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| Name | Class |
|---|---|
| Hadassah Medical Organization | OTHER |
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Ventilation of a bearded patient with the commonly used face mask has low efficiency because of difficulties to achieve a tight seal around the mouth and nose.
The purpose of this study is to evaluate the efficacy of a novel bag valve guedel adaptor (BVGA) that enables the direct connection of a bag valve device to a guedel - eliminating the need for a face mask.
Ventilating a patient using a bag valve and a face mask is not easy to perform, especially for a long period of time, and mandates experience and strength by the care giver. The need for a tight seal around the mouth and nose is a major challenge especially if the patient has a beard. Nevertheless, the face mask is the only approved respiratory support that medics and other basic care givers are allowed to use in the out-of-the-hospital setting, and only physicians and paramedics are allowed to use more advanced techniques, providing a definite airways. Thus, despite its lower effectiveness, the bag valve mask technique is the most commonly used in the field
The purpose of this study is to evaluate the efficacy of a novel bag valve guedel adaptor (BVGA) that enables the direct connection of a bag valve device to a guedel - eliminating the need for a face mask.
Study Design: Prospective, randomized, controlled. The volunteers will be asked randomly assigned to breathe through the BVGA/Face mask followed by the same protocol with the Face-mask/BVGA: 5 minutes room air, 5 minutes 100% oxygen, and 5 minutes room air again. The BVGAs/face masks well be connected to a standard operating room ventilation machines, and cardiopulmonary parameters will be monitored and documented.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Begin with BVGA | Active Comparator | The volunteers will be asked to breathe 5 minutes of room air through the BVGA, followed by, 5 minutes 100% oxygen, and 5 minutes room air again. This will be followed by 5 minutes room air breathing without the BVGA. Then the same volunteers will be asked to repeat the protocol with the face mask. |
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| Begin with Face-mask | Active Comparator | The volunteers will be asked to breathe 5 minutes of room air through the face mask, followed by, 5 minutes 100% oxygen, and 5 minutes room air again. This will be followed by 5 minutes room air breathing without the face mask. Then the same volunteers will be asked to repeat the protocol with the BVGA. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BVGA | Device | The BVGA enables the direct connection of a bag valve device to a guedel, eliminating the need for a face mask during ventilation |
|
| Measure | Description | Time Frame |
|---|---|---|
| End tidal CO2 levels (EtCO2) | EtCO2 will be monitored while the volunteer breathes through the BVGA or the face mask. | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| End tidal O2 (EtO2) | EtO2 will be monitored while the volunteer breathes through the BVGA or the face mask. | 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ruth Shaylor, MD | Hadassah Medical Organization | Principal Investigator |
| Lilach Gavish, PhD | Hebrew University of Jerusalem | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33444455 | Derived | Gavish L, Rittblat M, Gertz SD, Shaylor R, Weissman C, Eisenkraft A. Ventilating the Bearded: A Randomized Crossover Trial Comparing a Novel Bag-Valve-Guedel Adaptor to a Standard Mask. Mil Med. 2020 Aug 14;185(7-8):e1300-e1308. doi: 10.1093/milmed/usz378. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 22, 2022 | |
| Reset | Sep 15, 2022 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 22, 2022 | Sep 15, 2022 |
| ID | Term |
|---|---|
| D008397 | Masks |
| ID | Term |
|---|---|
| D058257 | Surgical Attire |
| D004865 | Equipment and Supplies, Hospital |
| D004864 | Equipment and Supplies |
| D011482 | Protective Devices |
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| Face Mask | Device | Classic face mask |
|
| D000067393 | Personal Protective Equipment |
| D013523 | Surgical Equipment |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |