or lost for follow up. The systems for evaluating feasibility of

decannulation were, closure of tracheostomy tube, laryngo-tracheoscopy, use of tracheal button

and down-sizing. Based on the findings, authors have concluded that, even though few major

complications of tracheostomy were reported, a considerable proportion of patients maintain the

tracheostomy despite not requiring mechanical ventilation.

Terragni P et al17., have stated that, orotracheal intubation avoids acute surgical complications

such as bleeding, nerve and posterior tracheal wall injury, and late complications such as wound

infection and tracheal lumen stenosis that may emerge due to tracheostomy tube placement.

Tracheostomy is often considered when mechanical ventilation is expected to be applied for

prolonged periods or for the improvement of respiratory status, as this approach provides airway

14

protection, facilitates access for secretion removal, improves patient comfort, and promotes

progression of care in and outside the intensive care unit (ICU).

Yuan CR et al18., have carried out a study to better examine the effect of tracheostomy on clinical

outcome among prolonged ventilator patients in Taiwan. A total of 3880 patients with ventilator

use for more than 14 days between 2005 and 2009 were identified. Among them, 645 patients

with tracheostomy conducted within 30 days of ventilator use were compared to 2715 patients

without tracheostomy on death. The tracheostomy rate was 30%, and 55% of tracheostomies

were performed within 30 days of mechanical ventilation. After adjustments, patients with

tracheostomy were at a lower risk of death during hospitalization (hazard ratio [HR] =0.51; 95%

confidence interval [CI] =0.43-0.61) and 5-year observation (HR = 0.73; 95% CI = 0.66-0.81),

and a lower probability of successful weaning (HR = 0.88; 95% CI = 0.79-0.99). Higher medical

use was also observed in patients with tracheostomy. Authors have finally concluded that

through this study, the beneficial effect for tracheostomy was observed which reciprocated in

reduction of death and also patients with tracheostomy were less likely to wean and more likely

to consume medical resources.

To examine the association between the performance of a tracheostomy and intensive care unit

and postintensive care unit mortality Clec'h C et al19., have carried out a prospective,

observational, cohort study. Of the 2,186 patients included, 177 (8.1%) received a tracheostomy.

Both models led to similar results. Tracheostomy did not improve intensive care unit survival

(model 1, odds ratio, 0.94, 95% confidence interval, 0.63-1.39, p = .74, model 2, odds ratio, 1.12,

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95% confidence interval, 0.75-1.67, p = .59). There was no difference whether tracheostomy was

performed early (within 7 days of ventilation) or late (after 7 days of ventilation). In patients

discharged free from mechanical ventilation, tracheostomy was associated with increased

postintensive care unit mortality when the tracheostomy tube was left in place (model 1: odds

ratio, 3.73; 95% confidence interval, 1.41-9.83, p = .008, model 2: odds ratio, 4.63, 95%

confidence interval, 1.68-12.72, p = .003). Based on the results obtained, authors have concluded

that, tracheostomy did not seem to reduce intensive care unit mortality when performed in

unselected patients but may represent a burden after intensive care unit discharge.

A retrospective study was carried out by Combes A et al.,20 to evaluate the effect of

tracheostomy on intensive care unit (ICU) and in-hospital mortality for patients requiring

prolonged (more than 3 days) mechanical ventilation Non tracheostomized patients had higher

ICU (42% vs. 33%, p = .06) and in-hospital (48% vs. 37%, p = .03) mortality rates and shorter

mechanical ventilation durations and ICU lengths of stay. Performing a tracheostomy (odds ratio,

0.58; 95% CI, 0.37-0.90) was independently associated with a lower probability of ICU death.

No significant differences were detected between the 120 cases and their matched controls

regarding ICU admission and day-3 clinical characteristics. Tracheostomy was associated with

lower risk of ICU (odds ratio, 0.47; 95% CI, 0.24-0.89) and in-hospital (odds ratio, 0.48; 95%

CI, 0.25-0.90) death. In the conclusions, authors have stated that tracheostomy performed in the

ICU for long-term patients on mechanical ventilation was associated with lower ICU and in-

hospital mortality rates.

