Safety and Efficacy of Carbon Dioxide Gas for Endoscopy

Abdominal Pain Clinical Trial

Official title:

Safety and Efficacy of Carbon Dioxide Gas for Endoscopic Insufflation in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06134154
• Other study ID #: IRB-300011252
• Status: Recruiting
• Phase: N/A
• Start date: January 24, 2024
• Est. completion date: December 2026

Study information

• Verified date: January 2024
• Source: University of Alabama at Birmingham
• Contact: Chinenye R Dike, MD MS
• Phone: 205 638 9918
• Email: cdike[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 18 Years

Eligibility

Inclusion Criteria:

• Infants and children 6 months to 18 years undergoing any upper endoscopy related procedure including but not limited to EGD/Colonoscopy, ERCP, EGD only, EUS, EGD with foreign body removal, Enteroscopy.

Exclusion Criteria:

• Patients with American Society of Anesthesiology (ASA) Physical Status Classification System of 4 and above
• Children with chronic lung disease,
• Children who are wards of the state will be excluded.
• Children needing language interpreting services that is not Spanish.

Related Conditions & MeSH terms

• Abdominal Pain

Intervention

Other:
• Endoscopic insufflation gas
Carbon dioxide gas versus air for endoscopic insufflation

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abdominal Pain	Rates of abdominal pain from pre-procedure to immediately after the procedure	baseline/ pre-procedure to immediately after the procedure
Secondary	PCO2 level	Incidence of elevated carbon dioxide level in the blood from pre-procedure to post -procedure	baseline/ preprocedural to immediately after the procedure