SuperNO2VA™ and General Anesthesia Postoperative Care

Vyaire Medical

Status: Unknown

Conditions: Acute Respiratory Failure; Hypoxemia

Treatments: Device: SuperNO2VA nasal positive airway pressure devic; Device: Supplemental oxygen

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03969615

2017-0371

Details and patient eligibility

About

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)

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18 years of age or older
2. Patients scheduled for general anesthesia with a supraglottic device or ETT
3. American Society of Anesthesiology (ASA) Physical Status I-IV (E)
4. Has provided written informed consent
5. BMI > 35 kg/m2 or documented Obstructive Sleep Apnea

Exclusion criteria

1. Inability to give informed consent
2. ASA V (E)
3. Allergy to Propofol
4. 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
5. BMI < 35 kg/m2 with no documented diagnosis (known) of Obstructive Sleep Apnea
6. Known diagnosis of moderate to severe COPD/lung disease
7. Patients that remained intubated post-operatively
8. Patient refusal to wear the treatment device (SuperNO2VA™, nasal cannula, or oxygen facemask) for the duration of the study period postoperatively

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Supplemental oxygen

Active Comparator group

Description:

5lpm of supplemental oxygen via a nasal cannula or face mask

Treatment:

Device: Supplemental oxygen

SuperNO2VA nasal positive airway pressure device

Experimental group

Description:

Intervention arm will receive the SuperNO2VA nasal positive pressure device at 10lpm

Treatment:

Device: SuperNO2VA nasal positive airway pressure devic