16

To estimate the prevalence of, the risk factors associated with, and the outcome of tracheostomy,

a prospective, observational cohort study was carried out by Frutos-Vivar F et al21., which

included 361 intensive care units from 12 countries. Parameters associated with the performance

of tracheostomy were duration of mechanical ventilation, need for reintubation, and neurologic

disease as the primary reason of mechanical ventilation. The intensive care unit stay of patients

with or without tracheostomy was a median of 21 days Vs 7 days, respectively, and the hospital

stay was a median 36 days Vs. 15 days, respectively. Mortality in the hospital was similar in both

groups (39% vs. 40%, p = .65). Authors have come to a conclusion that, though tracheostomy is

a common surgical procedure in the intensive care unit that is associated with a lower mortality

in the unit but with a longer stay and a similar mortality in the hospital than in patients without

tracheostomy.

Kojicic M et al22., have retrospectively reviewed the medical records of adult Olmsted county,

Minnesota, to assess the incidence and outcomes of tracheostomy in residents, who underwent

tracheostomy A total of Sixty-five patients, underwent tracheostomy for prolonged medical

ventilation, which resulted in an age-adjusted incidence of 13 (95% CI 10-17) per 100,000

patient-years at risk. Forty-six patients (71%) survived to hospital discharge, and 36 (55%) were

alive at 1-year follow-up. Authors have concluded that, there was a considerable incidence of

tracheostomy for prolonged medical ventilation and the presence of COPD was an independent

predictor of 1-year mortality.

17

In their article, Lazaridis C et al23., made an attempt to review the general principles of liberation

and the current literature related to neurosurgical patients with primary brain injury Patients who

remain ventilator or artificial airway dependent receive a tracheostomy. The appropriate timing

for the procedure is not well defined and may be different among an inhomogeneous population

of critically ill patients. The criteria for "readiness of extubation" include a combination of

neurologic assessment, hemodynamic, and respiratory parameters. Authors have suggested that,

more studies are required to better assess indicators for extubation readiness, evaluate the

predictors of extubation failure in brain-injured patients, and define the most appropriate timing

for a tracheostomy.

Maheshwari PK et al24., conducted a retrospective study to assess the frequency, indications,

postoperative course and short-term outcome of elective tracheostomy in a Paediatric Intensive

Care Unit (PICU) of Pakistan. Twenty-five patients underwent tracheostomy in last 5 years (2.2

% of all PICU admissions). The most common indication for tracheostomy was prolonged

mechanical ventilation secondary to neurological disease (60%), followed by upper airway

obstruction (40%). Major complications included accidental decannulation (20%) and tube

obstruction (20%). Three patients (12%) developed ventilator-associated pneumonia after

tracheostomy change while persistent bacterial colonization of trachea was observed in 8 patients

(32%). Decannulation was achieved in 40% (10/25). There was no mortality related to

tracheostomy in this study.

Mahmood K, and Wahidi MM.,25 in their study have reported that, percutaneous tracheostomy

with Ciaglia technique is commonly used and rivals the surgical approach. Percutaneous

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technique is associated with decreased risk of stomal inflammation, infection, and bleeding along

with reduction in health resource utilization when performed at bedside. Bronchoscopy and

ultrasound guidance improve the safety of percutaneous tracheostomy. Authors have stated in the

conclusion that, early tracheostomy decreases the need for sedation and intensive care unit stay

but may be unnecessary in some patients who can be extubated later successfully.

