Duplex Ultrasonography Performed by Nurses

Catheter Related Complication Clinical Trial

Official title:

Diagnostic Reliability of Duplex Ultrasonography of the Venous System for Screening of Catheter-related Thrombosis Performed by a General Nurse

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03924583
• Other study ID #: 258/40
• Status: Recruiting
• Start date: March 18, 2019
• Est. completion date: September 30, 2020

Study information

• Verified date: April 2019
• Source: Masaryk Hospital Krajská zdravotní a.s.
• Contact: Barbora Pakostová, M.D.
• Phone: +420477112202
• Email: barbora.pakostova[@]kzr.eu
• Is FDA regulated: No
• Study type: Observational

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 30, 2020
• Est. primary completion date: September 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Catheter Related Complication

Intervention

Diagnostic Test:
• Duplex ultrasonography
Ultrasound examination of whole vena cava venous system with central venous catheter inserted, using duplex US method to detect catheter related thrombosis

Locations

Country	Name	City	State
Czechia	Clinic of anaesthesiology, resuscitaion and perioperative care, Masaryk Hospital,	Ústí Nad Labem

Sponsors (1)

Lead Sponsor	Collaborator
Masaryk Hospital Krajská zdravotní a.s.

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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