NCT03969615

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 31, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2019

Completed
Last Updated

June 3, 2019

Status Verified

May 1, 2019

Enrollment Period

1 year

First QC Date

May 29, 2019

Last Update Submit

May 30, 2019

Conditions

HypoxemiaAcute Respiratory Failure

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Airway maneuvers

    Within 90 minutes of extubation

  • Post op respiratory complications

    Within 90 minutes of extubation

  • Length of PACU stay

    Within 24 hours of surgery

Study Arms (2)

Supplemental oxygen

ACTIVE COMPARATOR

5lpm of supplemental oxygen via a nasal cannula or face mask

Device: Supplemental oxygen

SuperNO2VA nasal positive airway pressure device

EXPERIMENTAL

Intervention arm will receive the SuperNO2VA nasal positive pressure device at 10lpm

Device: SuperNO2VA nasal positive airway pressure devic

Interventions

SuperNO2VA nasal positive airway pressure devicDEVICE

SuperNO2VA nasal positive airway pressure device utilizes supplemental oxygen and an adjustable pressure limiting valve to maintain upper airway latency

SuperNO2VA nasal positive airway pressure device
Supplemental oxygenDEVICE

5lpm of supplemental oxygen

Also known as: nasal cannula, face mask
Supplemental oxygen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years of age or older
  • Patients scheduled for general anesthesia with a supraglottic device or ETT
  • American Society of Anesthesiology (ASA) Physical Status I-IV (E)
  • Has provided written informed consent
  • BMI \> 35 kg/m2 or documented Obstructive Sleep Apnea

You may not qualify if:

  • Inability to give informed consent
  • ASA V (E)
  • Allergy to Propofol
  • 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
  • BMI \< 35 kg/m2 with no documented diagnosis (known) of Obstructive Sleep Apnea
  • Known diagnosis of moderate to severe COPD/lung disease
  • Patients that remained intubated post-operatively
  • Patient refusal to wear the treatment device (SuperNO2VA™, nasal cannula, or oxygen facemask) for the duration of the study period postoperatively

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas, MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Publications (8)

  • 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 Analg. 2015 Sep;121(3):709-715. doi: 10.1213/ANE.0000000000000836.

    PMID: 26287299RESULT

  • 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. doi: 10.1164/arrd.1983.128.5.899.

    PMID: 6638679RESULT

  • 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: 10.1097/ALN.0000000000000407.

    PMID: 25247853RESULT

  • 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.

    PMID: 25761980RESULT

  • 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. doi: 10.1152/jappl.1988.64.2.789.

    PMID: 3372436RESULT

  • 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.

    PMID: 24444661RESULT

  • 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.

    PMID: 19293693RESULT

  • 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.

    PMID: 25168304RESULT

MeSH Terms

Conditions

Hypoxia

Interventions

CannulaMasks

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CathetersEquipment and SuppliesSurgical AttireEquipment and Supplies, HospitalProtective DevicesPersonal Protective EquipmentSurgical EquipmentManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Carin Hagberg, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carin Hagberg, MD

CONTACT

7135633511chagberg@mdanderson.org

Shannon Hancher-Hodges, MD

CONTACT

shancher@mdanderson.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2019

First Posted

May 31, 2019

Study Start

October 15, 2018

Primary Completion

October 15, 2019

Study Completion

October 15, 2019

Last Updated

June 3, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)