Safety and Efficacy of Carbon Dioxide Gas for Endoscopy

Purpose

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.

Condition

  • Abdominal Pain

Eligibility

Eligible Ages
Between 6 Months and 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Air
  • Other: Endoscopic insufflation gas
    Carbon dioxide gas versus air for endoscopic insufflation
Experimental
Carbondioxide
  • Other: Endoscopic insufflation gas
    Carbon dioxide gas versus air for endoscopic insufflation

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35233
Contact:
Chinenye R Dike, MD
334-558-5519
cdike@uabmc.edu

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Chinenye R Dike, MD MS
205 638 9918
cdike@uabmc.edu

Detailed 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.