SuperNO2VA Et Versus Oxygen Face Mask During Deep Sedation
NCT ID: NCT05175573
Last Updated: 2022-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
110 participants
INTERVENTIONAL
2022-06-07
2022-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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SuperNO2VA Et
Continuous positive airway pressure with end-tidal CO2 monitoring
SuperNO2VA Et Nasal Positive Pressure Mask
Nasal mask with capnography providing continuous positive airway pressure at 10LPM
Supplemental Oxygen Face Mask
Supplemental Oxygen Face Mask
Face mask with capnography providing oxygenation at 10 LPM
Interventions
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SuperNO2VA Et Nasal Positive Pressure Mask
Nasal mask with capnography providing continuous positive airway pressure at 10LPM
Supplemental Oxygen Face Mask
Face mask with capnography providing oxygenation at 10 LPM
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients undergoing procedural deep sedation
3. American Society of Anesthesiology (ASA) Physical Status I-III
4. BMI ≥30 kg/m2 or documented Obstructive Sleep Apnea
5. Has provided written informed consent
6. Difficult airway
Exclusion Criteria
2. Emergent procedures
3. Pregnancy
4. Previous enrollment in this study
5. Inability to provide informed consent
6. History of allergic reaction to Propofol
7. Tracheostomy
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Vyaire Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Juan Cata, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Countries
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References
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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.
Other Identifiers
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2021-0845
Identifier Type: -
Identifier Source: org_study_id
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