Randomized. Controlled Trial of the Utilization of High Flow Nasal Cannula for Oxygenation of Sedated Morbidly Obese Patients in the Endoscopy Suite
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Montefiore Medical Center
- Enrollment
- 41
- Locations
- 2
- Primary Endpoint
- Ability to Maintain Oxygenation
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •Require either invasive or non-invasive ventilation for respiratory failure
- •Use home oxygen
- •Ventilation is via a tracheostomy
- •The procedure is emergent
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)