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OpenTrials
Completed

NCT Number: NCT02502136

Efficacy and Safety of Carbon Dioxide Insufflation During 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.

Completed

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Key information

Conditions

Carbon Dioxide Insufflation During Colonoscopy

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

carbon dioxide insufflation during endoscopy

Procedure

Efficacy and safety study of carbon dioxide insufflation instead of air during sedated endoscopy

Room air insufflation during endoscopy (Placebo)

Procedure

Efficacy and safety study of carbon dioxide insufflation instead of air during sedated endoscopy

Primary outcomes

  1. the participants' discomfort scale after endoscopy

    Time frame: within 24hours

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 20, 2015
Registry last updated
Jul 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.