Clinical Trial: A New Nasopharyngeal pH Probe for Diagnosis of Laryngopharyngeal Reflux

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: A New Nasopharyngeal pH Probe for Diagnosis of Laryngopharyngeal Reflux

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 Summary:

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 Pro
Sponsor: Children's Hospital of Philadelphia

Current Primary Outcome: nasopharyngeal pH [ Time Frame: 24 hours ]

Change in nasopharyngeal pH as measured by the Dx-pH probe


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Children's Hospital of Philadelphia

Dates:
Date Received: March 2, 2011
Date Started: January 2010
Date Completion: January 2012
Last Updated: March 29, 2012
Last Verified: March 2012