NCT02661607

Brief Summary

A prospective study to compare the use of point of care echocardiography versus routine chest radiography for the assessment of central venous catheter placement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 22, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

July 23, 2019

Status Verified

July 1, 2019

Enrollment Period

1.3 years

First QC Date

June 17, 2015

Last Update Submit

July 22, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Adequate placement of the central venous catheter

    Participants will be followed for the period after the intervention to assess correct placement, an expected average of 2 hours

    2 hours

Secondary Outcomes (4)

  • Time needed for the intervention (bedside echocardiography)

    5 Minutes

  • Performance of residents as assessed by the time needed to perform the echocardiography

    5 Minutes

  • Time needed for chest radiography to be performed

    2 hours

  • Adverse Events

    24 hours

Study Arms (1)

Point of care echocardiography after central venous catheter

OTHER

Point of care echocardiography plus chest radiography

Procedure: Point of care echocardiographyDevice: Central venous catheter placementProcedure: Chest radiography

Interventions

Point of echocardiography is performed after routine placement of central venous catheterization and compared with routine chest radiography

Point of care echocardiography after central venous catheter

Central venous catheter placement is performed as per local guidelines in critically ill patients

Point of care echocardiography after central venous catheter

Routine chest radiography is performed after central venous catheter placement in critically ill patients

Point of care echocardiography after central venous catheter

Eligibility Criteria

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

You may qualify if:

  • patients who require central venous catheterization in critical care environments (ICU, IMC)
  • patients (or legal guardian) who provide written informed consents
  • patients aged 18 years or older

You may not qualify if:

  • patients who are unable/unwilling to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Göttingen

Göttingen, 37075, Germany

Location

Related Publications (1)

  • Korsten P, Mavropoulou E, Wienbeck S, Ellenberger D, Patschan D, Zeisberg M, Vasko R, Tampe B, Muller GA. The "rapid atrial swirl sign" for assessing central venous catheters: Performance by medical residents after limited training. PLoS One. 2018 Jul 16;13(7):e0199345. doi: 10.1371/journal.pone.0199345. eCollection 2018.

MeSH Terms

Interventions

Central Venous CathetersX-Rays

Intervention Hierarchy (Ancestors)

Vascular Access DevicesCathetersEquipment and SuppliesElectromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Study Officials

  • Peter Korsten, MD

    University Medical Center Göttingen, Department of Nephrology and Rheumatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med.

Study Record Dates

First Submitted

June 17, 2015

First Posted

January 22, 2016

Study Start

October 1, 2014

Primary Completion

January 1, 2016

Study Completion

April 1, 2016

Last Updated

July 23, 2019

Record last verified: 2019-07

Locations