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Trial record 26 of 2406 for:    CARBON DIOXIDE

Carbon Dioxide Insufflation Versus Conventional Air Insufflation

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ClinicalTrials.gov Identifier: NCT02790359
Recruitment Status : Unknown
Verified June 2016 by Diana Lerner, Medical College of Wisconsin.
Recruitment status was:  Recruiting
First Posted : June 3, 2016
Last Update Posted : March 6, 2017
Sponsor:
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)
Estimated Enrollment : 200 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
Study Start Date : March 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Patient group 1
Air
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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02790359


Contacts
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Contact: Diana Lerner, MD dglerner@mcw.edu

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

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Responsible Party: Diana Lerner, MD, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT02790359     History of Changes
Other Study ID Numbers: 728555
First Posted: June 3, 2016    Key Record Dates
Last Update Posted: March 6, 2017
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Diana Lerner, Medical College of Wisconsin:
Carbon dioxide
Air
Colonoscopy

Additional relevant MeSH terms:
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Abdominal Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Signs and Symptoms, Digestive