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Clinical Trials/NCT02768246
NCT02768246
Completed
Not Applicable

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

Hebrew University of Jerusalem0 sites25 target enrollmentJune 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pre-hospital Ventilation
Sponsor
Hebrew University of Jerusalem
Enrollment
25
Primary Endpoint
End tidal CO2 levels (EtCO2)
Status
Completed
Last Updated
9 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
June 2016
End Date
December 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lilach Gavish

Study Director

Hebrew University of Jerusalem

Eligibility Criteria

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.

Outcomes

Primary Outcomes

End tidal CO2 levels (EtCO2)

Time Frame: 30 minutes

EtCO2 will be monitored while the volunteer breathes through the BVGA or the face mask.

Secondary Outcomes

  • End tidal O2 (EtO2)(30 minutes)

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