Point-of-Care Ultrasound in Primary Care

• Conditions: Ultrasound
• Interventions: Diagnostic Test: Ultrasound

• Registration Number: NCT04905719
• Lead Sponsor: Emergency Medical Service of the Central Bohemian Region, Czech Republic

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.

Study Timeline

• Study First Submitted: 2021-05-24
• Study First Submitted QC: 2021-05-26
• Study First Posted: 2021-05-28
• Study Start: 2021-06-10
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-11
• Last Update Posted: 2021-07-13
• Primary Completion: 2021-12-31
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with suspected deep vein thrombosis	Ultrasound	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.
Patients with abdominal pain	Ultrasound	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.
Patients with dyspnea	Ultrasound	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.

Primary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

Masaryk Hospital Usti nad Labem; 🇨🇿 Usti nad Labem, Czechia