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

Study Overview
=================
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.

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

Conditions
-----------------
Central Venous Catheterization, Ultrasound, Emergency Medicine, Critical Care

Intervention / Treatment
-----------------
* Procedure: Point of care echocardiography
* Device: Central venous catheter placement
* Procedure: Chest radiography


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention 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<br>Point of care echocardiography plus chest radiography | Procedure: Point of care echocardiography<br>* Point of echocardiography is performed after routine placement of central venous catheterization and compared with routine chest radiography<br>Device: Central venous catheter placement<br>* Central venous catheter placement is performed as per local guidelines in critically ill patients<br>Procedure: Chest radiography<br>* Routine chest radiography is performed after central venous catheter placement in critically ill patients<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time needed for the intervention (bedside echocardiography) | 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 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 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 | 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 |