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NCT04630236 Clinical Trial

Ultrasound Guided Positioning of Central Venous Catheters

Central Venous Catheter Clinical Trial

Official title:
Ultrasound Guided Positioning of Central Venous Catheters

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04630236
Other study ID # CVC061120
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date August 9, 2022

Study information
Verified date July 2022
Source Asklepios Neurological Clinic Bad Salzhausen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The current standard for (correct) position control of a central venous catheter (CVC) is X-ray control, which is associated with X-rays for the patient. In some clinics, radiological services are not offered "around the clock". Therefore, an alternative that is not burdensome for patients and is available on all sides would be desirable. The possibility of a sonographic CVC position control is to be investigated. The correct position of a central venous catheter is important. Complications/failure must be detected early/immediately. In addition to the X-ray of the thorax, a position control by means of an ECG derivative (α-card derivative) is available for position control. The method is easy to perform, but an epicardial or an arterial position of the CVC cannot be detected without the use of additional imaging in case of doubt. For the reasons mentioned above, sonography is a suitable method to show the inflow of injected 0.9% sodium chloride solution into the right atrium, which allows to conclude the correct position of the CVC.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date August 9, 2022
Est. primary completion date July 20, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - elective insertion of a central venous catheter. Exclusion Criteria: - emergency insertion of a central venous catheter

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Ultrasound
Using ultrasound control, the central vein catheter is injected with saline solution and the time to detect the saline bolus in the ultrasound is measured.

Locations
Country Name City State
Germany Neurologische Klinik Bad Salzhausen Nidda

Sponsors (2)
Lead Sponsor Collaborator
Asklepios Neurological Clinic Bad Salzhausen Kerckhoff Klinik

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Schummer W, Herrmann S, Schummer C, Funke F, Steenbeck J, Fuchs J, Uhlig T, Reinhart K. Intra-atrial ECG is not a reliable method for positioning left internal jugular vein catheters. Br J Anaesth. 2003 Oct;91(4):481-6. — View Citation

Schummer W, Schummer C, Schelenz C, Brandes H, Stock U, Müller T, Leder U, Hüttemann E. Central venous catheters--the inability of 'intra-atrial ECG' to prove adequate positioning. Br J Anaesth. 2004 Aug;93(2):193-8. Epub 2004 Jun 25. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary - correlation between the time of detection of the injected saline bolus and radiological position of the central venous catheter - ultrasound during injection of saline solution into a newly inserted central venous catheter up to 5 seconds
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