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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04376918 on ClinicalTrials.gov