Trials / Completed
CompletedNCT05175573
SuperNO2VA Et Versus Oxygen Face Mask During Deep Sedation
Comparison of Hypoxemia During Deep Sedation Procedures Between Oxygen Face Mask and the SuperNO2VA Et: a Randomized Controlled Trial. iOXIGENATe Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 110 (actual)
- Sponsor
- Vyaire Medical · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2022-06-07
- Primary completion
- 2022-11-01
- Completion
- 2022-11-01
- First posted
- 2022-01-04
- Last updated
- 2022-11-03
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05175573. Inclusion in this directory is not an endorsement.