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The Tao Mask is a new novel facemask for positive pressure ventilation which has recently been demonstrated (MUSC study Pro00047645) to have superior performance to our conventional (standard) positive pressure mask in a random distribution of patients with experiences users. This additional study will extend our investigation of the new masks capabilities by studying it's performance in the morbidly obese - which are more challenging patients to ventilate by mask. Our hypothesis is that the Tao mask will be even more effective in this challenging population than in the random distribution of patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tao Mask | Experimental | All anesthesiologists and CRNAs will view an instructional video on the use of the Tao Mask. Following induction of general anesthesia with the standard of care sequence of medications, each patient will then have mask ventilation performed and graded (Han and Warters Scales).Mask ventilation will be scored before and after the standard administration of paralytic medication. |
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| Standard Mask | Active Comparator | Following induction of general anesthesia with the standard of care sequence of medications, each patient will then have mask ventilation performed and graded (Han and Warters Scales).Mask ventilation will be scored before and after the standard administration of paralytic medication. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tao Mask | Device | All anesthesiologists and CRNAs will view an instructional video on the use of the Tao Mask. Following induction of general anesthesia with the standard of care sequence of medications, each patient will then have mask ventilation performed and graded (Han and Warters Scales). |
| Measure | Description | Time Frame |
|---|---|---|
| Tao Scale Score | The primary outcome will be the Tao Scale Score for each mask, compared between patients | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41263061 | Derived | Brewbaker CL, Wilson PR, McSwain JR, Tobin CD, Bridges KH, Roberts LL, Wilson DA, Skorke CA, Brown TA. Safety and efficacy of the Tao facemask for positive pressure ventilation in morbidly obese patients. J Perioper Pract. 2025 Dec;35(12):615-624. doi: 10.1177/17504589241268247. Epub 2024 Sep 18. |
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The sequence of standard vs Tao mask will be determined by random number generator. Mask ventilation will be scored with both masks before and after the standard administration of paralytic medication. The duration of the study procedures is variable but would last approximately 30-60 seconds, seldom exceeding 5 minutes additional time to the study patient from what is necessary in a non-study patient. The number of ventilations to achieve adequate ventilation is variable with both the standard mask and the Tao mask. After grading mask ventilation the study intervention is complete and the remainder of surgical and anesthesia care will be based on the clinical needs and decisions of the care team.
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| Standard Mask | Device | Following induction of general anesthesia with the standard of care sequence of medications, each patient will then have mask ventilation performed and graded (Han and Warters Scales).Mask ventilation will be scored before and after the standard administration of paralytic medication. |
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