NCT02472132

Brief Summary

Central venous catheter (CVC) is an essential tool in the management of both medical and surgical patients. Establishing venous access is critically important and is sometimes technically challenging. Among the many indications for point of care ultrasound (POCUS), ultrasound-guided venous catheter placement is well described and increasingly used. This study was designed to evaluate the utility of peri procedural transthoracic echocardiography (TTE) as a tool for positioning CVC and for ruling out complications.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
186

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2015

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 15, 2015

Completed
16 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

March 16, 2016

Status Verified

March 1, 2016

Enrollment Period

1.3 years

First QC Date

May 18, 2015

Last Update Submit

March 15, 2016

Conditions

Central Venous Catheter

Keywords

Central Venous CatheterPoint Of Care Ultra SoundSub Clavian VeinInternal Jugular VeinTrans Thoracic Echocardiography

Outcome Measures

Primary Outcomes (1)

  • Rate of misplacement of the tip of CVC.

    6 months

Secondary Outcomes (5)

  • Rate of ventricular arrhythmia during line insertion while using POC US

    6 months

  • Duration time of CVC insertion using POC US

    6 months

  • Number of CVC insertion complications using POC US

    6 months

  • Sensitivity (score-the device's ability to identify a condition correctly) of POC US in detection of CVC insertion complications

    6 months

  • Specificity (score-the device's ability to exclude a condition correctly) of POC US in detection of CVC insertion complications

    6 months

Study Arms (2)

Intervention

EXPERIMENTAL

Prospective implantation of POC US for CVC tip placement.

Device: POC US

Control

NO INTERVENTION

Retrospective data collection for CVC placement in the medical and surgical ICUs, before the initiation of the study and without the use of POCUS for CVC tip placement.

Interventions

POC USDEVICE

Use of point of care ultrasound in insertion of CVC

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients admitted to internal ward or medical intensive care unit
  • Patients in need for central venous catheter in the subclavian or internal jugular veins

You may not qualify if:

  • Subject currently enrolled in another investigational study
  • Surgical patients with open abdomen covered with bogota bag or vac - pac
  • Patients with pneumothorax prior to central venous catheter insertion
  • Patients in need for central venous catheter for hemodialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soroka University Medical Center

Beersheba, Israel

Location

Related Publications (18)

  • Byon HJ, Lee GW, Lee JH, Park YH, Kim HS, Kim CS, Kim JT. Comparison between ultrasound-guided supraclavicular and infraclavicular approaches for subclavian venous catheterization in children--a randomized trial. Br J Anaesth. 2013 Nov;111(5):788-92. doi: 10.1093/bja/aet202. Epub 2013 Jun 10.

    PMID: 23756247BACKGROUND

  • Troianos CA, Hartman GS, Glas KE, Skubas NJ, Eberhardt RT, Walker JD, Reeves ST; Councils on Intraoperative Echocardiography and Vascular Ultrasound of the American Society of Echocardiography; Society of Cardiovascular Anesthesiologists. Special articles: guidelines for performing ultrasound guided vascular cannulation: recommendations of the American Society of Echocardiography and the Society Of Cardiovascular Anesthesiologists. Anesth Analg. 2012 Jan;114(1):46-72. doi: 10.1213/ANE.0b013e3182407cd8. Epub 2011 Nov 29. No abstract available.

    PMID: 22127816RESULT

  • Levy JA, Noble VE. Bedside ultrasound in pediatric emergency medicine. Pediatrics. 2008 May;121(5):e1404-12. doi: 10.1542/peds.2007-1816.

    PMID: 18450883RESULT

  • 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: 12919984RESULT

  • Rabindranath KS, Kumar E, Shail R, Vaux E. Use of real-time ultrasound guidance for the placement of hemodialysis catheters: a systematic review and meta-analysis of randomized controlled trials. Am J Kidney Dis. 2011 Dec;58(6):964-70. doi: 10.1053/j.ajkd.2011.07.025.

    PMID: 22099570RESULT

  • Sigaut S, Skhiri A, Stany I, Golmar J, Nivoche Y, Constant I, Murat I, Dahmani S. Ultrasound guided internal jugular vein access in children and infant: a meta-analysis of published studies. Paediatr Anaesth. 2009 Dec;19(12):1199-206. doi: 10.1111/j.1460-9592.2009.03171.x. Epub 2009 Oct 23.

