Diagnostic Reliability of Duplex Ultrasonography of the Venous System for Screening of Catheter-related Thrombosis Performed by a General Nurse
Duplex Ultrasonography Performed by Nurses
Lead sponsor: Masaryk Hospital Krajská zdravotní a.s.
|Source||Masaryk Hospital Krajská zdravotní a.s.|
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.
Approximately 150 patients with central venous catheter will be enrolled in this study.
1. General nurses - trained and able to perform duplex ultrasonography examination of venous circulation
2. 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.
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
|Start Date||March 18, 2019|
|Completion Date||September 30, 2020|
|Primary Completion Date||September 18, 2019|
Intervention type: Diagnostic Test
Intervention name: Duplex ultrasonography
Description: Ultrasound examination of whole vena cava venous system with central venous catheter inserted, using duplex US method to detect catheter related thrombosis
Sampling method: Non-Probability Sample
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.
- central venous catheter more than 48 hours in situ
- consent of a patient
- technical difficulties of ultrasound machine
- unfavorable local findings - inflammation of skin, excoriation etc.
Minimum age: N/A
Maximum age: N/A
Healthy volunteers: No
Last name: Barbora Pakostová, M.D.
Email: [email protected]
Responsible party type: Principal Investigator
Investigator affiliation: Masaryk Hospital Krajská zdravotní a.s.
Investigator full name: Barbora Pakostová, M.D.
Investigator title: Medical doctor
|Has Expanded Access||No|
|Study Design Info||
Observational model: Other
Time perspective: Prospective