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

Sponsor

University of Göttingen (Other)

Overall Status

Completed

CT.gov ID

NCT02661607

Collaborator

(none)

100

Enrollment

Location

Arm

Duration (Months)

5.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Central Venous Catheterization Ultrasound Emergency Medicine Critical Care	Procedure: Point of care echocardiography Device: Central venous catheter placement Procedure: Chest radiography	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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 Start Date :

Oct 1, 2014

Actual Primary Completion Date :

Jan 1, 2016

Actual Study Completion Date :

Apr 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Adequate placement of the central venous catheter [2 hours]
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) [5 Minutes]
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 [5 Minutes]
Time needed to perform the echocardiography will be measured with an expected average of 5 minutes
Time needed for chest radiography to be performed [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
Adverse Events [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Göttingen	Göttingen		Germany	37075

Sponsors and Collaborators

University of Göttingen

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peter Korsten, Dr. med., University of Göttingen

ClinicalTrials.gov Identifier:

NCT02661607

Other Study ID Numbers:

1/3/14

First Posted:

Jan 22, 2016

Last Update Posted:

Jul 23, 2019

Last Verified:

Jul 1, 2019

Additional relevant MeSH terms:

Emergencies

Study Results

No Results Posted as of Jul 23, 2019