SuperNO2VA™ and General Anesthesia Postoperative Care

Not Applicable

• Conditions: Hypoxemia; Acute Respiratory Failure
• Interventions: Device: Supplemental oxygen; Device: SuperNO2VA nasal positive airway pressure devic

• Registration Number: NCT03969615
• Lead Sponsor: Vyaire Medical

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-15
• Status Verified: 2019-05
• Study First Submitted: 2019-05-29
• Study First Submitted QC: 2019-05-29
• Last Update Submitted: 2019-05-30
• Study First Posted: 2019-05-31
• Last Update Posted: 2019-06-03
• Primary Completion: 2019-10-15
• Study Completion: 2019-10-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supplemental oxygen	Supplemental oxygen	5lpm of supplemental oxygen via a nasal cannula or face mask
SuperNO2VA nasal positive airway pressure device	SuperNO2VA nasal positive airway pressure devic	Intervention arm will receive the SuperNO2VA nasal positive pressure device at 10lpm

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The University of Texas, MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States