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

NCT04463147 | Completed

• 1 other identifier: LOCAL/2019/AC-01
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Venous Catheters; Ultrasound Guidance

Keywords

Catheterization; Subclavian Vein; Vascular Access Devices

Outcome Measures

Primary Outcomes (1)

• First puncture success delay

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

  during the procedure

Secondary Outcomes (4)

• Failure Rate

  during the procedure

• Cutaneous wall

  during the procedure

• Posterior wall

  during the procedure

• Puncture comfort

  immediately after the procedure

Study Arms (2)

new residents

OTHER

new residents in ultrasound-guided central vascular catheterization.

Device: Needle-pilotTM device

experienced residents or ICU practitioners

OTHER

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

Device: Needle-pilotTM device

Interventions

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.

experienced residents or ICU practitioners; new residents

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes, Hôpital Universitaire Carémeau

Nîmes, France

Location

Related Publications (1)

• 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.

  PMID: 33196110 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: July 9, 2020
• Study Start: November 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: December 4, 2025

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)