Efficacy and Safety of Carbon Dioxide Insufflation During Endoscopy

Study Overview
=================
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.

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

Conditions
-----------------
Carbon Dioxide Insufflation During Colonoscopy

Intervention / Treatment
-----------------
* Procedure: carbon dioxide insufflation during endoscopy
* Procedure: Room air insufflation during endoscopy (Placebo)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CO2 insufflation