Clinical trial NCT04463147: Does the Needle-pilot Device Improve the Success of Vascular Catheterization Compared to the Classical Ultrasound-guided Technique
Official title: Does the Needle-pilot Device Improve the Success of Vascular Catheterization Compared to the Classical Ultrasound-guided Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Central Venous Catheters
Ultrasound Guidance
Keywords: Catheterization
Subclavian Vein
Vascular Access Devices
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility criteria: 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).

Primary outcomes:
measure: First puncture success delay
timeFrame: during the procedure
Secondary outcomes:
measure: Failure Rate
timeFrame: during the procedure
measure: Cutaneous wall
timeFrame: during the procedure
measure: Posterior wall
timeFrame: during the procedure
measure: Puncture comfort
timeFrame: immediately after the procedure
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nîmes, Hôpital Universitaire Carémeau
Study officials:
References:
citation: 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(1):CD011447. doi: 10.1002/14651858.CD011447.
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. No abstract available.
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.