Efficacy and Safety of Carbon Dioxide Insufflation During Endoscopy

Not Applicable

Completed

• Conditions: Carbon Dioxide Insufflation During Colonoscopy
• Interventions: Procedure: carbon dioxide insufflation during endoscopy; Procedure: Room air insufflation during endoscopy (Placebo)

• Registration Number: NCT02502136
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

The purpose of this study is to assess the differences of safety and efficacy of carbon dioxide insufflation instead of air during sedated or unsedated endoscopy.

Detailed Description

Total 640 participants who are indicated to accept endoscopic examinations or procedures will be enrolled in this study. The participants will be divided into 2 groups according to the examination field, esophagogastroduodenoscopy group (320 participants) and colonoscope group (320 participants). The participants in each group will be divided into sedated endoscope subgroup and sedated and unsedated endoscope subgroup (each subgroup is inclusive of 160 participants). Carbon dioxide (CO2) or room air will be used randomly to insufflate the bowel lumen during the procedure in each subgroup.

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2015-04
• Study First Submitted: 2015-07-01
• Study First Submitted QC: 2015-07-16
• Last Update Submitted: 2015-07-16
• Study First Posted: 2015-07-20
• Last Update Posted: 2015-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 640

Inclusion Criteria

• outpatients referred for panendoscopy or colonoscopy examination

Exclusion Criteria

• pregnancy, breast feeding, severe chronic obstructive lung disease or severe heart failure, renal function impairment, inability to understand participant information, a history of abdominal surgery, or refusal to participate in this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CO2 in mild sedated colonoscopy	carbon dioxide insufflation during endoscopy	Carbon dioxide insufflation during colonoscopy with mild sedation
Air in deep sedated colonoscopy	Room air insufflation during endoscopy (Placebo)	Room air insufflation during colonoscopy with deep sedation
CO2 in mild sedated panendoscopy	carbon dioxide insufflation during endoscopy	Carbon dioxide insufflation during panendoscopy with mild sedation
CO2 in sedated colonoscopy	carbon dioxide insufflation during endoscopy	Carbon dioxide insufflation during colonoscopy with sedation
CO2 in sedated panendoscopy	carbon dioxide insufflation during endoscopy	Carbon dioxide insufflation during panendoscopy with sedation
Air in deep sedated panendoscopy	Room air insufflation during endoscopy (Placebo)	Room air insufflation during panendoscopy with deep sedation
Air in sedated colonoscopy	Room air insufflation during endoscopy (Placebo)	Room air insufflation during colonoscopy with sedation
Air in sedated panendoscopy	Room air insufflation during endoscopy (Placebo)	Room air insufflation during panendoscopy with sedation

Primary Outcome Measures

Name	Time	Method
the participants' discomfort scale after endoscopy	within 24hours