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Completed

NCT Number: NCT05175573

SuperNO2VA Et Versus Oxygen Face Mask During Deep Sedation

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.

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Key information

Conditions

Hypoxemia Hypoxia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SuperNO2VA Et Nasal Positive Pressure Mask

Device

Nasal mask with capnography providing continuous positive airway pressure at 10LPM

Other names: SuperNO2VA Et

Supplemental Oxygen Face Mask

Device

Face mask with capnography providing oxygenation at 10 LPM

Primary outcomes

  1. Hypoxemia

    Time frame: Oxygen saturation below 90% for >15 seconds during procedure

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

Secondary outcomes

  1. 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.

  2. 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).

  3. Sedation

    Time frame: Total duration of procedure

    Compare the amount of propofol administered during induction and total dose administered for procedure.

  4. 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).

  5. Airway maneuvers

    Time frame: Total duration of procedure

    Compare the incidence, duration, and reason for airway maneuvers.

  6. 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).

  7. Recovery

    Time frame: Total duration of post procedure in PACU

    Compare recovery times

    • Ready to discharge
    • Actual discharge

  8. 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

    • Overall experience
    • Quality of sedation

  9. 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

    • 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

  10. Surgeon Satisfaction

    Time frame: Total duration of procedure

    Compare surgeon satisfaction scores for

    • Overall experience
    • Rating of sedation
    • Difficulty of patient to sedate
    • Quality of the procedure

  11. Anesthesiologist Satisfaction

    Time frame: Total duration of procedure

    Compare anesthesiologists satisfaction scores

    • Overall experience
    • Rating of sedation
    • Difficulty of patient to sedate

  12. Cardiac Complications

    Time frame: Total duration of procedure and post procedure in PACU

    Compare the incidence of cardiac complications

Sponsors and collaborators

Lead sponsor

Vyaire Medical

Industry

Collaborators

  • M.D. Anderson Cancer Center

Registry information

Official study title

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

Acronym: iOXYGENATE

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 4, 2022
Registry last updated
Nov 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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