Back to resultsPoint of Care Echocardiography Versus Chest Radiography for the Assessment of Central Venous Catheter Placement
Primary Purpose
Central Venous Catheterization, Ultrasound, Emergency Medicine
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Point of care echocardiography
Central venous catheter placement
Chest radiography
Sponsored by
About this trial
This is an interventional diagnostic trial for Central Venous Catheterization
Eligibility Criteria
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
Sites / Locations
- University of Göttingen
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Point of care echocardiography after central venous catheter
Arm Description
Point of care echocardiography plus chest radiography
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Time needed for the intervention (bedside echocardiography)
Time of the procedure will be measured, an expected average of 5 minutes
Performance of residents as assessed by the time needed to perform the echocardiography
Time needed to perform the echocardiography will be measured with an expected average of 5 minutes
Time needed for chest radiography to be performed
Time will be measured after requesting chest radiography via telephone until chest radiographs are available for review, an expected average of 2 hours
Adverse Events
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02661607
Brief Title
Point of Care Echocardiography Versus Chest Radiography for the Assessment of Central Venous Catheter Placement
Official Title
A Prospective Study to Compare Point of Care Echocardiography Versus Chest Radiography for the Assessment of Central Venous Catheter Placement in Critical Care Environments
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Göttingen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Venous Catheterization, Ultrasound, Emergency Medicine, Critical Care
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Point of care echocardiography after central venous catheter
Arm Type
Other
Arm Description
Point of care echocardiography plus chest radiography
Intervention Type
Procedure
Intervention Name(s)
Point of care echocardiography
Intervention Description
Point of echocardiography is performed after routine placement of central venous catheterization and compared with routine chest radiography
Intervention Type
Device
Intervention Name(s)
Central venous catheter placement
Intervention Description
Central venous catheter placement is performed as per local guidelines in critically ill patients
Intervention Type
Procedure
Intervention Name(s)
Chest radiography
Intervention Description
Routine chest radiography is performed after central venous catheter placement in critically ill patients
Primary Outcome Measure Information:
Title
Adequate placement of the central venous catheter
Description
Participants will be followed for the period after the intervention to assess correct placement, an expected average of 2 hours
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Time needed for the intervention (bedside echocardiography)
Description
Time of the procedure will be measured, an expected average of 5 minutes
Time Frame
5 Minutes
Title
Performance of residents as assessed by the time needed to perform the echocardiography
Description
Time needed to perform the echocardiography will be measured with an expected average of 5 minutes
Time Frame
5 Minutes
Title
Time needed for chest radiography to be performed
Description
Time will be measured after requesting chest radiography via telephone until chest radiographs are available for review, an expected average of 2 hours
Time Frame
2 hours
Title
Adverse Events
Description
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)
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Korsten, MD
Organizational Affiliation
University Medical Center Göttingen, Department of Nephrology and Rheumatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Göttingen
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
30011285
Citation
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.
Results Reference
derived
Learn more about this trial
Point of Care Echocardiography Versus Chest Radiography for the Assessment of Central Venous Catheter Placement
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