Carbon Dioxide Insufflation Versus Conventional Air Insufflation
Primary Purpose
Abdominal Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Air
Carbon dioxide
Sponsored by
About this trial
This is an interventional prevention trial for Abdominal Pain focused on measuring Carbon dioxide, Air, Colonoscopy
Eligibility 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
Sites / Locations
- Childrens Hospital of Wisconsin
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Patient group 1
Patient group 2
Arm Description
Air
Carbon dioxide
Outcomes
Primary Outcome Measures
Abdominal pain based on visual analog scale
Participants abdominal pain score will be assessed based on visual analog scale
Secondary Outcome Measures
Full Information
NCT ID
NCT02790359
First Posted
April 25, 2016
Last Updated
December 12, 2019
Sponsor
Medical College of Wisconsin
1. Study Identification
Unique Protocol Identification Number
NCT02790359
Brief Title
Carbon Dioxide Insufflation Versus Conventional Air Insufflation
Official Title
Carbon Dioxide Insufflation Versus Air Insufflation for Colonoscopy in Deeply Sedated Pediatric Patients: a Prospective, Randomized, Double Blind, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Pain
Keywords
Carbon dioxide, Air, Colonoscopy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient group 1
Arm Type
Active Comparator
Arm Description
Air
Arm Title
Patient group 2
Arm Type
Active Comparator
Arm Description
Carbon dioxide
Intervention Type
Other
Intervention Name(s)
Air
Intervention Description
Group of patients who would receive air insufflation
Intervention Type
Other
Intervention Name(s)
Carbon dioxide
Intervention Description
Group of patients who would receive carbon dioxide insufflation
Primary Outcome Measure Information:
Title
Abdominal pain based on visual analog scale
Description
Participants abdominal pain score will be assessed based on visual analog scale
Time Frame
72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Childrens Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Carbon Dioxide Insufflation Versus Conventional Air Insufflation
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