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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/15/2021.

Duplex Ultrasonography Performed by Nurses

Clinicaltrials.gov identifier NCT03924583

Recruitment Status Recruiting

First Posted April 23, 2019

Last update posted April 23, 2019

Study Description

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.

  • Condition or Disease:Catheter Related Complication
  • Intervention/Treatment: Diagnostic Test: Duplex ultrasonography
  • Phase: N/A
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

Study Design
  • Study Type: Observational
  • Estimated Enrollment: 150 participants
  • Observational Model: Other
  • Time Perspective: Prospective
  • Official Title: Diagnostic Reliability of Duplex Ultrasonography of the Venous System for Screening of Catheter-related Thrombosis Performed by a General Nurse
  • Actual Study Start Date: March 2019
  • Estimated Primary Completion Date: September 2019
  • Estimated Study Completion Date: September 2020
Outcome Measures
  • Primary Outcome Measures: 1. Incidence of catheter related thrombosis - physician and nurse [ Time Frame: 24hours ]
    Diagnostic reliability of duplex ultrasonography examination of the venous system for screening of catheter-related thrombosis performed by a general nurse
Eligibility Criteria
  • Ages Eligible for Study: (Child, Adult, Older Adult)
  • Sexes Eligible for Study: 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
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.

Contacts and Locations
Contacts

Contact: Barbora Pakostová, M.D. +420477112202 barbora.pakostova@kzr.eu

Locations

Czechia
Clinic of anaesthesiology, resuscitaion and perioperative care, Masaryk Hospital,
Ústí Nad Labem

Sponsors and Collaborators

Masaryk Hospital Krajská zdravotní a.s.

Investigators

Principal Investigator: Barbora Pakostová, M.D. Krajská zdravotní a.s., Masaryk Hospital

More Information
  • Responsible Party: Masaryk Hospital Krajská zdravotní a.s.
  • ClinicalTrials.gov Identifier: NCT03924583 History of Changes
  • Other Study ID Numbers: 258/40
  • First Posted: April 23, 2019 Key Record Dates
  • Last Update Posted: April 23, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Undecided
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No