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Trial record 16 of 1760 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. Identifier: NCT02790359
Recruitment Status : Completed
First Posted : June 3, 2016
Last Update Posted : December 13, 2019
Information provided by (Responsible Party):
Diana Lerner, Medical College of Wisconsin

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.

Condition or disease Intervention/treatment Phase
Abdominal Pain Other: Air Other: Carbon dioxide Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Carbon Dioxide Insufflation Versus Air Insufflation for Colonoscopy in Deeply Sedated Pediatric Patients: a Prospective, Randomized, Double Blind, Controlled Trial
Actual Study Start Date : March 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Patient group 1
Other: Air
Group of patients who would receive air insufflation

Active Comparator: Patient group 2
Carbon dioxide
Other: Carbon dioxide
Group of patients who would receive carbon dioxide insufflation

Primary Outcome Measures :
  1. Abdominal pain based on visual analog scale [ Time Frame: 72 hours ]
    Participants abdominal pain score will be assessed based on visual analog scale

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT02790359

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United States, Wisconsin
Childrens Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Sponsors and Collaborators
Medical College of Wisconsin

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Responsible Party: Diana Lerner, MD, Medical College of Wisconsin Identifier: NCT02790359    
Other Study ID Numbers: 728555
First Posted: June 3, 2016    Key Record Dates
Last Update Posted: December 13, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Diana Lerner, Medical College of Wisconsin:
Carbon dioxide
Additional relevant MeSH terms:
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Abdominal Pain
Neurologic Manifestations
Signs and Symptoms
Signs and Symptoms, Digestive