Clinical trial NCT05175573: SuperNO2VA Et Versus Oxygen Face Mask During Deep Sedation
Official title: Comparison of Hypoxemia During Deep Sedation Procedures Between Oxygen Face Mask and the SuperNO2VA Et: a Randomized Controlled Trial. iOXIGENATe Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxemia
Keywords: oxygenation
hypoxemia
deep sedation
end-tidal CO2
continuous positive airway pressure
Lead sponsor: Vyaire Medical
Sponsor class: INDUSTRY
Collaborators: name: M.D. Anderson Cancer Center
First posted: 2022-01-04
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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: BMI ≥30 kg/m2 or documented Obstructive Sleep Apnea.


Eligibility criteria: Inclusion Criteria:

1. Age 18 years of age or older
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:

1. Acute exacerbation of respiratory disorders, including COPD and asthma
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
8. Exclusion criteria: deep sedation procedures that require intra-oral instrumentation (ie: EGD, transesophageal echocardiography

Primary outcomes:
measure: Hypoxemia
timeFrame: Oxygen saturation below 90% for >15 seconds during procedure
Secondary outcomes:
measure: Oxygen desaturation
timeFrame: Oxygen saturation below 90% for >15 seconds during procedure
measure: Hypoxemic Episodes
timeFrame: Oxygen saturation below 90% for >15 seconds during procedure
measure: Sedation
timeFrame: Total duration of procedure
measure: Procedural Interruptions
timeFrame: Total duration of procedure
measure: Airway maneuvers
timeFrame: Total duration of procedure
measure: Procedure Duration
timeFrame: Total duration of procedure
measure: Recovery
timeFrame: Total duration of post procedure in PACU
measure: Patient Satisfaction
timeFrame: Total duration of procedure and post procedure in PACU (scale: 0 to 10; 0 - poor, 10 - excellent)
measure: Patient Tolerance
timeFrame: Total duration of procedure and post procedure in PACU (scale: None, Mild, Moderate, Severe; multiple choice: Yes or No))
measure: Surgeon Satisfaction
timeFrame: Total duration of procedure
measure: Anesthesiologist Satisfaction
timeFrame: Total duration of procedure
measure: Cardiac Complications
timeFrame: Total duration of procedure and post procedure in PACU
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Juan Cata, MD
role: PRINCIPAL_INVESTIGATOR
References: