SuperNO2VA Et Versus Oxygen Face Mask During Deep Sedation (iOXYGENATE)

Vyaire Medical

Status: Completed

Conditions: Hypoxemia

Treatments: Device: Supplemental Oxygen Face Mask; Device: SuperNO2VA Et Nasal Positive Pressure Mask

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05175573

2021-0845

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
8. Exclusion criteria: deep sedation procedures that require intra-oral instrumentation (ie: EGD, transesophageal echocardiography

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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110 participants in 2 patient groups

SuperNO2VA Et

Experimental group

Description:

Continuous positive airway pressure with end-tidal CO2 monitoring

Treatment:

Device: SuperNO2VA Et Nasal Positive Pressure Mask

Supplemental Oxygen Face Mask

Active Comparator group

Treatment:

Device: Supplemental Oxygen Face Mask