Catheter Related ComplicationNCT03924583
Duplex Ultrasonography Performed by Nurses
An observational study of Catheter Related Complication, run by Masaryk Hospital Krajská zdravotní a.s. at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Catheter Related Complication
- What is being tested?
- Duplex ultrasonography
- How many people
- 150 participants
- Where
- 1 siteCzechia
- Study dates
- 18 Mar 2019to 30 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patient hospitalized in ICU, with central venous catheter inserted for more than 48 hours
Who may be able to join
- central venous catheter more than 48 hours in situ
- consent of a patient
Who cannot join
- technical difficulties of ultrasound machine
- unfavorable local findings - inflammation of skin, excoriation etc.
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Clinic of anaesthesiology, resuscitaion and perioperative care, Masaryk Hospital,
Ústí nad Labem, 40113
Barbora Pakostová, M.D., +420477112202, barbora.pakostova@kzcr.eu
About this study
Official title: Diagnostic Reliability of Duplex Ultrasonography of the Venous System for Screening of Catheter-related Thrombosis Performed by a General Nurse
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:
- General nurses - trained and able to perform duplex ultrasonography examination of venous circulation
- 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
- Conditions
- Catheter Related Complication
- Being tested
- Duplex ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duplex ultrasonographyDiagnostic test
Ultrasound examination of whole vena cava venous system with central venous catheter inserted, using duplex US method to detect catheter related thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start18 Mar 2019
- Primary completion18 Sep 2019 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter Related ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masaryk Hospital Krajská zdravotní a.s.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbora Pakostová, M.D., Masaryk Hospital Krajská zdravotní a.s.
- Investigators
- Barbora Pakostová, M.D., Principal investigator, Krajská zdravotní a.s., Masaryk Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03924583
- Sponsor's protocol ID
- 258/40
- Status last verified
- Apr 2019
- First submitted
- 17 Apr 2019
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Reliability of Duplex Ultrasonography of the Venous System for Screening of Catheter-related Thrombosis Performed by a General Nurse
- ClinicalTrials.gov ID
- NCT03924583
- Acronym / sponsor ID
- 258/40
- Conditions
- Catheter Related Complication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Masaryk Hospital Krajská zdravotní a.s.University, hospital or other
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- 18 Sep 2019 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 23 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- General nurses - trained and able to perform duplex ultrasonography examination of venous circulation
- 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
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patient hospitalized in ICU, with central venous catheter inserted for more than 48 hours
Key inclusion criteria (2 listed)
- central venous catheter more than 48 hours in situ
- consent of a patient
Key exclusion criteria (2 listed)
- technical difficulties of ultrasound machine
- unfavorable local findings - inflammation of skin, excoriation etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Duplex ultrasonographyUltrasound examination of whole vena cava venous system with central venous catheter inserted, using duplex US method to detect catheter related thrombosis | Diagnostic test | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- Individual participant dataSharing planned: Undecided
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Catheter Related Complication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbora Pakostová, M.D. principal investigator
Krajská zdravotní a.s., Masaryk Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Catheter Related Complication, run by Masaryk Hospital Krajská zdravotní a.s. at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barbora Pakostová, M.D. (+420477112202, barbora.pakostova@kzr.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of catheter related thrombosis - physician and nurse (time frame: 24hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2019; AzTrials last refreshed its copy on 28 Oct 2026.