Safety and Efficacy of the Tao Facemask for Positive Pressure Ventilation in the Patients With Significantly Elevated BMIs
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/24/2019 |
| Start Date: | March 1, 2018 |
| End Date: | April 18, 2019 |
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.
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.
Inclusion Criteria:
1. Age >18 years.
2. BMI of >40.
3. Patients having elective surgery (designated by priority level of 5) requiring general
endotracheal anesthesia.
Exclusion Criteria:
1. Need for awake intubation based on standard preoperative evaluation by the attending
anesthesiologist.
2. 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.
3. Previous tracheostomy procedure.
4. Patient is cognitively incapable of providing their consent for the study.
We found this trial at
1
site
171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Brown Tod, MD
Phone: 843-792-2322
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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