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

April 6, 2020 updated by: Montefiore Medical Center

Randomized. Controlled Trial of the Utilization of High Flow Nasal Cannula for Oxygenation of Sedated Morbidly Obese Patients in the Endoscopy Suite

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High Flow Nasal Cannula
High flow nasal cannula will be utilized to deliver oxygen to morbidly obese patients undergoing deep sedation for gastrointestinal procedures.
Device: High flow nasal cannula
High flow nasal cannula at 50 liters per minute and 50% oxygen will initially be used for oxygenation.
Active Comparator: Nasal Cannula
Typical nasal cannula will be utilized to deliver oxygen to morbidly obese patients undergoing deep sedation for gastrointestinal procedures.
Device: Nasal Cannula
Control group will receive oxygen via standard flow nasal cannula at 5 liters per minute (approximately an FiO2 of 0.35)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ability to Maintain Oxygenation
Time Frame: During the period of sedation, on average up to 1 hour
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Requiring Airway Adjuncts During Procedure
Time Frame: During the period of sedation, on average up to 1 hour
The use of airway adjuncts such as oral and nasal airways to insure adequate oxygenation 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
Time Frame: During period of sedation, on average up to 1 hour
Need to increase the FiO2 to maintain adequate oxygenation
During period of sedation, on average up to 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Investigators

  • Principal Investigator: Jay S Berger, MD, Montefiore Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 28, 2016

Primary Completion (Actual)

September 28, 2018

Study Completion (Actual)

September 28, 2018

Study Registration Dates

First Submitted

August 4, 2016

First Submitted That Met QC Criteria

August 4, 2016

First Posted (Estimate)

August 9, 2016

Study Record Updates

Last Update Posted (Actual)

April 16, 2020

Last Update Submitted That Met QC Criteria

April 6, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-6677

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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