Reliability of Duplex Ultrasound for Diagnosis of Deep Vein Thrombosis Performed by Nurses

NCT ID: NCT04483193

Last Updated: 2020-08-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-28
• Study Completion Date: 2021-08-31

Brief 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.

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Critically ill patients

Critically ill patients hospitalised at the intensive care unit.

Duplex ultrasound

Intervention Type: DIAGNOSTIC_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.

Interventions

Duplex ultrasound

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Inpatients
• Critically ill patients hospitalised in the intensive care unit for more than 72 hours

Exclusion Criteria

• Known deep vein thrombosis
• Contraindication of ultrasound examination
• Refusal of ultrasound examination by patient

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Masaryk Hospital Usti nad Labem

OTHER

Sponsor Role: collaborator

Emergency Medical Service of the Central Bohemian Region, Czech Republic

OTHER

Sponsor Role: lead

Responsible Party

Roman Skulec

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roman Skulec, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Masaryk Hospital Usti nad Labem

Locations

Masaryk Hospital Usti nad Labem

Ústí nad Labem, , Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Roman Skulec, MD, PhD

Role: CONTACT

skulec@email.cz

00420777577497

Lenka Miksova

Role: CONTACT

lenusmiksova@seznam.cz

00420774140032

Facility Contacts

Roman Skulec, MD, PhD

Role: primary

skulec@email.cz

00420777577497

References

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.

Reference Type: BACKGROUND

PMID: 32216998 (View on PubMed)

Other Identifiers

284/36

Identifier Type: -

Identifier Source: org_study_id