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OpenTrials
Completed

NCT Number: NCT03707665

Deep Venous Thrombosis Screening in the ICU by Nurses

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Emergency Medical Service of the Central Bohemian Region

Beroun, Central Bohemia, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Compression ultrasound testing

Diagnostic Test

Compression ultrasound testing, screening technique for diagnosing deep venous thrombosis

Primary outcomes

  1. Validity of the compression ultrasound testing in the ICU patients performed by general nurses

    Time frame: One day

    Validity of testing performed by nurses will be compared with investigation by the physician, specialist for compression ultrasound testing

Sponsors and collaborators

Lead sponsor

Emergency Medical Service of the Central Bohemian Region, Czech Republic

Other

Collaborators

  • Masaryk Hospital Usti nad Labem

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 16, 2018
Registry last updated
Aug 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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