SuperNO2VA Et Versus Oxygen Face Mask During Deep Sedation (iOXYGENATE)

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

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.

Study Overview

• Status: Completed
• Conditions: Hypoxemia
• Intervention / Treatment: Device: SuperNO2VA Et Nasal Positive Pressure Mask; Device: Supplemental Oxygen Face Mask

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SuperNO2VA Et; Continuous positive airway pressure with end-tidal CO2 monitoring	Device: SuperNO2VA Et Nasal Positive Pressure Mask; Nasal mask with capnography providing continuous positive airway pressure at 10LPM; Other Names: SuperNO2VA Et
ACTIVE_COMPARATOR: Supplemental Oxygen Face Mask	Device: Supplemental Oxygen Face Mask; Face mask with capnography providing oxygenation at 10 LPM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypoxemia	Compare the percentage of time spent with oxygen saturation below 90%.	Oxygen saturation below 90% for >15 seconds during procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Sedation	Compare the amount of propofol administered during induction and total dose administered for procedure.	Total duration of procedure
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
Airway maneuvers	Compare the incidence, duration, and reason for airway maneuvers.	Total duration of procedure
Procedure Duration	Compare the length of time for the procedure (ie: length of time from procedure start to procedure end).	Total duration of procedure
Recovery	Compare recovery times; Ready to discharge; Actual discharge	Total duration of post procedure in PACU
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)
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))
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
Anesthesiologist Satisfaction	Compare anesthesiologists satisfaction scores; Overall experience; Rating of sedation; Difficulty of patient to sedate	Total duration of procedure
Cardiac Complications	Compare the incidence of cardiac complications	Total duration of procedure and post procedure in PACU

Collaborators and Investigators

• Sponsor: Vyaire Medical
• Collaborators: M.D. Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 7, 2022
• Primary Completion (ACTUAL): November 1, 2022
• Study Completion (ACTUAL): November 1, 2022

Study Registration Dates

• First Submitted: October 12, 2021
• First Submitted That Met QC Criteria: December 3, 2021
• First Posted (ACTUAL): January 4, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 3, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: oxygenation; continuous positive airway pressure; hypoxemia; deep sedation; end-tidal CO2
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: 2021-0845

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No