Point-of-Care Ultrasound in Primary Care

Ultrasound Clinical Trial

— POCUS iGP 1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04905719
• Other study ID #: POCUSiGP01
• Status: Recruiting
• Start date: June 10, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2021
• Source: Emergency Medical Service of the Central Bohemian Region, Czech Republic
• Contact: Roman Skulec, MD, PhD
• Phone: +420 777 577 497
• Email: skulec[@]email.cz
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: June 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Ultrasound

Intervention

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

Locations

Country	Name	City	State
Czechia	Masaryk Hospital Usti nad Labem	Usti nad Labem

Sponsors (3)

Lead Sponsor	Collaborator
Emergency Medical Service of the Central Bohemian Region, Czech Republic	Institute for Postgraduate Medical Education, Czech republic, The Society of General Practice, J. E. Purkyne Czech Medical Association

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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