    PMID: 19863734RESULT

  • Bedel J, Vallee F, Mari A, Riu B, Planquette B, Geeraerts T, Genestal M, Minville V, Fourcade O. Guidewire localization by transthoracic echocardiography during central venous catheter insertion: a periprocedural method to evaluate catheter placement. Intensive Care Med. 2013 Nov;39(11):1932-7. doi: 10.1007/s00134-013-3097-3. Epub 2013 Sep 20.

    PMID: 24052186RESULT

  • Gillman LM, Blaivas M, Lord J, Al-Kadi A, Kirkpatrick AW. Ultrasound confirmation of guidewire position may eliminate accidental arterial dilatation during central venous cannulation. Scand J Trauma Resusc Emerg Med. 2010 Jul 13;18:39. doi: 10.1186/1757-7241-18-39.

    PMID: 20626896RESULT

  • Hocking G. Central venous access and monitoring. Practical Procedures 2000;12:1-6.

    RESULT

  • Sznajder JI, Zveibil FR, Bitterman H, Weiner P, Bursztein S. Central vein catheterization. Failure and complication rates by three percutaneous approaches. Arch Intern Med. 1986 Feb;146(2):259-61. doi: 10.1001/archinte.146.2.259.

    PMID: 3947185RESULT

  • Keyes LE, Frazee BW, Snoey ER, Simon BC, Christy D. Ultrasound-guided brachial and basilic vein cannulation in emergency department patients with difficult intravenous access. Ann Emerg Med. 1999 Dec;34(6):711-4. doi: 10.1016/s0196-0644(99)70095-8.

    PMID: 10577399RESULT

  • Prekker ME, Chang R, Cole JB, Reardon R. Rapid confirmation of central venous catheter placement using an ultrasonographic "Bubble Test". Acad Emerg Med. 2010 Jul;17(7):e85-6. doi: 10.1111/j.1553-2712.2010.00785.x. No abstract available.

    PMID: 20653578RESULT

  • Vezzani A, Brusasco C, Palermo S, Launo C, Mergoni M, Corradi F. Ultrasound localization of central vein catheter and detection of postprocedural pneumothorax: an alternative to chest radiography. Crit Care Med. 2010 Feb;38(2):533-8. doi: 10.1097/CCM.0b013e3181c0328f.

    PMID: 19829102RESULT

  • Merrer J, De Jonghe B, Golliot F, Lefrant JY, Raffy B, Barre E, Rigaud JP, Casciani D, Misset B, Bosquet C, Outin H, Brun-Buisson C, Nitenberg G; French Catheter Study Group in Intensive Care. Complications of femoral and subclavian venous catheterization in critically ill patients: a randomized controlled trial. JAMA. 2001 Aug 8;286(6):700-7. doi: 10.1001/jama.286.6.700.

    PMID: 11495620RESULT

  • Ullman JI, Stoelting RK. Internal jugular vein location with the ultrasound Doppler blood flow detector. Anesth Analg. 1978 Jan-Feb;57(1):118. doi: 10.1213/00000539-197801000-00024. No abstract available.

    PMID: 564628RESULT

  • Lichtenstein DA, Menu Y. A bedside ultrasound sign ruling out pneumothorax in the critically ill. Lung sliding. Chest. 1995 Nov;108(5):1345-8. doi: 10.1378/chest.108.5.1345.

    PMID: 7587439RESULT

  • Lichtenstein D, Meziere G, Biderman P, Gepner A. The comet-tail artifact: an ultrasound sign ruling out pneumothorax. Intensive Care Med. 1999 Apr;25(4):383-8. doi: 10.1007/s001340050862.

    PMID: 10342512RESULT

  • Maury E, Guglielminotti J, Alzieu M, Guidet B, Offenstadt G. Ultrasonic examination: an alternative to chest radiography after central venous catheter insertion? Am J Respir Crit Care Med. 2001 Aug 1;164(3):403-5. doi: 10.1164/ajrccm.164.3.2009042.

    PMID: 11500340RESULT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2015

First Posted

June 15, 2015

Study Start

July 1, 2015

Primary Completion

October 1, 2016

Study Completion

July 1, 2017

Last Updated

March 16, 2016

Record last verified: 2016-03

Locations

IL(1)