Deep Venous Thrombosis Screening in the ICU by Nurses

Screening Ultrasound Compression Testing in Critically Ill Patients Performed by General Nurses - Validation Study

Despite of preventive measures, the incidence of deep venous thrombosis (DVT) in ICU patients is estimated to range from 5-31%. While clinical diagnostics is unreliable, ultrasound compression test (UCT) has proven to be a highly sensitive and specific modality for the recognition of lower extremity DVT. Delegating this competence to ICU nurses can increase UCT availability and enable preventive DVT screening. Therefore, the investigators decided to conduct a clinical study to evaluate the sensitivity and specificity of UCT performed by general ICU nurse in ICU patients compared to an investigation by ICU physician certified in ultrasound. Prior to the study, each nurse-investigator participating in the study undergo one-hour training in UCT and examine 5 patients under supervision. Then, ICU patients without known DVT will be investigated by UCT in the femoral and popliteal region of both lower extremities by trained general ICU nurse-investigators. On the same day, the examination will be repeated by an ICU physician-investigator. The results of the examinations of each patient will be blinded to each other for both investigators until both tests are performed. The sensitivity and specificity of the test performed by general nurse will be calculated in comparison with the examination by a specialist.

Study Overview

• Status: Completed
• Conditions: Deep Venous Thrombosis
• Intervention / Treatment: Diagnostic test: Compression ultrasound testing

• Study Type: Observational
• Enrollment (Actual): 115

Contacts and Locations

Study Locations

• Czechia
  • Central Bohemian Region
    • Beroun, Central Bohemian Region, Czechia
      • Emergency Medical Service of the Central Bohemian Region

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: Non-Probability Sample

Study Population

ICU patients

Description

Inclusion Criteria:

• all ICU patients without known deep venous thrombosis, hospitalised more than 72 hours

Exclusion Criteria:

• contraindication of compression ultrasound testing
• end-of-life decision regimen of care

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validity of the compression ultrasound testing in the ICU patients performed by general nurses	Validity of testing performed by nurses will be compared with investigation by the physician, specialist for compression ultrasound testing	One day

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, Department of Anesthesiology, Perioperative Medicine and Intensive Care, J.E. Purkinje University, Masaryk Hospital Usti nad Labem, Usti nad Labem, Czech Republic

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): April 30, 2019
• Study Completion (Actual): May 31, 2019

Study Registration Dates

• First Submitted: October 12, 2018
• First Submitted That Met QC Criteria: October 12, 2018
• First Posted (Actual): October 16, 2018

Study Record Updates

• Last Update Posted (Actual): August 2, 2019
• Last Update Submitted That Met QC Criteria: August 1, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Nurse; Compression Ultrasound testing
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis
• Other Study ID Numbers: 2018-01

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