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Completed

NCT Number: NCT04463147

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

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.

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Key information

Conditions

Central Venous Catheters Ultrasound Guidance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nîmes, Hôpital Universitaire Carémeau

Nîmes, France

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • all residents and practicioners of intensive care units in the Nîmes University Hospital, France.

Exclusion criteria

  • unavailability or operator refusal, and more than one year without subclavian central catheterization (for experienced subgroup).

Treatment and study plan

Needle-pilotTM device

Device

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

Primary outcomes

  1. First puncture success delay

    Time frame: during the procedure

    comparison of time (in seconds) between first puncture and successful "blood-aspiration" on a "subclavian venous" torso mannequin.

Secondary outcomes

  1. Failure Rate

    Time frame: during the procedure

    Failure is defined as a puncture time > 300 seconds. The criterion corresponds to an absolute value: failure or not

  2. Cutaneous wall

    Time frame: during the procedure

    Counting the number of times each participant will puncture the wall of the mannequin before succeeding in puncturing the vessel with the 2 techniques and comparing this number between groups.

  3. Posterior wall

    Time frame: during the procedure

    Number of posterior vessel wall penetration

  4. Puncture comfort

    Time frame: immediately after the procedure

    Operator puncture comfort feeling is assessed from 0 to 10 by each participants for each technique.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: NEEDLE-VISIO

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 9, 2020
Registry last updated
Dec 4, 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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