Duplex Ultrasonography Performed by Nurses
Diagnostic Reliability of Duplex Ultrasonography of the Venous System for Screening of Catheter-related Thrombosis Performed by a General Nurse
1 other identifier
observational
150
1 country
1
Brief Summary
Catheter-related thrombosis (CRT) has been found as the major complication of the established central venous catheter in intensive care unit (ICU) patients. Its reported incidence varies from 5 to 66 %. Although most cases are asymptomatic, in up to 10 - 15 % of the patients pulmonary embolism occurs. In addition, CRT is associated with the risk of infection, post-thrombotic syndrome and with general disruption of the management of the underlying disease. The most accessible diagnostic method for CRT recognition is duplex ultrasonography. However, screening of CRT by duplex ultrasonography is not common approach in ICUs. Normally, duplex ultrasonography is performed by physicians. In this setting, implementation of the screening in ICU would be time consuming and practically unrealizable. Delegating this competence to ICU nurses can increase availability of this screening method. Therefore, as a first step, investigators decided to perform a validation clinical study to verify the diagnostic accuracy of duplex ultrasonography of the venous system for CRT screening performed by a general nurse.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 18, 2019
CompletedFirst Submitted
Initial submission to the registry
April 17, 2019
CompletedFirst Posted
Study publicly available on registry
April 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 18, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2020
CompletedApril 23, 2019
April 1, 2019
6 months
April 17, 2019
April 20, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of catheter related thrombosis - physician and nurse
Diagnostic reliability of duplex ultrasonography examination of the venous system for screening of catheter-related thrombosis performed by a general nurse
24hours
Interventions
Ultrasound examination of whole vena cava venous system with central venous catheter inserted, using duplex US method to detect catheter related thrombosis
Eligibility Criteria
All patient hospitalized in ICU, with central venous catheter inserted for more than 48 hours
You may qualify if:
- central venous catheter more than 48 hours in situ
- consent of a patient
You may not qualify if:
- technical difficulties of ultrasound machine
- unfavorable local findings - inflammation of skin, excoriation etc.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinic of anaesthesiology, resuscitaion and perioperative care, Masaryk Hospital,
Ústí nad Labem, 40113, Czechia
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Barbora Pakostová, M.D.
Krajská zdravotní a.s., Masaryk Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical doctor
Study Record Dates
First Submitted
April 17, 2019
First Posted
April 23, 2019
Study Start
March 18, 2019
Primary Completion
September 18, 2019
Study Completion
September 30, 2020
Last Updated
April 23, 2019
Record last verified: 2019-04