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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03707665
Other study ID # 2018-01
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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