Ergonomics in Ultrasound Procedures

February 18, 2025 updated by: Alessandro De Cassai, University of Padova

The Position of the Ultrasound Machine in the Placement of the Central Venous Catheter: a Randomized Controlled Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

239

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Veneto
      • Padova, Veneto, Italy, 35127
        • University Hospital of Padova

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Frontal position of Ultrasound machine (Ergonomic group)
Participants will simulate a CVC positioning keeping the ultrasound machine facing them
Other: Frontal Ultrasound Machine
Ultrasound machine will be placed in a frontal position
Other: 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.
Other: Lateral Ultrasound Machine
Ultrasound machine will be placed in a lateral position

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to correct CVC position
Time Frame: baseline
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Needle tip visualization
Time Frame: baseline

Procedure will be recorded as a clip in ultrasound machine. A blind assessor will evaluate the clip using the following scale (1-During the advancement of the needles, only the distortion of the tissue could be observed.

2-Only the tip of the needle was visible. 3-The tip of the needle was visible throughout the advancement, but the body of the needle was only partially visible.

4-The needle was completely visible during its advancement.)
baseline
Complications
Time Frame: baseline
A complication is defined as participants puncturing the arterial vessel of the simulator
baseline
Success of the procedure
Time Frame: 10 minutes from the baseline
Procedure will be considered successful if participants will be able to insert the guidewire in a 10 minutes timeframe
10 minutes from the baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Padova

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2024

Primary Completion (Actual)

February 10, 2025

Study Completion (Actual)

February 10, 2025

Study Registration Dates

First Submitted

April 9, 2024

First Submitted That Met QC Criteria

May 15, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 18, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 25148/2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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