Pulmonary VentilationNCT04274686
Tegarderm® Placement for Bag Mask Ventilation in the Bearded Patient
A study testing Tegaderm placement and No Tegaderm in people with Pulmonary Ventilation, run by University of New Mexico at 1 site in United States.
Trial summary
Difficult Bag Mask Ventilation is well described in the anesthesiology literature, and bearded patients are likely to experience this phenomenon. This study involves application of a large and perforated Tegaderm® across the lower face of the bearded patient to quantify its effectiveness at improving mask ventilation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Ventilation
- What is being tested?
- Tegaderm placement and No Tegaderm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2020to 3 May 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with perioral facial hair >5mm in length
- Undergoing elective non-cardiac surgery with planned bag-mask ventilation during anesthesia induction
Who cannot join
- Known allergy to Tegaderm product and/or its adhesive
- Emergency surgery
- Active or unstable cardiac disease
- ASA (American Society of Anesthesiologists) physical status ≥4
- External or internal active airway obstruction from tumor, abscess, or laryngeal edema
- Organic or non-organic oropharyngeal anatomical defects including history of radiation treatment to the neck
Show all 12Show fewer
- Moderate to severe acute and chronic restrictive or obstructive lung diseases, e.g. chronic obstructive pulmonary disease, asthma, etc.
- Requirement for rapid sequence intubation, or known aspiration risk
- Cervical spine injury
- Previously documented difficult mask ventilation or intubation
- BMI ≥50
- Vulnerable populations: children, prisoners, pregnant patients, cognitively impaired adults
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico Hospital
Albuquerque, New Mexico, 87131
About this study
Official title: Efficacy of Tegarderm® Placement for Bag Mask Ventilation in the Bearded Patient
Difficult Bag Mask Ventilation is well described in the anesthesiology literature, and bearded patients are likely to experience this phenomenon. This study involves application of a large and perforated Tegaderm® across the lower face of the bearded patient to quantify its effectiveness at improving mask ventilation in this anesthetized population.
Read the detailed description
This study is a prospective crossover trial in bearded patients who will undergo elective or urgent surgery at the main operating rooms of the University of New Mexico Hospital.
It is planned to test the efficacy of the novel bag mask ventilation augmentation technique of placing a large perforated Tegaderm® over the mouth of bearded male patients in order to improve seal after induction of general anesthesia. The perforation is a diamond-shaped hole to be aligned with the patient's mouth. Patients will either start with Tegaderm application or without Tegaderm, and will then cross over to the other condition in order to be their own controls. The primary endpoint is to measure inspiratory and expiratory tidal volumes.
If shown efficacious this intervention would be an easy and cost-effective intervention to improve bag mask ventilation for bearded patients in the operating room and non-operating room environments alike.
- Conditions
- Pulmonary Ventilation
- Being tested
- Tegaderm placement, No Tegaderm
- Keywords
- Tegaderm bandage, Bag mask ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tegaderm placementDevice
Placement of perforated Tegaderm bandage over lower face, with diamond-shaped hole aligned with the patient's mouth, for use during bag-mask ventilation
No TegadermOther
Bag-mask ventilation performed in ordinary fashion, without use of Tegaderm bandage
| Study group | Role | What they receive |
|---|---|---|
| Bag-Mask Ventilation with Tegaderm | Experimental | Patients will receive bag-mask ventilation with Tegaderm placement Receives: Device: Tegaderm placement |
| Bag-Mask Ventilation without Tegaderm | Active comparator | Patients will receive bag-mask ventilation without Tegaderm placement Receives: Other: No Tegaderm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Air Leakage During Bag-mask Ventilation
Leakage defined as difference in inspired and expired tidal volumes during bag-mask ventilation, as a percentage of inspired tidal volume.
Measured: <5 minutes
Secondary outcomes (2)
Resistance
Airflow resistance during bag-mask ventilation
Measured: <5 minutes
Peak Inspiratory Pressure
Maximum air pressure observed during bag-mask ventilation
Measured: <5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start12 Feb 2020
- Primary completion3 May 2021
- Study completion3 May 2021
Why it stopped: Intervention was not seen to be effective on interim analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary VentilationStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neal Gerstein, University of New Mexico
- Investigators
- Neal Gerstein, MD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04274686
- Sponsor's protocol ID
- UNMBMVbeard
- Status last verified
- Aug 2022
- First submitted
- 14 Feb 2020
- Last updated
- 21 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Gerstein NS, Braude DA, Petersen TR, Goumas A, Fish AC, Panikkath PV. Use of Transparent Film Dressing to Facilitate Mask Ventilation in Bearded Patients. J Emerg Med. 2024 Feb;66(2):163-169. doi: 10.1016/j.jemermed.2023.07.008. Epub 2023 Jul 20.
