Point of Care Echocardiography Versus Chest Radiography for the Assessment of Central Venous Catheter Placement

July 22, 2019 updated by: Peter Korsten, University of Göttingen

A Prospective Study to Compare Point of Care Echocardiography Versus Chest Radiography for the Assessment of Central Venous Catheter Placement in Critical Care Environments

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Göttingen, Germany, 37075
        • University of Göttingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • patients who are unable/unwilling to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Point of care echocardiography after central venous catheter
Point of care echocardiography plus chest radiography
Procedure: Point of care echocardiography
Point of echocardiography is performed after routine placement of central venous catheterization and compared with routine chest radiography
Device: Central venous catheter placement
Central venous catheter placement is performed as per local guidelines in critically ill patients
Procedure: Chest radiography
Routine chest radiography is performed after central venous catheter placement in critically ill patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adequate placement of the central venous catheter
Time Frame: 2 hours
Participants will be followed for the period after the intervention to assess correct placement, an expected average of 2 hours
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time needed for the intervention (bedside echocardiography)
Time Frame: 5 Minutes
Time of the procedure will be measured, an expected average of 5 minutes
5 Minutes
Performance of residents as assessed by the time needed to perform the echocardiography
Time Frame: 5 Minutes
Time needed to perform the echocardiography will be measured with an expected average of 5 minutes
5 Minutes
Time needed for chest radiography to be performed
Time Frame: 2 hours
Time will be measured after requesting chest radiography via telephone until chest radiographs are available for review, an expected average of 2 hours
2 hours
Adverse Events
Time Frame: 24 hours
Patients will be followed as per local guidelines to detect complications by central venous catheter placement, usual time Frame of 24 hours (e. g. pneumothorax from cvc placement)
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Göttingen

Investigators

  • Principal Investigator: Peter Korsten, MD, University Medical Center Göttingen, Department of Nephrology and Rheumatology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

June 17, 2015

First Submitted That Met QC Criteria

January 21, 2016

First Posted (Estimate)

January 22, 2016

Study Record Updates

Last Update Posted (Actual)

July 23, 2019

Last Update Submitted That Met QC Criteria

July 22, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1/3/14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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