Comparison of Oxygenation Between Nasal PAP vs Nasal During Propofol-based Sedation for EUS

Study Overview
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Brief Summary
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Randomized controlled single site study involves oxygenation, continuous positive airway pressure, and ventilation of subject via nasal mask and oxygenationvia closed facemask. The intervention of the study are delivery form of supplemental oxygen, bag-mask ventilation, and continuous nasal CPAP intraoperatively and in the post anesthesia care period.

Detailed Description
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124 patients with BMI> or equal to 35kg.m2 or documented Obstructive Sleep Apnea scheduled for an EUS with Propofol sedation will be randomized to CPAP vs nasal mask for oxygenation during their procedure. Patients will be monitored every 2 minutes during the procedure and in the recovery area until discharge. If patients have difficulty or refuse to wear the mask, 2 or more simultaneous or non-synchronous adverse events, change in heart rhythm or ST changes on EKG they will immediately changed to the other group. The ansethesiologist, gastroenterologist & patient will complete post-procedure questionnaires regarding their opinion of the oxygen delivery system.

Official Title
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Comparison of Oxygenation Between Nasal Positive Airway Pressure (PAP) Versus Standard Care During Propofol-based Sedation for Endoscopic Ultrasound in an Ambulatory Surgical Setting: a Prospective Randomized Control Trial

Conditions
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Endoscopic Ultrasound

Intervention / Treatment
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* Device: SuperNO2VA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years of age or older Patients undergoing upper endoscopic ultrasound American Society of Anesthesiology (ASA) Physical Status I-III BMI ≥35 kg/m2 or documented Obstructive Sleep Apnea Has provided written informed consent Exclusion Criteria: Inpatient status Active Congestive Heart Failure Exacerbation Untreated ischemic heart disease Acute exacerbation of respiratory disorders, including COPD and asthma Emergent procedures Pregnancy Previous enrollment in this study Inability to provide informed consent Additional medical testing planned for the same day History of allergic reaction to Propofol Tracheostomy Supra-glottic or sub-glottic tumor Gastrointestinal tract obstruction or delayed transit (including delayed gastric emptying, gastric bezoar, achalasia, toxic megacolon).

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Random assignment to oxygen delivery system: facial mask or SuperNO2VA Et. Crossover to other oxygen delivery system if patient experiences difficulty with assigned system.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Facial mask<br>facial mask for oxygen delivery | Device: SuperNO2VA<br>* SUPERNO2VA is nasal PAP device for oxygen delivery<br>|
| Experimental: SuperNO2VA<br>SuperNO2VA is CPAP device to deliver oxygen with nasal mask rather than with facial mask | Device: SuperNO2VA<br>* SUPERNO2VA is nasal PAP device for oxygen delivery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Benefit of Nasal PAP Versus Nasal Administration of Oxygen | Compare the incidence, duration, and severity of oxygen desaturation | 60 minutes. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Amount of Propofol for Adequate Sedation | Compares amounts of Propofol for induction and entire procedure | 60 minutes. | 
| Modified Observer's Assessment and Alertness/Sedation Scale (MOAAS) | Compare MOAAS immediately prior to intubation and during procedure | 120 minutes | 
| Procedural Interruptions | Compare incidence, duration and reason for procedural interruptions | 60 minutes |