A New Nasopharyngeal pH Probe for Diagnosis of Laryngopharyngeal Reflux
Primary Purpose
Laryngopharyngeal Reflux
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dx-pH probe
Sponsored by
About this trial
This is an interventional diagnostic trial for Laryngopharyngeal Reflux focused on measuring laryngopharyngeal reflux, LPR, GERD, gastroesophageal reflux, nasopharyngeal probe
Eligibility Criteria
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.
Sites / Locations
- Children's Hospital of Philadelphia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Probe
Arm Description
Children with airway obstruction
Outcomes
Primary Outcome Measures
nasopharyngeal pH
Change in nasopharyngeal pH as measured by the Dx-pH probe
Secondary Outcome Measures
Full Information
NCT ID
NCT01308502
First Posted
March 2, 2011
Last Updated
March 29, 2012
Sponsor
Children's Hospital of Philadelphia
1. Study Identification
Unique Protocol Identification Number
NCT01308502
Brief Title
A New Nasopharyngeal pH Probe for Diagnosis of Laryngopharyngeal Reflux
Official Title
A New Nasopharyngeal pH Probe for Diagnosis of Laryngopharyngeal Reflux
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Difficulty recruiting patients due to logistics
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
January 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital of Philadelphia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laryngopharyngeal Reflux
Keywords
laryngopharyngeal reflux, LPR, GERD, gastroesophageal reflux, nasopharyngeal probe
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probe
Arm Type
Experimental
Arm Description
Children with airway obstruction
Intervention Type
Device
Intervention Name(s)
Dx-pH probe
Other Intervention Name(s)
ResTech Dx-pH probe
Intervention Description
Dx-pH probe with 24 hour recording
Primary Outcome Measure Information:
Title
nasopharyngeal pH
Description
Change in nasopharyngeal pH as measured by the Dx-pH probe
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Zur
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
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A New Nasopharyngeal pH Probe for Diagnosis of Laryngopharyngeal Reflux
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