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Intervention was not seen to be effective on interim analysis
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bag-Mask Ventilation with Tegaderm | Experimental | Patients will receive bag-mask ventilation with Tegaderm placement |
|
| Bag-Mask Ventilation without Tegaderm | Active Comparator | Patients will receive bag-mask ventilation without Tegaderm placement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tegaderm placement | Device | Placement of perforated Tegaderm bandage over lower face, with diamond-shaped hole aligned with the patient's mouth, for use during bag-mask ventilation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | <5 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Resistance | Airflow resistance during bag-mask ventilation | <5 minutes |
| Peak Inspiratory Pressure | Maximum air pressure observed during bag-mask ventilation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neal Gerstein, MD | University of New Mexico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New Mexico Hospital | Albuquerque | New Mexico | 87131 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38238230 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tegaderm-First Group | Patients will first receive bag-mask ventilation with a perforated Tegaderm sheet in place, and then with the sheet removed |
| FG001 | Without-Tegaderm First Group | Patients will first receive bag-mask ventilation as in usual practice without a Tegaderm sheet in place, and then will receive bag-mask ventilation with a perforated Tegaderm sheet covering the lower face and beard |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All participants in the study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | percentage of inspired tidal volume | <5 minutes |
|
10 minutes
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bag-mask Ventilation With Tegaderm Placement | Bag-mask ventilation performed with perforated Tegaderm sheet placed over the lower face and beard |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Neal Gerstein | University of New Mexico | 505-272-2610 | ngerstein@salud.unm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 11, 2020 | Jun 23, 2022 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 11, 2020 | Jun 23, 2022 | ICF_003.pdf |
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| No Tegaderm | Other | Bag-mask ventilation performed in ordinary fashion, without use of Tegaderm bandage |
|
| <5 minutes |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Beard Length | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Resistance | Airflow resistance during bag-mask ventilation | Posted | Mean | Standard Deviation | cm H2O/L/s | <5 minutes |
|
|
|
|
| Secondary | Peak Inspiratory Pressure | Maximum air pressure observed during bag-mask ventilation | Posted | Mean | Standard Deviation | cm H2O | <5 minutes |
|
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Bag-mask Ventilation Without Tegaderm Placement | Bag-mask ventilation performed as in usual practice, with mask placed directly over lower face and beard | 0 | 25 | 0 | 25 | 0 | 25 |
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