NCT03969615

SuperNO2VA™ and General Anesthesia Postoperative Care

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Vyaire Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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)

Conditions

• Hypoxemia
• Acute Respiratory Failure

Interventions

Type	Name	Description
DEVICE	SuperNO2VA nasal positive airway pressure devic	SuperNO2VA nasal positive airway pressure device utilizes supplemental oxygen and an adjustable pressure limiting valve to maintain upper airway latency
DEVICE	Supplemental oxygen	5lpm of supplemental oxygen

Timeline

• Start date: 2018-10-15
• Primary completion: 2019-10-15
• Completion: 2019-10-15
• First posted: 2019-05-31
• Last updated: 2019-06-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study