Airway pH:

Measuring Aerosolized Acidity

and Alkalinity

New Product

Technology Review

1974

The Johnson – DeMeester Score

1998

San Diego based Endonetics

Young engineer / inventor Ross Tsukashima

Medical Advisor Dr. Tom DeMeester

Sold to Medtronics

2006

Restech patented

Oropharyngeal Probe

RYAN Score for LPR

Developed by Dr. Tom DeMeester USC

Score Calculation

- Components used:

- % Time Below Cutoff

- Number of Episode

- Duration of the Longest Episode

- Cutoffs:

Upright 5.5

Supine 5.0

Light Emitting Diode simplifies positioning

No Manometry

No xray

Esophageal pH Probe Placement

Esophagus

(20-24 cm)

Upper Esophageal Sphincter

Lower Esophageal Sphincter

Dual Channel Catheter

Sensor Design of Esophageal pH Catheters

Reference Sensor

» Reference Sensor must be in direct fluid contact with pH sensors.

Dryout can cause: » Loss of Signal, which shows up as… » Drift, Artifact or

Pseudo Reflux

Traditional Dual Channel

Probe

Problems Using Esophageal Sensor in the Pharynx

» Esophageal Sensors too low for detection of LPRD

Esophagus

(20-24 cm)

Upper Esophageal Sphincter

Lower Esophageal Sphincter

» If the 2nd channel is placed higher it dries out due to air contact

» Sensor can be fouled by mucus

» Mucosal contact can mask reflux events

Restech Sensor Technology

» Coplanar Ionic Bridge pH sensor

» Does not require immersion in Liquid

» Designed to work in the Oropharynx

Sensitivity Improvements

» 1 mm size requires less fluid to measure pH

» Reference electrode next to Antimony sensor allows for measurement of aerosolized events

» Downward aim reduces masking

» Teardrop shape reduces fouling

» Comfort allows for 48 hour studies at 2 Hz sampling rate

Antimony

Reference

Manometry Free Positioning

Light Emitting Diode simplifies positioning

Data Feed Adapter

Design allows for comfort during sleep

Direct connection to PSG monitors

Works well with CPAP

Plugs into any device with an analogue 0-1v port

Clinical Validation

Tom DeMeester, MD Advanced Esophageal Function Laboratory

Keck School of Medicine,University of Southern California

Greg Postma, MDCenter for Voice and Swallowing Disorders

Medical College of Georgia

Michael Vaezi, MD, PhDDigestive Disease Center

Vanderbilt University Medical Center

Triple probe conventional study –

checking for Extraesophageal Reflux – what do the results indicate? No LPR?

Headed for print:

Annals of ORL

- Greg Postma, MD Medical College of Georgia

- Michael Johns, III, MD Emory Medical College

Journal of Gastroenterology

- Tom DeMeester, MD USC Keck School of Medicine

Journal of Voice

- Michael Vaezi, MD, PhD Vanderbilt University School of Medicine

- Gregory Wiener, MD Private Practice

Current Diagnostic Techniques

• Endoscopy, EGD• Bravo• Esophogram/Barium Swallow• Empiric Therapeutic Trial with H2 Blockers or PPIs• Refer for 24 hr pH esophageal probe testing• Restech pH probe

– Highly sensitive pH probe specifically developed to detect aerosolized reflux

Normal StudyNormal Study

Patient 1Patient 1

7 year old male7 year old male

Initial eval Jan 2007 for chronic rhinitis and snoringInitial eval Jan 2007 for chronic rhinitis and snoring• Pediatrician ordered MRI: maxillary “sinusitis” and Pediatrician ordered MRI: maxillary “sinusitis” and

adenoid hypertrophyadenoid hypertrophy• PMH: RAD, ADHD, Developmental Delay, Bipolar PMH: RAD, ADHD, Developmental Delay, Bipolar

DisorderDisorder• PSH: NonePSH: None• Medications: Singulair, RisperdalMedications: Singulair, Risperdal• Exam: 2+ Tonsils, 80% obstructing adenoidsExam: 2+ Tonsils, 80% obstructing adenoids

Patient 1Patient 1

Treatment CourseTreatment Course

Feb 2007: Adenoidectomy Feb 2007: Adenoidectomy

May-Aug 07: Recurrent rhinitis, headaches without May-Aug 07: Recurrent rhinitis, headaches without improvement despite addition of Flonaseimprovement despite addition of Flonase

Aug 07: pH probe: marked AM/PM LPR; Aug 07: pH probe: marked AM/PM LPR; Rx PrevacidRx Prevacid

Patient 1Patient 1

Treatment CourseTreatment Course

Nov 07: Clinical resolution of all sinus symptomsNov 07: Clinical resolution of all sinus symptoms

Dec 07: Repeat pH probe: Normal (on Rx)Dec 07: Repeat pH probe: Normal (on Rx)

