Comparison of Bag-Valve-Guedel Adaptor to Common Face Mask for the Ventilation of Bearded Men

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of the Efficacy of a Bag-Valve-Guedel Adaptor to the Commonly Used Face Mask in Healthy Bearded Volunteers

Conditions
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Pre-hospital Ventilation

Intervention / Treatment
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* Device: BVGA
* Device: Face Mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males more than 18 years of age. 22 with beards, 3 without beards. Exclusion Criteria: Presence of facial fractures or injuries. Claustrophobia. Respiratory diseases. Severe illness such as cardiac or neurological diseases.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Begin with BVGA<br>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. | Device: BVGA<br>* The BVGA enables the direct connection of a bag valve device to a guedel, eliminating the need for a face mask during ventilation<br>* Other names: Bag Valve Guedel Adaptor;Device: Face Mask<br>* Classic face mask<br>|
| Active Comparator: Begin with Face-mask<br>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. | Device: BVGA<br>* The BVGA enables the direct connection of a bag valve device to a guedel, eliminating the need for a face mask during ventilation<br>* Other names: Bag Valve Guedel Adaptor;Device: Face Mask<br>* Classic face mask<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |