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

November 1, 2022 updated by: Vyaire Medical

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hypoxemia
Time Frame: Oxygen saturation below 90% for >15 seconds during procedure
Compare the percentage of time spent with oxygen saturation below 90%.
Oxygen saturation below 90% for >15 seconds during procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Oxygen desaturation
Time Frame: 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.
Oxygen saturation below 90% for >15 seconds during procedure
Hypoxemic Episodes
Time Frame: Oxygen saturation below 90% for >15 seconds during procedure
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
Time Frame: Total duration of procedure
Compare the amount of propofol administered during induction and total dose administered for procedure.
Total duration of procedure
Procedural Interruptions
Time Frame: 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).
Total duration of procedure
Airway maneuvers
Time Frame: Total duration of procedure
Compare the incidence, duration, and reason for airway maneuvers.
Total duration of procedure
Procedure Duration
Time Frame: Total duration of procedure
Compare the length of time for the procedure (ie: length of time from procedure start to procedure end).
Total duration of procedure
Recovery
Time Frame: Total duration of post procedure in PACU

Compare recovery times

  1. Ready to discharge
  2. Actual discharge
Total duration of post procedure in PACU
Patient Satisfaction
Time Frame: 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
Total duration of procedure and post procedure in PACU (scale: 0 to 10; 0 - poor, 10 - excellent)
Patient Tolerance
Time Frame: 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
Total duration of procedure and post procedure in PACU (scale: None, Mild, Moderate, Severe; multiple choice: Yes or No))
Surgeon Satisfaction
Time Frame: 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
Total duration of procedure
Anesthesiologist Satisfaction
Time Frame: Total duration of procedure

Compare anesthesiologists satisfaction scores

  1. Overall experience
  2. Rating of sedation
  3. Difficulty of patient to sedate
Total duration of procedure
Cardiac Complications
Time Frame: Total duration of procedure and post procedure in PACU
Compare the incidence of cardiac complications
Total duration of procedure and post procedure in PACU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vyaire Medical

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
M.D. Anderson Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 7, 2022

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 4, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 3, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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