To investigate trends in tracheostomy use, timing, and outcomes in the United States, Mehta AB

et al26 have calculated estimates of tracheostomy use and outcomes from the National Inpatient

Sample from 1993 to 2012.Results have shown that, tracheostomy was more common in surgical

patients, men, and racial/ethnic minorities. Age-adjusted incidence of tracheostomy increased by

106%, rising disproportionately to mechanical ventilation use. Over time, tracheostomies were

performed earlier, whereas hospital length of stay declined, discharges to long-term facilities

increased (40.1% vs. 71.9%; P < 0.0001), and hospital mortality declined (38.1% vs. 14.7%, P <

0.0001). Authors have concluded that, the observed drastic increase in discharge of tracheostomy

patients to long-term care facilities may have substantial implications for clinical care, healthcare

costs, policy, and research.

Early and late tracheostomy

There are no specific and standardized definitions for both early as well as late tracheostomy.

Based on the review of previous studies that have been carried out in the past decade, early

tracheostomy was defined as performing tracheostomy within 3 to 10 days of mechanical

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ventilation, whereas late was defined as any time outside the early period, within 7 to 14 days, 14

to 28 days, or 28 days after initiation of mechanical ventilation27.

There is no uniformity in the literature about the definition of “early” tracheostomy. In the

1980s, tracheostomy was considered “early” if it was performed before 21 days of translaryngeal

intubation28. But the timing of tracheostomy has changed over a period of time, and now many

suggest tracheostomy within 2–10 days. This definition of “early” corresponds to that proposed

by the otorhinolarygologists, who have always suggested tracheostomy within several days to

prevent laryngeal injury from even these short intubation periods29.

Indications for early and late tracheostomy

General indications for the placement of tracheostomy include acute respiratory failure with the

expected need for prolonged mechanical ventilation, failure to wean from mechanical

ventilation, upper airway obstruction, and difficult airway secretions.

The most common indications27 for tracheostomy include:

1. Acute respiratory failure and need for prolonged mechanical ventilation

2. Traumatic or catastrophic neurologic insult requiring airway, or mechanical ventilation or

both.

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Early tracheostomy outcomes

Arabi Y et al30., have carried out a prospective study to examine the impact of early

tracheostomy on the duration of mechanical ventilation, ICU length of stay, and outcomes in

trauma ICU patients. Out of the total 653 patients included in the study, 36 (21%) required

tracheostomies, 29 of whom were early and 107 were late. Patients with early tracheostomy were

more likely to have maxillofacial injuries and to have lower Glasgow Coma Scale score.

Duration of mechanical ventilation was significantly shorter with early. Similarly, ICU length of

stay was significantly shorter. Following tracheostomy, patients were discharged from the ICU

after comparable periods in both groups (4.9 + 1.2 days versus 4.9 + 1.1 days). ICU and hospital

mortality rates were similar. Late tracheostomy was an independent predictor of prolonged ICU

stay (>14 days). Based on the study findings, authors have concluded that, early tracheostomy in

trauma ICU patients is associated with shorter duration of mechanical ventilation and ICU length

of stay.

To see if early tracheostomy (fifth day) reduces duration of mechanical ventilation, ICU stay,

incidence of pneumonia and mortality in comparison with prolonged intubation (PI) in patients

with head injury, Bouderka MA et al31 have carried out a prospective study. Randomization was

done in two groups, early tracheostomy group (T group, n = 31) and prolonged endotracheal

intubation group (I group, n = 31). The mean time of mechanical ventilator support was shorter

in T group (14.5 + 7.3) versus I group (17.5 + 10.6) (p value = 0.02). After pneumonia was

diagnosed, mechanical ventilator time was 6 + 4.7 days for ET group versus 11.7 + 6.7 days for

prolonged endotracheal intubation group (p = 0.01). There was no difference in frequency of

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pneumonia or mortality between the two groups. From the results it was evident and the authors

have concluded that, in severe head injury early tracheostomy decreases total days of mechanical

ventilation or mechanical ventilation time after development of pneumonia.

