Ultrasound Guided Positioning of Central Venous Catheters

NCT04630236 | Completed

• 1 other identifier: CVC061120
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Central Venous Catheter

Outcome Measures

Primary Outcomes (1)

• - 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

Study Arms (1)

Ultrasound

OTHER

Diagnostic Test: Ultrasound

Interventions

Ultrasound DIAGNOSTIC_TEST

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.

Ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elective insertion of a central venous catheter.

You may not qualify if:

• emergency insertion of a central venous catheter

Sponsors & Collaborators

• Asklepios Neurological Clinic Bad Salzhausen: lead
• Kerckhoff Klinik: collaborator

Study Sites (1)

Neurologische Klinik Bad Salzhausen

Nidda, 63667, Germany

Location

Related Publications (2)

• 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.

  PMID: 15220179 BACKGROUND

• 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.

  PMID: 14504146 BACKGROUND

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: November 16, 2020
• Study Start: March 1, 2021
• Primary Completion: July 20, 2022
• Study Completion: August 9, 2022
• Last Updated: August 11, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)