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

Not Applicable

Completed

• Conditions: Deep Sedation; Noninvasive Ventilation; Morbid Obesity
• Interventions: Device: High flow nasal cannula; Device: Nasal Cannula

• Registration Number: NCT02859597
• Lead Sponsor: Montefiore Medical Center

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.

Study Timeline

• Study First Submitted: 2016-08-04
• Study First Submitted QC: 2016-08-04
• Study First Posted: 2016-08-09
• Study Start: 2016-12-28
• Primary Completion: 2018-09-28
• Study Completion: 2018-09-28
• Results First Submitted: 2020-02-13
• Status Verified: 2020-04
• Results First Submitted QC: 2020-04-06
• Last Update Submitted: 2020-04-06
• Results First Posted: 2020-04-16
• Last Update Posted: 2020-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Flow Nasal Cannula	High flow nasal cannula	High flow nasal cannula will be utilized to deliver oxygen to morbidly obese patients undergoing deep sedation for gastrointestinal procedures.
Nasal Cannula	Nasal Cannula	Typical nasal cannula will be utilized to deliver oxygen to morbidly obese patients undergoing deep sedation for gastrointestinal procedures.

Primary Outcome Measures

Name	Time	Method
Ability to Maintain Oxygenation	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Requiring Airway Adjuncts During Procedure	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.
Number of Participants Who Need an Increase in Fraction of Inspired Oxygen	During period of sedation, on average up to 1 hour	Need to increase the FiO2 to maintain adequate oxygenation

Trial Locations

Locations (1)

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States