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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2022-07-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Anesthesia Induction Ventilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Tao Mask

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.

Group Type EXPERIMENTAL

Tao Mask

Intervention Type 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).

Standard 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.

Group Type ACTIVE_COMPARATOR

Standard Mask

Intervention Type 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.

Interventions

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Tao Mask

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).

Intervention Type DEVICE

Standard 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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes