Copyright © 2007 by Lippincott Williams & Wilkins.Unauthorized reproduction of this article is prohibited. Accuracy and Tolerability of the Bravo Catheter-free pH Capsule in Patients Between the Ages of 4 and 18 Years  Joseph M. Croffie,  Joseph F. Fitzgerald,  Jean P. Molleston,  Sandeep K. Gupta,  Mark R. Corkins, and  Marian D. Pfefferkorn,  Joel R. Lim,  Steven J. Steiner and y Steven K. Dadzie  Section of Pediatric Gastroenterology, Hepatology and Nutrition, Indiana University School of Medicine, Indianapolis, IN, and { Department of Mathematics and Science, Chabot College, Haywood, CA ABSTRACT Objective: The aim of this study was to determine if the Bravo pH capsule is comparable to the nasally placed pH catheter in terms of pH-metry, safety, and tolerability in children. Methods: Ten patients each in the age ranges of 4 to 6 years, 7 to 10 years, and >10 years were tested simultaneously with the catheter and the capsule. Six each were tested with the catheter alone or the capsule alone. Subjects recorded adverse events and graded tolerance (in terms of activity, appetite, and satisfaction) on a scale of 1 to 5, with a score of 5 indicating that the device was well tolerated. A 24-hour reflux index and 24- and 48-hour reflux indices were generated from the catheter and capsule, respectively. Student t test, Mann-Whitney U test, and Fisher exact test were used to compare reflux index, tolerability, and adverse events between the catheter and capsule. Results: Sixty-six patients 4 to 16 years of age (mean, 9.4 years) were enrolled. There was no statistically significant difference between the mean reflux indices (RIs) obtained simultaneously with the catheter and capsule in all patients combined on day 1 (P ¼ 0.0665). There was a significant difference between day 2 and days 1 and 2 combined with the capsule versus the catheter (P ¼ 0.007 and P ¼ 0.0107); however, a discordant result of normal RI on day 1 and pathological RI on day 2 was seen in only 1 patient. The capsule was better tolerated than the catheter in terms of appetite (P ¼ 0.029), activity (P ¼ 0.001), and satisfaction (P ¼ 0.003). There were no significant compli- cations. Conclusions: The Bravo pH capsule was as accurate and safe and better tolerated than the conventional pH catheter in children 4 years of age and older. JPGN 45:559–563, 2007. Key Words: Bravo capsule—Esophageal pH test— Gastroesophageal reflux—Wireless esophageal pH testing. # 2007 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition INTRODUCTION Ambulatory extended esophageal pH monitoring is considered the gold standard test for establishing the presence of abnormal gastroesophageal reflux in chil- dren. This is performed by placing an esophageal catheter through the nose and advancing it to a manometrically determined fluoroscopically guided or precalculated dis- tance above the lower esophageal sphincter. The presence of the catheter in the nose is often associated with morbidity. Older children are uncomfortable, may not eat well, and may not carry out their usual activities in the presence of the catheter. Younger children may be irritable, may refuse to eat, and often require restraints to prevent them from pulling the catheter out. The test may therefore not be truly representative of the normal daily life in these patients, particularly when usual activity or eating is curtailed, and may result in false-negative results. The Bravo pH system (Medtronic, Shoreview, MN) consists of a small capsule containing a radiotransmitter, an internal battery, and an antimony pH electrode. It is attached to the mucosal wall of the distal esophagus so that no tube protrudes from the nose. The capsule monitors pH and transmits data to a pager-sized device that may be worn on the patient’s belt or placed next to the patient. The capsule detaches after several days and is expelled from the body in the stool. Studies in adults suggest that data obtained from the Bravo system are comparable to data obtained with the Address correspondence and reprint requests to Joseph M. Croffie, MD, MPH, Section of Pediatric Gastroenterology, Hepatology and Nutrition, Indiana University School of Medicine, James Whitcomb Riley Hospital for Children, 702 Barnhill Drive, Room ROC 4210, Indianapolis, IN 46202 (e-mail: jcroffie@iupui.edu). This study was supported by an unrestricted grant and contributed devices from Medtronics, Inc, Shoreview, MN. It was presented in part at the NASPGHAN Annual Meeting in Salt Lake City, UT, October 2005. Journal of Pediatric Gastroenterology and Nutrition 45:559–563 # 2007 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition 559