Status:
COMPLETED
Safety and Efficacy of the Tao Facemask for Positive Pressure Ventilation in the Patients With Significantly Elevated BMIs
Lead Sponsor:
Medical University of South Carolina
Conditions:
Anesthesia Induction Ventilation
Eligibility:
All Genders
18+ years
Phase:
NA
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) positiv...
Eligibility Criteria
Inclusion
- Age \>18 years.
- BMI of \>40.
- Patients having elective surgery (designated by priority level of 5) requiring general endotracheal anesthesia.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 22 2022
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT03473366
Start Date
March 1 2018
End Date
July 22 2022
Last Update
January 23 2023
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425