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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Morbid Obesity, Noninvasive Ventilation, Deep Sedation

Intervention / Treatment
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* Device: High flow nasal cannula
* Device: Nasal Cannula


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | During the period of sedation, on average up to 1 hour | 
| Number of Participants Who Need an Increase in Fraction of Inspired Oxygen | Need to increase the FiO2 to maintain adequate oxygenation | During period of sedation, on average up to 1 hour |