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 Corkins, Marian D. Pfefferkorn, Joel R. Lim, Steven J. Steiner, Steven K. Dadzie

Research output: Contribution to journalArticle

24 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)559-563
Number of pages5
JournalJournal of Pediatric Gastroenterology and Nutrition
Volume45
Issue number5
DOIs
StatePublished - Nov 1 2007
Externally publishedYes

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tetrachloroisophthalonitrile
Capsules
Catheters
Appetite

All Science Journal Classification (ASJC) codes

  • Pediatrics, Perinatology, and Child Health
  • Gastroenterology

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Accuracy and tolerability of the Bravo catheter-free pH capsule in patients between the ages of 4 and 18 years. / Croffie, Joseph M.; Fitzgerald, Joseph F.; Molleston, Jean P.; Gupta, Sandeep K.; Corkins, Mark; Pfefferkorn, Marian D.; Lim, Joel R.; Steiner, Steven J.; Dadzie, Steven K.

In: Journal of Pediatric Gastroenterology and Nutrition, Vol. 45, No. 5, 01.11.2007, p. 559-563.

Research output: Contribution to journalArticle

Croffie, JM, Fitzgerald, JF, Molleston, JP, Gupta, SK, Corkins, M, Pfefferkorn, MD, Lim, JR, Steiner, SJ & Dadzie, SK 2007, 'Accuracy and tolerability of the Bravo catheter-free pH capsule in patients between the ages of 4 and 18 years', Journal of Pediatric Gastroenterology and Nutrition, vol. 45, no. 5, pp. 559-563. https://doi.org/10.1097/MPG.0b013e3180dc9349
Croffie, Joseph M. ; Fitzgerald, Joseph F. ; Molleston, Jean P. ; Gupta, Sandeep K. ; Corkins, Mark ; Pfefferkorn, Marian D. ; Lim, Joel R. ; Steiner, Steven J. ; Dadzie, Steven K. / Accuracy and tolerability of the Bravo catheter-free pH capsule in patients between the ages of 4 and 18 years. In: Journal of Pediatric Gastroenterology and Nutrition. 2007 ; Vol. 45, No. 5. pp. 559-563.
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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.",
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T1 - Accuracy and tolerability of the Bravo catheter-free pH capsule in patients between the ages of 4 and 18 years

AU - Croffie, Joseph M.

AU - Fitzgerald, Joseph F.

AU - Molleston, Jean P.

AU - Gupta, Sandeep K.

AU - Corkins, Mark

AU - Pfefferkorn, Marian D.

AU - Lim, Joel R.

AU - Steiner, Steven J.

AU - Dadzie, Steven K.

PY - 2007/11/1

Y1 - 2007/11/1

N2 - 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.

AB - 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.

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