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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03969615
Other study ID # 2017-0371
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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