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Does the Needle-pilot Device Improve the Success of Vascular Catheterization Compared to the Classical Ultrasound-guided Technique

NCT04463147 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2025-12-04

No results posted yet for this study

Summary

Real-time ultrasound guidance for central venous catheter catheterism is recommended in order to reduce complication, in particular for internal jugular site1. Nevertheless, the usefulness of ultrasound guidance for subclavian approach remains controversial, in particular because needle visualisation is more complex as compared to jugular site2,3. New magnetic devices (Needle-pilotTM device, Samsung Healthcare) could theoretically allow a better needle visualisation and a better success rate. The investigators hypothesize that such device could improve the feasibility of subclavian catheterism. As this device has not been evaluated in patients, the investigators decided to perform a simulation study on a human torso mannequin. This methodology has been already used by Vogel et al in 20154. The main objective aims to compare the procedure time between conventional real time ultrasound guidance and guidance with Needle-pilot™ device.

Conditions

  • Central Venous Catheters
  • Ultrasound Guidance

Interventions

DEVICE

Needle-pilotTM device

The main objective aims to compare the procedure time between conventional real time ultrasound guidance and guidance with Needle-pilotTM device.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nīmes

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04463147 on ClinicalTrials.gov