title: Accuracy and tolerability of the Bravo catheter-free pH capsule in patients between the ages of 4 and 18 years.
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 = 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.
authors.affiliation: Section of Pediatric Gastroenterology, Hepatology and Nutrition, Indiana University School of Medicine, Indianapolis, IN 46202, USA. jcroffie@iupui.edu
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Croffie
authors.forename: Joseph F
authors.initials: JF
authors.lastname: Fitzgerald
authors.forename: Jean P
authors.initials: JP
authors.lastname: Molleston
authors.forename: Sandeep K
authors.initials: SK
authors.lastname: Gupta
authors.forename: Mark R
authors.initials: MR
authors.lastname: Corkins
authors.forename: Marian D
authors.initials: MD
authors.lastname: Pfefferkorn
authors.forename: Joel R
authors.initials: JR
authors.lastname: Lim
authors.forename: Steven J
authors.initials: SJ
authors.lastname: Steiner
authors.forename: Steven K
authors.initials: SK
authors.lastname: Dadzie
mesh_terms: D000293:Adolescent; D000367:Age Factors; D002404:Catheterization / Q000009:adverse effects; D002637:Chest Pain / Q000209:etiology; D002648:Child; D002675:Child, Preschool; D003371:Cough / Q000209:etiology; D050782:Esophageal pH Monitoring / Q000009:adverse effects* / Q000295:instrumentation*; D004945:Esophagoscopy; D004947:Esophagus; D005260:Female; D005764:Gastroesophageal Reflux / Q000175:diagnosis*; D006356:Heartburn / Q000209:etiology; D006801:Humans; D008297:Male; D018670:Monitoring, Ambulatory / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D017060:Patient Satisfaction; D015203:Reproducibility of Results; D013686:Telemetry / Q000009:adverse effects / Q000295:instrumentation*; D014839:Vomiting / Q000209:etiology