Deep Venous Thrombosis Screening in the ICU by Nurses

NCT03707665 | Completed

• 1 other identifier: 2018-01
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Deep Venous Thrombosis

Keywords

Compression Ultrasound testing; Nurse

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Compression ultrasound testing DIAGNOSTIC_TEST

Compression ultrasound testing, screening technique for diagnosing deep venous thrombosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ICU patients

You may qualify if:

• all ICU patients without known deep venous thrombosis, hospitalised more than 72 hours

You may not qualify if:

• contraindication of compression ultrasound testing
• end-of-life decision regimen of care

Sponsors & Collaborators

• Emergency Medical Service of the Central Bohemian Region, Czech Republic: lead
• Masaryk Hospital Usti nad Labem: collaborator

Study Sites (1)

Emergency Medical Service of the Central Bohemian Region

Beroun, Central Bohemia, Czechia

Location

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head physician for science and research

Study Record Dates

• First Submitted: October 12, 2018
• First Posted: October 16, 2018
• Study Start: November 1, 2018
• Primary Completion: April 30, 2019
• Study Completion: May 31, 2019
• Last Updated: August 2, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)