University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Location status: Recruiting
NCT Number: NCT06134154
The goal of this clinical trial is to compare the efficacy and safety of air versus carbon dioxide gas insufflation for endoscopy in children.
The main question[s] it aims to answer are:
•to determine safety of CO2 Assess patient comfort (abdominal pain, flatulence and bloating) with CO2 use when compared to air.
Interested in participating?
Request Info6 month–18 year
All sexes
Interventional
Not applicable
Birmingham, Alabama, 35233, United States
Location status: Recruiting
In this study, children (6 months -18 years) undergoing all endoscopic procedures that includes an upper endoscopy including but not limited to Esophagogastroduodenoscopy (EGD/ upper endoscopy), EGD/ Colonoscopy, Endoscopic Retrograde Cholangiopancreatography (ERCP), Endoscopic ultrasound (EUS) e.t.c after appropriate consent, will be randomized 1:1 to either Air or CO2 gas for endoscopic insufflation. We will record demographics (name, age, sex, MRN, race/ethnicity), anthropometrics including weight, height/length, weight for length (WFL), WFL z score, BMI, BMI z score, indication/ reason for scope, other co-morbidities (other medical problems), personnel involved (faculty only, vs faculty + trainee), minute by minute end tidal CO2 levels, minute by minute minute ventilation levels, baseline blood pCO2, and blood pCO2 after each procedure. Pre and post procedure patient reported abdominal pain, bloating and flatulence. Pre and post procedure nurse assessed pain. Pre and post procedure vital signs. Patients will be randomized using a sealed envelope method by the endoscopy technician. Both patients and providers will be blinded to arm of enrollment.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Carbon dioxide gas versus air for endoscopic insufflation
Time frame: baseline/ pre-procedure to immediately after the procedure
Rates of abdominal pain from pre-procedure to immediately after the procedure
Time frame: baseline/ preprocedural to immediately after the procedure
Incidence of elevated carbon dioxide level in the blood from pre-procedure to post -procedure
Contact information is provided by the study sponsor or research team.
University of Alabama at Birmingham
Other
Safety and Efficacy of Carbon Dioxide Gas for Endoscopic Insufflation in Children
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06543316
Abdominal Pain, Deglutition Disorders
Boston, Massachusetts, United States
View Trial DetailsNCT07591584
Abdominal Pain, Bloating
Los Angeles, California, United States
View Trial DetailsNCT06827730
Abdominal Pain, Chest Pain
Brussels, Belgium
View Trial DetailsNCT05730491
Abdominal Pain, Behavior
Seattle, Washington, United States
View Trial Details