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Trial record 7 of 2448 for:    CARBON DIOXIDE

Efficacy and Safety of Carbon Dioxide Insufflation During Endoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE July 1, 2015
First Posted Date  ICMJE July 20, 2015
Last Update Posted Date July 20, 2015
Study Start Date  ICMJE April 2011
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2015)
the participants' discomfort scale after endoscopy [ Time Frame: within 24hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Carbon Dioxide Insufflation During Endoscopy
Official Title  ICMJE The Assessment of Differences in Clinical Safety and Efficacy of Carbon Dioxide Insufflation During Sedated and Conventional Endoscopy
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Carbon Dioxide Insufflation During Colonoscopy
Intervention  ICMJE
  • Procedure: carbon dioxide insufflation during endoscopy
    Efficacy and safety study of carbon dioxide insufflation instead of air during sedated endoscopy
  • Procedure: Room air insufflation during endoscopy (Placebo)
    Efficacy and safety study of carbon dioxide insufflation instead of air during sedated endoscopy
Study Arms  ICMJE
  • Experimental: CO2 in sedated colonoscopy
    Carbon dioxide insufflation during colonoscopy with sedation
    Intervention: Procedure: carbon dioxide insufflation during endoscopy
  • Placebo Comparator: Air in sedated colonoscopy
    Room air insufflation during colonoscopy with sedation
    Intervention: Procedure: Room air insufflation during endoscopy (Placebo)
  • Experimental: CO2 in mild sedated colonoscopy
    Carbon dioxide insufflation during colonoscopy with mild sedation
    Intervention: Procedure: carbon dioxide insufflation during endoscopy
  • Placebo Comparator: Air in deep sedated colonoscopy
    Room air insufflation during colonoscopy with deep sedation
    Intervention: Procedure: Room air insufflation during endoscopy (Placebo)
  • Experimental: CO2 in sedated panendoscopy
    Carbon dioxide insufflation during panendoscopy with sedation
    Intervention: Procedure: carbon dioxide insufflation during endoscopy
  • Placebo Comparator: Air in sedated panendoscopy
    Room air insufflation during panendoscopy with sedation
    Intervention: Procedure: Room air insufflation during endoscopy (Placebo)
  • Experimental: CO2 in mild sedated panendoscopy
    Carbon dioxide insufflation during panendoscopy with mild sedation
    Intervention: Procedure: carbon dioxide insufflation during endoscopy
  • Placebo Comparator: Air in deep sedated panendoscopy
    Room air insufflation during panendoscopy with deep sedation
    Intervention: Procedure: Room air insufflation during endoscopy (Placebo)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 16, 2015)
640
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02502136
Other Study ID Numbers  ICMJE 99-4160A3
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chang Gung Memorial Hospital
Study Sponsor  ICMJE Chang Gung Memorial Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shuo-Wei Chen, MD Chang Gung Memorial Hospital
PRS Account Chang Gung Memorial Hospital
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP