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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03969615

Enrollment

150

Registered

2019-05-31

Start date

2018-10-15

Completion date

2019-10-15

Last updated

2019-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxemia, Acute Respiratory Failure

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)

Interventions

DEVICESuperNO2VA 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

DEVICESupplemental oxygen

5lpm of supplemental oxygen

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Airway maneuvers	Within 90 minutes of extubation	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
Post op respiratory complications	Within 90 minutes of extubation	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)
Length of PACU stay	Within 24 hours of surgery	Compare the length of stay (time ready for discharge) in the recovery period between the control group and the SuperNO2VA™ group.

Countries

United States

Contacts

Primary ContactCarin Hagberg, MD

chagberg@mdanderson.org7135633511

Backup ContactShannon Hancher-Hodges, MD

shancher@mdanderson.org

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026