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

Not Applicable

Completed

• Conditions: Ultrasound Guidance; Central Venous Catheters
• Interventions: Device: Needle-pilotTM device

• Registration Number: NCT04463147
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Study First Submitted: 2020-02-14
• Study First Submitted QC: 2020-07-03
• Study First Posted: 2020-07-09
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-06
• Last Update Posted: 2021-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
experienced residents or ICU practitioners	Needle-pilotTM device	experienced residents or ICU practitioners in ultrasound-guided central vascular catheterization.
new residents	Needle-pilotTM device	new residents in ultrasound-guided central vascular catheterization.

Primary Outcome Measures

Name	Time	Method
First puncture success delay	during the procedure	comparison of time (in seconds) between first puncture and successful "blood-aspiration" on a "subclavian venous" torso mannequin.

Secondary Outcome Measures

Name	Time	Method
Puncture comfort	immediately after the procedure	Operator puncture comfort feeling is assessed from 0 to 10 by each participants for each technique.
Failure Rate	during the procedure	Failure is defined as a puncture time \> 300 seconds. The criterion corresponds to an absolute value: failure or not
Posterior wall	during the procedure	Number of posterior vessel wall penetration
Cutaneous wall	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.

Trial Locations

Locations (1)

CHU de Nîmes, Hôpital Universitaire Carémeau; 🇫🇷 Nîmes, France