SuperNO2VA Et Versus Oxygen Face Mask During Deep Sedation

Vyaire Medical110 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

110

Conditions

Hypoxemia

Interventions

SuperNO2VA Et Nasal Positive Pressure MaskDEVICE

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

Supplemental Oxygen Face MaskDEVICE

Face mask with capnography providing oxygenation at 10 LPM

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

Hypoxemia

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

Time frame: Oxygen saturation below 90% for >15 seconds during procedure

Secondary Outcomes

Oxygen desaturation

Compare area under the curve of oxygen desaturation (AUCDesat), a metric which combines incidence, duration, and severity into a single measurement.

Time frame: Oxygen saturation below 90% for >15 seconds during procedure

Hypoxemic Episodes

Compare incidence, duration, and severity of oxygen desaturation (oxygen saturation below 90% for ≥15 seconds).

Time frame: Oxygen saturation below 90% for >15 seconds during procedure

Sedation

Compare the amount of propofol administered during induction and total dose administered for procedure.

Time frame: Total duration of procedure

Procedural Interruptions

Compare the incidence and duration of procedural interruptions (ie: number of times and length of time the surgery has to be stopped due to light sedation).

Time frame: Total duration of procedure

Airway maneuvers

Compare the incidence, duration, and reason for airway maneuvers.

Time frame: Total duration of procedure

Procedure Duration

Compare the length of time for the procedure (ie: length of time from procedure start to procedure end).

Time frame: Total duration of procedure

Data from ClinicalTrials.gov

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