Clinical trial NCT03969615: SuperNO2VA™ and General Anesthesia Postoperative Care
Official title: SuperNO2VA™ and General Anesthesia Postoperative Care: Comparing the Incidence, Severity, and Duration of Postoperative Oxygen Desaturation Between SuperNO2VA™ and Standard of Care, a RCT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypoxemia
Acute Respiratory Failure
Lead sponsor: Vyaire Medical
Sponsor class: INDUSTRY
Collaborators: name: M.D. Anderson Cancer Center
First posted: 2019-05-31
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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)


Eligibility criteria: 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

Primary outcomes:
measure: Hypoxemia
timeFrame: Within 90 minutes of extubation between the two study groups.
Secondary outcomes:
measure: Airway maneuvers
timeFrame: Within 90 minutes of extubation
measure: Post op respiratory complications
timeFrame: Within 90 minutes of extubation
measure: Length of PACU stay
timeFrame: Within 24 hours of surgery
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas, MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: The University of Texas MD Anderson Cancer Center
name: Carin Hagberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Abdelsattar ZM, Hendren S, Wong SL, Campbell DA Jr, Ramachandran SK. The Impact of Untreated Obstructive Sleep Apnea on Cardiopulmonary Complications in General and Vascular Surgery: A Cohort Study. Sleep. 2015 Aug 1;38(8):1205-10. doi: 10.5665/sleep.4892.
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citation: Cabrini L, Nobile L, Plumari VP, Landoni G, Borghi G, Mucchetti M, Zangrillo A. Intraoperative prophylactic and therapeutic non-invasive ventilation: a systematic review. Br J Anaesth. 2014 Apr;112(4):638-47. doi: 10.1093/bja/aet465. Epub 2014 Jan 19.
citation: Neligan PJ, Malhotra G, Fraser M, Williams N, Greenblatt EP, Cereda M, Ochroch EA. Continuous positive airway pressure via the Boussignac system immediately after extubation improves lung function in morbidly obese patients with obstructive sleep apnea undergoing laparoscopic bariatric surgery. Anesthesiology. 2009 Apr;110(4):878-84. doi: 10.1097/ALN.0b013e31819b5d8c.
citation: Jaber S, De Jong A, Castagnoli A, Futier E, Chanques G. Non-invasive ventilation after surgery. Ann Fr Anesth Reanim. 2014 Jul-Aug;33(7-8):487-91. doi: 10.1016/j.annfar.2014.07.742. Epub 2014 Aug 29.