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SuperNO2VA™ and General Anesthesia Postoperative Care

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ClinicalTrials.gov Identifier: NCT03969615
Recruitment Status : Recruiting
First Posted : May 31, 2019
Last Update Posted : June 3, 2019
Sponsor:
Collaborator:
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


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.



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

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 ClinicalTrials.gov identifier (NCT number): NCT03969615


Contacts
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Contact: Carin Hagberg, MD 7135633511 chagberg@mdanderson.org
Contact: Shannon Hancher-Hodges, MD shancher@mdanderson.org

Locations
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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    chagberg@mdanderson.org   
Sub-Investigator: Shannon Hancher-Hodges, MD         
Sponsors and Collaborators
Vyaire Medical
M.D. Anderson Cancer Center
Investigators
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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
ClinicalTrials.gov Identifier: NCT03969615     History of Changes
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
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Hypoxia
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms