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Status unknownNCT03924583Updated Apr 23, 2019

Duplex Ultrasonography Performed by Nurses

An observational study in Catheter Related Complication, sponsored by Masaryk Hospital Krajská zdravotní a.s.. Status unknown at 1 site in Czechia. Per ClinicalTrials.gov, last updated 2019-04-23.

Sponsored by Masaryk Hospital Krajská zdravotní a.s. · Observational

The sponsor has not verified this record recently (last verified Apr 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
150
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Catheter Related Complication
03

In context

Lead sponsor

Masaryk Hospital Krajská zdravotní a.s. is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patient hospitalized in ICU, with central venous catheter inserted for more than 48 hours

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • central venous catheter more than 48 hours in situ
  • consent of a patient

Exclusion criteria

Exclusion Criteria:

  • technical difficulties of ultrasound machine
  • unfavorable local findings - inflammation of skin, excoriation etc.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testDuplex ultrasonography

    Ultrasound examination of whole vena cava venous system with central venous catheter inserted, using duplex US method to detect catheter related thrombosis

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 24hours

07

Study locations

1 of 1 sites recruiting
  • Clinic of anaesthesiology, resuscitaion and perioperative care, Masaryk Hospital,
    Ústí Nad Labem, 40113, Czechia
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2019 (actual). Primary completion is estimated for Sep 2019, 6 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 17, 2019
First posted
Apr 23, 2019
StartActual
Mar 18, 2019
Primary completionEst.
Sep 18, 2019
CompletionEst.
Sep 30, 2020
Last update
Apr 23, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 23, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03924583
Lead sponsor
Masaryk Hospital Krajská zdravotní a.s.
Responsible party
Barbora Pakostová, M.D. (Medical doctor, Masaryk Hospital Krajská zdravotní a.s.) — Principal investigator
First posted
Apr 23, 2019
Start date
Mar 18, 2019
Primary completion
Sep 18, 2019 (estimated)
Completion
Sep 30, 2020 (estimated)
Last update
Apr 23, 2019

Study contacts

Barbora Pakostová, M.D.
Contact
barbora.pakostova@kzr.eu
+420477112202
Barbora Pakostová, M.D.
principal investigator · Krajská zdravotní a.s., Masaryk Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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