NCT04483193

Brief Summary

The purpose of this study is to assess validity of extended duplex ultrasound examination for diagnosis of proximal deep vein thrombosis performed by general intensive care unit nurses in the critically ill patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 23, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

July 28, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

August 19, 2020

Status Verified

August 1, 2020

Enrollment Period

11 months

First QC Date

July 20, 2020

Last Update Submit

August 18, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Validity of duplex ultrasound

    Validity of duplex ultrasound examination performed by a trained general intensive care nurses when compared with the examination performed by a trained physician - intensivist, specialist in Point-of-Care ultrasound.

    Comparison of two examinations performed with a maximum interval of 24 hours.

Study Arms (1)

Critically ill patients

Critically ill patients hospitalised at the intensive care unit.

Diagnostic Test: Duplex ultrasound

Interventions

Duplex ultrasoundDIAGNOSTIC_TEST

Point-of-Care compression ultrasound test combined with colour doppler imaging in the range from the groin to the popliteal region of both lower extremities.

Critically ill patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult critically ill patients.

You may qualify if:

  • Inpatients
  • Critically ill patients hospitalised in the intensive care unit for more than 72 hours

You may not qualify if:

  • Known deep vein thrombosis
  • Contraindication of ultrasound examination
  • Refusal of ultrasound examination by patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Masaryk Hospital Usti nad Labem

Ústí nad Labem, 40113, Czechia

RECRUITING

Related Publications (1)

  • Skulec R, Kohlova A, Miksova L, Cerny V. The reliability of ultrasound compression test performed by general ICU nurses in the critically ill patients: A preliminary prospective clinical study. Eur J Intern Med. 2020 Jun;76:130-131. doi: 10.1016/j.ejim.2020.03.007. Epub 2020 Mar 23. No abstract available.

    PMID: 32216998BACKGROUND

MeSH Terms

Interventions

Ultrasonography, Doppler, Duplex

Intervention Hierarchy (Ancestors)

Ultrasonography, DopplerUltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Roman Skulec, MD, PhD

    Masaryk Hospital Usti nad Labem

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Roman Skulec, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 20, 2020

First Posted

July 23, 2020

Study Start

July 28, 2020

Primary Completion

June 30, 2021

Study Completion

August 31, 2021

Last Updated

August 19, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations