search
Back to results

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

Primary Purpose

Hypoxemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SuperNO2VA Et Nasal Positive Pressure Mask
Supplemental Oxygen Face Mask
Sponsored by
Vyaire Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypoxemia focused on measuring oxygenation, hypoxemia, deep sedation, end-tidal CO2, continuous positive airway pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SuperNO2VA Et

Supplemental Oxygen Face Mask

Arm Description

Continuous positive airway pressure with end-tidal CO2 monitoring

Outcomes

Primary Outcome Measures

Hypoxemia
Compare the percentage of time spent with oxygen saturation below 90%.

Secondary Outcome Measures

Oxygen desaturation
Compare area under the curve of oxygen desaturation (AUCDesat), a metric which combines incidence, duration, and severity into a single measurement.
Hypoxemic Episodes
Compare incidence, duration, and severity of oxygen desaturation (oxygen saturation below 90% for ≥15 seconds).
Sedation
Compare the amount of propofol administered during induction and total dose administered for 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).
Airway maneuvers
Compare the incidence, duration, and reason for airway maneuvers.
Procedure Duration
Compare the length of time for the procedure (ie: length of time from procedure start to procedure end).
Recovery
Compare recovery times Ready to discharge Actual discharge
Patient Satisfaction
Compare patient satisfaction scores (visual analog scale (VAS)) immediately after procedure Overall experience Quality of sedation
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
Surgeon Satisfaction
Compare surgeon satisfaction scores for Overall experience Rating of sedation Difficulty of patient to sedate Quality of the procedure
Anesthesiologist Satisfaction
Compare anesthesiologists satisfaction scores Overall experience Rating of sedation Difficulty of patient to sedate
Cardiac Complications
Compare the incidence of cardiac complications

Full Information

First Posted
October 12, 2021
Last Updated
November 1, 2022
Sponsor
Vyaire Medical
Collaborators
M.D. Anderson Cancer Center
search

1. Study Identification

Unique Protocol Identification Number
NCT05175573
Brief Title
SuperNO2VA Et Versus Oxygen Face Mask During Deep Sedation
Acronym
iOXYGENATE
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
June 7, 2022 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
November 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vyaire Medical
Collaborators
M.D. Anderson Cancer Center

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxemia
Keywords
oxygenation, hypoxemia, deep sedation, end-tidal CO2, continuous positive airway pressure

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SuperNO2VA Et
Arm Type
Experimental
Arm Description
Continuous positive airway pressure with end-tidal CO2 monitoring
Arm Title
Supplemental Oxygen Face Mask
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
SuperNO2VA Et Nasal Positive Pressure Mask
Other Intervention Name(s)
SuperNO2VA Et
Intervention Description
Nasal mask with capnography providing continuous positive airway pressure at 10LPM
Intervention Type
Device
Intervention Name(s)
Supplemental Oxygen Face Mask
Intervention Description
Face mask with capnography providing oxygenation at 10 LPM
Primary Outcome Measure Information:
Title
Hypoxemia
Description
Compare the percentage of time spent with oxygen saturation below 90%.
Time Frame
Oxygen saturation below 90% for >15 seconds during procedure
Secondary Outcome Measure Information:
Title
Oxygen desaturation
Description
Compare area under the curve of oxygen desaturation (AUCDesat), a metric which combines incidence, duration, and severity into a single measurement.
Time Frame
Oxygen saturation below 90% for >15 seconds during procedure
Title
Hypoxemic Episodes
Description
Compare incidence, duration, and severity of oxygen desaturation (oxygen saturation below 90% for ≥15 seconds).
Time Frame
Oxygen saturation below 90% for >15 seconds during procedure
Title
Sedation
Description
Compare the amount of propofol administered during induction and total dose administered for procedure.
Time Frame
Total duration of procedure
Title
Procedural Interruptions
Description
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).
Time Frame
Total duration of procedure
Title
Airway maneuvers
Description
Compare the incidence, duration, and reason for airway maneuvers.
Time Frame
Total duration of procedure
Title
Procedure Duration
Description
Compare the length of time for the procedure (ie: length of time from procedure start to procedure end).
Time Frame
Total duration of procedure
Title
Recovery
Description
Compare recovery times Ready to discharge Actual discharge
Time Frame
Total duration of post procedure in PACU
Title
Patient Satisfaction
Description
Compare patient satisfaction scores (visual analog scale (VAS)) immediately after procedure Overall experience Quality of sedation
Time Frame
Total duration of procedure and post procedure in PACU (scale: 0 to 10; 0 - poor, 10 - excellent)
Title
Patient Tolerance
Description
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
Time Frame
Total duration of procedure and post procedure in PACU (scale: None, Mild, Moderate, Severe; multiple choice: Yes or No))
Title
Surgeon Satisfaction
Description
Compare surgeon satisfaction scores for Overall experience Rating of sedation Difficulty of patient to sedate Quality of the procedure
Time Frame
Total duration of procedure
Title
Anesthesiologist Satisfaction
Description
Compare anesthesiologists satisfaction scores Overall experience Rating of sedation Difficulty of patient to sedate
Time Frame
Total duration of procedure
Title
Cardiac Complications
Description
Compare the incidence of cardiac complications
Time Frame
Total duration of procedure and post procedure in PACU

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years of age or older Patients undergoing procedural deep sedation American Society of Anesthesiology (ASA) Physical Status I-III BMI ≥30 kg/m2 or documented Obstructive Sleep Apnea Has provided written informed consent Difficult airway Exclusion Criteria: Acute exacerbation of respiratory disorders, including COPD and asthma Emergent procedures Pregnancy Previous enrollment in this study Inability to provide informed consent History of allergic reaction to Propofol Tracheostomy Exclusion criteria: deep sedation procedures that require intra-oral instrumentation (ie: EGD, transesophageal echocardiography
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Cata, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

SuperNO2VA Et Versus Oxygen Face Mask During Deep Sedation

We'll reach out to this number within 24 hrs