Deep Venous Thrombosis Screening in the ICU by Nurses

Deep Venous Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03707665
• Other study ID #: 2018-01
• Status: Completed
• Start date: November 1, 2018
• Est. completion date: May 31, 2019

Study information

• Verified date: August 2019
• Source: Emergency Medical Service of the Central Bohemian Region, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: May 31, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deep Venous Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Diagnostic Test:
• Compression ultrasound testing
Compression ultrasound testing, screening technique for diagnosing deep venous thrombosis

Locations

Country	Name	City	State
Czechia	Emergency Medical Service of the Central Bohemian Region	Beroun	Central Bohemian Region

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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