NCT04905719

Brief Summary

The purpose of this study is to evaluate reliability of Point-of-Care ultrasound evaluation performed by general practitioners.

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
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

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

May 24, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 28, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

June 10, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

July 13, 2021

Status Verified

July 1, 2021

Enrollment Period

7 months

First QC Date

May 24, 2021

Last Update Submit

July 11, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Reliability of Point-of-Care ultrasound investigation of the lungs, gall bladder or proximal deep veins of lower extremities performed by general practitioner compared with the expert diagnostic method

    General practitioners will perform the type of Point-of-Care ultrasound investigation which will relate to the type of symptoms. Then, the result of this investigation will be compared with the expert diagnostic method. This will be chest X ray scan or pulmonary CT for group 1 patients, expert abdominal ultrasound for group 2 patients and expert complete compression ultrasound for group 3 patients. These examinations are not study interventions, while they are a routine procedures, which would be indicated irrespective of the study.

    7 months

Study Arms (3)

Patients with dyspnea

Patients who visit a general practitioner for dyspnea will undergo a Point-of-Care ultrasound examination of the lungs to identify the presence or the absence of A-profile, B-profile and pleural effusion.

Diagnostic Test: Ultrasound

Patients with abdominal pain

Patients who visit a general practitioner for abdominal pain in the right upper quadrant will undergo abdominal Point-of-Care ultrasound examination to identify cholecystolithiasis.

Diagnostic Test: Ultrasound

Patients with suspected deep vein thrombosis

Patients who visit a general practitioner for pain and / or swelling of the lower extremity will undergo compression ultrasound testing to identify proximal deep vein thrombosis.

Diagnostic Test: Ultrasound

Interventions

UltrasoundDIAGNOSTIC_TEST

Each patient included to the study will undergo Point-of-Care ultrasound testing specific for the area defined in the Groups section.

Patients with abdominal painPatients with dyspneaPatients with suspected deep vein thrombosis

Eligibility Criteria

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

Adult outpatients.

You may qualify if:

  • Patient with abdominal pain in the right upper quadrant (will be indicated for the abdominal ultrasound) or patient with dyspnoea (will be indicated for lung ultrasound) or patient with suspected deep vein thrombosis (will be indicated for compression ultrasound testing)
  • Signing of informed consent to participate in the study

You may not qualify if:

  • Age \<18 years
  • Refusal of ultrasound examination by patient
  • Any circumstance that prevents ultrasonographic examination (eg allergy to ultrasonographic gel, skin lesions that do not allow safe examination, etc.)

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)

  • Halata D, Zhor D, Skulec R, Seifert B. Accuracy of point-of-care ultrasound examination of the lung in primary care performed by general practitioners: a cross-sectional study. BMC Prim Care. 2025 Apr 8;26(1):99. doi: 10.1186/s12875-025-02802-4.

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic 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

David Halata, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 24, 2021

First Posted

May 28, 2021

Study Start

June 10, 2021

Primary Completion

December 31, 2021

Study Completion

June 30, 2022

Last Updated

July 13, 2021

Record last verified: 2021-07

Locations