In order to determine if tracheostomy performed before postoperative day 10 improves patient

outcomes, Devarajan J et al32, have conducted a retrospective review of prospectively collected

patient information on adult patients recovering from coronary artery bypass grafting and/or

valve surgery. Patients were divided into 2 groups based on the timing of their tracheostomy,

early (less than 10 days) and late (14 to 28 days). Results showed that, after propensity matching

(n = 114 patients), early tracheostomy was associated with decreased in-hospital mortality

(21.1% vs 40.4%, p = 0.002) and cardiac morbidity (14.0% vs 33.3%, p < 0.001), along with

decreased ICU (median difference 7.2 days, p < 0.001) and hospital (median difference 7.5 days,

p = 0.010) durations. The occurrence of sternal wound infection (6.0% vs 19.5%, p = 0.009) was

less in the early tracheostomy group, but mediastinitis did not differ significantly (3.5% vs 7.0%,

p = 0.24). Based on the results, authors have to come to a conclusion that, tracheostomy within

10 postoperative days in cardiac surgery was associated with decreased length of stay, morbidity,

and mortality.

To test their hypothesis, that timing of tracheostomy for severely injured children would

similarly impact outcomes. Holscher CM et al33 had reviewed the data regarding injured children

who underwent tracheostomy over 10 years of time period. During the study period, 91 patients

underwent tracheostomy following injury. Twenty-nine (32%) patients were less than 12 years

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old, of these, 38% received early tracheostomy. Sixty-two (68%) patients were age 13 to 18, of

these, 52% underwent early tracheostomy. Patients undergoing early tracheostomy had fewer

ventilator days (p = 0.003), ICU days (p = 0.003), hospital days (p = 0.046), and tracheal

complications (p = 0.03) compared to late tracheostomy. There was no difference in pneumonia

(p = 0.48) between early and late tracheostomy. Authors have concluded that, children

undergoing early tracheostomy had improved outcomes compared to those who underwent late

tracheostomy

Szakmany T et al34., have carried a systematic review of randomized trials in patients allocated to

tracheostomy within 10 days of start of mechanical ventilation and were compared with

placement of tracheostomy after 10 days if still required. Results have shown that, tracheostomy

within 10 days was not associated with any difference in mortality (risk ratio = 0.93 (0.83–

1.05)). There were no differences in duration of mechanical ventilation, intensive care stay, or

incidence of VAP. Yet, duration of sedation was reduced in the early tracheostomy groups. More

tracheostomies were performed in patients randomly assigned to receive early tracheostomy (risk

ratio = 2.53 (1.18–5.40)).In the conclusion, authors have stated that they have found no evidence

that early (within 10 days) tracheostomy reduced mortality, duration of mechanical ventilation,

intensive care stay, or VAP. Early tracheostomy leads to more procedures and a shorter duration

of sedation.

Outcomes of late tracheostomy

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Average duration of mechanical ventilation in patients undergoing late tracheostomy was found

to be 24 days11, 35. As reported by studies10 which compared the proportion of patients who died

in ICU with respect to early tracheostomy 34.7% in the late tracheostomy group and it was

higher than the early procedure group11.In a study by Nasim ahmed and Yen-Hong Kuo36, have

reported comparatively higher results, compared to the early tracheostomy group among

parameters like Glasgow Coma scale score, number of units of blood required for blood

transfusion.Other factors which were compared included number of days In ICU, percent to

rehabilitation, duration of stay at the hospital and the total charges incurred or the total

expenditure for the whole procedure.All the reports have higher values, making the early

tracheostomy procedure mmore advantageous than late tracheostomy.

Early Vs late tracheostomy outcomes

A Retrospective clinical study was carried out by Aissaoui Y et al37., to assess the impact of

tracheostomy timing on outcome of critically ill patients requiring mechanical ventilation.

