Safety and Efficacy of Carbon Dioxide Gas for Endoscopy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Abdominal Pain

Intervention / Treatment
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* Other: Endoscopic insufflation gas


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Air<br> | Other: Endoscopic insufflation gas<br>* Carbon dioxide gas versus air for endoscopic insufflation<br>|
| Experimental: Carbondioxide<br> | Other: Endoscopic insufflation gas<br>* Carbon dioxide gas versus air for endoscopic insufflation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal Pain | Rates of abdominal pain from pre-procedure to immediately after the procedure | baseline/ pre-procedure to immediately after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCO2 level | Incidence of elevated carbon dioxide level in the blood from pre-procedure to post -procedure | baseline/ preprocedural to immediately after the procedure |