Status:
COMPLETED
Safety and Efficacy of CO2 for Endoscopy
Lead Sponsor:
Warren Bishop
Conditions:
Endoscopy
Insufflation
Eligibility:
All Genders
6-21 years
Phase:
PHASE4
Brief Summary
Hypothesis: Carbon dioxide gas use for endoscopic insufflation is safe and results in less abdominal distension and discomfort; it is equally effective as air in pediatric patients undergoing endosco...
Detailed Description
STUDY DESIGN: A Prospective, Randomized, Double-Blinded, Controlled Trial We intend to enroll 250 patients aged between 6 months and 21 years in a randomized, double-blind study comparing the use of a...
Eligibility Criteria
Inclusion
- Pediatric gastroenterology patients aged 6 months through 21 years undergoing endoscopic procedures in the Stead Family Children's Hospital (SFCH) Lower Level 2 procedure room or the operating room in the SFCH who willingly consent/ascent to the study. These procedures will range from Esophagogastroduodenoscopy, Colonoscopy, and those having both Esophagogastroduodenoscopy and Colonoscopy.
Exclusion
- Non English speaking families who require the services of a translator Children outside the stipulated age range of study. Children in foster care homes or wards of the court. Children and parents who do not willingly consent to the study Children with history of bronchopulmonary dysplasia or other chronic respiratory compromise.
Key Trial Info
Start Date :
November 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 9 2019
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT03287687
Start Date
November 27 2017
End Date
April 9 2019
Last Update
January 19 2022
Active Locations (1)
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1
University of Iowa
Iowa City, Iowa, United States, 52242