UltrasoundNCT04483193
Reliability of Duplex Ultrasound for Diagnosis of Deep Vein Thrombosis Performed by Nurses
An observational study of Ultrasound, run by Emergency Medical Service of the Central Bohemian Region, Czech Republic at 1 site in Czechia.
Trial summary
The purpose of this study is to assess validity of extended duplex ultrasound examination for diagnosis of proximal deep vein thrombosis performed by general intensive care unit nurses in the critically ill patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ultrasound
- What is being tested?
- Duplex ultrasound
- How many people
- 500 participants
- Where
- 1 siteCzechia
- Study dates
- 28 Jul 2020to 31 Aug 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult critically ill patients.
Who may be able to join
- Inpatients
- Critically ill patients hospitalised in the intensive care unit for more than 72 hours
Who cannot join
- Known deep vein thrombosis
- Contraindication of ultrasound examination
- Refusal of ultrasound examination by patient
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Masaryk Hospital Usti nad Labem
Ústí nad Labem, 40113
Roman Skulec, MD, PhD, 00420777577497, skulec@email.cz
About this study
Official title: Reliability of Extended Duplex Ultrasound for Diagnosis of Proximal Deep Vein Thrombosis Performed by General Intensive Care Unit Nurses in the Critically Ill Patients
The purpose of this study is to assess validity of extended duplex ultrasound examination for diagnosis of proximal deep vein thrombosis performed by general intensive care unit nurses in the critically ill patients.
Read the detailed description
Critically ill patients hospitalized in the intensive care unit are in increased risk of proximal deep vein thrombosis despite thromboprophylactic measures. Diagnostic method of the first choice is Point-of-Care ultrasound examination. This method is usually performed by a trained intensive care physician. However, if this examination could be performed by trained nurses, its availability would be greatly increased. The results of the investigator's pilot study showed that general nurses are able to diagnose proximal deep vein thrombosis in critically ill patients by compression ultrasound test with a sensitivity of 88,9 % and a specificity of 99 %. Before implementation of this examination into the optional competencies of general nurses, the results need to be confirmed in a larger group of patients. This is the goal of proposed clinical study.
In this prospective observational study, the patients will be investigated by extended duplex ultrasound (compression ultrasound test combined with colour doppler imaging in the range from the groin to the popliteal region) by a trained nurse and on the same day, the examination will be repeated by a trained physician - intensivist. The results of the examinations of each patient will be blinded until both tests will be performed.
- Conditions
- Ultrasound
- Being tested
- Duplex ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duplex ultrasoundDiagnostic test
Point-of-Care compression ultrasound test combined with colour doppler imaging in the range from the groin to the popliteal region of both lower extremities.
| Study group | Role | What they receive |
|---|---|---|
| Critically ill patients | Critically ill patients hospitalised at the intensive care unit. Receives: Diagnostic Test: Duplex ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity of duplex ultrasound
Validity of duplex ultrasound examination performed by a trained general intensive care nurses when compared with the examination performed by a trained physician - intensivist, specialist in Point-of-Care ultrasound.
Measured: Comparison of two examinations performed with a maximum interval of 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start28 Jul 2020
- Primary completion30 Jun 2021 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UltrasoundStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emergency Medical Service of the Central Bohemian Region, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- Masaryk Hospital Usti nad Labem
- Responsible party
- Principal investigator, Roman Skulec, Masaryk Hospital Usti nad Labem
- Investigators
- Roman Skulec, MD, PhD, Principal investigator, Masaryk Hospital Usti nad Labem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04483193
- Sponsor's protocol ID
- 284/36
- Status last verified
- Aug 2020
- First submitted
- 20 Jul 2020
- Last updated
- 19 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Skulec R, Kohlova A, Miksova L, Cerny V. The reliability of ultrasound compression test performed by general ICU nurses in the critically ill patients: A preliminary prospective clinical study. Eur J Intern Med. 2020 Jun;76:130-131. doi: 10.1016/j.ejim.2020.03.007. Epub 2020 Mar 23. No abstract available.
PubMed 32216998
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Extended Duplex Ultrasound for Diagnosis of Proximal Deep Vein Thrombosis Performed by General Intensive Care Unit Nurses in the Critically Ill Patients
- ClinicalTrials.gov ID
- NCT04483193
- Acronym / sponsor ID
- 284/36
- Conditions
- Ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Emergency Medical Service of the Central Bohemian Region, Czech RepublicUniversity, hospital or other
- Collaborators
- Masaryk Hospital Usti nad Labem
- Study start
- 28 Jul 2020 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 23 Jul 2020 (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.
The purpose of this study is to assess validity of extended duplex ultrasound examination for diagnosis of proximal deep vein thrombosis performed by general intensive care unit nurses in the critically ill patients.
Detailed description
Critically ill patients hospitalized in the intensive care unit are in increased risk of proximal deep vein thrombosis despite thromboprophylactic measures. Diagnostic method of the first choice is Point-of-Care ultrasound examination. This method is usually performed by a trained intensive care physician. However, if this examination could be performed by trained nurses, its availability would be greatly increased. The results of the investigator's pilot study showed that general nurses are able to diagnose proximal deep vein thrombosis in critically ill patients by compression ultrasound test with a sensitivity of 88,9 % and a specificity of 99 %. Before implementation of this examination into the optional competencies of general nurses, the results need to be confirmed in a larger group of patients. This is the goal of proposed clinical study.
In this prospective observational study, the patients will be investigated by extended duplex ultrasound (compression ultrasound test combined with colour doppler imaging in the range from the groin to the popliteal region) by a trained nurse and on the same day, the examination will be repeated by a trained physician - intensivist. The results of the examinations of each patient will be blinded until both tests will be performed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill patients | – | Diagnostic Test: Duplex ultrasoundCritically ill patients hospitalised at the intensive care unit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult critically ill patients.
Key inclusion criteria (2 listed)
- Inpatients
- Critically ill patients hospitalised in the intensive care unit for more than 72 hours
Key exclusion criteria (3 listed)
- Known deep vein thrombosis
- Contraindication of ultrasound examination
- Refusal of ultrasound examination by patient
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 ultrasoundPoint-of-Care compression ultrasound test combined with colour doppler imaging in the range from the groin to the popliteal region of both lower extremities. | Diagnostic test | Critically ill patients |
Primary outcome
Validity of duplex ultrasound
Time frame: Comparison of two examinations performed with a maximum interval of 24 hours.
Validity of duplex ultrasound examination performed by a trained general intensive care nurses when compared with the examination performed by a trained physician - intensivist, specialist in Point-of-Care ultrasound.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
- Background: PubMed 32216998Skulec R, Kohlova A, Miksova L, Cerny V. The reliability of ultrasound compression test performed by general ICU nurses in the critically ill patients: A preliminary prospective clinical study. Eur J Intern Med. 2020 Jun;76:130-131. doi: 10.1016/j.ejim.2020.03.007. Epub 2020 Mar 23. No abstract available.
- Individual participant dataSharing planned: No
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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.
Roman Skulec, MD, PhD principal investigator
Masaryk Hospital Usti nad Labem
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 Ultrasound, run by Emergency Medical Service of the Central Bohemian Region, Czech Republic 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 3 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 19 Aug 2020. 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 Roman Skulec, MD, PhD (00420777577497, skulec@email.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity of duplex ultrasound (time frame: Comparison of two examinations performed with a maximum interval of 24 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04483193, which also lists 1 linked publication.
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 19 Aug 2020.