Ultrasound for Guidewire Detection

March 27, 2019 updated by: Krzysztof Letachowicz, Wroclaw Medical University

Dialysis Catheter Insertion With Substernal Ultrasound Guidance

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Wroclaw, Poland, 55-556
        • Department of Nephrology and Transplantation Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful guidewire insertion
Time Frame: 5 minutes
Visualization of guidewire in right atrium-inferior vena cava junction
5 minutes
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.
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication rate
Time Frame: 24 hours
Presence of pneumothorax, hematoma, catheter dysfunction
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wroclaw Medical University

Investigators

  • Principal Investigator: Krzysztof Letachowicz, MD, PhD, Wroclaw Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2018

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

October 30, 2018

First Submitted That Met QC Criteria

October 30, 2018

First Posted (Actual)

November 1, 2018

Study Record Updates

Last Update Posted (Actual)

March 28, 2019

Last Update Submitted That Met QC Criteria

March 27, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • st40

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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