Efficacy and Safety of Carbon Dioxide Insufflation During Endoscopy

Chang Gung Medical Foundation

Status: Completed

Conditions: Carbon Dioxide Insufflation During Colonoscopy

Treatments: Procedure: carbon dioxide insufflation during endoscopy; Procedure: Room air insufflation during endoscopy (Placebo)

Study type: Interventional

Funder types: Other

Identifiers

NCT02502136

99-4160A3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 640 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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640 participants in 8 patient groups, including a placebo group

CO2 in sedated colonoscopy

Experimental group

Description:

Carbon dioxide insufflation during colonoscopy with sedation

Treatment:

Procedure: carbon dioxide insufflation during endoscopy

Air in sedated colonoscopy

Placebo Comparator group

Description:

Room air insufflation during colonoscopy with sedation

Treatment:

Procedure: Room air insufflation during endoscopy (Placebo)

CO2 in mild sedated colonoscopy

Experimental group

Description:

Carbon dioxide insufflation during colonoscopy with mild sedation

Treatment:

Procedure: carbon dioxide insufflation during endoscopy

Air in deep sedated colonoscopy

Placebo Comparator group

Description:

Room air insufflation during colonoscopy with deep sedation

Treatment:

Procedure: Room air insufflation during endoscopy (Placebo)

CO2 in sedated panendoscopy

Experimental group

Description:

Carbon dioxide insufflation during panendoscopy with sedation

Treatment:

Procedure: carbon dioxide insufflation during endoscopy

Air in sedated panendoscopy

Placebo Comparator group

Description:

Room air insufflation during panendoscopy with sedation

Treatment:

Procedure: Room air insufflation during endoscopy (Placebo)

CO2 in mild sedated panendoscopy

Experimental group

Description:

Carbon dioxide insufflation during panendoscopy with mild sedation

Treatment:

Procedure: carbon dioxide insufflation during endoscopy

Air in deep sedated panendoscopy

Placebo Comparator group

Description:

Room air insufflation during panendoscopy with deep sedation

Treatment:

Procedure: Room air insufflation during endoscopy (Placebo)