HypoxemiaNCT03969615
SuperNO2VA™ and General Anesthesia Postoperative Care
A study testing SuperNO2VA nasal positive airway pressure devic and Supplemental oxygen in people with Hypoxemia and Acute Respiratory Failure, run by Vyaire Medical at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxemia, Acute Respiratory Failure
- What is being tested?
- SuperNO2VA nasal positive airway pressure devic and Supplemental oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2018to 15 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Shannon Hancher-Hodges, MD contact
United States1 site, 1 recruiting
- Recruiting
The University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030
Carin Hagberg, MD, 713-563-3511, chagberg@mdanderson.org
Shannon Hancher-Hodges, MD
About this study
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
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)
- Conditions
- Hypoxemia, Acute Respiratory Failure
- Being tested
- SuperNO2VA nasal positive airway pressure devic, Supplemental oxygen
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Supplemental oxygenDevice
Also called nasal cannula, face mask
5lpm of supplemental oxygen
| Study group | Role | What they receive |
|---|---|---|
| Supplemental oxygen | Active comparator | 5lpm of supplemental oxygen via a nasal cannula or face mask Receives: Device: Supplemental oxygen |
| SuperNO2VA nasal positive airway pressure device | Experimental | Intervention arm will receive the SuperNO2VA nasal positive pressure device at 10lpm Receives: Device: SuperNO2VA nasal positive airway pressure devic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoxemia
Compare the incidence, severity, and duration of postoperative oxygen desaturation (oxygen saturation below 90% for greater than 1 consecutive minute)
Measured: Within 90 minutes of extubation between the two study groups.
Secondary outcomes (3)
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
Measured: Within 90 minutes of extubation
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)
Measured: Within 90 minutes of extubation
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.
Measured: Within 24 hours of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start15 Oct 2018
- Primary completion15 Oct 2019 (estimated)
- Study completion15 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for HypoxemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vyaire Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- M.D. Anderson Cancer Center
- Responsible party
- Sponsor
- Investigators
- Carin Hagberg, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03969615
- Sponsor's protocol ID
- 2017-0371
- Status last verified
- May 2019
- First submitted
- 29 May 2019
- Last updated
- 3 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 26287299Simonneau 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.
PubMed 6638679Mutter 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.
PubMed 25247853Abdelsattar 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.
PubMed 25761980Smith 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.
PubMed 3372436Cabrini 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.
PubMed 24444661Neligan 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.
PubMed 19293693Jaber 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.
PubMed 25168304
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03969615
- Acronym / sponsor ID
- 2017-0371
- Conditions
- Hypoxemia, Acute Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Vyaire MedicalIndustry (pharma, biotech, devices)
- Collaborators
- M.D. Anderson Cancer Center
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 15 Oct 2019 (estimated)
- Study completion
- 15 Oct 2019 (estimated)
- First posted
- 31 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplemental oxygen | Active comparator | Device: Supplemental oxygen5lpm of supplemental oxygen via a nasal cannula or face mask |
| SuperNO2VA nasal positive airway pressure device | Experimental | Device: SuperNO2VA nasal positive airway pressure devicIntervention arm will receive the SuperNO2VA nasal positive pressure device at 10lpm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SuperNO2VA nasal positive airway pressure devicSuperNO2VA nasal positive airway pressure device utilizes supplemental oxygen and an adjustable pressure limiting valve to maintain upper airway latency | Device | SuperNO2VA nasal positive airway pressure device |
| Supplemental oxygenAlso: nasal cannula, face mask5lpm of supplemental oxygen | Device | Supplemental oxygen |
Primary outcome
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)
3 secondary outcomes
Airway maneuvers
Time frame: Within 90 minutes of extubation
Post op respiratory complications
Time frame: Within 90 minutes of extubation
Length of PACU stay
Time frame: Within 24 hours of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2019.
- Results publication: PubMed 26287299Sun 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 publication: PubMed 6638679Simonneau 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 publication: PubMed 25247853Mutter 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 publication: PubMed 25761980Abdelsattar 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 publication: PubMed 3372436Smith 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 publication: PubMed 24444661Cabrini 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 publication: PubMed 19293693Neligan 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 publication: PubMed 25168304Jaber 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shannon Hancher-Hodges, MD contact
Carin Hagberg, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SuperNO2VA nasal positive airway pressure devic and Supplemental oxygen in people with Hypoxemia and Acute Respiratory Failure, run by Vyaire Medical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carin Hagberg, MD (7135633511, chagberg@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoxemia (time frame: Within 90 minutes of extubation between the two study groups.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03969615, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2019.