Ultrasound Guided Positioning of Central Venous Catheters

Sponsor
Asklepios Neurological Clinic Bad Salzhausen (Other)
Overall Status
Completed
CT.gov ID
NCT04630236
Collaborator
Kerckhoff Klinik (Other)
100
1
1
17.3
5.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Ultrasound
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:
Ultrasound Guided Positioning of Central Venous Catheters
Actual Study Start Date :
Mar 1, 2021
Actual Primary Completion Date :
Jul 20, 2022
Actual Study Completion Date :
Aug 9, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. - correlation between the time of detection of the injected saline bolus and radiological position of the central venous catheter [up to 5 seconds]

    - ultrasound during injection of saline solution into a newly inserted central venous catheter

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • elective insertion of a central venous catheter.
Exclusion Criteria:
  • emergency insertion of a central venous catheter

Contacts and Locations

Locations

Site City State Country Postal Code
1 Neurologische Klinik Bad Salzhausen Nidda Germany 63667

Sponsors and Collaborators

  • Asklepios Neurological Clinic Bad Salzhausen
  • Kerckhoff Klinik

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Asklepios Neurological Clinic Bad Salzhausen
ClinicalTrials.gov Identifier:
NCT04630236
Other Study ID Numbers:
  • CVC061120
First Posted:
Nov 16, 2020
Last Update Posted:
Aug 11, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 11, 2022