Safety and Efficacy of the Tao Facemask for Positive Pressure Ventilation in the Patients With Significantly Elevated BMIs
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Anesthesia Induction Ventilation
- Sponsor
- Medical University of South Carolina
- Enrollment
- 153
- Locations
- 1
- Primary Endpoint
- Tao Scale Score
- Status
- Completed
- Last Updated
- 3 years ago
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.
Investigators
Carey Brewbaker
Assistant Professor Anesthesiology
Medical University of South Carolina
Eligibility Criteria
Inclusion Criteria
- •Age \>18 years.
- •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.
Outcomes
Primary Outcomes
Tao Scale Score
Time Frame: one year
The primary outcome will be the Tao Scale Score for each mask, compared between patients