Effect of Nasal Positive Airway Pressure Versus Standard Care on Oxygenation and Ventilation During Propofol-based Sedation for Colonoscopy in Patients With High Risk of Airway Obstruction
NCT ID: NCT05524220
Last Updated: 2025-04-22
Study Results
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View full resultsBasic Information
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COMPLETED
NA
139 participants
INTERVENTIONAL
2022-12-19
2023-08-09
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
TREATMENT
NONE
Study Groups
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Group A: Standard care with a facemask.
Standard care with a facemask.
The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM)
Group B: SuperNO2VA™EtCO2
SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)
The anesthesia provider will attach the SuperNO2VA™ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)
Interventions
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Standard care with a facemask.
The anesthesia provider will supply oxygen via the closed facemask at 10 liters per minute (LPM)
SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)
The anesthesia provider will attach the SuperNO2VA™ EtCO2 circuit port to the hyperinflation bag with the oxygen flow rate to 10 L/min. The oxygenation, continuous positive airway pressure, and ventilation of the subject will be done via SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus)
Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiology (ASA) Physical Status I-III
* BMI ≥30 kg/m2 or suspected Obstructive Sleep Apnea
Exclusion Criteria
* Active Congestive Heart Failure Exacerbation
* Untreated ischemic heart disease
* Acute exacerbation of respiratory disorders, including Chronic obstructive pulmonary disease (COPD) and asthma
* Emergent procedures
* Pregnancy
* Previous enrollment in this study
* Inability to provide informed consent
* Additional medical testing planned for the same day
* History of allergic reaction to Propofol
* Tracheostomy
* Supra-glottic or sub-glottic tumor
* Gastrointestinal tract obstruction or delayed transit (including delayed gastric emptying, gastric bezoar, achalasia, toxic megacolon).
* Prisoners
* Unable to fit SuperNoVa
18 Years
ALL
No
Sponsors
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Vyaire Medical
INDUSTRY
The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Erikka L Washington
Assistant Professor
Principal Investigators
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Erikka Washington, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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HSC-MS-22-0351
Identifier Type: -
Identifier Source: org_study_id
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