Manual Ventilation Efficacy With MVG Device

NCT05059366 | Completed Results FDA Device

• 1 other identifier: 20200039
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ventilator Lung

Keywords

Manual Ventilation Grip Device

Outcome Measures

Primary Outcomes (1)

• Tidal Volume

  As measured using the ventilator machine in milliliters

  Day 1

Secondary Outcomes (2)

• Fatigue as Measured by NASA-TLX Questionnaire

  Day 1

• Fatigue as Measured by SOFI Questionnaire

  Day 1

Study Arms (4)

Expert participants randomized to MVG followed by 2VE

EXPERIMENTAL

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; Other: 2VE

Expert participants randomized to 2VE followed by MVG

EXPERIMENTAL

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; Other: 2VE

Novice participants randomized to MVG followed by 2VE

EXPERIMENTAL

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; Other: 2VE

Novice participants randomized to 2VE followed by MVG

EXPERIMENTAL

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; Other: 2VE

Interventions

Manual Ventilation Grip Device DEVICE

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

Expert participants randomized to 2VE followed by MVG; Expert participants randomized to MVG followed by 2VE; Novice participants randomized to 2VE followed by MVG; Novice participants randomized to MVG followed by 2VE

2VE OTHER

the standard 2VE technique for ventilation

Expert participants randomized to 2VE followed by MVG; Expert participants randomized to MVG followed by 2VE; Novice participants randomized to 2VE followed by MVG; Novice participants randomized to MVG followed by 2VE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Results Point of Contact

• Title: Alecia Sabartinelli Stein, MD
• Organization: University of Miami

asabartinelli@med.miami.edu

305 585 8380

Study Officials

• Alecia Stein

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical

Model Details: The study is a repeated-measures cross over design.

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 28, 2021
• Study Start: August 11, 2021
• Primary Completion: August 20, 2021
• Study Completion: August 20, 2021
• Last Updated: July 18, 2022
• Results First Posted: July 18, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)