NCT02768246

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Hebrew University of Jerusalem · Academic / Other
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Pre-hospital Ventilation

Interventions

Type	Name	Description
DEVICE	BVGA	The BVGA enables the direct connection of a bag valve device to a guedel, eliminating the need for a face mask during ventilation
DEVICE	Face Mask	Classic face mask

Timeline

• Start date: 2016-06-01
• Primary completion: 2016-07-01
• Completion: 2016-12-01
• First posted: 2016-05-11
• Last updated: 2017-03-03