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Efficacy and Safety of Carbon Dioxide Insufflation During Endoscopy

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ClinicalTrials.gov Identifier: NCT02502136
Recruitment Status : Completed
First Posted : July 20, 2015
Last Update Posted : July 20, 2015
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Carbon Dioxide Insufflation During Colonoscopy Procedure: carbon dioxide insufflation during endoscopy Procedure: Room air insufflation during endoscopy (Placebo) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 640 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Assessment of Differences in Clinical Safety and Efficacy of Carbon Dioxide Insufflation During Sedated and Conventional Endoscopy
Study Start Date : April 2011
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

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




Primary Outcome Measures :
  1. the participants' discomfort scale after endoscopy [ Time Frame: within 24hours ]


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02502136


Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Shuo-Wei Chen, MD Chang Gung Memorial Hospital

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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02502136     History of Changes
Other Study ID Numbers: 99-4160A3
First Posted: July 20, 2015    Key Record Dates
Last Update Posted: July 20, 2015
Last Verified: April 2015

Keywords provided by Chang Gung Memorial Hospital:
CO2 insufflation