Carbon Dioxide Insufflation Versus Conventional Air Insufflation
Public ClinicalTrials.gov record NCT02790359. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Carbon Dioxide Insufflation Versus Air Insufflation for Colonoscopy in Deeply Sedated Pediatric Patients: a Prospective, Randomized, Double Blind, Controlled Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02790359
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 100 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 8 Years to 21 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2015
- Primary completion
- Feb 29, 2016
- Completion
- Feb 29, 2016
- Last update posted
- Dec 12, 2019
2015 – 2016
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Childrens Hospital of Wisconsin | Milwaukee | Wisconsin | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02790359, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 12, 2019 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02790359 live on ClinicalTrials.gov.