Duplex Ultrasonography Performed by Nurses

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Approximately 150 patients with central venous catheter will be enrolled in this study.

Investigators:

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.

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 Design

Related Conditions & MeSH terms

Catheter Related Complication

Clinical Trial Details

NCT number	NCT03924583
Study type	Observational
Source	Masaryk Hospital Krajská zdravotní a.s.
Contact	Barbora Pakostová, M.D.
Phone	+420477112202
Email	barbora.pakostova@kzr.eu
Status	Recruiting
Phase
Start date	March 18, 2019
Completion date	September 30, 2020

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.