Results from the study have shown that, early tracheostomy was associated with significant

reduction of length of sedation (10 + 3 vs 17+ 5 days, P<0.001), length of MV (21+19 vs 29 + 17

days, P=0.02) and length of stay in ICU (33 + 22 vs 42 +18 days, P=0.042). There were no

differences in prevalence of pneumonia (21% for early tracheostomy group vs 31% for late

tracheostomy group, P=0, 13), weaning from mechanical ventilation (50 vs 36%, P=0.19), and

mortality rates between the 2 groups (38 vs 54%, P=0.15). Authors have concluded that, that

early tracheostomy, was associated with shorter length of sedation, shorter duration of

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mechanical ventilation and shorter ICU length of stay, without affecting weaning from

mechanical ventilation, prevalence of nosocomial pneumonia or survival.

A meta-analysis was conducted by Andriolo BN et al8., to evaluate the effectiveness and safety

of early versus late tracheostomy in critically ill adults predicted to be on prolonged mechanical

ventilation with different clinical conditions. A total of 8 randomized control studies in which (N

= 1977 participants) were included in the study. At the longest follow-up time available in these

studies, evidence of moderate quality from seven RCTs (n = 1903) showed lower mortality rates

in the early as compared with the late tracheostomy group (risk ratio (RR) 0.83, 95% confidence

interval (CI) 0.70 to 0.98; P value 0.03). Authors have finally concluded that, the whole findings

of the study can suggest the superiority of early over late tracheostomy because no information

of high quality is available for specific subgroups with particular characteristics.

Arabi YM et 38 carried out a cohort observational study to examine the potential effects of time to

tracheostomy on mechanical ventilation duration, intensive care unit (ICU), and hospital length

of stay (LOS), and ICU and hospital mortality. Results have shown that, time to tracheostomy

was associated with an increased duration of mechanical ventilation (beta-coefficient = 1.31 for

each day, 95% confidence interval 1.14-1.48), ICU length of stay (beta-coefficient = 1.31 for

each day, 95% CI, 1.13-1.48), and hospital length of stay (beta-coefficient = 1.80 for each day,

95% CI, 0.65-2.94). On the other hand, time to tracheostomy was not associated with increased

ICU or hospital mortality. Authors have concluded that, performing tracheostomy earlier in the

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course of ICU stay might have an effect on ICU resources and could necessitate significant cost-

savings without adversely affecting patient mortality.

A prospective observational study was carried out by Brook A Det al.,39 to compare the clinical

outcomes of early versus late tracheostomy in patients who require prolonged mechanical

ventilation. A cohort of 90 patients who had tracheostomy in the medical intensive care unit were

included in the study. From the total population, 53 patients had early tracheostomy (mean + SD

= day 5.9 +7.2 of ventilation), and 37 patients had late tracheostomy (mean + SD = day 16.7 +

2.9) (P < .001). The mean (+ SD) duration of mechanical ventilation was 28.3 + 28.2 days in the

early-tracheostomy group versus 34.4 + 17.8 days in the late-tracheostomy group (P = .005).

Total cost of hospitalization was significantly lower in the early-tracheostomy group than in the

late-tracheostomy group (P = .001). The timing of tracheostomy was not associated with hospital

mortality. In the conclusions, authors have stated that early tracheostomy was associated with

shorter lengths of stay and lower hospital costs than is late tracheostomy.

Freeman BD et al., to determine the relationship between tracheostomy timing and duration of

mechanical ventilation, intensive care unit length of stay, and hospital length of stay and to

evaluate the relative influence of clinical and nonclinical factors on tracheostomy practice:

Tracheostomy was performed in 2,473 (5.6%) of 43,916 patients analysed. Tracheostomy

patients had a higher survival rate than non-tracheostomy patients (78.1 vs. 71.7%, p < .001) and

underwent this procedure following a median (25th-75th percentile) of 9.0 (5.0-14.0) days of

26

ventilatory support. Tracheostomy timing correlated significantly with duration of mechanical

ventilation (r = .690), intensive care unit (r = .610), and hospital length of stay (r = .341, p < .001

for all). At most, 22% of patients were supported via tracheostomy at any given time. Although a

minority, tracheostomy patients accounted for 26.2%, 21.0%, and 13.5% of all ventilator,

intensive care unit, and hospital days, respectively. Authors have concluded that, tracheostomy

timing appears significantly associated with duration of mechanical ventilation, intensive care

unit length of stay, and hospital length of stay.

