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OpenTrials
Completed

NCT Number: NCT02231528

Interest of Ultrasound Coupled to a Guidance System (GPS) for Central Venous Catheters (CVC) Insertion.

The GPS system would simplify the technical implementation of central venous catheter under ultrasound guidance. We can assume that the introduction of deep venous pathways (as a reference, the internal jugular) will be faster, and this, whatever the level of expertise. By checking this hypothesis, this technique could be applied to much less frequent situations establishment of difficult central venous catheters (hemodynamic status precarious, hypovolemia, or cardiac arrest).

The main objective of this study is to evaluate the time savings provided by the ultrasound assisted GPS guidance for installing central venous catheters in the internal jugular. Central venous catheters are inserted in the operating room under conditions scheduled in advance that is to say outside emergency. The installation time for the central venous catheter is compared with that obtained by using the ultrasound machine without the GPS guide ("conventional" technique).

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU de Grenoble

Grenoble, 38043, France

About this study

The techniques of reference for the central venous access (internal jugular, subclavian or femoral) are based on anatomical landmarks and the low probability of anatomical variations. With these techniques, the central venous puncture, with Seldinger method, is associated to complications both in adults and in children (pneumothorax, hemothorax, infection, thrombosis, arterial puncture, inappropriate location). The frequency of these adverse events is highly variable and ranges between 1 and 20% of central venous catheters in place. Ultrasound, visualizing anatomical structures before (echo tracking) or during (ultrasound guidance) the puncture, improves about 80% the success of the first puncture, and decreases by 50% the complications. The ultrasound guidance is better than echo tracking to reduce the time of implementation of the central venous catheter. However, this technique requires more practice. On the other hand, visualization of the needle path is not always easy especially for the subclavian access, because it requires a puncture in the ultrasound plane.

GPS system (Guidance Positioning System) is an original system of guidance. This is a simple navigation system for projecting the theoretical position of the puncture needle in the ultrasound plane. The guidance system consists of a receiver and two motion sensors. The receiver is connected to the system. A motion sensor is incorporated into the end of the needle. Another motion sensor is located within the ultrasound probe. The relative positions and the axes of the needle and the ultrasound probe are transmitted with coordinates in three dimensions.

The puncture can be carried out of the plane (ultrasound probe perpendicular to the axis puncture) and the direct visualization of the needle is not necessary. Before the puncture, the end of the needle is placed on the skin. The direction and the axis of the needle relative to the skin are adjusted, before the puncture, depending on the position of the target to be achieved, displayed by a mark on the screen. Throughout the puncture, a projected image of the needle is displayed on the screen.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults 2 sexes
  • Age> 18years
  • Indication for placing a central venous catheter in internal jugular
  • Scheduled installation

Exclusion criteria

  • Persons referred to in Articles L. 1121-5 to L. 1121-8 Code of Public Health,
  • Lack of coverage by social security
  • Refusal of patient consent
  • Contraindication for placement of a central venous catheter in internal jugular
  • Emergency
  • Pregnancy
  • Doppler data from the supra-aortic trunks if it exists (eg bilateral carotid stenosis)
  • Pacemaker, defibrillator

Treatment and study plan

Use of ultrasound with active GPS

Device

CVC insertion with ultrasound with active GPS function and appropriate needles

Use of ultrasound with inactive GPS

Device

CVC insertion with ultrasound with inactive GPS function and conventional needles

Primary outcomes

  1. Time required for CVC insertion

    Time frame: at the end of the insertion of the guide wire, an average of one and a half minutes after the beginning of the procedure

Secondary outcomes

  1. Total number of puncture

    Time frame: at the end of the insertion of the guide wire, an average of one and a half minutes after the beginning of the procedure

  2. Complication rate in the superior vena cava territory

    Time frame: At 24 hours

    Complication rate secondary to cannulation in the territory superior vena cava: arterial puncture, subcutaneous hematoma, pneumothorax, difficulty progression of the guide, aberrant pathway, transfixion of the vein

  3. Insertion failure rate

    Time frame: at the end of the insertion of the guide wire, an average of one and a half minutes after the beginning of the procedure

    Failure is defined as the necessity to change anatomical site despite the visualization of the vein or stop using the GPS function

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: VVC and GPS

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 4, 2014
Registry last updated
Jun 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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