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Clinical Trials/NCT04905719
NCT04905719
Unknown
Not Applicable

Reliability of Point-of-Care Ultrasound Examination in Primary Care Performed by a General Practitioner

Emergency Medical Service of the Central Bohemian Region, Czech Republic1 site in 1 country600 target enrollmentJune 10, 2021
ConditionsUltrasound

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ultrasound
Sponsor
Emergency Medical Service of the Central Bohemian Region, Czech Republic
Enrollment
600
Locations
1
Primary Endpoint
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
Last Updated
4 years ago

Overview

Brief Summary

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

Detailed Description

The purpose of this study is to evaluate reliability of Point-of-Care ultrasound (POCUS) evaluation performed by general practitioners. General practitioners who underwent predefined training in POCUS will perform ultrasound examination in outpatients meeting inclusion criteria. While this is observational study, result will not have an impact on the management of the patients. Regardless of the POCUS examination, patients undergo a routine diagnostic process which is appropriate for the initial symptom. Imaging examinations will always be a part of this. This will serve as an expert control to evaluate the reliability of POCUS Each POCUS examination will also be recorded as a video loop, subsequently assessed by an expert in the POCUS and also used as an expert control. The data will be analyzed by standard reliability testing.

Registry
clinicaltrials.gov
Start Date
June 10, 2021
End Date
June 30, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Emergency Medical Service of the Central Bohemian Region, Czech Republic
Responsible Party
Principal Investigator
Principal Investigator

Roman Skulec

Principal Investigator

Emergency Medical Service of the Central Bohemian Region, Czech Republic

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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.)

Outcomes

Primary Outcomes

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

Time Frame: 7 months

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.

Study Sites (1)

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