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OpenTrials
Completed

NCT Number: NCT06417021

Ergonomics in Ultrasound Procedures

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Padova

Padova, Veneto, 35127, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Frontal Ultrasound Machine

Other

Ultrasound machine will be placed in a frontal position

Lateral Ultrasound Machine

Other

Ultrasound machine will be placed in a lateral position

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.)

  2. Complications

    Time frame: baseline

    A complication is defined as participants puncturing the arterial vessel of the simulator

  3. 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

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 16, 2024
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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