Efficacy of Dx-pH Probe in Diagnosing Extra-esophageal Reflux Disease

NCT00388453 | Completed Results

• 1 other identifier: 060860
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to establish the clinical application of a new device that records pH changes in the hypopharynx. The investigators also aim to compare the consistency of distal esophageal pH with hypopharyngeal pH using both the "short" and the "long" catheters in patients.

Conditions

GERD; Larynx Disease

Keywords

Healthy volunteers

Outcome Measures

Primary Outcomes (3)

• Decrease in pH From Baseline to <4

  The three study groups underwent dual pH measurements of the oropharyngeal as well as esophageal acid exposure employing the regular length probe for the oropharynx and the custom-designed long probe for the distal esophagus. The reason for the custom-designed esophageal measurement was to ensure that events noted in the oropharynx originated distally and were of gastric source. Measurements for the two locations were time synchronized to ensure accuracy. Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions.

  24 hours

• Decrease in pH From Baseline to <5

  The three study groups underwent dual pH measurements of the oropharyngeal as well as esophageal acid exposure employing the regular length probe for the oropharynx and the custom-designed long probe for the distal esophagus. The reason for the custom-designed esophageal measurement was to ensure that events noted in the oropharynx originated distally and were of gastric source. Measurements for the two locations were time synchronized to ensure accuracy. Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions. Reflux event was calculated for a drop in pH from baseline to either \<4, or \<5, or \<6 and each event had to last more than 5 seconds and could not be during the meals.

  24 hours

• Decrease in pH From Baseline to <6

  The three study groups underwent dual pH measurements of the oropharyngeal as well as esophageal acid exposure employing the regular length probe for the oropharynx and the custom-designed long probe for the distal esophagus. The reason for the custom-designed esophageal measurement was to ensure that events noted in the oropharynx originated distally and were of gastric source. Measurements for the two locations were time synchronized to ensure accuracy. Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions. Reflux event was calculated for a drop in pH from baseline to either \<4, or \<5, or \<6 and each event had to last more than 5 seconds and could not be during the meals.

  24 hours

Secondary Outcomes (1)

• Number of Reflux Events

  24 hours

Study Arms (3)

1

ACTIVE COMPARATOR

Healthy volunteers with no history of GERD or EERD or Proton Pump Inhibitor (PPI) use

Device: Dx-pH Probe; Procedure: Manometry

2

EXPERIMENTAL

subject is known to have GERD based on symptoms and previous positive response to PPI

Device: Dx-pH Probe; Procedure: Manometry

3

EXPERIMENTAL

subject is known to have EERD based on symptoms and previous positive response to PPI

Device: Dx-pH Probe; Procedure: Manometry

Interventions

Dx-pH Probe DEVICE

24 hour ph monitoring

1; 2; 3

Manometry PROCEDURE

procedure to measure pH at the Lower esophageal sphincter (LES) and Upper esophageal sphincter (UES)

1; 2; 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female volunteers aged 18 to 65 years old.
• Control group: No known history of GERD or EERD or prior PPI use.
• GERD group: Patients with known history of GERD based on prior response to either histamine inhibitors (H2 blockers) or proton pump inhibitors (PPIs) and/or endoscopic esophagitis identified at endoscopy.
• EERD group: Patients with chronic cough, asthma and laryngeal findings felt to be GERD related.

You may not qualify if:

• Use of H2 blockers or PPIs within one week prior to and during the study for the GERD and EERD patients. No prior PPI use is allowed for the control population.
• Use of antacids (Rolaids, Tums, Pepto-Bismol, etc.) within one day prior to or during the study.
• Esophageal motility abnormalities (achalasia, esophageal spasm, severe dysphagia)
• Expected non-compliance.
• Positive history of ongoing alcohol or tobacco use and inability to refrain from using either during study duration (24 hours).
• Recent nasal surgery or nasal obstruction.
• Significant medical conditions that, in the investigator's judgment, would compromise the subject's health and safety (mental disability, psychiatric impairment, inability to read or comprehend the consent form)
• Pregnancy

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Laryngeal Diseases

Interventions

Manometry

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Limitations and Caveats

Lack of prior validation studies on appropriate positioning of the oropharyngeal pH probe.

Results Point of Contact

• Title: Michael Vaezi, MD, PhD
• Organization: Vanderbilt University

michael.vaezi@vanderbilt.edu

615.322.3739

Study Officials

• Michael F Vaezi, MD, PhD, MS

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigatori

Study Record Dates

• First Submitted: October 13, 2006
• First Posted: October 16, 2006
• Study Start: October 1, 2006
• Primary Completion: September 1, 2012
• Study Completion: July 1, 2013
• Last Updated: June 27, 2017
• Results First Posted: June 27, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)