Griffiths J et al.,40 To compare outcomes in critically ill patients undergoing artificial ventilation

who received a tracheostomy early or late in their The results reported that, early tracheostomy

did not significantly alter mortality (relative risk 0.79, 95% confidence interval 0.45 to 1.39).

The risk of pneumonia was also unaltered by the timing of tracheostomy (0.90, 0.66 to 1.21).

Early tracheostomy significantly reduced duration of artificial ventilation (weighted mean

difference -8.5 days, 95% confidence interval -15.3 to -1.7) and length of stay in intensive care (-

15.3 days, -24.6 to -6.1). Authors have concluded that, in critically ill adult patients who require

prolonged mechanical ventilation, performing a tracheostomy at an earlier stage than is currently

practised may shorten the duration of artificial ventilation and length of stay in intensive care.

A retrospective cohort study was done by Holloway AJ et al41., to associate timing of

tracheostomy with clinical outcomes in PICU patients: Seventy-three patients were analysed

27

with a median of 22 days of ventilation prior to tracheostomy. Patient factors associated with

longer pretracheostomy ventilation included congenital heart disease and vasoactive drug use.

Clinical events associated with longer pretracheostomy ventilation included bloodstream

infection, ventilator-associated pneumonia, and cardiac arrest. For patients undergoing early

tracheostomy, ICU and total hospital lengths of stay were 4 days and 4 weeks shorter,

respectively. In the conclusion, authors have stated that a longer duration of ventilation prior to

tracheostomy is associated with increased ICU morbidities and length of stay.

Hsu CL et al42., conducted a study on a total of 163 patients (93 men and 70 women) to assess,

the optimal timing of tracheostomy, and its impact on weaning from mechanical ventilation and

outcomes in critically ill. Patients were classified into two groups, successful weaning (n = 78)

and failure to wean (n = 85). Patients who underwent tracheostomy more than 3 weeks after

intubation had higher ICU mortality rates and rates of weaning failure. The length of intubation

correlated with the length of ICU stay in the successful weaning group (r = 0.70; P < 0.001).

Tracheostomy after 3 weeks of intubation, poor oxygenation before tracheostomy and occurrence

of nosocomial pneumonia after tracheostomy were independent predictors of weaning failure. In

the conclusion, authors have suggested that tracheostomy after 21 days of intubation is

associated with a higher rate of failure to wean from mechanical ventilation, longer ICU stay and

higher ICU mortality.

A prospective randomized study was carried out by Koch T et al43., to examine whether early

tracheostomy improved outcome in critically ill patients. In a period of two years, 100 critically

28

ill, predominantly surgical patients were enrolled in the study. A percutaneous dilatational

tracheostomy was performed either early (</=4 days, 2.8 days median) or late (>/=6 days, 8.1

days median) after intubation. Authors could demonstrate that mortality was not significantly

reduced in the early tracheostomy (ET) group in contrast to the late tracheostomy (LT) group. ET

was associated with decreased VAP incidence (ET 38% vs. LT 64%), decreased duration of

ventilation (ET 367.5 h vs LT 507.5 h), and shorter time of hospitalization both in hospital (ET

31.5 days vs LT 68 days) and in ICU (ET 21.5 days vs LT 27 days). It was concluded by the

authors that, despite many advantages like reduced time of ventilation and hospitalization, early

tracheostomy is not associated with decreased mortality in critically ill patients.

