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

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Anesthesia Induction Ventilation

Treatments: Device: Tao Mask; Device: Standard Mask

Study type: Interventional

Funder types: Other

Identifiers

NCT03473366

Pro00073465

Details and patient eligibility

About

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.

Enrollment: 153 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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153 participants in 2 patient groups

Tao Mask

Experimental group

Description:

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.

Treatment:

Device: Tao Mask

Standard Mask

Active Comparator group

Description:

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.

Treatment:

Device: Standard Mask