Ultrasound for Guidewire Detection

• Sponsor: Wroclaw Medical University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03727581
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Actual Duration (Months): 7.1
• Patients Per Site Per Month: 4.2

Study Details

Study Description

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	Phase
Kidney Failure, Acute; Kidney Failure, Chronic	Diagnostic Test: Ultrasound guidance

Study Design

• 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: Dec 31, 2018
• Actual Study Completion Date: Dec 31, 2018

Outcome Measures

Primary Outcome Measures

1. Successful guidewire insertion [5 minutes]

   Visualization of guidewire in right atrium-inferior vena cava junction

2. Successful catheter placement [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 [24 hours]

   Presence of pneumothorax, hematoma, catheter dysfunction

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Nephrology and Transplantation Medicine	Wroclaw		Poland	55-556

Sponsors and Collaborators

• Wroclaw Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Krzysztof Letachowicz, Principal Investigator, Wroclaw Medical University
• ClinicalTrials.gov Identifier: NCT03727581
• Other Study ID Numbers: st40
• First Posted: Nov 1, 2018
• Last Update Posted: Mar 28, 2019
• Last Verified: Mar 1, 2019

• 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
• Keywords provided by Krzysztof Letachowicz, Principal Investigator, Wroclaw Medical University: hemodialysis; vascular access; dialysis catheter
• Additional relevant MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Acute Kidney Injury

Study Results

No Results Posted as of Mar 28, 2019