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| Name | Class |
|---|---|
| M.D. Anderson Cancer Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SuperNO2VA Et | Experimental | Continuous positive airway pressure with end-tidal CO2 monitoring |
|
| Supplemental Oxygen Face Mask | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SuperNO2VA Et Nasal Positive Pressure Mask | Device | Nasal mask with capnography providing continuous positive airway pressure at 10LPM |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hypoxemia | Compare the percentage of time spent with oxygen saturation below 90%. | Oxygen saturation below 90% for >15 seconds during procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen desaturation | Compare area under the curve of oxygen desaturation (AUCDesat), a metric which combines incidence, duration, and severity into a single measurement. | Oxygen saturation below 90% for >15 seconds during procedure |
| Hypoxemic Episodes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan Cata, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37406462 | Derived | Cukierman DS, Perez M, Guerra-Londono JJ, Carlson R, Hagan K, Ghebremichael S, Hagberg C, Ge PS, Raju GS, Rhim A, Cata JP. Nasal continuous positive pressure versus simple face mask oxygenation for adult obese and obstructive sleep apnea patients undergoing colonoscopy under propofol-based general anesthesia without tracheal intubation: A randomized controlled trial. J Clin Anesth. 2023 Oct;89:111196. doi: 10.1016/j.jclinane.2023.111196. Epub 2023 Jul 3. |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Supplemental Oxygen Face Mask | Device | Face mask with capnography providing oxygenation at 10 LPM |
|
Compare incidence, duration, and severity of oxygen desaturation (oxygen saturation below 90% for ≥15 seconds). |
| Oxygen saturation below 90% for >15 seconds during procedure |
| Sedation | Compare the amount of propofol administered during induction and total dose administered for procedure. | 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). | Total duration of procedure |
| Airway maneuvers | Compare the incidence, duration, and reason for airway maneuvers. | Total duration of procedure |
| Procedure Duration | Compare the length of time for the procedure (ie: length of time from procedure start to procedure end). | Total duration of procedure |
| Recovery | Compare recovery times
| Total duration of post procedure in PACU |
| Patient Satisfaction | Compare patient satisfaction scores (visual analog scale (VAS)) immediately after procedure
| Total duration of procedure and post procedure in PACU (scale: 0 to 10; 0 - poor, 10 - excellent) |
| Patient Tolerance | Compare patient tolerance to SuperNO2VA Et compared to control (ie: nasal cannula at 10LPM) immediately after procedure
k. Would work at discharge if permitted | Total duration of procedure and post procedure in PACU (scale: None, Mild, Moderate, Severe; multiple choice: Yes or No)) |
| Surgeon Satisfaction | Compare surgeon satisfaction scores for
| Total duration of procedure |
| Anesthesiologist Satisfaction | Compare anesthesiologists satisfaction scores
| Total duration of procedure |
| Cardiac Complications | Compare the incidence of cardiac complications | Total duration of procedure and post procedure in PACU |