Use of High Flow Nasal Cannula During Sedation of Morbidly Obese Patients in the Endoscopy Suite
Randomized. Controlled Trial of the Utilization of High Flow Nasal Cannula for Oxygenation of Sedated Morbidly Obese Patients in the Endoscopy Suite
1 other identifier
interventional
41
1 country
1
Brief Summary
This study evaluates the ability of high flow nasal cannula versus nasal cannula to oxygenate morbidly obese patients undergoing moderate to deep sedation for gastrointestinal procedures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2016
CompletedFirst Posted
Study publicly available on registry
August 9, 2016
CompletedStudy Start
First participant enrolled
December 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 28, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 28, 2018
CompletedResults Posted
Study results publicly available
April 16, 2020
CompletedApril 16, 2020
April 1, 2020
1.8 years
August 4, 2016
February 13, 2020
April 6, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Ability to Maintain Oxygenation
The ease at which the Anesthesiologist is able to maintain adequate oxygenation during the period of sedation required for the procedure. the ability of each oxygen device to maintain oxygenation was based on the number of manipulations; more manipulations, the device is less effective at maintaining saturation for this population.
During the period of sedation, on average up to 1 hour
Secondary Outcomes (2)
Number of Participants Requiring Airway Adjuncts During Procedure
During the period of sedation, on average up to 1 hour
Number of Participants Who Need an Increase in Fraction of Inspired Oxygen
During period of sedation, on average up to 1 hour
Study Arms (2)
High Flow Nasal Cannula
EXPERIMENTALHigh flow nasal cannula will be utilized to deliver oxygen to morbidly obese patients undergoing deep sedation for gastrointestinal procedures.
Nasal Cannula
ACTIVE COMPARATORTypical nasal cannula will be utilized to deliver oxygen to morbidly obese patients undergoing deep sedation for gastrointestinal procedures.
Interventions
High flow nasal cannula at 50 liters per minute and 50% oxygen will initially be used for oxygenation.
Control group will receive oxygen via standard flow nasal cannula at 5 liters per minute (approximately an FiO2 of 0.35)
Eligibility Criteria
You may qualify if:
- Body Mass Index greater than or equal to 40
- Scheduled for a gastrointestinal endoscopy that requires MAC sedation
You may not qualify if:
- Body Mass Index less than 40
- Pregnant
- Require either invasive or non-invasive ventilation for respiratory failure
- Use home oxygen
- Ventilation is via a tracheostomy
- The procedure is emergent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Montefiore Medical Center
The Bronx, New York, 10467, United States
Related Publications (6)
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.
PMID: 21316669BACKGROUNDNishimura 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.
PMID: 27016353BACKGROUNDCorley 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.
PMID: 21908497BACKGROUNDKabon 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.
PMID: 14739800BACKGROUNDStandards 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.
PMID: 18984096BACKGROUNDRigg 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.
PMID: 8150356BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr.Jay Berger
- Organization
- Montefiore Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Jay S Berger, MD
Montefiore Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2016
First Posted
August 9, 2016
Study Start
December 28, 2016
Primary Completion
September 28, 2018
Study Completion
September 28, 2018
Last Updated
April 16, 2020
Results First Posted
April 16, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share