The Use of Point of Care Ultra Sound for Correct Placement of Central Venous Catheter

NCT ID: NCT02472132

Last Updated: 2016-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-07-31

Brief Summary

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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.

Detailed Description

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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.

The study population will be screened at the internal wards and medical intensive care unit of Soroka Medical Center.

Research candidates' files will be screened routinely by a study coordinator. The study population will be enrolled according to the inclusion and exclusion criteria.

The primary objective for the study is to evaluate whether the use of POCUS in CVC insertion can help inaccurate CVC tip placement, detect misplacement and complications and better than chest X ray.

Conditions

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Central Venous Catheter

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Intervention

Prospective implantation of POC US for CVC tip placement.

Group Type EXPERIMENTAL

POC US

Intervention Type DEVICE

Use of point of care ultrasound in insertion of CVC

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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POC US

Use of point of care ultrasound in insertion of CVC

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Subject currently enrolled in another investigational study
2. Surgical patients with open abdomen covered with bogota bag or vac - pac
3. Patients with pneumothorax prior to central venous catheter insertion
4. Patients in need for central venous catheter for hemodialysis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Soroka University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Soroka University Medical Center

Beersheba, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type BACKGROUND
PMID: 23756247 (View on PubMed)

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.

Reference Type RESULT
PMID: 22127816 (View on PubMed)

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

Reference Type RESULT
PMID: 18450883 (View on PubMed)

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.

Reference Type RESULT
PMID: 12919984 (View on PubMed)

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.

Reference Type RESULT
PMID: 22099570 (View on PubMed)

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.

Reference Type RESULT
PMID: 19863734 (View on PubMed)

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.

Reference Type RESULT
PMID: 24052186 (View on PubMed)

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.

Reference Type RESULT
PMID: 20626896 (View on PubMed)

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

Reference Type 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.

Reference Type RESULT
PMID: 3947185 (View on PubMed)

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.

Reference Type RESULT
PMID: 10577399 (View on PubMed)

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.

Reference Type RESULT
PMID: 20653578 (View on PubMed)

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.

Reference Type RESULT
PMID: 19829102 (View on PubMed)

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.

Reference Type RESULT
PMID: 11495620 (View on PubMed)

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.

Reference Type RESULT
PMID: 564628 (View on PubMed)

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.

Reference Type RESULT
PMID: 7587439 (View on PubMed)

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.

Reference Type RESULT
PMID: 10342512 (View on PubMed)

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.

Reference Type RESULT
PMID: 11500340 (View on PubMed)

Other Identifiers

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SOR-0131-15-CTIL

Identifier Type: -

Identifier Source: org_study_id

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