HypoxemiaiOXYGENATENCT05175573
SuperNO2VA Et Versus Oxygen Face Mask During Deep Sedation
A study testing SuperNO2VA Et Nasal Positive Pressure Mask and Supplemental Oxygen Face Mask in people with Hypoxemia, run by Vyaire Medical at 1 site in United States.
Trial summary
The primary objective of the study is to prospectively and randomly compare the incidence, duration, and severity of oxygen desaturation between a nasal mask with nasal positive airway pressure (PAP) versus oxygen therapy with a facemask during procedural deep sedation in patients considered high risk for hypoxia (ie… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxemia
- What is being tested?
- SuperNO2VA Et Nasal Positive Pressure Mask and Supplemental Oxygen Face Mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2022to 1 Nov 2022
- 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 undergoing procedural deep sedation
- American Society of Anesthesiology (ASA) Physical Status I-III
- BMI ≥30 kg/m2 or documented Obstructive Sleep Apnea
- Has provided written informed consent
- Difficult airway
Who cannot join
- Acute exacerbation of respiratory disorders, including COPD and asthma
- Emergent procedures
- Pregnancy
- Previous enrollment in this study
- Inability to provide informed consent
- History of allergic reaction to Propofol
- Tracheostomy
- Exclusion criteria: deep sedation procedures that require intra-oral instrumentation (ie: EGD, transesophageal echocardiography
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Comparison of Hypoxemia During Deep Sedation Procedures Between Oxygen Face Mask and the SuperNO2VA Et: a Randomized Controlled Trial. iOXIGENATe Trial
The primary objective of the study is to prospectively and randomly compare the incidence, duration, and severity of oxygen desaturation between a nasal mask with nasal positive airway pressure (PAP) versus oxygen therapy with a facemask during procedural deep sedation in patients considered high risk for hypoxia (ie: BMI ≥30 kg/m2 or documented Obstructive Sleep Apnea.
- Conditions
- Hypoxemia
- Being tested
- SuperNO2VA Et Nasal Positive Pressure Mask, Supplemental Oxygen Face Mask
- Keywords
- oxygenation, hypoxemia, deep sedation, end-tidal CO2, continuous positive airway pressure
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuperNO2VA Et Nasal Positive Pressure MaskDevice
Also called SuperNO2VA Et
Nasal mask with capnography providing continuous positive airway pressure at 10LPM
Supplemental Oxygen Face MaskDevice
Face mask with capnography providing oxygenation at 10 LPM
| Study group | Role | What they receive |
|---|---|---|
| SuperNO2VA Et | Experimental | Continuous positive airway pressure with end-tidal CO2 monitoring Receives: Device: SuperNO2VA Et Nasal Positive Pressure Mask |
| Supplemental Oxygen Face Mask | Active comparator | Not described Receives: Device: Supplemental Oxygen Face Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoxemia
Compare the percentage of time spent with oxygen saturation below 90%.
Measured: Oxygen saturation below 90% for >15 seconds during procedure
Secondary outcomes (12)
Oxygen desaturation
Compare area under the curve of oxygen desaturation (AUCDesat), a metric which combines incidence, duration, and severity into a single measurement.
Measured: Oxygen saturation below 90% for >15 seconds during procedure
Hypoxemic Episodes
Compare incidence, duration, and severity of oxygen desaturation (oxygen saturation below 90% for ≥15 seconds).
Measured: Oxygen saturation below 90% for >15 seconds during procedure
Sedation
Compare the amount of propofol administered during induction and total dose administered for procedure.
Measured: Total duration of procedure
Procedural Interruptions
Compare the incidence and duration of procedural interruptions (ie: number of times and length of time the surgery has to be stopped due to light sedation).
Measured: Total duration of procedure
Airway maneuvers
Compare the incidence, duration, and reason for airway maneuvers.
Measured: Total duration of procedure
Procedure Duration
Compare the length of time for the procedure (ie: length of time from procedure start to procedure end).
Measured: Total duration of procedure
Recovery
Compare recovery times
- Ready to discharge
- Actual discharge
Measured: Total duration of post procedure in PACU
Patient Satisfaction
Compare patient satisfaction scores (visual analog scale (VAS)) immediately after procedure
- Overall experience
- Quality of sedation
Measured: Total duration of procedure and post procedure in PACU (scale: 0 to 10; 0 - poor, 10 - excellent)
Patient Tolerance
Compare patient tolerance to SuperNO2VA Et compared to control (ie: nasal cannula at 10LPM) immediately after procedure
- Pain experienced during procedure
- Pain after the procedure
- Nausea after awakening
- Vomiting after awakening
- Dizziness after awakening
- Recollection of scope insertion
- Recollection of scope removal
- Awake during the procedure
- Could drive at discharge if permitted
- Would work at discharge if permitted
Measured: Total duration of procedure and post procedure in PACU (scale: None, Mild, Moderate, Severe; multiple choice: Yes or No))
Surgeon Satisfaction
Compare surgeon satisfaction scores for
- Overall experience
- Rating of sedation
- Difficulty of patient to sedate
- Quality of the procedure
Measured: Total duration of procedure
Anesthesiologist Satisfaction
Compare anesthesiologists satisfaction scores
- Overall experience
- Rating of sedation
- Difficulty of patient to sedate
Measured: Total duration of procedure
Cardiac Complications
Compare the incidence of cardiac complications
Measured: Total duration of procedure and post procedure in PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start7 Jun 2022
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vyaire Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- M.D. Anderson Cancer Center
- Responsible party
- Sponsor
- Investigators
- Juan Cata, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05175573
- Sponsor's protocol ID
- 2021-0845
- Acronym
- iOXYGENATE
- Status last verified
- Nov 2022
- First submitted
- 12 Oct 2021
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Cukierman DS, Perez M, Guerra-Londono JJ, Carlson R, Hagan K, Ghebremichael S, Hagberg C, Ge PS, Raju GS, Rhim A, Cata JP. Nasal continuous positive pressure versus simple face mask oxygenation for adult obese and obstructive sleep apnea patients undergoing colonoscopy under propofol-based general anesthesia without tracheal intubation: A randomized controlled trial. J Clin Anesth. 2023 Oct;89:111196. doi: 10.1016/j.jclinane.2023.111196. Epub 2023 Jul 3.
