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SuperNO2VA™ and General Anesthesia Postoperative Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03969615
Recruitment Status : Unknown
Verified May 2019 by Vyaire Medical.
Recruitment status was:  Recruiting
First Posted : May 31, 2019
Last Update Posted : June 3, 2019
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
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)

Condition or disease Intervention/treatment Phase
Hypoxemia Acute Respiratory Failure Device: SuperNO2VA nasal positive airway pressure devic Device: Supplemental oxygen Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive 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
Actual Study Start Date : October 15, 2018
Estimated Primary Completion Date : October 15, 2019
Estimated Study Completion Date : October 15, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Supplemental oxygen
5lpm of supplemental oxygen via a nasal cannula or face mask
Device: Supplemental oxygen
5lpm of supplemental oxygen
Other Names:
  • nasal cannula
  • face mask

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

Primary Outcome Measures :
  1. Hypoxemia [ Time Frame: 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 :
  1. Airway maneuvers [ Time Frame: 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

  2. Post op respiratory complications [ Time Frame: 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)

  3. Length of PACU stay [ Time Frame: 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03969615

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Contact: Carin Hagberg, MD 7135633511
Contact: Shannon Hancher-Hodges, MD

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United States, Texas
The University of Texas, MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Carin Hagberg, MD    713-563-3511   
Sub-Investigator: Shannon Hancher-Hodges, MD         
Sponsors and Collaborators
Vyaire Medical
M.D. Anderson Cancer Center
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Principal Investigator: Carin Hagberg, MD The University of Texas MD Anderson Cancer Center
Publications of Results:

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Responsible Party: Vyaire Medical Identifier: NCT03969615    
Other Study ID Numbers: 2017-0371
First Posted: May 31, 2019    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory