Is End Tidal CO2 Level Elevation During Upper Endoscopy With CO2 Gas Insufflation Physiologically Significant
NCT ID: NCT04541667
Last Updated: 2023-10-10
Study Results
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View full resultsBasic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2019-11-18
2022-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Air for luminal inflation
Patients randomized into this arm will have luminal inflation using air.
Air
Air will be used for luminal inflation.
Carbon Dioxide for luminal inflation
Patients randomized into this arm will have luminal inflation using carbon dioxide.
Carbon Dioxide
Carbon dioxide will be used for luminal inflation.
Interventions
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Air
Air will be used for luminal inflation.
Carbon Dioxide
Carbon dioxide will be used for luminal inflation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Undergoing upper endoscopy at Children's Hospital \& Medical Center in Omaha, NE and
* Parents or legal guardians consent to the study
Exclusion Criteria
* 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
6 Months
19 Years
ALL
No
Sponsors
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Children's Hospital and Medical Center, Omaha, Nebraska
OTHER
University of Nebraska
OTHER
Responsible Party
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Principal Investigators
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Chinenye R Dike, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital & Medical Center / University of Nebraska Medical Center
Locations
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Children's Hospital & Medical Center
Omaha, Nebraska, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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0632-19-FB
Identifier Type: -
Identifier Source: org_study_id
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