Safety and Efficacy of CO2 for Endoscopy

NCT03287687 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 201706767
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endoscopy; Insufflation

Outcome Measures

Primary Outcomes (1)

• Change in Abdominal Distension

  Change in abdominal girth from baseline to end of procedure (Time Difference 1) or Change in abdominal girth from baseline to time of discharge ((Time Difference 2)

  Mean change in abdominal girth between time points were compared between groups

Secondary Outcomes (2)

• Elevations of End Tidal Carbon Dioxide

  Time frame of monitoring from start to end of procedure (average of 12 minutes for EGD procedures)

• Procedures With Post Endoscopy Reported Symptoms

  Frequency of reported symptoms up to 4 hours post endoscopy was compared between groups

Study Arms (2)

Air for insufflation

ACTIVE COMPARATOR

In this arm of patients, air which is currently used as standard of care will be used for insufflation

Drug: Air insufflation

Carbon dioxide gas for insufflation

EXPERIMENTAL

in this arm of patients, carbon dioxide (CO2) will be used for insufflation during endoscopy

Drug: Carbon dioxide (CO2) gas insufflation

Interventions

Carbon dioxide (CO2) gas insufflation DRUG

CO2 gas use for insufflation during endoscopy instead of air insufflation

Also known as: CO2

Carbon dioxide gas for insufflation

Air insufflation DRUG

Air insufflation is the standard of practice (used in the control arm)

Also known as: Control

Air for insufflation

Eligibility Criteria

• Age: 6 Months - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Warren Bishop: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (2)

• Homan M, Mahkovic D, Orel R, Mamula P. Randomized, double-blind trial of CO2 versus air insufflation in children undergoing colonoscopy. Gastrointest Endosc. 2016 May;83(5):993-7. doi: 10.1016/j.gie.2015.08.073. Epub 2015 Sep 10.

  PMID: 26363332 RESULT

• Dike CR, Rahhal R, Bishop WP. Is Carbon Dioxide Insufflation During Endoscopy in Children as Safe and as Effective as We Think? J Pediatr Gastroenterol Nutr. 2020 Aug;71(2):211-215. doi: 10.1097/MPG.0000000000002724.

  PMID: 32304555 DERIVED

MeSH Terms

Interventions

Carbon Dioxide

Intervention Hierarchy (Ancestors)

Carbon Compounds, Inorganic; Inorganic Chemicals; Gases; Oxides; Oxygen Compounds

Results Point of Contact

• Title: Dr. Warren Bishop, Professor of Pediatrics
• Organization: University of Iowa

warren-bishop@uiowa.edu

319 356 2977

Study Officials

• Warren P Bishop, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization will be done 1:1, double blinded. - Procedure nurse will randomly choose an envelope from a box; the envelope contains a card listing either "CO2" or "Air". The envelopes will be unmarked and will be prepared with an equal number of cards for each arm. The procedure nurse then turns on either CO2 or air insufflation according to the card in the envelope. The air/CO2 controls will be kept covered to preserve blinding of the endoscopist. She will also record the patient's arm allocation in a logbook, which will be kept in a locked cabinet. * These events will precede entry of the patient and endoscopist into the procedure room. * Therefore, all study participants are blinded and allocation is also blinded also.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Double blinded, placebo controlled study

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: September 19, 2017
• Study Start: November 27, 2017
• Primary Completion: April 9, 2019
• Study Completion: April 9, 2019
• Last Updated: January 19, 2022
• Results First Posted: January 19, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)