SuperNO2VA Et Versus Oxygen Face Mask During Deep Sedation

NCT05175573 | Completed FDA Device

• 1 other identifier: 2021-0845
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxemia

Keywords

oxygenation; hypoxemia; deep sedation; end-tidal CO2; continuous positive airway pressure

Outcome Measures

Primary Outcomes (1)

• Hypoxemia

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

  Oxygen saturation below 90% for >15 seconds during procedure

Secondary Outcomes (12)

• Oxygen desaturation

  Oxygen saturation below 90% for >15 seconds during procedure

• Hypoxemic Episodes

  Oxygen saturation below 90% for >15 seconds during procedure

• Sedation

  Total duration of procedure

• Procedural Interruptions

  Total duration of procedure

• Airway maneuvers

  Total duration of procedure

Study Arms (2)

SuperNO2VA Et

EXPERIMENTAL

Continuous positive airway pressure with end-tidal CO2 monitoring

Device: SuperNO2VA Et Nasal Positive Pressure Mask

Supplemental Oxygen Face Mask

ACTIVE COMPARATOR

Device: Supplemental Oxygen Face Mask

Interventions

SuperNO2VA Et Nasal Positive Pressure Mask DEVICE

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

Also known as: SuperNO2VA Et

SuperNO2VA Et

Supplemental Oxygen Face Mask DEVICE

Face mask with capnography providing oxygenation at 10 LPM

Supplemental Oxygen Face Mask

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vyaire Medical: lead
• M.D. Anderson Cancer Center: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Cukierman DS, Perez M, Guerra-Londono JJ, Carlson R, Hagan K, Ghebremichael S, Hagberg C, Ge PS, Raju GS, Rhim A, Cata JP. Nasal continuous positive pressure versus simple face mask oxygenation for adult obese and obstructive sleep apnea patients undergoing colonoscopy under propofol-based general anesthesia without tracheal intubation: A randomized controlled trial. J Clin Anesth. 2023 Oct;89:111196. doi: 10.1016/j.jclinane.2023.111196. Epub 2023 Jul 3.

  PMID: 37406462 DERIVED

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Juan Cata, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: January 4, 2022
• Study Start: June 7, 2022
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: November 3, 2022

Record last verified: 2022-11

Locations

US (1)