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NCT05059366 Clinical Trial

Manual Ventilation Efficacy With MVG Device

Ventilator Lung Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05059366
Other study ID # 20200039
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 11, 2021
Est. completion date August 20, 2021

Study information
Verified date July 2022
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 32
Est. completion date August 20, 2021
Est. primary completion date August 20, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. 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: 1. Refusal to participate in the study. 2. 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) 3. Any physical inability to adequately perform ventilation

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Manual Ventilation Grip Device
Manual Ventilation Grip Device is an add-on device placed on a standard valve mask to assist ventilation.
Other:
• 2VE
the standard 2VE technique for ventilation

Locations
Country Name City State
United States University of Miami Miami Florida

Sponsors (1)
Lead Sponsor Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Tidal Volume As measured using the ventilator machine in milliliters Day 1
Secondary Fatigue as Measured by NASA-TLX Questionnaire NASA Task Load Index (TLX) questionnaire has a total overall workload score ranging from 0 and 126 with the higher score indicating greater demand. Day 1
Secondary Fatigue as Measured by SOFI Questionnaire Swedish Occupational Fatigue Inventory (SOFI) questionnaire has a total score ranging from 0 to 120 with the higher score indicating greater fatigue Day 1
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