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

NCT02231528 | Completed Phase 3 DMC

• 1 other identifier: 1230
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Surgery

Keywords

anesthesia; central venous catheter; jugular vein; ultrasound guidance

Outcome Measures

Primary Outcomes (1)

• Time required for CVC insertion

  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)

• Total number of puncture

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

• Complication rate in the superior vena cava territory

  At 24 hours

• Insertion failure rate

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

Study Arms (2)

Use of ultrasound with active GPS

EXPERIMENTAL

Device: Use of ultrasound with active GPS

Use of ultrasound with inactive GPS

ACTIVE COMPARATOR

Device: Use of ultrasound with inactive GPS

Interventions

Use of ultrasound with active GPS DEVICE

CVC insertion with ultrasound with active GPS function and appropriate needles

Use of ultrasound with active GPS

Use of ultrasound with inactive GPS DEVICE

CVC insertion with ultrasound with inactive GPS function and conventional needles

Use of ultrasound with inactive GPS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

CHU de Grenoble

Grenoble, 38043, France

Location

Related Publications (5)

• 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.

  PMID: 17522396 BACKGROUND

• 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.

  PMID: 12919984 BACKGROUND

• 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.

  PMID: 8968276 BACKGROUND

• 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.

  PMID: 18073546 BACKGROUND

• 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.

  PMID: 22307320 BACKGROUND

Study Officials

• Pierre ALBALADEJO, MD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2014
• First Posted: September 4, 2014
• Study Start: October 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: June 2, 2015

Record last verified: 2015-06

Locations

FR (1)