Use of High Flow Nasal Cannula During Sedation of Morbidly Obese Patients in the Endoscopy Suite
NCT ID: NCT02859597
Last Updated: 2020-04-16
Study Results
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View full resultsBasic Information
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COMPLETED
NA
41 participants
INTERVENTIONAL
2016-12-28
2018-09-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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High Flow Nasal Cannula
High flow nasal cannula will be utilized to deliver oxygen to morbidly obese patients undergoing deep sedation for gastrointestinal procedures.
High flow nasal cannula
High flow nasal cannula at 50 liters per minute and 50% oxygen will initially be used for oxygenation.
Nasal Cannula
Typical nasal cannula will be utilized to deliver oxygen to morbidly obese patients undergoing deep sedation for gastrointestinal procedures.
Nasal Cannula
Control group will receive oxygen via standard flow nasal cannula at 5 liters per minute (approximately an FiO2 of 0.35)
Interventions
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High flow nasal cannula
High flow nasal cannula at 50 liters per minute and 50% oxygen will initially be used for oxygenation.
Nasal Cannula
Control group will receive oxygen via standard flow nasal cannula at 5 liters per minute (approximately an FiO2 of 0.35)
Eligibility Criteria
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Inclusion Criteria
* Scheduled for a gastrointestinal endoscopy that requires MAC sedation
Exclusion Criteria
* Pregnant
* Require either invasive or non-invasive ventilation for respiratory failure
* Use home oxygen
* Ventilation is via a tracheostomy
* The procedure is emergent
18 Years
ALL
Yes
Sponsors
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Montefiore Medical Center
OTHER
Responsible Party
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Principal Investigators
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Jay S Berger, MD
Role: PRINCIPAL_INVESTIGATOR
Montefiore Medical Center
Locations
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Montefiore Medical Center
The Bronx, New York, United States
Countries
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References
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Berzin TM, Sanaka S, Barnett SR, Sundar E, Sepe PS, Jakubowski M, Pleskow DK, Chuttani R, Sawhney MS. A prospective assessment of sedation-related adverse events and patient and endoscopist satisfaction in ERCP with anesthesiologist-administered sedation. Gastrointest Endosc. 2011 Apr;73(4):710-7. doi: 10.1016/j.gie.2010.12.011. Epub 2011 Feb 12.
Nishimura M. High-Flow Nasal Cannula Oxygen Therapy in Adults: Physiological Benefits, Indication, Clinical Benefits, and Adverse Effects. Respir Care. 2016 Apr;61(4):529-41. doi: 10.4187/respcare.04577.
Corley A, Caruana LR, Barnett AG, Tronstad O, Fraser JF. Oxygen delivery through high-flow nasal cannulae increase end-expiratory lung volume and reduce respiratory rate in post-cardiac surgical patients. Br J Anaesth. 2011 Dec;107(6):998-1004. doi: 10.1093/bja/aer265. Epub 2011 Sep 9.
Kabon B, Nagele A, Reddy D, Eagon C, Fleshman JW, Sessler DI, Kurz A. Obesity decreases perioperative tissue oxygenation. Anesthesiology. 2004 Feb;100(2):274-80. doi: 10.1097/00000542-200402000-00015.
Standards of Practice Committee of the American Society for Gastrointestinal Endoscopy; Lichtenstein DR, Jagannath S, Baron TH, Anderson MA, Banerjee S, Dominitz JA, Fanelli RD, Gan SI, Harrison ME, Ikenberry SO, Shen B, Stewart L, Khan K, Vargo JJ. Sedation and anesthesia in GI endoscopy. Gastrointest Endosc. 2008 Nov;68(5):815-26. doi: 10.1016/j.gie.2008.09.029. No abstract available.
Rigg JD, Watt TC, Tweedle DE, Martin DF. Oxygen saturation during endoscopic retrograde cholangiopancreatography: a comparison of two protocols of oxygen administration. Gut. 1994 Mar;35(3):408-11. doi: 10.1136/gut.35.3.408.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2016-6677
Identifier Type: -
Identifier Source: org_study_id
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