SuperNO2VA Et Versus Oxygen Face Mask During Deep Sedation

Hypoxemia Clinical Trial

— iOXYGENATE  

Official title:

Comparison of Hypoxemia During Deep Sedation Procedures Between Oxygen Face Mask and the SuperNO2VA Et: a Randomized Controlled Trial. iOXIGENATe Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05175573
• Other study ID #: 2021-0845
• Status: Completed
• Phase: N/A
• Start date: June 7, 2022
• Est. completion date: November 1, 2022

Study information

• Verified date: November 2022
• Source: Vyaire Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypoxemia
• Hypoxia

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Vyaire Medical	M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypoxemia	Compare the percentage of time spent with oxygen saturation below 90%.	Oxygen saturation below 90% for >15 seconds during procedure
Secondary	Oxygen desaturation	Compare area under the curve of oxygen desaturation (AUCDesat), a metric which combines incidence, duration, and severity into a single measurement.	Oxygen saturation below 90% for >15 seconds during procedure
Secondary	Hypoxemic Episodes	Compare incidence, duration, and severity of oxygen desaturation (oxygen saturation below 90% for =15 seconds).	Oxygen saturation below 90% for >15 seconds during procedure
Secondary	Sedation	Compare the amount of propofol administered during induction and total dose administered for procedure.	Total duration of procedure
Secondary	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).	Total duration of procedure
Secondary	Airway maneuvers	Compare the incidence, duration, and reason for airway maneuvers.	Total duration of procedure
Secondary	Procedure Duration	Compare the length of time for the procedure (ie: length of time from procedure start to procedure end).	Total duration of procedure
Secondary	Recovery	Compare recovery times; Ready to discharge; Actual discharge	Total duration of post procedure in PACU
Secondary	Patient Satisfaction	Compare patient satisfaction scores (visual analog scale (VAS)) immediately after procedure; Overall experience; Quality of sedation	Total duration of procedure and post procedure in PACU (scale: 0 to 10; 0 - poor, 10 - excellent)
Secondary	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; k. Would work at discharge if permitted	Total duration of procedure and post procedure in PACU (scale: None, Mild, Moderate, Severe; multiple choice: Yes or No))
Secondary	Surgeon Satisfaction	Compare surgeon satisfaction scores for; Overall experience; Rating of sedation; Difficulty of patient to sedate; Quality of the procedure	Total duration of procedure
Secondary	Anesthesiologist Satisfaction	Compare anesthesiologists satisfaction scores; Overall experience; Rating of sedation; Difficulty of patient to sedate	Total duration of procedure
Secondary	Cardiac Complications	Compare the incidence of cardiac complications	Total duration of procedure and post procedure in PACU