Manual Ventilation Efficacy With MVG Device

Not Applicable

Completed

• Conditions: Ventilator Lung
• Interventions: Device: Manual Ventilation Grip Device; Other: 2VE

• Registration Number: NCT05059366
• Lead Sponsor: University of Miami

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-11
• Primary Completion: 2021-08-20
• Study Completion: 2021-08-20
• Study First Submitted: 2021-09-03
• Study First Submitted QC: 2021-09-19
• Study First Posted: 2021-09-28
• Results First Submitted: 2022-06-14
• Status Verified: 2022-07
• Results First Submitted QC: 2022-07-15
• Last Update Submitted: 2022-07-15
• Results First Posted: 2022-07-18
• Last Update Posted: 2022-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Expert participants randomized to MVG followed by 2VE	Manual Ventilation Grip Device	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.
Expert participants randomized to 2VE followed by MVG	Manual Ventilation Grip Device	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).
Novice participants randomized to MVG followed by 2VE	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
Expert participants randomized to MVG followed by 2VE	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.
Novice participants randomized to 2VE followed by MVG	Manual Ventilation Grip Device	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)
Expert participants randomized to 2VE followed by MVG	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 standard technique (2VE) alone first followed by Manual ventilation grip device (MVG).
Novice participants randomized to MVG followed by 2VE	Manual Ventilation Grip Device	Novice participants (Current medical students or residents with no prior experience in hand mask ventilation techniques) first followed by the standard technique (2VE) alone
Novice participants randomized to 2VE followed by MVG	2VE	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)

Primary Outcome Measures

Name	Time	Method
Tidal Volume	Day 1	As measured using the ventilator machine in milliliters

Secondary Outcome Measures

Name	Time	Method
Fatigue as Measured by NASA-TLX Questionnaire	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.
Fatigue as Measured by SOFI Questionnaire	Day 1	Swedish Occupational Fatigue Inventory (SOFI) questionnaire has a total score ranging from 0 to 120 with the higher score indicating greater fatigue

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States