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

Sponsors

Lead sponsor: Masaryk Hospital Krajská zdravotní a.s.

Source Masaryk Hospital Krajská zdravotní a.s.
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.

Detailed 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

Overall Status Recruiting
Start Date March 18, 2019
Completion Date September 30, 2020
Primary Completion Date September 18, 2019
Study Type Observational
Primary Outcome
Measure Time Frame
Incidence of catheter related thrombosis - physician and nurse 24hours
Enrollment 150
Condition
Intervention

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

Eligibility

Sampling method: Non-Probability Sample

Criteria:

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.

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Barbora Pakostová, M.D. Principal Investigator Krajská zdravotní a.s., Masaryk Hospital
Overall Contact

Last name: Barbora Pakostová, M.D.

Phone: +420477112202

Email: [email protected]

Location
facility status contact Clinic of anaesthesiology, resuscitaion and perioperative care, Masaryk Hospital, Barbora Pakostová, M.D. +420477112202 [email protected]
Location Countries

Czechia

Verification Date

April 2019

Responsible Party

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
Patient Data Undecided
Study Design Info

Observational model: Other

Time perspective: Prospective

Source: ClinicalTrials.gov