Point-of-Care Ultrasound in Primary Care (POCUS iGP 1)

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

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

Study Overview

• Status: Recruiting
• Conditions: Ultrasound
• Intervention / Treatment: Diagnostic test: Ultrasound

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 Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: Roman Skulec, MD, PhD; Phone Number: +420 777 577 497; Email: skulec@email.cz
• Study Contact Backup: Name: David Halata, MD; Phone Number: +420 731 826 557; Email: halatad@gmail.com

Study Locations

• Czechia
  • Usti nad Labem, Czechia, 40113
    • Recruiting
    • Masaryk Hospital Usti nad Labem
    • Contact: Roman Skulec, MD, PhD; Phone Number: +420777577497; Email: skulec@email.cz
    • Contact: Barbora Pakostova, MD; Phone Number: +420720172670; Email: Barbora.Pakostova@kzcr.eu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult outpatients.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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 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; Each patient included to the study will undergo Point-of-Care ultrasound testing specific for the area defined in the Groups section.
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; Each patient included to the study will undergo Point-of-Care ultrasound testing specific for the area defined in the Groups section.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Emergency Medical Service of the Central Bohemian Region, Czech Republic
• Collaborators: The Society of General Practice, J. E. Purkyne Czech Medical Association; Institute for Postgraduate Medical Education, Czech republic
• Investigators: Principal Investigator: Roman Skulec, MD, PhD, Masaryk Hospital Usti nad Labem

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: May 24, 2021
• First Submitted That Met QC Criteria: May 26, 2021
• First Posted (Actual): May 28, 2021

Study Record Updates

• Last Update Posted (Actual): July 13, 2021
• Last Update Submitted That Met QC Criteria: July 11, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: POCUSiGP01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No