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

Central Venous Catheters Clinical Trial

— NEEDLE-VISIO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04463147
• Other study ID #: LOCAL/2019/AC-01
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2021
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Central Venous Catheters
• Ultrasound Guidance

Intervention

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

Locations

Country	Name	City	State
France	CHU de Nîmes, Hôpital Universitaire Carémeau	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

References & Publications (3)

Brass P, Hellmich M, Kolodziej L, Schick G, Smith AF. Ultrasound guidance versus anatomical landmarks for subclavian or femoral vein catheterization. Cochrane Database Syst Rev. 2015 Jan 9;1:CD011447. doi: 10.1002/14651858.CD011447. Review. — View Citation

Jiang L, Zhang M, Ma Y. Ultrasound-Guided Subclavian Vein Catheterization: A Systematic Review and Meta-Analysis: Several Facts Need To Be Noticed. Crit Care Med. 2015 Oct;43(10):e474-5. doi: 10.1097/CCM.0000000000001071. — View Citation

Vogel JA, Haukoos JS, Erickson CL, Liao MM, Theoret J, Sanz GE, Kendall J. Is long-axis view superior to short-axis view in ultrasound-guided central venous catheterization? Crit Care Med. 2015 Apr;43(4):832-9. doi: 10.1097/CCM.0000000000000823. — View Citation

Outcome

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