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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02661607
Other study ID # 1/3/14
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2014
Est. completion date April 2016

Study information

Verified date July 2019
Source University of Göttingen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date April 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Germany University of Göttingen Göttingen

Sponsors (1)

Lead Sponsor Collaborator
University of Göttingen

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Time needed for the intervention (bedside echocardiography) Time of the procedure will be measured, an expected average of 5 minutes 5 Minutes
Secondary 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 5 Minutes
Secondary 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 2 hours
Secondary 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) 24 hours
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