- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03924583
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Approximately 150 patients with central venous catheter will be enrolled in this study.
Investigators:
- General nurses - trained and able to perform duplex ultrasonography examination of venous circulation
- Doctors - experienced specialists in intensive care or urgent medicine
Every patient with central venous catheter enrolled in clinical study is examined with duplex ultrasonography within 24 hours by both investigators, doctor and nurse. Each examination includes ultrasonography of a whole vena cava venous system with central venous catheter, bilaterally. Results of both examinations are blinded until the end of study, with one exception. In case of positive result - catheter related thrombosis is present, investigator ( nurse )informs patients attending physician.
Results of investigations are recorded in Investigation Form with some other routine medical data.
Timetable:
18.3.2019 - 30.6.2020: Enrolling, collection of data 1.7.2020 - 30.9.2020: Finalization od database, statistic analysis 1.10.2020 - 31.1.2021: Preparation of publications 1.2. 2021 - 31.12.2021: Result presentation
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Barbora Pakostová, M.D.
- Phone Number: +420477112202
- Email: barbora.pakostova@kzr.eu
Study Locations
-
-
-
Ústí Nad Labem, Czechia, 40113
- Recruiting
- Clinic of anaesthesiology, resuscitaion and perioperative care, Masaryk Hospital,
-
Contact:
- Barbora Pakostová, M.D.
- Phone Number: +420477112202
- Email: barbora.pakostova@kzcr.eu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- central venous catheter more than 48 hours in situ
- consent of a patient
Exclusion Criteria:
- technical difficulties of ultrasound machine
- unfavorable local findings - inflammation of skin, excoriation etc.
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of catheter related thrombosis - physician and nurse
Time Frame: 24hours
|
Diagnostic reliability of duplex ultrasonography examination of the venous system for screening of catheter-related thrombosis performed by a general nurse
|
24hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: Barbora Pakostová, M.D., Krajská zdravotní a.s., Masaryk Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 258/40
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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