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

Endoscopy Clinical Trial

— ETCO2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04541667
• Other study ID #: 0632-19-FB
• Status: Completed
• Phase: N/A
• Start date: November 18, 2019
• Est. completion date: May 31, 2022

Study information

• Verified date: September 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Luminal inflation is essential for adequate visualization and endoscope advancement during endoscopy. Although air has previously been the standard gas used, CO2 is increasing preferred in adult endoscopy centers, due to reports of decreased post-procedural abdominal discomfort compared to air. Few published studies in children demonstrated decreased abdominal discomfort with use of CO2, but safety concerns for its use in pediatric endoscopy remain. This is a Double-blinded, prospective, randomized study of all pediatric patients undergoing procedures involving upper endoscopy in the Childrens Hospital & Medical Center. Randomization will be for patients undergoing upper endoscopy related procedures. Patients will be randomized 1:1 for air or CO2. Vital signs will be recorded before the procedure, throughout the procedure and after the procedure until fully awake. While in the procedure room, end-tidal CO2 level will be continuously recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 31, 2022
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 19 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Endoscopy

Intervention

Other:
• Air
Air will be used for luminal inflation.
• Carbon Dioxide
Carbon dioxide will be used for luminal inflation.

Locations

Country	Name	City	State
United States	Children's Hospital & Medical Center	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
University of Nebraska	Children's Hospital and Medical Center, Omaha, Nebraska

Country where clinical trial is conducted

United States, 

References & Publications (14)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants Reporting Abdominal Pain	Pain rating scales using FLACC and VAS will be used to assess self reported pain before and after the procedure	This will be assessed before and after the procedure