Is End Tidal CO2 Level Elevation During Upper Endoscopy With CO2 Gas Insufflation Physiologically Significant

NCT04541667 | Completed Results

• 1 other identifier: 0632-19-FB
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

During the course of an endoscopic procedure, air has historically been used to inflate the lumen to provide adequate visualization and allow for the endoscope to advance as necessary. In many adult centers, carbon dioxide is used for insufflation for all procedures. Many pediatric centers have started using carbon dioxide for insufflation during endoscopy based on the adult studies. Few pediatric studies have been done. This study is designed to test whether carbon dioxide is associated with any negative, post-procedural, outcomes in pediatric patients.

Conditions

Endoscopy

Keywords

upper endoscopy; endoscope; abdominal discomfort; insufflation; carbon dioxide

Outcome Measures

Primary Outcomes (1)

• Number of Procedures With Elevated End-tidal CO2 Levels

  Compare the peak end-tidal CO2 levels (\>/= 60 mmHg) observed during endoscopy in children managed with endotracheal intubation or laryngeal mask airway using CO2 versus air

  Measured from time of procedure start to time of procedure conclusion this lasts usually from 1-2.5 hours.

Secondary Outcomes (1)

• Number of Participants Reporting Abdominal Pain

  This will be assessed before and after the procedure

Study Arms (2)

Air for luminal inflation

ACTIVE COMPARATOR

Patients randomized into this arm will have luminal inflation using air.

Other: Air

Carbon Dioxide for luminal inflation

ACTIVE COMPARATOR

Patients randomized into this arm will have luminal inflation using carbon dioxide.

Other: Carbon Dioxide

Interventions

Air OTHER

Air will be used for luminal inflation.

Also known as: Gas

Air for luminal inflation

Carbon Dioxide OTHER

Carbon dioxide will be used for luminal inflation.

Also known as: Gas

Carbon Dioxide for luminal inflation

Eligibility Criteria

• Age: 6 Months - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children 6 months to 19 years old and
• Undergoing upper endoscopy at Children's Hospital \& Medical Center in Omaha, NE and
• Parents or legal guardians consent to the study

You may not qualify if:

• Patients and legal guardians who decline participation in the study
• Patients with chronic respiratory disease (defined as severe asthma, bronchopulmonary dysplasia and cystic fibrosis-related pulmonary disease)
• Patients with cyanotic heart disease
• Patients with an ASA status of ≥ 3.
• Patients who are wards of the state or in foster care
• Prisoners
• Patients undergoing colonoscopy only procedures or procedures not related to upper endoscopy

Sponsors & Collaborators

• University of Nebraska: lead
• Children's Hospital and Medical Center, Omaha, Nebraska: collaborator

Study Sites (1)

Children's Hospital & Medical Center

Omaha, Nebraska, 68114, United States

Location

Related Publications (15)

• Steppan J, Hogue CW Jr. Cerebral and tissue oximetry. Best Pract Res Clin Anaesthesiol. 2014 Dec;28(4):429-39. doi: 10.1016/j.bpa.2014.09.002. Epub 2014 Sep 28.

  PMID: 25480772 BACKGROUND

• ASGE Technology Committee; Lo SK, Fujii-Lau LL, Enestvedt BK, Hwang JH, Konda V, Manfredi MA, Maple JT, Murad FM, Pannala R, Woods KL, Banerjee S. The use of carbon dioxide in gastrointestinal endoscopy. Gastrointest Endosc. 2016 May;83(5):857-65. doi: 10.1016/j.gie.2016.01.046. Epub 2016 Mar 3. No abstract available.

  PMID: 26946413 BACKGROUND

• Chen SW, Hui CK, Chang JJ, Lee TS, Chan SC, Chien CH, Hu CC, Lin CL, Chen LW, Liu CJ, Yen CL, Hsieh PJ, Liu CK, Su CS, Yu CY, Chien RN. Carbon dioxide insufflation during colonoscopy can significantly decrease post-interventional abdominal discomfort in deeply sedated patients: A prospective, randomized, double-blinded, controlled trial. J Gastroenterol Hepatol. 2016 Apr;31(4):808-13. doi: 10.1111/jgh.13181.

  PMID: 26421801 BACKGROUND

• Liu X, Liu D, Li J, Ou D, Zhou Z. [Safety and efficacy of carbon dioxide insufflation during colonoscopy]. Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2009 Aug;34(8):825-9. Chinese.

  PMID: 19734597 BACKGROUND

• Lynch I, Hayes A, Buffum MD, Conners EE. Insufflation using carbon dioxide versus room air during colonoscopy: comparison of patient comfort, recovery time, and nursing resources. Gastroenterol Nurs. 2015 May-Jun;38(3):211-7. doi: 10.1097/SGA.0000000000000109.

