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SurgeryPhase 3VVC and GPSNCT02231528

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

A Phase 3 study testing Use of ultrasound with active GPS and Use of ultrasound with inactive GPS in people with Surgery, run by University Hospital, Grenoble at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Surgery
What is being tested?
Use of ultrasound with active GPS and Use of ultrasound with inactive GPS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteFrance
Study dates
Oct 2013to Sep 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU de Grenoble

    Grenoble, 38043

Other trials in France

About this study

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).

Read the detailed description

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.

Conditions
Surgery
Being tested
Use of ultrasound with active GPS, Use of ultrasound with inactive GPS
Keywords
anesthesia, central venous catheter, jugular vein, ultrasound guidance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Use of ultrasound with active GPSDevice

    CVC insertion with ultrasound with active GPS function and appropriate needles

  • Use of ultrasound with inactive GPSDevice

    CVC insertion with ultrasound with inactive GPS function and conventional needles

Study groups in NCT02231528
Study groupRoleWhat they receive
Use of ultrasound with active GPSExperimentalNot described
Receives: Device: Use of ultrasound with active GPS
Use of ultrasound with inactive GPSActive comparatorNot described
Receives: Device: Use of ultrasound with inactive GPS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time required for CVC insertion

    Measured: 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 (3)

  1. Total number of puncture

    Measured: 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

    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

    Measured: At 24 hours

  3. Insertion failure rate

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2014 (estimated)
  2. Study startOct 2013
  3. Primary completionSep 2014
  4. Study completionSep 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02231528
Sponsor's protocol ID
1230
Acronym
VVC and GPS
Status last verified
Jun 2015
First submitted
27 Aug 2014
Last updated
2 Jun 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Graham AS, Ozment C, Tegtmeyer K, Lai S, Braner DA. Videos in clinical medicine. Central venous catheterization. N Engl J Med. 2007 May 24;356(21):e21. doi: 10.1056/NEJMvcm055053. No abstract available.

    PubMed 17522396

  • Hind D, Calvert N, McWilliams R, Davidson A, Paisley S, Beverley C, Thomas S. Ultrasonic locating devices for central venous cannulation: meta-analysis. BMJ. 2003 Aug 16;327(7411):361. doi: 10.1136/bmj.327.7411.361.

    PubMed 12919984

  • Randolph AG, Cook DJ, Gonzales CA, Pribble CG. Ultrasound guidance for placement of central venous catheters: a meta-analysis of the literature. Crit Care Med. 1996 Dec;24(12):2053-8. doi: 10.1097/00003246-199612000-00020.

    PubMed 8968276

  • Hosokawa K, Shime N, Kato Y, Hashimoto S. A randomized trial of ultrasound image-based skin surface marking versus real-time ultrasound-guided internal jugular vein catheterization in infants. Anesthesiology. 2007 Nov;107(5):720-4. doi: 10.1097/01.anes.0000287024.19704.96.

    PubMed 18073546

  • American Society of Anesthesiologists Task Force on Central Venous Access; Rupp SM, Apfelbaum JL, Blitt C, Caplan RA, Connis RT, Domino KB, Fleisher LA, Grant S, Mark JB, Morray JP, Nickinovich DG, Tung A. Practice guidelines for central venous access: a report by the American Society of Anesthesiologists Task Force on Central Venous Access. Anesthesiology. 2012 Mar;116(3):539-73. doi: 10.1097/ALN.0b013e31823c9569. No abstract available.

    PubMed 22307320

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Use of ultrasound with active GPS and Use of ultrasound with inactive GPS in people with Surgery, run by University Hospital, Grenoble at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02231528, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2015.

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