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Ergonomics in Ultrasound Procedures

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06417021
Enrollment
239
Registered
2024-05-16
Start date
2024-05-25
Completion date
2025-02-10
Last updated
2025-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Competence, Procedural Complication

Keywords

Central Venous Access, Ultrasound, Ergonomics

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.

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.

Interventions

OTHERFrontal Ultrasound Machine

Ultrasound machine will be placed in a frontal position

OTHERLateral Ultrasound Machine

Ultrasound machine will be placed in a lateral position

Sponsors

University of Padova
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Masking description

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

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Time to correct CVC positionbaselineInvestigators 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

MeasureTime frameDescription
Needle tip visualizationbaselineProcedure 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.)
ComplicationsbaselineA complication is defined as participants puncturing the arterial vessel of the simulator
Success of the procedure10 minutes from the baselineProcedure will be considered successful if participants will be able to insert the guidewire in a 10 minutes timeframe

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026