Deep Venous Thrombosis Screening in the ICU by Nurses

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ClinicalTrials.gov Identifier: NCT03707665

Recruitment Status : Completed

First Posted : October 16, 2018

Last Update Posted : August 2, 2019

Sponsor:

Collaborator:

Masaryk Hospital Usti nad Labem

Information provided by (Responsible Party):

Roman Skulec, Emergency Medical Service of the Central Bohemian Region, Czech Republic

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Deep Venous Thrombosis	Diagnostic Test: Compression ultrasound testing

Study Design

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Study Type :	Observational
Actual Enrollment :	115 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Screening Ultrasound Compression Testing in Critically Ill Patients Performed by General Nurses - Validation Study
Actual Study Start Date :	November 1, 2018
Actual Primary Completion Date :	April 30, 2019
Actual Study Completion Date :	May 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots Deep Vein Thrombosis

U.S. FDA Resources

Groups and Cohorts

Intervention Details:

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

ICU patients

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03707665

Locations

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

Sponsors and Collaborators

Emergency Medical Service of the Central Bohemian Region, Czech Republic

Masaryk Hospital Usti nad Labem

Investigators

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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

More Information

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Responsible Party:	Roman Skulec, Head physician for science and research, Emergency Medical Service of the Central Bohemian Region, Czech Republic
ClinicalTrials.gov Identifier:	NCT03707665
Other Study ID Numbers:	2018-01
First Posted:	October 16, 2018 Key Record Dates
Last Update Posted:	August 2, 2019
Last Verified:	August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Roman Skulec, Emergency Medical Service of the Central Bohemian Region, Czech Republic:


Compression Ultrasound testing Nurse

Additional relevant MeSH terms:

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Thrombosis Venous Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases

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