Recruiting

SuperNO2VA™

Sponsor:

Vyaire Medical

Code:

NCT03969615

Conditions

Hypoxemia

Acute Respiratory Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SuperNO2VA nasal positive airway pressure devic

Supplemental oxygen

Study Details

Brief 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

Study ID

NCT03969615

Start date

Oct 15, 2018

Status verified date

May, 2019

Completion date

Oct 15, 2019

Anticipated

Primary completion date

Oct 15, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Supplemental oxygen

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

experimental: SuperNO2VA nasal positive airway pressure device

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

Interventions

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

Supplemental oxygen

5lpm of supplemental oxygen

Primary outcome measure

  • Hypoxemia [ Time Frame: Within 90 minutes of extubation between the two study groups. ]

Central Contacts and Locations

Central contacts

Carin Hagberg, MD

7135633511chagberg@mdanderson.org

Shannon Hancher-Hodges, MD

shancher@mdanderson.org

Locations

The University of Texas, MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Carin Hagberg, MD

713-563-3511chagberg@mdanderson.org

More Information

Sponsor

Vyaire Medical

Last update posted

Jun 3, 2019

Last verified

May, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vyaire Medical on 2019-06-03.