UltrasoundPOCUS iGP 1NCT04905719
Point-of-Care Ultrasound in Primary Care
An observational study of Ultrasound, run by Emergency Medical Service of the Central Bohemian Region, Czech Republic at 1 site in Czechia.
Trial summary
The purpose of this study is to evaluate reliability of Point-of-Care ultrasound evaluation performed by general practitioners. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ultrasound
- What is being tested?
- Ultrasound
- How many people
- 600 participants
- Where
- 1 siteCzechia
- Study dates
- 10 Jun 2021to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult outpatients.
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Masaryk Hospital Usti nad Labem
Ústí nad Labem, 40113
Roman Skulec, MD, PhD, +420777577497, skulec@email.cz
Barbora Pakostova, MD, +420720172670, Barbora.Pakostova@kzcr.eu
About this study
Official title: 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.
Read the 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.
- Conditions
- Ultrasound
- Being tested
- Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
Each patient included to the study will undergo Point-of-Care ultrasound testing specific for the area defined in the Groups section.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Ultrasound | |
| 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. Receives: Diagnostic Test: Ultrasound | |
| 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. Receives: Diagnostic Test: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start10 Jun 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UltrasoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emergency Medical Service of the Central Bohemian Region, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- The Society of General Practice, J. E. Purkyne Czech Medical Association, Institute for Postgraduate Medical Education, Czech republic
- Responsible party
- Principal investigator, Roman Skulec, Emergency Medical Service of the Central Bohemian Region, Czech Republic
- Investigators
- Roman Skulec, MD, PhD, Principal investigator, Masaryk Hospital Usti nad Labem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905719
- Sponsor's protocol ID
- POCUSiGP01
- Acronym
- POCUS iGP 1
- Status last verified
- Jul 2021
- First submitted
- 24 May 2021
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Halata D, Zhor D, Skulec R, Seifert B. Accuracy of point-of-care ultrasound examination of the lung in primary care performed by general practitioners: a cross-sectional study. BMC Prim Care. 2025 Apr 8;26(1):99. doi: 10.1186/s12875-025-02802-4.
PubMed 40200132
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Point-of-Care Ultrasound Examination in Primary Care Performed by a General Practitioner
- ClinicalTrials.gov ID
- NCT04905719
- Acronym / sponsor ID
- POCUS iGP 1 / POCUSiGP01
- Conditions
- Ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Emergency Medical Service of the Central Bohemian Region, Czech RepublicUniversity, hospital or other
- Collaborators
- The Society of General Practice, J. E. Purkyne Czech Medical Association, Institute for Postgraduate Medical Education, Czech republic
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 28 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with dyspnea | – | Diagnostic Test: UltrasoundPatients 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. |
| Patients with abdominal pain | – | Diagnostic Test: UltrasoundPatients 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 suspected deep vein thrombosis | – | Diagnostic Test: UltrasoundPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult outpatients.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundEach patient included to the study will undergo Point-of-Care ultrasound testing specific for the area defined in the Groups section. | Diagnostic test | Patients with abdominal pain, Patients with dyspnea, Patients with suspected deep vein thrombosis |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
- Derived from this study: PubMed 40200132Halata D, Zhor D, Skulec R, Seifert B. Accuracy of point-of-care ultrasound examination of the lung in primary care performed by general practitioners: a cross-sectional study. BMC Prim Care. 2025 Apr 8;26(1):99. doi: 10.1186/s12875-025-02802-4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roman Skulec, MD, PhD principal investigator
Masaryk Hospital Usti nad Labem
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasound, run by Emergency Medical Service of the Central Bohemian Region, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roman Skulec, MD, PhD (+420 777 577 497, skulec@email.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04905719, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2021.