At a glance
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The Safety and Efficacy of Carbon Dioxide for Insufflation During Endoscopy in Pediatric Patients
In Brief
A Phase 4 clinical trial evaluating Carbon dioxide (CO2) gas insufflation and Air insufflation for Endoscopy and Insufflation. Completed, enrolled 180 participants across 1 site.
Detailed 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 endoscopic procedures. Aim 1: Determine the occurrence and severity of abdominal discomfort and distension associated with endoscopic procedures at baseline, upon awakening from anesthesia, at discharge and at 4 hours after discharge in carbon dioxide group when compared to the air group. Aim 2: Determine if the expertise level of the endoscopist contributes to abdominal discomfort and distension following endoscopy, and whether this differs in the carbon dioxide group versus air group. Aim 3: Determine if carbon dioxide is as effective as air for insufflation.
Study Details
Timeline
Interventions
CO2 gas use for insufflation during endoscopy instead of air insufflation
Air insufflation is the standard of practice (used in the control arm)