Bag-Valve-Guedel Adaptor Vs Common Face Mask for the Ventilation of Anesthetized Bearded Men
NCT04376918 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 101
Last updated 2025-03-12
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 in anesthetized bearded men.
Conditions
- Ventilation
Interventions
- DEVICE
-
Begin with BVGA
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 Other Names: • Bag Valve Guedel Adaptor Device: Face Mask Classic face mask
- DEVICE
-
Begin with Face-mask
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 Other Names: • Bag Valve Guedel Adaptor Device: Face Mask Classic face mask
Sponsors & Collaborators
-
Hadassah Medical Organization
collaborator OTHER -
Hebrew University of Jerusalem
lead OTHER
Principal Investigators
-
Shimon Firman, MD · Hadassah Medical Organization
-
Lilach Gavish, PhD · Hebrew University of Jerusalem
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-04-01
- Primary Completion
- 2023-01-31
- Completion
- 2023-07-31
Countries
- Israel
Study Locations
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