Working… Menu

Ultrasound for Guidewire Detection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03727581
Recruitment Status : Completed
First Posted : November 1, 2018
Last Update Posted : March 28, 2019
Information provided by (Responsible Party):
Krzysztof Letachowicz, Wroclaw Medical University

Brief 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.

Condition or disease Intervention/treatment
Kidney Failure, Acute Kidney Failure, Chronic Diagnostic Test: Ultrasound guidance

Layout table for study information
Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Dialysis Catheter Insertion With Substernal Ultrasound Guidance
Actual Study Start Date : May 28, 2018
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Intervention Details:
  • 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.

Primary Outcome Measures :
  1. Successful guidewire insertion [ Time Frame: 5 minutes ]
    Visualization of guidewire in right atrium-inferior vena cava junction

  2. Successful catheter placement [ Time Frame: 2 hours ]
    Catheter tip in lower part of superior vena cava or right atrium on chest x-ray. Good catheter function.

Secondary Outcome Measures :
  1. Complication rate [ Time Frame: 24 hours ]
    Presence of pneumothorax, hematoma, catheter dysfunction

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with acute kidney disease or end stage renal disease who need dialysis catheter insertion for hemodialysis performance

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03727581

Layout table for location information
Department of Nephrology and Transplantation Medicine
Wroclaw, Poland, 55-556
Sponsors and Collaborators
Wroclaw Medical University
Layout table for investigator information
Principal Investigator: Krzysztof Letachowicz, MD, PhD Wroclaw Medical University

Layout table for additonal information
Responsible Party: Krzysztof Letachowicz, Principal Investigator, Wroclaw Medical University Identifier: NCT03727581     History of Changes
Other Study ID Numbers: st40
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Krzysztof Letachowicz, Wroclaw Medical University:
vascular access
dialysis catheter
Additional relevant MeSH terms:
Layout table for MeSH terms
Renal Insufficiency
Kidney Failure, Chronic
Acute Kidney Injury
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic