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NCT03727581 Clinical Trial

Ultrasound for Guidewire Detection

Kidney Failure, Chronic Clinical Trial

Official title:
Dialysis Catheter Insertion With Substernal Ultrasound Guidance

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03727581
Other study ID # st40
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 28, 2018
Est. completion date December 31, 2018

Study information
Verified date March 2019
Source Wroclaw Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of the project is to check if there is a possibility for a nephrologist to visualise the guidewire by means of available ultrasound scanners. To evaluate that, the procedure of catheter insertion will be expanded by ultrasound examination of right atrium and inferior vena cava border using substernal view. Such imaging seems to ameliorate the safety of catheter implementation and could be a good alternative for fluoroscopy, eliminating its adverse effects.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria:

- Renal failure requiring hemodialysis through a dialysis catheter

- Capable of giving informed consent

- Placement of internal jugular vein catheter

Exclusion Criteria:

- Inability to provide informed consent

- Poor visualisation of inferior vena cava

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Ultrasound guidance
Jugular vein is punctured with ultrasound guidance and guidewire is advanced. Right atrium and inferior vena cava junction is visualized by ultrasound using substernal view. Presence of guidewire in inferior vena cava or right atrium is confirmed. The procedure of catheter insertion is continued.

Locations
Country Name City State
Poland Department of Nephrology and Transplantation Medicine Wroclaw

Sponsors (1)
Lead Sponsor Collaborator
Wroclaw Medical University

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Successful guidewire insertion Visualization of guidewire in right atrium-inferior vena cava junction 5 minutes
Primary Successful catheter placement Catheter tip in lower part of superior vena cava or right atrium on chest x-ray. Good catheter function. 2 hours
Secondary Complication rate Presence of pneumothorax, hematoma, catheter dysfunction 24 hours
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