SuperNO2VA™ and General Anesthesia Postoperative Care

Study Overview
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Brief Summary
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The purpose of the study is to randomly and prospectively evaluate the differences in outcomes between the control group (closed full facemask immediate post-extubation with standard oxygenating device used post-operatively in PACU) and the SuperNO2VA™ group (SuperNO2VA™ immediate post-extubation and post-operatively in PACU)

Official Title
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SuperNO2VA™ and General Anesthesia Postoperative Care: Comparing the Incidence, Severity, and Duration of Postoperative Oxygen Desaturation Between SuperNO2VA™ and Standard of Care, a RCT

Conditions
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Hypoxemia, Acute Respiratory Failure

Intervention / Treatment
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* Device: SuperNO2VA nasal positive airway pressure devic
* Device: Supplemental oxygen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years of age or older Patients scheduled for general anesthesia with a supraglottic device or ETT American Society of Anesthesiology (ASA) Physical Status I-IV (E) Has provided written informed consent BMI > 35 kg/m2 or documented Obstructive Sleep Apnea Exclusion Criteria: Inability to give informed consent ASA V (E) Allergy to Propofol Any condition, in the Investigator's opinion, that would conflict or otherwise prevent the subject from complying with study required procedures, schedule or other study conduct BMI < 35 kg/m2 with no documented diagnosis (known) of Obstructive Sleep Apnea Known diagnosis of moderate to severe COPD/lung disease Patients that remained intubated post-operatively Patient refusal to wear the treatment device (SuperNO2VA™, nasal cannula, or oxygen facemask) for the duration of the study period postoperatively

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Supplemental oxygen<br>5lpm of supplemental oxygen via a nasal cannula or face mask | Device: Supplemental oxygen<br>* 5lpm of supplemental oxygen<br>* Other names: face mask;|
| Experimental: SuperNO2VA nasal positive airway pressure device<br>Intervention arm will receive the SuperNO2VA nasal positive pressure device at 10lpm | Device: SuperNO2VA nasal positive airway pressure devic<br>* SuperNO2VA nasal positive airway pressure device utilizes supplemental oxygen and an adjustable pressure limiting valve to maintain upper airway latency<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoxemia | Compare the incidence, severity, and duration of postoperative oxygen desaturation (oxygen saturation below 90% for greater than 1 consecutive minute) | Within 90 minutes of extubation between the two study groups. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Airway maneuvers | Compare the number of airway interventions including chin up and/or jaw thrust, oral and/or nasal airway insertion, mask ventilation, intubation with ETT or SGA insertion performed by anesthesia providers | Within 90 minutes of extubation | 
| Post op respiratory complications | Compare the incidence of respiratory complications between the two groups (shortness of breath, respiratory rate > 20 breaths per minute, accessory muscle use, difficulty breathing/swallowing/speaking) | Within 90 minutes of extubation | 
| Length of PACU stay | Compare the length of stay (time ready for discharge) in the recovery period between the control group and the SuperNO2VA™ group. | Within 24 hours of surgery |