Manual Ventilation Efficacy With MVG Device

NCT ID: NCT05059366

Last Updated: 2022-07-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-11

Study Completion Date

2021-08-20

Brief Summary

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

Detailed Description

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Conditions

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Ventilator Lung

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The study is a repeated-measures cross over design.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Manual Ventilation Grip Device

Intervention Type DEVICE

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

2VE

Intervention Type OTHER

the standard 2VE technique for ventilation

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).

Group Type EXPERIMENTAL

Manual Ventilation Grip Device

Intervention Type DEVICE

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

2VE

Intervention Type OTHER

the standard 2VE technique for ventilation

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

Group Type EXPERIMENTAL

Manual Ventilation Grip Device

Intervention Type DEVICE

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

2VE

Intervention Type OTHER

the standard 2VE technique for ventilation

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)

Group Type EXPERIMENTAL

Manual Ventilation Grip Device

Intervention Type DEVICE

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

2VE

Intervention Type OTHER

the standard 2VE technique for ventilation

Interventions

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Manual Ventilation Grip Device

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

Intervention Type DEVICE

2VE

the standard 2VE technique for ventilation

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Alecia Stein

Assistant Professor of Clinical

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alecia Stein

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami

Miami, Florida, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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20200039

Identifier Type: -

Identifier Source: org_study_id

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