Central Venous CatheterNCT02472132

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

A study testing POC US in people with Central Venous Catheter, run by Soroka University Medical Center at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Central Venous Catheter
What is being tested?: POC US
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 186 participants
Where: 1 siteIsrael
Study dates: Jul 2015to Jul 2017
Phase: Interventional
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

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Israel1 site

Soroka University Medical Center
Beersheba

Other trials in Israel

About this study

Official title: The Use of Point of Care Ultra Sound for Correct Placement of Central Venous Catheter and for the Detection of Complications

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.

Read the detailed description

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: Central Venous Catheter
Being tested: POC US
Keywords: Central Venous Catheter, Point Of Care Ultra Sound, Sub Clavian Vein, Internal Jugular Vein, Trans Thoracic Echocardiography

What participants receive

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

POC USDevice
Use of point of care ultrasound in insertion of CVC

Study groups in NCT02472132
Study group	Role	What they receive
Intervention	Experimental	Prospective implantation of POC US for CVC tip placement. Receives: 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.

What is being measured

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

Rate of misplacement of the tip of CVC.
Measured: 6 months

Secondary outcomes (5)

Rate of ventricular arrhythmia during line insertion while using POC US
Measured: 6 months
Duration time of CVC insertion using POC US
Measured: 6 months
Number of CVC insertion complications using POC US
Measured: 6 months
Sensitivity (score-the device's ability to identify a condition correctly) of POC US in detection of CVC insertion complications
Measured: 6 months
Specificity (score-the device's ability to exclude a condition correctly) of POC US in detection of CVC insertion complications
Measured: 6 months

Timeline

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

Jul 2015Jul 2017

First posted15 Jun 2015 (estimated)
Study startJul 2015
Primary completionOct 2016 (estimated)
Study completionJul 2017 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (18)Papers the sponsor has linked to this study.
Other trials for Central Venous CatheterStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 N/A
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 186 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02472132
Sponsor's protocol ID: SOR-0131-15-CTIL
Status last verified: Mar 2016
First submitted: 18 May 2015
Last updated: 16 Mar 2016
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 23756247
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.
PubMed 22127816
Levy JA, Noble VE. Bedside ultrasound in pediatric emergency medicine. Pediatrics. 2008 May;121(5):e1404-12. doi: 10.1542/peds.2007-1816.
PubMed 18450883
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
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.
PubMed 22099570
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.
PubMed 19863734
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.
PubMed 24052186
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.
PubMed 20626896
Hocking G. Central venous access and monitoring. Practical Procedures 2000;12:1-6.
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.
PubMed 3947185
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.
PubMed 10577399
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.
PubMed 20653578
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.
PubMed 19829102
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.
PubMed 11495620
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.
PubMed 564628

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
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All Central Venous Catheter trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Use of Point of Care Ultra Sound for Correct Placement of Central Venous Catheter and for the Detection of Complications
ClinicalTrials.gov ID: NCT02472132
Acronym / sponsor ID: SOR-0131-15-CTIL
Conditions: Central Venous Catheter
Keywords: Central Venous Catheter, Point Of Care Ultra Sound, Sub Clavian Vein, Internal Jugular Vein, Trans Thoracic Echocardiography
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 186 participants (actual)
Lead sponsor: Soroka University Medical CenterUniversity, hospital or other
Study start: Jul 2015
Primary completion: Oct 2016 (estimated)
Study completion: Jul 2017 (estimated)
First posted: 15 Jun 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Intervention	Experimental	Device: POC USProspective implantation of POC US for CVC tip placement.
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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
POC USUse of point of care ultrasound in insertion of CVC	Device	Intervention

Primary outcome

Rate of misplacement of the tip of CVC.
Time frame: 6 months

5 secondary outcomes

Rate of ventricular arrhythmia during line insertion while using POC US
Time frame: 6 months
Duration time of CVC insertion using POC US
Time frame: 6 months
Number of CVC insertion complications using POC US
Time frame: 6 months
Sensitivity (score-the device's ability to identify a condition correctly) of POC US in detection of CVC insertion complications
Time frame: 6 months
Specificity (score-the device's ability to exclude a condition correctly) of POC US in detection of CVC insertion complications
Time frame: 6 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
Background: PubMed 23756247Byon 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.
Results publication: PubMed 22127816Troianos 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.
Results publication: PubMed 18450883Levy JA, Noble VE. Bedside ultrasound in pediatric emergency medicine. Pediatrics. 2008 May;121(5):e1404-12. doi: 10.1542/peds.2007-1816.
Results publication: PubMed 12919984Hind 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.
Results publication: PubMed 22099570Rabindranath 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.
Results publication: PubMed 19863734Sigaut 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.
Results publication: PubMed 24052186Bedel 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.
Results publication: PubMed 20626896Gillman 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.
Results publicationHocking G. Central venous access and monitoring. Practical Procedures 2000;12:1-6.
Results publication: PubMed 3947185Sznajder 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.
Results publication: PubMed 10577399Keyes 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.
Results publication: PubMed 20653578Prekker 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.

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Compassionate-Use of 4% T-EDTA Lock Solution for Central Venous Lines of Pediatric PN Patients
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing POC US in people with Central Venous Catheter, run by Soroka University Medical Center at 1 site in Israel.

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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 16 Mar 2016. 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 Israel. 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.

Are results available for this study?

Results are not available in the source record.

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?

Rate of misplacement of the tip of CVC. (time frame: 6 months). 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 NCT02472132, which also lists 18 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 16 Mar 2016.