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Ultrasound for Guidewire Detection

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ClinicalTrials.gov Identifier: NCT03727581
Recruitment Status : Completed
First Posted : November 1, 2018
Last Update Posted : March 28, 2019
Sponsor:
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

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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



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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03727581


Locations
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Poland
Department of Nephrology and Transplantation Medicine
Wroclaw, Poland, 55-556
Sponsors and Collaborators
Wroclaw Medical University
Investigators
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Principal Investigator: Krzysztof Letachowicz, MD, PhD Wroclaw Medical University

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Responsible Party: Krzysztof Letachowicz, Principal Investigator, Wroclaw Medical University
ClinicalTrials.gov 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

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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:
hemodialysis
vascular access
dialysis catheter
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Acute Kidney Injury
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic