Safety and Efficacy of the Tao Facemask for Positive Pressure Ventilation in the Patients With Significantly Elevated BMIs

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Safety and Efficacy of the Tao Facemask for Positive Pressure Ventilation in the Patients With Significantly Elevated BMIs

Conditions
-----------------
Anesthesia Induction Ventilation

Intervention / Treatment
-----------------
* Device: Tao Mask
* Device: Standard Mask


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years. BMI of >40. Patients having elective surgery (designated by priority level of 5) requiring general endotracheal anesthesia. Exclusion Criteria: Need for awake intubation based on standard preoperative evaluation by the attending anesthesiologist. Increased risk for aspiration of gastric contents due to full stomach, pregnancy, gastro-esophageal reflux disease, and/or hiatal hernia as identified during the pre-operative assessment. Previous tracheostomy procedure. Patient is cognitively incapable of providing their consent for the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tao Mask<br>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. | Device: Tao Mask<br>* 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).<br>|
| Active Comparator: Standard Mask<br>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. | Device: Standard Mask<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tao Scale Score | The primary outcome will be the Tao Scale Score for each mask, compared between patients | one year |