Efficacy and Safety of Carbon Dioxide Insufflation During Endoscopy

The Assessment of Differences in Clinical Safety and Efficacy of Carbon Dioxide Insufflation During Sedated and Conventional Endoscopy

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.

Study Overview

• Status: Completed
• Conditions: Carbon Dioxide Insufflation During Colonoscopy
• Intervention / Treatment: Procedure: carbon dioxide insufflation during endoscopy; Procedure: Room air insufflation during endoscopy (Placebo)

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 Type: Interventional
• Enrollment (Actual): 640
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CO2 in sedated colonoscopy; Carbon dioxide insufflation during colonoscopy with sedation	Procedure: carbon dioxide insufflation during endoscopy; Efficacy and safety study of carbon dioxide insufflation instead of air during sedated endoscopy
Placebo Comparator: Air in sedated colonoscopy; Room air insufflation during colonoscopy with sedation	Procedure: Room air insufflation during endoscopy (Placebo); Efficacy and safety study of carbon dioxide insufflation instead of air during sedated endoscopy
Experimental: CO2 in mild sedated colonoscopy; Carbon dioxide insufflation during colonoscopy with mild sedation	Procedure: carbon dioxide insufflation during endoscopy; Efficacy and safety study of carbon dioxide insufflation instead of air during sedated endoscopy
Placebo Comparator: Air in deep sedated colonoscopy; Room air insufflation during colonoscopy with deep sedation	Procedure: Room air insufflation during endoscopy (Placebo); Efficacy and safety study of carbon dioxide insufflation instead of air during sedated endoscopy
Experimental: CO2 in sedated panendoscopy; Carbon dioxide insufflation during panendoscopy with sedation	Procedure: carbon dioxide insufflation during endoscopy; Efficacy and safety study of carbon dioxide insufflation instead of air during sedated endoscopy
Placebo Comparator: Air in sedated panendoscopy; Room air insufflation during panendoscopy with sedation	Procedure: Room air insufflation during endoscopy (Placebo); Efficacy and safety study of carbon dioxide insufflation instead of air during sedated endoscopy
Experimental: CO2 in mild sedated panendoscopy; Carbon dioxide insufflation during panendoscopy with mild sedation	Procedure: carbon dioxide insufflation during endoscopy; Efficacy and safety study of carbon dioxide insufflation instead of air during sedated endoscopy
Placebo Comparator: Air in deep sedated panendoscopy; Room air insufflation during panendoscopy with deep sedation	Procedure: Room air insufflation during endoscopy (Placebo); Efficacy and safety study of carbon dioxide insufflation instead of air during sedated endoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the participants' discomfort scale after endoscopy	within 24hours

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Shuo-Wei Chen, MD, Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: July 1, 2015
• First Submitted That Met QC Criteria: July 16, 2015
• First Posted (Estimate): July 20, 2015

Study Record Updates

• Last Update Posted (Estimate): July 20, 2015
• Last Update Submitted That Met QC Criteria: July 16, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: CO2 insufflation
• Other Study ID Numbers: 99-4160A3