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SuperNO2VA Et Versus Oxygen Face Mask During Deep Sedation

NCT05175573 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2022-11-03

No results posted yet for this study

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

Interventions

DEVICE

SuperNO2VA Et Nasal Positive Pressure Mask

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

DEVICE

Supplemental Oxygen Face Mask

Face mask with capnography providing oxygenation at 10 LPM

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • Vyaire Medical

    lead INDUSTRY

Principal Investigators

  • Juan Cata, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-07
Primary Completion
2022-11-01
Completion
2022-11-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05175573 on ClinicalTrials.gov