09/13/06

An recently developed device for detecting gastric reflux in the airway was put to the test as Chris Landon, MD, chief of pediatrics at Ventura County Medical Center, conducted a clinical study to test the efficacy of Restech’s Dx–pH Measurement System™ on infants and children.

The study features six patients, five of whom range in age from three months to nine years old, and the sixth, a 20-year-old with severe muscular dystrophy. Each patient was experiencing pulmonary manifestations of gastroesophageal reflux disease (GERD) including: sleep apnea, asthma, hoarseness of the throat, pulmonary fibrosis, and chronic cough, among others.

GERD occurs when acid from the stomach flows up through the lower esophageal sphincter (LES) and into the esophagus. Reflux that escapes the upper esophageal sphincter (UES) into the oropharynx is deemed laryngopharyngeal reflux (LPR).

In the pediatric population, LPR has been implicated in the development of asthma, sinusitis, otitis media, and sudden infant death syndrome. The absence of a device that can accurately detect reflux in the airway inspired Restech to develop the Dx–pH Measurement System.

“What’s exciting about this [Dx–pH Measurement System] device is that it is the first to measure and record pH in the oropharynx, and its positioning is ideal for detecting LPR in real-time,” said Landon.

Each patient was objectively assessed; depending upon symptoms and conditions, they were administered either a 24 or 48 hour test. The miniature 1.5mm diameter Dx–pH Probe™ was visually guided by a light emitting diode (LED) to a comfortable location in the airway posterior to the uvula. Thanks to a streamlined placement process, the children tolerated the test with minimal discomfort, a crucial refinement from conventional pH measurement catheters.