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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04463147
Acronym
NEEDLE-VISIO
Enrollment
51
Registered
2020-07-09
Start date
2019-11-01
Completion date
2021-12-31
Last updated
2025-12-04

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

Conditions

Central Venous Catheters, Ultrasound Guidance

Keywords

Catheterization, Subclavian Vein, Vascular Access Devices

Brief 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.

Interventions

DEVICENeedle-pilotTM device

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

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
First puncture success delayduring the procedurecomparison of time (in seconds) between first puncture and successful blood-aspiration on a subclavian venous torso mannequin.

Secondary

MeasureTime frameDescription
Failure Rateduring the procedureFailure is defined as a puncture time \> 300 seconds. The criterion corresponds to an absolute value: failure or not
Cutaneous wallduring the procedureCounting 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.
Posterior wallduring the procedureNumber of posterior vessel wall penetration
Puncture comfortimmediately after the procedureOperator puncture comfort feeling is assessed from 0 to 10 by each participants for each technique.

Countries

France

Outcome results

None listed

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