Ergonomics in Ultrasound Procedures

NCT ID: NCT06417021

Last Updated: 2025-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

239 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-25

Study Completion Date

2025-02-10

Brief Summary

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The study will compare two different positions of the ultrasound machine during simulated CVC positioning.

The position of the ultrasound machine will be randomized. Group A will perform the procedure with the ultrasound monitor facing them, while subjects randomized to group B will perform the procedure with the ultrasound machine positioned at a 90° angle to their visual axis.

Detailed Description

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We will recruit medical trainees affiliated with the 'Anesthesia and Intensive Care' and 'Emergency Medicine' schools. Data collected for each participant will include: age, gender, specialty school, year of specialization training, expertise in using ultrasound for ultrasound-guided procedures. Once informed consent is obtained, subjects will be divided through simple randomization (a list generated in advance with Excel and subjected to the opaque envelope method) into two groups: A and B. All subjects will be asked to perform CVC placement using the simulator through an 'oblique in-plane' approach. Subjects randomized to group A will perform the procedure with the ultrasound monitor facing them, while subjects randomized to group B will perform the procedure with the ultrasound machine positioned at a 90° angle to their visual axis.

Conditions

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Procedural Complication Competence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
A clip of the ultrasound procedure will be saved and reviewed by a blind assessor that will value the quality of the procedure

Study Groups

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Frontal position of Ultrasound machine (Ergonomic group)

Participants will simulate a CVC positioning keeping the ultrasound machine facing them

Group Type OTHER

Frontal Ultrasound Machine

Intervention Type OTHER

Ultrasound machine will be placed in a frontal position

Lateral position (90°) of Ultrasound machine (No Ergonomic group)

Participants will simulate a CVC positioning keeping the ultrasound machine in a lateral position on the same side of the needle.

Group Type OTHER

Lateral Ultrasound Machine

Intervention Type OTHER

Ultrasound machine will be placed in a lateral position

Interventions

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Frontal Ultrasound Machine

Ultrasound machine will be placed in a frontal position

Intervention Type OTHER

Lateral Ultrasound Machine

Ultrasound machine will be placed in a lateral position

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 'Anesthesia and Intensive Care' and 'Emergency Medicine' residents
* Informed consent

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Padova

OTHER

Sponsor Role lead

Responsible Party

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Alessandro De Cassai

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital of Padova

Padua, Veneto, Italy

Site Status

Countries

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Italy

Other Identifiers

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25148/2024

Identifier Type: -

Identifier Source: org_study_id

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