SuperNO2VA™ and General Anesthesia Postoperative Care

Acute Respiratory Failure Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03969615
• Other study ID #: 2017-0371
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2018
• Est. completion date: October 15, 2019

Study information

• Verified date: May 2019
• Source: Vyaire Medical
• Contact: Carin Hagberg, MD
• Phone: 7135633511
• Email: chagberg[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 15, 2019
• Est. primary completion date: October 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Hypoxemia
• Hypoxia
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	The University of Texas, MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Vyaire Medical	M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

References & Publications (8)

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 — View 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. Rev — View 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. Review. — View Citation

Mutter TC, Chateau D, Moffatt M, Ramsey C, Roos LL, Kryger M. A matched cohort study of postoperative outcomes in obstructive sleep apnea: could preoperative diagnosis and treatment prevent complications? Anesthesiology. 2014 Oct;121(4):707-18. doi: 10.10 — View 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 un — View Citation

Simonneau G, Vivien A, Sartene R, Kunstlinger F, Samii K, Noviant Y, Duroux P. Diaphragm dysfunction induced by upper abdominal surgery. Role of postoperative pain. Am Rev Respir Dis. 1983 Nov;128(5):899-903. — View Citation

Smith PL, Wise RA, Gold AR, Schwartz AR, Permutt S. Upper airway pressure-flow relationships in obstructive sleep apnea. J Appl Physiol (1985). 1988 Feb;64(2):789-95. — View Citation

Sun Z, Sessler DI, Dalton JE, Devereaux PJ, Shahinyan A, Naylor AJ, Hutcherson MT, Finnegan PS, Tandon V, Darvish-Kazem S, Chugh S, Alzayer H, Kurz A. Postoperative Hypoxemia Is Common and Persistent: A Prospective Blinded Observational Study. Anesth Anal — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypoxemia	Compare the incidence, severity, and duration of postoperative oxygen desaturation (oxygen saturation below 90% for greater than 1 consecutive minute)	Within 90 minutes of extubation between the two study groups.
Secondary	Airway maneuvers	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	Within 90 minutes of extubation
Secondary	Post op respiratory complications	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)	Within 90 minutes of extubation
Secondary	Length of PACU stay	Compare the length of stay (time ready for discharge) in the recovery period between the control group and the SuperNO2VA™ group.	Within 24 hours of surgery