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 = 0.0665). There was a significant difference between day 2 and days 1 and 2 combined with the capsule versus the catheter (P = 0.007 and P = 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 = 0.029), activity (P = 0.001), and satisfaction (P = 0.003). There were no significant complications. 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.
RCT Entities:
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 = 0.0665). There was a significant difference between day 2 and days 1 and 2 combined with the capsule versus the catheter (P = 0.007 and P = 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 = 0.029), activity (P = 0.001), and satisfaction (P = 0.003). There were no significant complications. 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.