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Trial record 16 of 1704 for:    CARBON DIOXIDE AND dioxide

Carbon Dioxide Insufflation Versus Conventional Air Insufflation

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: NCT02790359
Recruitment Status : Completed
First Posted : June 3, 2016
Last Update Posted : December 13, 2019
Sponsor:
Information provided by (Responsible Party):
Diana Lerner, Medical College of Wisconsin

Tracking Information
First Submitted Date  ICMJE April 25, 2016
First Posted Date  ICMJE June 3, 2016
Last Update Posted Date December 13, 2019
Actual Study Start Date  ICMJE March 2015
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2016)
Abdominal pain based on visual analog scale [ Time Frame: 72 hours ]
Participants abdominal pain score will be assessed based on visual analog scale
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02790359 on ClinicalTrials.gov Archive Site
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 Carbon Dioxide Insufflation Versus Conventional Air Insufflation
Official Title  ICMJE Carbon Dioxide Insufflation Versus Air Insufflation for Colonoscopy in Deeply Sedated Pediatric Patients: a Prospective, Randomized, Double Blind, Controlled Trial
Brief Summary The safety and effectiveness of esophagogastroduodenoscopy and colonoscopy in the detection of gastrointestinal-tract pathology in children has been established during the last three decades. Insufflation of the intestinal tract, usually with room air, is necessary to improve visualization during the procedure; however, air in the bowels can also result in abdominal distension and increased pain. This potential discomfort associated with upper endoscopy and colonoscopy may be an important barrier to patients undergoing this procedure. Insufflation with carbon dioxide is another method used in endoscopic procedures for distention of the lumen and is currently used at the Children's Hospital of Wisconsin based on provider preference. The aim of this study is to perform a randomized controlled trial comparing insufflation with room air to carbon dioxide in patients undergoing routine upper endoscopy and colonoscopy. The investigators primary outcome is measurement of patient comfort level as measured by pain scores during recovery. The investigators hypothesize that carbon dioxide insufflation during endoscopy and colonoscopy improves patient comfort level as compared with insufflation with room air. Secondary outcome measures include changes in end tidal carbon dioxide, time to discharge, duration of colonoscopy and cecal intubation rate, changes in abdominal girth, rescue pain medications used during recovery and post-procedure events. This is a prospective randomized single-blinded study. The investigators will recruit consecutive patients, between the ages of 8 and 21 years, scheduled for elective outpatient upper endoscopy and colonoscopy at children's hospital of Wisconsin from March 2015 until we reach target population numbers. The investigators will exclude all inpatients, non-English speaking patients, children under 8 years of age, patients undergoing colonic manometry studies, and patients with hemodynamic instability, gastrointestinal bleeding, acute abdomen, previous colectomy, oxygen-dependent pulmonary disease and obstructive sleep apnea requiring the use of continuous positive airway pressure device. On the basis of a computer-generated randomization scheme in a 1:1 ratio, patients will be assigned to receive room air or carbon dioxide for insufflation during colonoscopy. Power calculation was done and determined that we will need to enroll 100 patients in each arm of the study. Informed consent will be obtained from all patients by the endoscopist or gastrointestinal fellow.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Condition  ICMJE Abdominal Pain
Intervention  ICMJE
  • Other: Air
    Group of patients who would receive air insufflation
  • Other: Carbon dioxide
    Group of patients who would receive carbon dioxide insufflation
Study Arms  ICMJE
  • Active Comparator: Patient group 1
    Air
    Intervention: Other: Air
  • Active Comparator: Patient group 2
    Carbon dioxide
    Intervention: Other: Carbon dioxide
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: May 31, 2016)
100
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ages of 8 and 21 years
  • elective outpatient upper endoscopy and colonoscopy

Exclusion Criteria:

  • inpatients
  • non-English speaking patients
  • children under 8 years of age
  • patients undergoing colonic manometry studies
  • patients with hemodynamic instability
  • GI bleeding
  • acute abdomen
  • previous colectomy
  • oxygen-dependent pulmonary disease and obstructive sleep apnea
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02790359
Other Study ID Numbers  ICMJE 728555
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Diana Lerner, Medical College of Wisconsin
Study Sponsor  ICMJE Medical College of Wisconsin
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medical College of Wisconsin
Verification Date December 2019

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