Ergonomics in Ultrasound Procedures

Competence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06417021
• Other study ID #: 25148/2024
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 25, 2024
• Est. completion date: January 1, 2025

Study information

• Verified date: May 2024
• Source: University of Padova
• Contact: Alessandro De Cassai, MD
• Phone: 0498216739
• Email: alessandro.decassai[@]aopd.veneto.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 254
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

• Informed consent

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Competence
• Procedural Complication

Intervention

Other:
• Frontal Ultrasound Machine
Ultrasound machine will be placed in a frontal position
• Lateral Ultrasound Machine
Ultrasound machine will be placed in a lateral position

Locations

Country	Name	City	State
Italy	University Hospital of Padova	Padova	Veneto

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Needle tip visualization	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
Secondary	Complications	A complication is defined as participants puncturing the arterial vessel of the simulator	baseline
Secondary	Success of the procedure	Procedure will be considered successful if participants will be able to insert the guidewire in a 10 minutes timeframe	10 minutes from the baseline