Manual Ventilation Efficacy With MVG Device

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

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

Study Overview

• Status: Completed
• Conditions: Ventilator Lung
• Intervention / Treatment: Device: Manual Ventilation Grip Device; Other: 2VE

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Expert participants randomized to MVG followed by 2VE; Expert participants (Anesthesiology residents and attendings with at least 2 or more years of clinical experience) randomized to perform the ventilation on a manikin using the Manual ventilation grip device (MVG) first followed by the standard 2VE technique alone.	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
Experimental: Expert participants randomized to 2VE followed by MVG; Expert participants (Anesthesiology residents and attendings with at least 2 or more years of clinical experience) randomized to perform the ventilation on a manikin using the standard technique (2VE) alone first followed by Manual ventilation grip device (MVG).	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
Experimental: Novice participants randomized to MVG followed by 2VE; Novice participants (Current medical students or residents with no prior experience in hand mask ventilation techniques) first followed by the standard technique (2VE) alone	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
Experimental: Novice participants randomized to 2VE followed by MVG; Novice participants (Current medical students or residents with no prior experience in hand mask ventilation techniques) randomized to perform the ventilation on a manikin using the standard technique (2VE) alone first followed by Manual ventilation grip device (MVG)	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tidal Volume	As measured using the ventilator machine in milliliters	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Alecia Stein, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2021
• Primary Completion (Actual): August 20, 2021
• Study Completion (Actual): August 20, 2021

Study Registration Dates

• First Submitted: September 3, 2021
• First Submitted That Met QC Criteria: September 19, 2021
• First Posted (Actual): September 28, 2021

Study Record Updates

• Last Update Posted (Actual): July 18, 2022
• Last Update Submitted That Met QC Criteria: July 15, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Manual Ventilation Grip Device
• Other Study ID Numbers: 20200039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No