PubMed 38238230
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Tegarderm® Placement for Bag Mask Ventilation in the Bearded Patient
- ClinicalTrials.gov ID
- NCT04274686
- Acronym / sponsor ID
- UNMBMVbeard
- Conditions
- Pulmonary Ventilation
- Keywords
- Tegaderm bandage, Bag mask ventilation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Intervention was not seen to be effective on interim analysis
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 3 May 2021 (actual)
- Study completion
- 3 May 2021 (actual)
- First posted
- 18 Feb 2020 (actual)
- Results
- Posted 21 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Difficult Bag Mask Ventilation is well described in the anesthesiology literature, and bearded patients are likely to experience this phenomenon. This study involves application of a large and perforated Tegaderm® across the lower face of the bearded patient to quantify its effectiveness at improving mask ventilation in this anesthetized population.
Detailed description
This study is a prospective crossover trial in bearded patients who will undergo elective or urgent surgery at the main operating rooms of the University of New Mexico Hospital.
It is planned to test the efficacy of the novel bag mask ventilation augmentation technique of placing a large perforated Tegaderm® over the mouth of bearded male patients in order to improve seal after induction of general anesthesia. The perforation is a diamond-shaped hole to be aligned with the patient's mouth. Patients will either start with Tegaderm application or without Tegaderm, and will then cross over to the other condition in order to be their own controls. The primary endpoint is to measure inspiratory and expiratory tidal volumes.
If shown efficacious this intervention would be an easy and cost-effective intervention to improve bag mask ventilation for bearded patients in the operating room and non-operating room environments alike.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bag-Mask Ventilation with Tegaderm | Experimental | Device: Tegaderm placementPatients will receive bag-mask ventilation with Tegaderm placement |
| Bag-Mask Ventilation without Tegaderm | Active comparator | Other: No TegadermPatients will receive bag-mask ventilation without Tegaderm placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients with perioral facial hair >5mm in length
- Undergoing elective non-cardiac surgery with planned bag-mask ventilation during anesthesia induction
Key exclusion criteria (12 listed)
- Known allergy to Tegaderm product and/or its adhesive
- Emergency surgery
- Active or unstable cardiac disease
- ASA (American Society of Anesthesiologists) physical status ≥4
- External or internal active airway obstruction from tumor, abscess, or laryngeal edema
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 |
|---|---|---|
| Tegaderm placementPlacement of perforated Tegaderm bandage over lower face, with diamond-shaped hole aligned with the patient's mouth, for use during bag-mask ventilation | Device | Bag-Mask Ventilation with Tegaderm |
| No TegadermBag-mask ventilation performed in ordinary fashion, without use of Tegaderm bandage | Other | Bag-Mask Ventilation without Tegaderm |
Primary outcome
Percent Air Leakage During Bag-mask Ventilation
Time frame: <5 minutes
Leakage defined as difference in inspired and expired tidal volumes during bag-mask ventilation, as a percentage of inspired tidal volume.
2 secondary outcomes
Resistance
Time frame: <5 minutes
Peak Inspiratory Pressure
Time frame: <5 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38238230Gerstein NS, Braude DA, Petersen TR, Goumas A, Fish AC, Panikkath PV. Use of Transparent Film Dressing to Facilitate Mask Ventilation in Bearded Patients. J Emerg Med. 2024 Feb;66(2):163-169. doi: 10.1016/j.jemermed.2023.07.008. Epub 2023 Jul 20.
- Individual participant dataSharing planned: No
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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.
Neal Gerstein, MD principal investigator
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tegaderm placement and No Tegaderm in people with Pulmonary Ventilation, run by University of New Mexico 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 2 inclusion and 12 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: stopped early, as of the sponsor's last update on 21 Sep 2022. 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?
Yes. Results are posted in the registry (first posted 21 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Air Leakage During Bag-mask Ventilation (time frame: <5 minutes). 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 NCT04274686, 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 21 Sep 2022.