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

NCT ID: NCT04463147

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Central Venous Catheters Ultrasound Guidance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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new residents

new residents in ultrasound-guided central vascular catheterization.

Group Type OTHER

Needle-pilotTM device

Intervention Type DEVICE

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

experienced residents or ICU practitioners

experienced residents or ICU practitioners in ultrasound-guided central vascular catheterization.

Group Type OTHER

Needle-pilotTM device

Intervention Type DEVICE

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

Interventions

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Needle-pilotTM device

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

Intervention Type DEVICE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Nîmes, Hôpital Universitaire Carémeau

Nîmes, , France

Site Status

Countries

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France

References

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Grau-Mercier L, Chetioui A, Muller L, Roger C, Genre Grandpierre R, de La Coussaye JE, Cuvillon P, Claret PG, Bobbia X. Magnetic needle-tracking device for ultrasound guidance of radial artery puncture: A randomized study on a simulation model. J Clin Ultrasound. 2021 Mar;49(3):212-217. doi: 10.1002/jcu.22945. Epub 2020 Nov 16.

Reference Type RESULT
PMID: 33196110 (View on PubMed)

Other Identifiers

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LOCAL/2019/AC-01

Identifier Type: -

Identifier Source: org_study_id

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