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Use of High Flow Nasal Cannula During Sedation of Morbidly Obese Patients in the Endoscopy Suite

Primary Purpose

Morbid Obesity, Noninvasive Ventilation, Deep Sedation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High flow nasal cannula
Nasal Cannula
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Morbid Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Body Mass Index greater than or equal to 40
  • Scheduled for a gastrointestinal endoscopy that requires MAC sedation

Exclusion Criteria:

  • 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

Sites / Locations

  • Montefiore Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High Flow Nasal Cannula

Nasal Cannula

Arm Description

High flow nasal cannula will be utilized to deliver oxygen to morbidly obese patients undergoing deep sedation for gastrointestinal procedures.

Typical nasal cannula will be utilized to deliver oxygen to morbidly obese patients undergoing deep sedation for gastrointestinal procedures.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Participants Requiring Airway Adjuncts During Procedure
The use of airway adjuncts such as oral and nasal airways to insure adequate oxygenation during procedure.
Number of Participants Who Need an Increase in Fraction of Inspired Oxygen
Need to increase the FiO2 to maintain adequate oxygenation

Full Information

First Posted
August 4, 2016
Last Updated
April 6, 2020
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02859597
Brief Title
Use of High Flow Nasal Cannula During Sedation of Morbidly Obese Patients in the Endoscopy Suite
Official Title
Randomized. Controlled Trial of the Utilization of High Flow Nasal Cannula for Oxygenation of Sedated Morbidly Obese Patients in the Endoscopy Suite
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
December 28, 2016 (Actual)
Primary Completion Date
September 28, 2018 (Actual)
Study Completion Date
September 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center

4. Oversight

Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The respiratory physiology of morbidly obese patients is altered due to restriction of the chest wall motion which decreases pulmonary compliance. In addition, anatomical changes lead to an increased incidence of airway obstruction in morbidly obese patients during periods of sedation. Both a typical nasal cannula and high flow nasal cannula provide supplemental oxygen to the patients to prevent desaturation and hypoxia. However, the higher flow rates of high flow nasal cannulas are able to produce allows for washout of carbon dioxide from the respiratory system aiding with ventilation and creates 3 to 5 cm H2O of positive end expiration pressure which helps prevent collapse of the airway aiding with oxygenation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity, Noninvasive Ventilation, Deep Sedation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Flow Nasal Cannula
Arm Type
Experimental
Arm Description
High flow nasal cannula will be utilized to deliver oxygen to morbidly obese patients undergoing deep sedation for gastrointestinal procedures.
Arm Title
Nasal Cannula
Arm Type
Active Comparator
Arm Description
Typical nasal cannula will be utilized to deliver oxygen to morbidly obese patients undergoing deep sedation for gastrointestinal procedures.
Intervention Type
Device
Intervention Name(s)
High flow nasal cannula
Intervention Description
High flow nasal cannula at 50 liters per minute and 50% oxygen will initially be used for oxygenation.
Intervention Type
Device
Intervention Name(s)
Nasal Cannula
Intervention Description
Control group will receive oxygen via standard flow nasal cannula at 5 liters per minute (approximately an FiO2 of 0.35)
Primary Outcome Measure Information:
Title
Ability to Maintain Oxygenation
Description
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.
Time Frame
During the period of sedation, on average up to 1 hour
Secondary Outcome Measure Information:
Title
Number of Participants Requiring Airway Adjuncts During Procedure
Description
The use of airway adjuncts such as oral and nasal airways to insure adequate oxygenation during procedure.
Time Frame
During the period of sedation, on average up to 1 hour
Title
Number of Participants Who Need an Increase in Fraction of Inspired Oxygen
Description
Need to increase the FiO2 to maintain adequate oxygenation
Time Frame
During period of sedation, on average up to 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Body Mass Index greater than or equal to 40 Scheduled for a gastrointestinal endoscopy that requires MAC sedation Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay S Berger, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21316669
Citation
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.
Results Reference
background
PubMed Identifier
27016353
Citation
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.
Results Reference
background
PubMed Identifier
21908497
Citation
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.
Results Reference
background
PubMed Identifier
14739800
Citation
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.
Results Reference
background
PubMed Identifier
18984096
Citation
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.
Results Reference
background
PubMed Identifier
8150356
Citation
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.
Results Reference
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Use of High Flow Nasal Cannula During Sedation of Morbidly Obese Patients in the Endoscopy Suite

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