Back to resultsSuperNO2VA™ and General Anesthesia Postoperative Care
Primary Purpose
Hypoxemia, Acute Respiratory Failure
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SuperNO2VA nasal positive airway pressure devic
Supplemental oxygen
Sponsored by
About this trial
This is an interventional supportive care trial for Hypoxemia
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- The University of Texas, MD Anderson Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Supplemental oxygen
SuperNO2VA nasal positive airway pressure device
Arm Description
5lpm of supplemental oxygen via a nasal cannula or face mask
Intervention arm will receive the SuperNO2VA nasal positive pressure device at 10lpm
Outcomes
Primary Outcome Measures
Hypoxemia
Compare the incidence, severity, and duration of postoperative oxygen desaturation (oxygen saturation below 90% for greater than 1 consecutive minute)
Secondary Outcome Measures
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
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)
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.
Full Information
NCT ID
NCT03969615
First Posted
May 29, 2019
Last Updated
May 30, 2019
Sponsor
Vyaire Medical
Collaborators
M.D. Anderson Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT03969615
Brief Title
SuperNO2VA™ and General Anesthesia Postoperative 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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2018 (Actual)
Primary Completion Date
October 15, 2019 (Anticipated)
Study Completion Date
October 15, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vyaire Medical
Collaborators
M.D. Anderson Cancer Center
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxemia, Acute Respiratory Failure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Supplemental oxygen
Arm Type
Active Comparator
Arm Description
5lpm of supplemental oxygen via a nasal cannula or face mask
Arm Title
SuperNO2VA nasal positive airway pressure device
Arm Type
Experimental
Arm Description
Intervention arm will receive the SuperNO2VA nasal positive pressure device at 10lpm
Intervention Type
Device
Intervention Name(s)
SuperNO2VA nasal positive airway pressure devic
Intervention Description
SuperNO2VA nasal positive airway pressure device utilizes supplemental oxygen and an adjustable pressure limiting valve to maintain upper airway latency
Intervention Type
Device
Intervention Name(s)
Supplemental oxygen
Other Intervention Name(s)
nasal cannula, face mask
Intervention Description
5lpm of supplemental oxygen
Primary Outcome Measure Information:
Title
Hypoxemia
Description
Compare the incidence, severity, and duration of postoperative oxygen desaturation (oxygen saturation below 90% for greater than 1 consecutive minute)
Time Frame
Within 90 minutes of extubation between the two study groups.
Secondary Outcome Measure Information:
Title
Airway maneuvers
Description
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
Time Frame
Within 90 minutes of extubation
Title
Post op respiratory complications
Description
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)
Time Frame
Within 90 minutes of extubation
Title
Length of PACU stay
Description
Compare the length of stay (time ready for discharge) in the recovery period between the control group and the SuperNO2VA™ group.
Time Frame
Within 24 hours of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carin Hagberg, MD
Phone
7135633511
Email
chagberg@mdanderson.org
First Name & Middle Initial & Last Name or Official Title & Degree
Shannon Hancher-Hodges, MD
Email
shancher@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carin Hagberg, MD
Organizational Affiliation
The University of Texas MD Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas, MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carin Hagberg, MD
Phone
713-563-3511
Email
chagberg@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Shannon Hancher-Hodges, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26287299
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 Analg. 2015 Sep;121(3):709-715. doi: 10.1213/ANE.0000000000000836.
Results Reference
result
PubMed Identifier
6638679
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. doi: 10.1164/arrd.1983.128.5.899.
Results Reference
result
PubMed Identifier
25247853
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: 10.1097/ALN.0000000000000407.
Results Reference
result
PubMed Identifier
25761980
Citation
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.
Results Reference
result
PubMed Identifier
3372436
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. doi: 10.1152/jappl.1988.64.2.789.
Results Reference
result
PubMed Identifier
24444661
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.
Results Reference
result
PubMed Identifier
19293693
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 undergoing laparoscopic bariatric surgery. Anesthesiology. 2009 Apr;110(4):878-84. doi: 10.1097/ALN.0b013e31819b5d8c.
Results Reference
result
PubMed Identifier
25168304
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.
Results Reference
result
Learn more about this trial
SuperNO2VA™ and General Anesthesia Postoperative Care
We'll reach out to this number within 24 hrs