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

Ultrasound Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04483193
• Other study ID #: 284/36
• Status: Recruiting
• Start date: July 28, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: August 2020
• Source: Emergency Medical Service of the Central Bohemian Region, Czech Republic
• Contact: Roman Skulec, MD, PhD
• Phone: 00420777577497
• Email: skulec[@]email.cz
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: August 31, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thrombosis
• Ultrasound
• Venous Thrombosis

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Czechia	Masaryk Hospital Usti nad Labem	Usti nad Labem

Sponsors (2)

Lead Sponsor	Collaborator
Emergency Medical Service of the Central Bohemian Region, Czech Republic	Masaryk Hospital Usti nad Labem

Country where clinical trial is conducted

Czechia, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Comparison of two examinations performed with a maximum interval of 24 hours.