Ultrasound Guided Positioning of Central Venous Catheters

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.

Study Overview

• Status: Completed
• Conditions: Central Venous Catheter
• Intervention / Treatment: Diagnostic test: Ultrasound

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Nidda, Germany, 63667
    • Neurologische Klinik Bad Salzhausen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• elective insertion of a central venous catheter.

Exclusion Criteria:

• emergency insertion of a central venous catheter

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Ultrasound	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
- 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

Collaborators and Investigators

• Sponsor: Asklepios Neurological Clinic Bad Salzhausen
• Collaborators: Kerckhoff Klinik

Publications and helpful links

General Publications

• Schummer W, Schummer C, Schelenz C, Brandes H, Stock U, Muller T, Leder U, Huttemann E. Central venous catheters--the inability of 'intra-atrial ECG' to prove adequate positioning. Br J Anaesth. 2004 Aug;93(2):193-8. doi: 10.1093/bja/aeh191. Epub 2004 Jun 25.
• 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. doi: 10.1093/bja/aeg208.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2021
• Primary Completion (ACTUAL): July 20, 2022
• Study Completion (ACTUAL): August 9, 2022

Study Registration Dates

• First Submitted: November 6, 2020
• First Submitted That Met QC Criteria: November 13, 2020
• First Posted (ACTUAL): November 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 11, 2022
• Last Update Submitted That Met QC Criteria: August 10, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CVC061120

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No