Safety and Efficacy of CO2 for Endoscopy (NCT03287687) | Clinical Trial Compass
CompletedPhase 4
Safety and Efficacy of CO2 for Endoscopy
United States180 participantsStarted 2017-11-27
Plain-language summary
Hypothesis:
Carbon dioxide gas use for endoscopic insufflation is safe and results in less abdominal distension and discomfort; it is equally effective as air in pediatric patients undergoing endoscopic procedures.
Aim 1:
Determine the occurrence and severity of abdominal discomfort and distension associated with endoscopic procedures at baseline, upon awakening from anesthesia, at discharge and at 4 hours after discharge in carbon dioxide group when compared to the air group.
Aim 2:
Determine if the expertise level of the endoscopist contributes to abdominal discomfort and distension following endoscopy, and whether this differs in the carbon dioxide group versus air group.
Aim 3:
Determine if carbon dioxide is as effective as air for insufflation.
Who can participate
Age range
6 Months – 21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Pediatric gastroenterology patients aged 6 months through 21 years undergoing endoscopic procedures in the Stead Family Children's Hospital (SFCH) Lower Level 2 procedure room or the operating room in the SFCH who willingly consent/ascent to the study. These procedures will range from Esophagogastroduodenoscopy, Colonoscopy, and those having both Esophagogastroduodenoscopy and Colonoscopy.
Exclusion Criteria:
* Non English speaking families who require the services of a translator Children outside the stipulated age range of study. Children in foster care homes or wards of the court. Children and parents who do not willingly consent to the study Children with history of bronchopulmonary dysplasia or other chronic respiratory compromise.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Abdominal Distension
Timeframe: Mean change in abdominal girth between time points were compared between groups