Deep Venous Thrombosis Screening in the ICU by Nurses

NCT ID: NCT03707665

Last Updated: 2019-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

115 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-01

Study Completion Date

2019-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Deep Venous Thrombosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Compression ultrasound testing

Compression ultrasound testing, screening technique for diagnosing deep venous thrombosis

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Masaryk Hospital Usti nad Labem

OTHER

Sponsor Role collaborator

Emergency Medical Service of the Central Bohemian Region, Czech Republic

OTHER

Sponsor Role lead

Responsible Party

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Roman Skulec

Head physician for science and research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roman Skulec, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Emergency Medical Service of the Central Bohemian Region

Beroun, Central Bohemia, Czechia

Site Status

Countries

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Czechia

Other Identifiers

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2018-01

Identifier Type: -

Identifier Source: org_study_id

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