Patient 2Patient 2

8 year old male8 year old maleInitial evaluation June 07 for hoarsenessInitial evaluation June 07 for hoarseness • Hx: 2 years duration hoarseness w/o voice abuseHx: 2 years duration hoarseness w/o voice abuse• No Allergic Rhinitis or LPR sxNo Allergic Rhinitis or LPR sx• PMH / PSH / Medications: NonePMH / PSH / Medications: None• Exam: NPL showed lymphoid aggregates lining upper airway to Exam: NPL showed lymphoid aggregates lining upper airway to

hypopharynx; posterior glottic and TVC erythema and edema hypopharynx; posterior glottic and TVC erythema and edema w/o nodulesw/o nodules

Patient 2Patient 2

Treatment CourseTreatment Course

Jun 07: pH Probe: PM LPR; Rx PepcidJun 07: pH Probe: PM LPR; Rx Pepcid

Patient 2Patient 2

Treatment CourseTreatment Course

Sept 07: Hoarseness markedly improvedSept 07: Hoarseness markedly improved

Sept 07: Repeat pH probe: Normal (on Rx)Sept 07: Repeat pH probe: Normal (on Rx)

Application of Ambulatory Supraesophageal pH Probe Monitoring in Infants and Children

Chris Landon, M.D.

FAAP, FCCP, CMD

Ventura County Medical Center

Pulmonary Manifestations of

Gastroesophageal Reflux Disease

Apnea

Aspiration Pneumonia

Atelectasis

Bronchiectasis

Bronchitis

Chronic Asthma

Hemoptysis

Hoarseness or Laryngitis

Pulmonary Fibrosis

Seizures relate to Hypoxia

Age 3 months

• Diagnosis: Cystic Fibrosis, failure to thrive

• Presenting Symptoms of Cough

• Evaluation UGI no GERD/anatomic obstruction, mildly prolonged gastric emptying scan

• Course Hospitalization and PICU• Study site: Outpatient

• SE Result Drops to pH<4 associated with respiratory symptoms

• Intervention Nissen and G tube

• Course resolution at six week follow-up

Age 4 months

• Diagnosis: Infant in foster care with cough, no records

• Presenting Symptoms 3 months of cough

• Evaluation Hyperinflation on CXR

• Course Hospitalization and ER visits• Study site: Hospital

• SE Study Result Drops to pH<4 associated with respiratory symptoms

• Intervention Proton pump inhibitor and H2 blocker

• Course resolution at six week follow-up

Age 15 months• Diagnosis: 26 week premature, Infant in

foster care, spitting up, asthma

• Presenting Symptoms 3 months of cough

• Evaluation UGI -No GERD/anatomic obstruction. No delay on gastric emptying scan

• Course Hospitalizations for asthma• Study site: Hospital

• SE Study result Nocturnal pH>7,drop to 4.5 one half hour post daytime feeds

• Intervention Prokinetic agent and H2 blocker,decrease volume feeds (overfeeding)

• Course resolution at six week follow-up

Age 5 years

• Diagnosis: Normal child

• Presenting symptoms Hoarse voice

• Evaluation Vocal cord erythema on endoscopy

• Course ENT consultation, multiple office visits

• Study site: Outpatient

• SE Study Result No drop in pH <6.5

• Intervention Behavioral intervention re:screaming

• Course resolution at six week follow-up

Elements of the RYAN Score

________________________________________________________

Score Calculation

Components used

- % Time Below Cutoff- Number of Episode- Duration of the Longest Episode

CutoffsUpright 5.5 Confirmatory Threshold

Supine 5.0 Confirmatory Threshold

Clinical Value of Restech’s Dx-pH System?

• This is a ‘measuring stick’ that provides a definitive measure of acid / alkaline levels in the airway.

• Co-occurring events are captured at a point in time and marked with the real time capture of the pH of patients breath

• Dx provides the ability to “see” what is happening during sleep and throughout the patients day.

• Visual report has an impact on patient or parents

• Etiology for cough / recurrent laryngitis / sinusitis / otitis / lesions / edema can be better studied

• Acid can be ‘ruled in’ or ‘ruled out’ without using an empirical trial

• Improvement or progression of disease / symptoms can be monitored

• Dual purpose – can be used for esophageal monitoring if the case requires

• Accelerates the diagnostic pathway

Exposure / Penetration

2007 North America Respiratory Devices Product Innovation of the Year AwardAward Recipient: Respiratory Technology Corporation

Presentations in GERDReviewed by Joel E. Richter, MDRichard L. Evans Professor of MedicineChairman, Department of MedicineTemple University School of Medicine

Dx–pH Measurement System: A Sensitive Device for Detecting Liquid and Aerosolized Supraesophageal Gastric Reflux

Thank you!