Carbon Dioxide Insufflation During Colonoscopy
Conditions
Keywords
CO2 insufflation
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.
Interventions
PROCEDUREcarbon dioxide insufflation during endoscopy
Efficacy and safety study of carbon dioxide insufflation instead of air during sedated endoscopy
PROCEDURERoom air insufflation during endoscopy (Placebo)
Efficacy and safety study of carbon dioxide insufflation instead of air during sedated endoscopy
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the participants' discomfort scale after endoscopy | within 24hours |
Outcome results
None listed