A New Nasopharyngeal pH Probe for Diagnosis of Laryngopharyngeal Reflux

March 29, 2012 updated by: Karen Zur, Children's Hospital of Philadelphia
The purpose of this study is to evaluate the utility of a minimally invasive nasopharyngeal pH probe for the diagnosis of laryngopharyngeal reflux (LPR) in children with airway compromise; to determine whether it is comparable to the gold standard esophageal pH probe in identifying LPR in this population; and to correlate results of pH testing with validated questionnaires. Our hypothesis is that a nasopharyngeal pH probe is equivalent to an esophageal probe in identifying laryngopharyngeal reflux.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Laryngopharyngeal reflux (LPR) has been repeatedly linked to upper respiratory symptoms in the pediatric population. Children with LPR may present with laryngomalacia, subglottic stenosis, laryngitis, and vocal cord nodules among other illnesses. Pharyngeal reflux has even been implicated in causing common childhood illnesses such as sinusitis and otitis media. Diagnosing LPR can be difficult, especially in children. Often otolaryngologists depend on a general gestalt to diagnosis LPR. In some cases, physicians rely on a Reflux Symptoms Index (RSI) questionnaire filled out by the caretaker and/or a Reflux Finding Score (RFS) filled out by the practitioner. Others have attempted to use a variety of tools to measure pH in the upper airway and proximal esophagus.

Initial research focused on correlating gastroesophageal reflux (GER) with otolaryngologic illnesses. These studies relied mostly on esophageal pH probes placed at the lower esophageal sphincter. With the realization that extraesophageal reflux or LPR was a separate disease, new methods have developed to quantify it. The dual esophageal pH probe is the current gold standard for measuring LPR as it records pH just above the proximal esophageal sphincter. Conditions such as chronic pediatric sinusitis, otitis media, laryngitis and globus are believed to arise from laryngopharyngeal reflux. Unfortunately, this device fails to identify many patients with LPR who would benefit from treatment, and radiographic studies are limited by their short duration of evaluation and risk of radiation. In addition, the placement of the esophageal pH probe is relatively invasive requiring both sedation and x-rays to confirm placement. Finally, they are difficult to place and maintain in children, necessitating a hospital stay for 24 hours while data is collected. The alternative is empiric treatment with Histamine 2 blockers and/or Protein Pump Inhibitors for an extended course, which has been shown to improve symptoms in many of these patients but is not without risk.

The new Dx-pH nasopharyngeal probe is the only tool available for directly measuring nasopharyngeal pH. It is an exempted class I medical device and is Food and Drug Administration (FDA)-approved for general use in the population. The device, manufactured by Respiratory Technology Corporation ISO (ResTech), measures the pH of both liquid and aerosolized droplets. It is positioned posterior to the soft palate and placement is confirmed by visualizing the light-emitting diode (LED) at the tip of the device. It is significantly less invasive than esophageal pH probes, does not require general anesthesia for placement, and can be used in an outpatient setting.

The Dx-pH probe is currently being used clinically in adult and pediatric practices to diagnose and monitor laryngopharyngeal reflux with only limited research supporting its use. A literature review finds only 6 studies that address the Dx-pH probe, of which, only 1 pilot study has been performed in children. This study looked at changes in pH in the trachea of 3 children with chronic tracheostomies. However, to date, no research has been published on the utility of the probe in diagnosing LPR in children. The probe, if effective, would be a valuable tool for diagnosing LPR in the pediatric population because of its limited risk and potential ability to replace more invasive and costly procedures.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • History of airway compromise
  • Undergoing microlaryngoscopy, bronchoscopy, esophagoscopy, and esophageal pH probe placement at CHOP

Exclusion Criteria:

  • Patients not undergoing esophageal pH probe placement
  • Neonates under 1 month of age
  • Adults over 18 years of age or older.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probe
Children with airway obstruction
Device: Dx-pH probe
Dx-pH probe with 24 hour recording
Other Names:
  • ResTech Dx-pH probe

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
nasopharyngeal pH
Time Frame: 24 hours
Change in nasopharyngeal pH as measured by the Dx-pH probe
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Philadelphia

Investigators

  • Principal Investigator: Karen Zur, Children's Hospital of Philadelphia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Anticipated)

January 1, 2012

Study Completion (Anticipated)

January 1, 2012

Study Registration Dates

First Submitted

March 2, 2011

First Submitted That Met QC Criteria

March 2, 2011

First Posted (Estimate)

March 4, 2011

Study Record Updates

Last Update Posted (Estimate)

March 30, 2012

Last Update Submitted That Met QC Criteria

March 29, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-007341

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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