SuperNO2VA Et Versus Oxygen Face Mask During Deep Sedation

NCT ID: NCT05175573

Last Updated: 2022-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-07

Study Completion Date

2022-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Hypoxemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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SuperNO2VA Et

Continuous positive airway pressure with end-tidal CO2 monitoring

Group Type EXPERIMENTAL

SuperNO2VA Et Nasal Positive Pressure Mask

Intervention Type DEVICE

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

Supplemental Oxygen Face Mask

Group Type ACTIVE_COMPARATOR

Supplemental Oxygen Face Mask

Intervention Type DEVICE

Face mask with capnography providing oxygenation at 10 LPM

Interventions

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SuperNO2VA Et Nasal Positive Pressure Mask

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

Intervention Type DEVICE

Supplemental Oxygen Face Mask

Face mask with capnography providing oxygenation at 10 LPM

Intervention Type DEVICE

Other Intervention Names

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SuperNO2VA Et

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role collaborator

Vyaire Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Juan Cata, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37406462 (View on PubMed)

Other Identifiers

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2021-0845

Identifier Type: -

Identifier Source: org_study_id

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