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

NCT03473366 | Completed DMC

• 1 other identifier: Pro00073465
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia Induction Ventilation

Outcome Measures

Primary Outcomes (1)

• Tao Scale Score

  The primary outcome will be the Tao Scale Score for each mask, compared between patients

  one year

Study Arms (2)

Tao Mask

EXPERIMENTAL

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

Standard Mask

ACTIVE COMPARATOR

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

Interventions

Tao Mask DEVICE

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).

Tao Mask

Standard Mask DEVICE

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.

Standard Mask

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years.
• BMI of \>40.
• Patients having elective surgery (designated by priority level of 5) requiring general endotracheal anesthesia.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

• Brewbaker CL, Wilson PR, McSwain JR, Tobin CD, Bridges KH, Roberts LL, Wilson DA, Skorke CA, Brown TA. Safety and efficacy of the Tao facemask for positive pressure ventilation in morbidly obese patients. J Perioper Pract. 2025 Dec;35(12):615-624. doi: 10.1177/17504589241268247. Epub 2024 Sep 18.

  PMID: 41263061 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Anesthesiology

Model Details: 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.

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: March 22, 2018
• Study Start: March 1, 2018
• Primary Completion: July 22, 2022
• Study Completion: July 22, 2022
• Last Updated: January 23, 2023

Record last verified: 2023-01

Locations

US (1)