POCUS iGP 1: Point-of-Care Ultrasound in Primary Care

• Sponsor: Emergency Medical Service of the Central Bohemian Region, Czech Republic (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04905719
• Collaborator: The Society of General Practice, J. E. Purkyne Czech Medical Association (Other), Institute for Postgraduate Medical Education, Czech republic (Other)
• Enrollment: 600
• Location: 1
• Anticipated Duration (Months): 12.6
• Patients Per Site Per Month: 47.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Ultrasound	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 Design

• Study Type: Observational
• Anticipated Enrollment: 600 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Reliability of Point-of-Care Ultrasound Examination in Primary Care Performed by a General Practitioner
• Actual Study Start Date: Jun 10, 2021
• Anticipated Primary Completion Date: Dec 31, 2021
• Anticipated Study Completion Date: Jun 30, 2022

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Masaryk Hospital Usti nad Labem	Usti nad Labem		Czechia	40113

Sponsors and Collaborators

• Emergency Medical Service of the Central Bohemian Region, Czech Republic
• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Roman Skulec, Principal Investigator, Emergency Medical Service of the Central Bohemian Region, Czech Republic
• ClinicalTrials.gov Identifier: NCT04905719
• Other Study ID Numbers: POCUSiGP01
• First Posted: May 28, 2021
• Last Update Posted: Jul 13, 2021
• Last Verified: Jul 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 13, 2021