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

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Ultrasound Guidance; Central Venous Catheters

Treatments: Device: Needle-pilotTM device

Study type: Interventional

Funder types: Other

Identifiers

NCT04463147

LOCAL/2019/AC-01

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

new residents

Other group

Description:

new residents in ultrasound-guided central vascular catheterization.

Treatment:

Device: Needle-pilotTM device

experienced residents or ICU practitioners

Other group

Description:

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

Treatment:

Device: Needle-pilotTM device