To investigate whether early tracheostomy leads to improved outcomes compared with late

tracheostomy, a systematic search was carried out by Liu CC et al44., a total of eleven studies

were included for final analysis. There was a significant decrease in the intensive care unit length

of stay in the early tracheostomy group. There was no significant difference in hospital mortality

(relative risk, 0.84, 95% CI, 0.67 to 1.04, P = .11). A pooled analysis was not performed for the

incidence of pneumonia or length of mechanical ventilation, secondary to considerable

heterogeneity among the studies. None of the studies reporting laryngotracheal outcomes found a

significant difference between the early and late tracheostomy groups, whereas all 3 studies

reporting sedation use found a significant decrease in the early tracheostomy group. From the

findings, authors have come to a conclusion that, early tracheostomy performed within 7 days of

intubation was associated with a decrease in intensive care unit length of stay.

29

A retrospective study was carried out by Moller MG et al45., to determine if early tracheostomy

(ET) of severely injured patients reduces days of ventilatory support, the frequency of ventilator-

associated pneumonia (VAP), and surgical intensive care unit (SICU) length of stay. Results

have reported that the incidence of VAP was significantly higher in the LT group, relative to the

ET group (42.3% vs. 27.2%, respectively, P <.05). Acute Physiology and Chronic Health

Evaluation II scores, hospital and SICU length of stay, and the number of ventilator days were

significantly higher in the LT group. Based on the reported findings, authors have come to a

conclusion that, among patients who required prolonged mechanical ventilation, there was

significant decreased incidence of VAP, less ventilator time, and lower ICU length of stay when

tracheostomy was performed within 7 days after admission to the surgical intensive care unit.

Siempos et al46., in their study, have aimed to assess the benefit of early versus late or no

tracheostomy on mortality and pneumonia in critically ill patients who need mechanical

ventilation, through extensive and systematic literature review. Analyses of 13 trials which were

included in the study showed that all-cause mortality in the intensive-care unit was not

significantly lower in patients assigned to the early versus the late or no tracheostomy group (OR

0.80, 95% CI 0.59-1.09; p=0.16). This result persisted when we considered only trials with a low

risk of bias (511 deaths; OR 0.80, 95% CI 0.59-1.09; p=0.16; eight trials with 1934 patients).

Incidence of ventilator-associated pneumonia was lower in mechanically ventilated patients

assigned to the early versus the late or no tracheostomy group (691 cases; OR 0.60, 95% CI 0.41-

0.90; p=0.01; 13 trials with 1599 patients). Through this study, authors have suggested that early

tracheostomy is not associated with lower mortality in the intensive-care unit than late or no

tracheostomy.

30

In their systematic review and meta-analysis of randomized trials in patients allocated to

tracheostomy, Szakmany T et al47., have reported that, tracheostomy within 10 days was not

associated with any difference in mortality (risk ratio (RR), 0.93 (0.83-1.05)). There were no

differences in duration of mechanical ventilation, intensive care stay, or incidence of VAP.

However, duration of sedation was reduced in the early tracheostomy groups. More

tracheostomies were performed in patients randomly assigned to receive early tracheostomy.

Authors have concluded that, they found no evidence that early (within 10 days) tracheostomy

reduced mortality, duration of mechanical ventilation, intensive care stay, or VAP.

Young D et al48., have carried out an open multicentre randomized clinical trial, to test whether

early vs late tracheostomy would be associated with lower mortality in adult patients requiring

mechanical ventilation in critical care units. A total of 1032 eligible patients were included in the

final analysis. Results have shown that, all-cause mortality 30 days after randomization was

30.8% in the early and 31.5% in the late group (absolute risk reduction for early vs late, 0.7%;

95% CI, -5.4% to 6.7%). Two-year mortality was 51.0% in the early and 53.7% in the late group

(P = 0.74). Tracheostomy-related complications were reported for 6.3% of patients (5.5% in the

early group, 7.8% in the late group). Authors have concluded that, tracheostomy within 4 days of

critical care admission was not associated with an improvement in 30-day mortality or other

important secondary outcomes.

