Hypoxemia
Conditions
Keywords
oxygenation, hypoxemia, deep sedation, end-tidal CO2, continuous positive airway pressure
Brief 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.
Interventions
DEVICESuperNO2VA Et Nasal Positive Pressure Mask
Nasal mask with capnography providing continuous positive airway pressure at 10LPM
DEVICESupplemental Oxygen Face Mask
Face mask with capnography providing oxygenation at 10 LPM
Sponsors
M.D. Anderson Cancer Center
Vyaire Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypoxemia | Oxygen saturation below 90% for >15 seconds during procedure | Compare the percentage of time spent with oxygen saturation below 90%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypoxemic Episodes | Oxygen saturation below 90% for >15 seconds during procedure | Compare incidence, duration, and severity of oxygen desaturation (oxygen saturation below 90% for ≥15 seconds). |
| Sedation | Total duration of procedure | Compare the amount of propofol administered during induction and total dose administered for procedure. |
| Procedural Interruptions | Total duration of procedure | 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). |
| Airway maneuvers | Total duration of procedure | Compare the incidence, duration, and reason for airway maneuvers. |
| Procedure Duration | Total duration of procedure | Compare the length of time for the procedure (ie: length of time from procedure start to procedure end). |
| Oxygen desaturation | Oxygen saturation below 90% for >15 seconds during procedure | Compare area under the curve of oxygen desaturation (AUCDesat), a metric which combines incidence, duration, and severity into a single measurement. |
| Patient Satisfaction | Total duration of procedure and post procedure in PACU (scale: 0 to 10; 0 - poor, 10 - excellent) | Compare patient satisfaction scores (visual analog scale (VAS)) immediately after procedure 1. Overall experience 2. Quality of sedation |
| Patient Tolerance | Total duration of procedure and post procedure in PACU (scale: None, Mild, Moderate, Severe; multiple choice: Yes or No)) | Compare patient tolerance to SuperNO2VA Et compared to control (ie: nasal cannula at 10LPM) immediately after procedure 1. Pain experienced during procedure 2. Pain after the procedure 3. Nausea after awakening 4. Vomiting after awakening 5. Dizziness after awakening 6. Recollection of scope insertion 7. Recollection of scope removal 8. Awake during the procedure 9. Could drive at discharge if permitted k. Would work at discharge if permitted |
| Surgeon Satisfaction | Total duration of procedure | Compare surgeon satisfaction scores for 1. Overall experience 2. Rating of sedation 3. Difficulty of patient to sedate 4. Quality of the procedure |
| Anesthesiologist Satisfaction | Total duration of procedure | Compare anesthesiologists satisfaction scores 1. Overall experience 2. Rating of sedation 3. Difficulty of patient to sedate |
| Cardiac Complications | Total duration of procedure and post procedure in PACU | Compare the incidence of cardiac complications |
| Recovery | Total duration of post procedure in PACU | Compare recovery times 1. Ready to discharge 2. Actual discharge |
Countries
United States
Outcome results
None listed