SuperNO2VA™ and General Anesthesia Postoperative Care

Status unconfirmed · Not applicable

Conditions studied: Hypoxemia, Acute Respiratory Failure

In brief

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)

Key facts

Study ID

NCT03969615

Run by

Vyaire Medical

People needed

150

Starts

2018-10-15

Expected to finish

2019-10-15

Last updated by the study team

2019-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The University of Texas, MD Anderson Cancer Center — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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