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

Study Overview
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Brief Summary
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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.

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

Conditions
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Central Venous Catheters, Ultrasound Guidance

Intervention / Treatment
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* Device: Needle-pilotTM device


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: new residents<br>new residents in ultrasound-guided central vascular catheterization. | Device: Needle-pilotTM device<br>* The main objective aims to compare the procedure time between conventional real time ultrasound guidance and guidance with Needle-pilotTM device.<br>|
| Other: experienced residents or ICU practitioners<br>experienced residents or ICU practitioners in ultrasound-guided central vascular catheterization. | Device: Needle-pilotTM device<br>* The main objective aims to compare the procedure time between conventional real time ultrasound guidance and guidance with Needle-pilotTM device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Catheterization, Subclavian Vein, Vascular Access Devices