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

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.

Study Overview

• Status: Unknown
• Conditions: Ultrasound
• Intervention / Treatment: Diagnostic test: Duplex ultrasound

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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• Czechia
  • Usti nad Labem, Czechia, 40113
    • Recruiting
    • Masaryk Hospital Usti nad Labem
    • Contact: Roman Skulec, MD, PhD; Phone Number: 00420777577497; Email: skulec@email.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult critically ill patients.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Critically ill patients; Critically ill patients hospitalised at the intensive care unit.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Emergency Medical Service of the Central Bohemian Region, Czech Republic
• Collaborators: Masaryk Hospital Usti nad Labem
• Investigators: Principal Investigator: Roman Skulec, MD, PhD, Masaryk Hospital Usti nad Labem

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2020
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): August 31, 2021

Study Registration Dates

• First Submitted: July 20, 2020
• First Submitted That Met QC Criteria: July 22, 2020
• First Posted (Actual): July 23, 2020

Study Record Updates

• Last Update Posted (Actual): August 19, 2020
• Last Update Submitted That Met QC Criteria: August 18, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis
• Other Study ID Numbers: 284/36

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No