SuperNO2VA Et Versus Oxygen Face Mask During Deep Sedation

Not Applicable

Completed

• Conditions: Hypoxemia
• Interventions: Device: Supplemental Oxygen Face Mask; Device: SuperNO2VA Et Nasal Positive Pressure Mask

• Registration Number: NCT05175573
• Lead Sponsor: Vyaire Medical

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-12
• Study First Submitted QC: 2021-12-03
• Study First Posted: 2022-01-04
• Study Start: 2022-06-07
• Status Verified: 2022-11
• Primary Completion: 2022-11-01
• Study Completion: 2022-11-01
• Last Update Submitted: 2022-11-01
• Last Update Posted: 2022-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supplemental Oxygen Face Mask	Supplemental Oxygen Face Mask	-
SuperNO2VA Et	SuperNO2VA Et Nasal Positive Pressure Mask	Continuous positive airway pressure with end-tidal CO2 monitoring

Primary Outcome Measures

Name	Time	Method
Hypoxemia	Oxygen saturation below 90% for >15 seconds during procedure	Compare the percentage of time spent with oxygen saturation below 90%.

Secondary Outcome Measures

Name	Time	Method
Oxygen desaturation	Oxygen saturation below 90% for >15 seconds during procedure	Compare area under the curve of oxygen desaturation (AUCDesat), a metric which combines incidence, duration, and severity into a single measurement.
Sedation	Total duration of procedure	Compare the amount of propofol administered during induction and total dose administered for procedure.
Airway maneuvers	Total duration of procedure	Compare the incidence, duration, and reason for airway maneuvers.
Procedure Duration	Total duration of procedure	Compare the length of time for the procedure (ie: length of time from procedure start to procedure end).
Patient Tolerance	Total duration of procedure and post procedure in PACU (scale: None, Mild, Moderate, Severe; multiple choice: Yes or No))	Compare patient tolerance to SuperNO2VA Et compared to control (ie: nasal cannula at 10LPM) immediately after procedure; 1. Pain experienced during procedure; 2. Pain after the procedure; 3. Nausea after awakening; 4. Vomiting after awakening; 5. Dizziness after awakening; 6. Recollection of scope insertion; 7. Recollection of scope removal; 8. Awake during the procedure; 9. Could drive at discharge if permitted; k. Would work at discharge if permitted
Anesthesiologist Satisfaction	Total duration of procedure	Compare anesthesiologists satisfaction scores; 1. Overall experience; 2. Rating of sedation; 3. Difficulty of patient to sedate
Hypoxemic Episodes	Oxygen saturation below 90% for >15 seconds during procedure	Compare incidence, duration, and severity of oxygen desaturation (oxygen saturation below 90% for ≥15 seconds).
Patient Satisfaction	Total duration of procedure and post procedure in PACU (scale: 0 to 10; 0 - poor, 10 - excellent)	Compare patient satisfaction scores (visual analog scale (VAS)) immediately after procedure; 1. Overall experience; 2. Quality of sedation
Surgeon Satisfaction	Total duration of procedure	Compare surgeon satisfaction scores for; 1. Overall experience; 2. Rating of sedation; 3. Difficulty of patient to sedate; 4. Quality of the procedure
Cardiac Complications	Total duration of procedure and post procedure in PACU	Compare the incidence of cardiac complications
Procedural Interruptions	Total duration of procedure	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).
Recovery	Total duration of post procedure in PACU	Compare recovery times; 1. Ready to discharge; 2. Actual discharge

Trial Locations

Locations (1)

University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States