  PMID: 25946475 BACKGROUND

• Memon MA, Memon B, Yunus RM, Khan S. Carbon Dioxide Versus Air Insufflation for Elective Colonoscopy: A Meta-Analysis and Systematic Review of Randomized Controlled Trials. Surg Laparosc Endosc Percutan Tech. 2016 Apr;26(2):102-16. doi: 10.1097/SLE.0000000000000243.

  PMID: 26841319 BACKGROUND

• Riss S, Akan B, Mikola B, Rieder E, Karner-Hanusch J, Dirlea D, Mittlbock M, Weiser FA. CO2 insufflation during colonoscopy decreases post-interventional pain in deeply sedated patients: a randomized controlled trial. Wien Klin Wochenschr. 2009;121(13-14):464-8. doi: 10.1007/s00508-009-1202-y.

  PMID: 19657610 BACKGROUND

• Sajid MS, Caswell J, Bhatti MI, Sains P, Baig MK, Miles WF. Carbon dioxide insufflation vs conventional air insufflation for colonoscopy: a systematic review and meta-analysis of published randomized controlled trials. Colorectal Dis. 2015 Feb;17(2):111-23. doi: 10.1111/codi.12837.

  PMID: 25393051 BACKGROUND

• Singh R, Neo EN, Nordeen N, Shanmuganathan G, Ashby A, Drummond S, Nind G, Murphy E, Luck A, Tucker G, Tam W. Carbon dioxide insufflation during colonoscopy in deeply sedated patients. World J Gastroenterol. 2012 Jul 7;18(25):3250-3. doi: 10.3748/wjg.v18.i25.3250.

  PMID: 22783048 BACKGROUND

• 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 BACKGROUND

• Kresz A, Mayer B, Zernickel M, Posovszky C. Carbon dioxide versus room air for colonoscopy in deeply sedated pediatric patients: a randomized controlled trial. Endosc Int Open. 2019 Feb;7(2):E290-E297. doi: 10.1055/a-0806-7060. Epub 2019 Jan 30.

  PMID: 30705964 BACKGROUND

• Thornhill C, Navarro F, Alabd Alrazzak B, Hashmi SS, DebRoy AN, Rhoads JM, Imseis E. Insufflation With Carbon Dioxide During Pediatric Colonoscopy for Control of Postprocedure Pain. J Clin Gastroenterol. 2018 Sep;52(8):715-720. doi: 10.1097/MCG.0000000000000910.

  PMID: 29210902 BACKGROUND

• Eastwood GM, Tanaka A, Bellomo R. Cerebral oxygenation in mechanically ventilated early cardiac arrest survivors: The impact of hypercapnia. Resuscitation. 2016 May;102:11-6. doi: 10.1016/j.resuscitation.2016.02.009. Epub 2016 Feb 21.

  PMID: 26903288 BACKGROUND

• Erdogan S, Oto A, Bosnak M. Reliability of cerebral oximeter in non-invasive diagnosis and follow-up of hypercapnia. Turk J Pediatr. 2016;58(4):389-394. doi: 10.24953/turkjped.2016.04.007.

  PMID: 28276211 BACKGROUND

• Dike CR, Huang Pacheco A, Lyden E, Freestone D, Choudhry O, Bishop WP, Shukry M. Elevations in End-Tidal CO 2 With CO 2 Use During Pediatric Endoscopy With Airway Protection: Is This Physiologically Significant? J Pediatr Gastroenterol Nutr. 2023 May 1;76(5):660-666. doi: 10.1097/MPG.0000000000003748. Epub 2023 Feb 22.

  PMID: 36821847 DERIVED

MeSH Terms

Interventions

Air; Gases; Carbon Dioxide

Intervention Hierarchy (Ancestors)

Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health; Inorganic Chemicals; Carbon Compounds, Inorganic; Oxides; Oxygen Compounds

Results Point of Contact

• Title: Chinenye Dike
• Organization: University of Nebraska Medical Center

chinenye.dike@unmc.edu

402-955-5700

Study Officials

• Chinenye R Dike, MD

  Children's Hospital & Medical Center / University of Nebraska Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a double-blinded, prospective, randomized study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible study participants will be randomized 1:1 into two study arms; one receiving air and the other receiving carbon dioxide for luminal inflation.

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 9, 2020
• Study Start: November 18, 2019
• Primary Completion: July 31, 2021
• Study Completion: May 31, 2022
• Last Updated: October 10, 2023
• Results First Posted: February 15, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)