SuperNO2VA Et Versus Oxygen Face Mask During Deep Sedation

Study Overview
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Brief Summary
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The primary objective of the study is to prospectively and randomly compare the incidence, duration, and severity of oxygen desaturation between a nasal mask with nasal positive airway pressure (PAP) versus oxygen therapy with a facemask during procedural deep sedation in patients considered high risk for hypoxia (ie: BMI ≥30 kg/m2 or documented Obstructive Sleep Apnea.

Official Title
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Comparison of Hypoxemia During Deep Sedation Procedures Between Oxygen Face Mask and the SuperNO2VA Et: a Randomized Controlled Trial. iOXIGENATe Trial

Conditions
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Hypoxemia

Intervention / Treatment
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* Device: SuperNO2VA Et Nasal Positive Pressure Mask
* Device: Supplemental Oxygen Face Mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years of age or older Patients undergoing procedural deep sedation American Society of Anesthesiology (ASA) Physical Status I-III BMI ≥30 kg/m2 or documented Obstructive Sleep Apnea Has provided written informed consent Difficult airway Exclusion Criteria: Acute exacerbation of respiratory disorders, including COPD and asthma Emergent procedures Pregnancy Previous enrollment in this study Inability to provide informed consent History of allergic reaction to Propofol Tracheostomy Exclusion criteria: deep sedation procedures that require intra-oral instrumentation (ie: EGD, transesophageal echocardiography

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SuperNO2VA Et<br>Continuous positive airway pressure with end-tidal CO2 monitoring | Device: SuperNO2VA Et Nasal Positive Pressure Mask<br>* Nasal mask with capnography providing continuous positive airway pressure at 10LPM<br>* Other names: SuperNO2VA Et;|
| Active Comparator: Supplemental Oxygen Face Mask<br> | Device: Supplemental Oxygen Face Mask<br>* Face mask with capnography providing oxygenation at 10 LPM<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoxemia | Compare the percentage of time spent with oxygen saturation below 90%. | Oxygen saturation below 90% for >15 seconds during procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen desaturation | Compare area under the curve of oxygen desaturation (AUCDesat), a metric which combines incidence, duration, and severity into a single measurement. | Oxygen saturation below 90% for >15 seconds during procedure | 
| Hypoxemic Episodes | Compare incidence, duration, and severity of oxygen desaturation (oxygen saturation below 90% for ≥15 seconds). | Oxygen saturation below 90% for >15 seconds during procedure | 
| Sedation | Compare the amount of propofol administered during induction and total dose administered for procedure. | Total duration of procedure | 
| Procedural Interruptions | Compare the incidence and duration of procedural interruptions (ie: number of times and length of time the surgery has to be stopped due to light sedation). | Total duration of procedure | 
| Airway maneuvers | Compare the incidence, duration, and reason for airway maneuvers. | Total duration of procedure | 
| Procedure Duration | Compare the length of time for the procedure (ie: length of time from procedure start to procedure end). | Total duration of procedure | 
| Recovery | Compare recovery times Ready to discharge Actual discharge | Total duration of post procedure in PACU | 
| Patient Satisfaction | Compare patient satisfaction scores (visual analog scale (VAS)) immediately after procedure Overall experience Quality of sedation | Total duration of procedure and post procedure in PACU (scale: 0 to 10; 0 - poor, 10 - excellent) | 
| Patient Tolerance | Compare patient tolerance to SuperNO2VA Et compared to control (ie: nasal cannula at 10LPM) immediately after procedure Pain experienced during procedure Pain after the procedure Nausea after awakening Vomiting after awakening Dizziness after awakening Recollection of scope insertion Recollection of scope removal Awake during the procedure Could drive at discharge if permitted k. Would work at discharge if permitted | Total duration of procedure and post procedure in PACU (scale: None, Mild, Moderate, Severe; multiple choice: Yes or No)) | 
| Surgeon Satisfaction | Compare surgeon satisfaction scores for Overall experience Rating of sedation Difficulty of patient to sedate Quality of the procedure | Total duration of procedure | 
| Anesthesiologist Satisfaction | Compare anesthesiologists satisfaction scores Overall experience Rating of sedation Difficulty of patient to sedate | Total duration of procedure | 
| Cardiac Complications | Compare the incidence of cardiac complications | Total duration of procedure and post procedure in PACU | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oxygenation, hypoxemia, deep sedation, end-tidal CO2, continuous positive airway pressure