Anesthesia Induction VentilationNCT03473366
Safety and Efficacy of the Tao Facemask for Positive Pressure Ventilation in the Patients With Significantly Elevated BMIs
A study testing Tao Mask and Standard Mask in people with Anesthesia Induction Ventilation, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia Induction Ventilation
- What is being tested?
- Tao Mask and Standard Mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to 22 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >18 years.
- BMI of >40.
- Patients having elective surgery (designated by priority level of 5) requiring general endotracheal anesthesia.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
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
- Being tested
- Tao Mask, Standard Mask
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tao MaskDevice
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 MaskDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Standard Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tao Scale Score
The primary outcome will be the Tao Scale Score for each mask, compared between patients
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start1 Mar 2018
- Primary completion22 Jul 2022
- Study completion22 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthesia Induction VentilationStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carey Brewbaker, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03473366
- Sponsor's protocol ID
- Pro00073465
- Status last verified
- Jan 2023
- First submitted
- 15 Mar 2018
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41263061
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the Tao Facemask for Positive Pressure Ventilation in the Patients With Significantly Elevated BMIs
- ClinicalTrials.gov ID
- NCT03473366
- Acronym / sponsor ID
- Pro00073465
- Conditions
- Anesthesia Induction Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 22 Jul 2022 (actual)
- Study completion
- 22 Jul 2022 (actual)
- First posted
- 22 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Tao Mask | Experimental | Device: Tao MaskAll 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. |
| Standard Mask | Active comparator | Device: Standard MaskFollowing 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18 years.
- BMI of >40.
- Patients having elective surgery (designated by priority level of 5) requiring general endotracheal anesthesia.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tao MaskAll 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). | Device | Tao Mask |
| Standard MaskFollowing 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 |
Primary outcome
Tao Scale Score
Time frame: one year
The primary outcome will be the Tao Scale Score for each mask, compared between patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
- Derived from this study: PubMed 41263061Brewbaker 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tao Mask and Standard Mask in people with Anesthesia Induction Ventilation, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tao Scale Score (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03473366, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2023.