To investigate whether early percutaneous dilational tracheostomy (PDT) can reduce duration of

mechanical ventilation, and to further verify whether early PDT can reduce sedative use, shorten

31

intensive care unit (ICU) stay, decrease the incidence of ventilator associated pneumonia (VAP),

and increase successful weaning and ICU discharge rate, Zheng Y et al49., conducted a

prospective, randomized controlled trial in a surgical ICU. A total of 119 patients were

randomized to either the early PDT group (n = 58) or the late PDT group (n = 61). The

successful weaning and ICU discharge rate was significantly higher in early PDT group than in

late PDT group (74.1% vs. 55.7%, P < 0.05, and 67.2% vs. 47.5%, P < 0.05 respectively). VAP

was observed in 17 patients (29.3%) in early PDT group and in 30 patients (49.2%) in late PDT

group (P < 0.05). There was no significant difference between the two groups in the cumulative

60-day incidence of death after randomization (P = 0.949). From the study findings, authors have

come toa conclusion that, the early PDT resulted in more ventilator-free, sedation-free, and ICU-

free days, higher successful weaning and ICU discharge rate, and lower incidence of VAP, but

did not change the cumulative 60-day incidence of death in the patients.

32

MATERIALS & METHODS

33

Study site: This study was conducted in the Department of…………………………….

Study population: Patients who had indications for tracheostomy in the ICU at

………………… were considered as study population.

Study design: The current study was a prospective observational study

Sample size:

Sampling method: All the eligible subjects were recruited into the study consecutively by

convenient sampling till the sample size is reached.

Study duration: The data collection for the study was done between March 2017 to September

2018 for a period of 1.6 year.

Inclusion Criteria:

1. ICU patients on endotracheal intubation receiving mechanical ventilation.

2. Patients on endotracheal intubation who is not receiving mechanical ventilation.

3. Patients of either sex.

4. Patients above 16yrs of age.

Exclusion criteria:

1. Patient not ready to give informed consent.

2. Patients below the age of 16years.

3. Patient who is already on a tracheostomy tube from an outside hospital.

4. Previous laryngeal pathology.

5. Emergency tracheostomy cases.

34

Ethical considerations: Study was approved by institutional human ethics committee. Informed

written consent was obtained from all the study participants and only those participants willing to

sign the informed consent were included in the study. The risks and benefits involved in the

study and voluntary nature of participation were explained to the participants before obtaining

consent. Confidentiality of the study participants was maintained.

Data collection tools: All the relevant parameters were documented in a structured study proforma.

Methodology:

A prospective observational study was been done with a sample of 144 patients in a tertiary care

center –……………….. in the intensive care unit. Tracheostomy was defined as early if

performed within day 7 of mechanical ventilation and late if performed thereafter. The outcomes

studied were:

Weaning off from ventilator

Weaning off from oxygen

Decannulation

Factors to be studied include : ( 1week, 1 month and 3 months after decannulation)

o Incidence of complications like –

Intubation granuloma

subglottic stenosis

tracheal stenosis

o Quality of voice after decannulation

Voice analysis recorder.

o Duration of intubation and tracheostomy

o Quality of life- (before and after decannulation)

35

• Are you able to move around?

• Are you able to speak on the phone with friends/family?

• Are you able to take oral feeds?

• Are you coughing often?

o Infection rate

o Ability to swallow [post recovery]

INVESTIGATIONS:

Blood: HB% TC, DC, AEC, BT, CT, platelet count, APTT, PT INR ESR, serology, RBS,

RFT, blood grouping, cross matching.

Urine routine

Others:

Bacteriological examination: culture and sensitivity.

Radiological examination:

Plain x ray of neck.

Plain x ray of chest.

Statistical Methods:

36

OBSERVATIONS AND RESULTS

37

RESULTS:

38

DISCUSSION

DISCUSSION:

39

BIBLIOGRAPHY

40

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ANNEXURES

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