Ergonomics in Ultrasound Procedures

NCT06417021 | Completed

• 1 other identifier: 25148/2024
• Study Type: interventional
• Target: 239
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Procedural Complication; Competence

Keywords

Central Venous Access; Ultrasound; Ergonomics

Outcome Measures

Primary Outcomes (1)

• Time to correct CVC position

  Investigators will measure time needed to correctly perform the procedure in seconds. The chronometer will be started when the participant takes the ultrasound probe and will be stopped when the guidewire will be correctly placed

  baseline

Secondary Outcomes (3)

• Needle tip visualization

  baseline

• Complications

  baseline

• Success of the procedure

  10 minutes from the baseline

Study Arms (2)

Frontal position of Ultrasound machine (Ergonomic group)

OTHER

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

Other: Frontal Ultrasound Machine

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

OTHER

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

Other: Lateral Ultrasound Machine

Interventions

Frontal Ultrasound Machine OTHER

Ultrasound machine will be placed in a frontal position

Frontal position of Ultrasound machine (Ergonomic group)

Lateral Ultrasound Machine OTHER

Ultrasound machine will be placed in a lateral position

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

University Hospital of Padova

Padua, Veneto, 35127, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A clip of the ultrasound procedure will be saved and reviewed by a blind assessor that will value the quality of the procedure
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: May 16, 2024
• Study Start: May 25, 2024
• Primary Completion: February 10, 2025
• Study Completion: February 10, 2025
• Last Updated: February 20, 2025

Record last verified: 2025-02

Locations

IT (1)