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OpenTrials
Completed

NCT Number: NCT05059366

Manual Ventilation Efficacy With MVG Device

The purpose of this research is to investigate the efficacy of the newly designed ventilation grip device (MVG device).

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Key information

Conditions

Ventilator Lung

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Current medical students, Post Graduate Year 1 (PGY1) residents or residents from other specialties with no prior experience in hand mask ventilation techniques or anesthesiology residents and attendings with at least 2 or more years of clinical experience

Exclusion criteria

  • Refusal to participate in the study.
  • Medical students with prior experience in hand mask ventilation techniques (i.e. experiences in previous careers such as nursing or Emergency Medical Technician (EMT) professions)
  • Any physical inability to adequately perform ventilation

Treatment and study plan

Manual Ventilation Grip Device

Device

Manual Ventilation Grip Device is an add-on device placed on a standard valve mask to assist ventilation.

2VE

Other

the standard 2VE technique for ventilation

Primary outcomes

  1. Tidal Volume

    Time frame: Day 1

    As measured using the ventilator machine in milliliters

Secondary outcomes

  1. Fatigue as Measured by NASA-TLX Questionnaire

    Time frame: Day 1

    NASA Task Load Index (TLX) questionnaire has a total overall workload score ranging from 0 and 126 with the higher score indicating greater demand.

  2. Fatigue as Measured by SOFI Questionnaire

    Time frame: Day 1

    Swedish Occupational Fatigue Inventory (SOFI) questionnaire has a total score ranging from 0 to 120 with the higher score indicating greater fatigue

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

Improvement of Manual Ventilation Efficacy With Ventilation Grip Device: A Manikin Study

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 28, 2021
Registry last updated
Jul 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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