PubMed 37406462
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Hypoxemia During Deep Sedation Procedures Between Oxygen Face Mask and the SuperNO2VA Et: a Randomized Controlled Trial. iOXIGENATe Trial
- ClinicalTrials.gov ID
- NCT05175573
- Acronym / sponsor ID
- iOXYGENATE / 2021-0845
- Conditions
- Hypoxemia
- Keywords
- oxygenation, hypoxemia, deep sedation, end-tidal CO2, continuous positive airway pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Vyaire MedicalIndustry (pharma, biotech, devices)
- Collaborators
- M.D. Anderson Cancer Center
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 4 Jan 2022 (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 primary objective of the study is to prospectively and randomly compare the incidence, duration, and severity of oxygen desaturation between a nasal mask with nasal positive airway pressure (PAP) versus oxygen therapy with a facemask during procedural deep sedation in patients considered high risk for hypoxia (ie: BMI ≥30 kg/m2 or documented Obstructive Sleep Apnea.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SuperNO2VA Et | Experimental | Device: SuperNO2VA Et Nasal Positive Pressure MaskContinuous positive airway pressure with end-tidal CO2 monitoring |
| Supplemental Oxygen Face Mask | Active comparator | Device: Supplemental Oxygen Face Mask |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years of age or older
- Patients undergoing procedural deep sedation
- American Society of Anesthesiology (ASA) Physical Status I-III
- BMI ≥30 kg/m2 or documented Obstructive Sleep Apnea
- Has provided written informed consent
Key exclusion criteria (8 listed)
- Acute exacerbation of respiratory disorders, including COPD and asthma
- Emergent procedures
- Pregnancy
- Previous enrollment in this study
- Inability to provide informed consent
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 Et Nasal Positive Pressure MaskAlso: SuperNO2VA EtNasal mask with capnography providing continuous positive airway pressure at 10LPM | Device | SuperNO2VA Et |
| Supplemental Oxygen Face MaskFace mask with capnography providing oxygenation at 10 LPM | Device | Supplemental Oxygen Face Mask |
Primary outcome
Hypoxemia
Time frame: Oxygen saturation below 90% for >15 seconds during procedure
Compare the percentage of time spent with oxygen saturation below 90%.
12 secondary outcomes
Oxygen desaturation
Time frame: Oxygen saturation below 90% for >15 seconds during procedure
Hypoxemic Episodes
Time frame: Oxygen saturation below 90% for >15 seconds during procedure
Sedation
Time frame: Total duration of procedure
Procedural Interruptions
Time frame: Total duration of procedure
Airway maneuvers
Time frame: Total duration of procedure
Procedure Duration
Time frame: Total duration of procedure
Recovery
Time frame: Total duration of post procedure in PACU
Patient Satisfaction
Time frame: Total duration of procedure and post procedure in PACU (scale: 0 to 10; 0 - poor, 10 - excellent)
Patient Tolerance
Time frame: Total duration of procedure and post procedure in PACU (scale: None, Mild, Moderate, Severe; multiple choice: Yes or No))
Surgeon Satisfaction
Time frame: Total duration of procedure
Anesthesiologist Satisfaction
Time frame: Total duration of procedure
Cardiac Complications
Time frame: Total duration of procedure and post procedure in PACU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Derived from this study: PubMed 37406462Cukierman DS, Perez M, Guerra-Londono JJ, Carlson R, Hagan K, Ghebremichael S, Hagberg C, Ge PS, Raju GS, Rhim A, Cata JP. Nasal continuous positive pressure versus simple face mask oxygenation for adult obese and obstructive sleep apnea patients undergoing colonoscopy under propofol-based general anesthesia without tracheal intubation: A randomized controlled trial. J Clin Anesth. 2023 Oct;89:111196. doi: 10.1016/j.jclinane.2023.111196. Epub 2023 Jul 3.
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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.
Juan Cata, 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 Et Nasal Positive Pressure Mask and Supplemental Oxygen Face Mask in people with Hypoxemia, 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 6 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: finished, as of the sponsor's last update on 3 Nov 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoxemia (time frame: Oxygen saturation below 90% for >15 seconds during procedure). 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 NCT05175573, which also lists 1 linked publication.
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 Nov 2022.