Transthoracic EchocardiographyNCT04521933
Reliability of Subjective Assessment of the Heart by Cardiac Point-of-Care Ultrasound
An observational study of Transthoracic Echocardiography, 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 subjective qualitative assessment of the basic cardiac parameters by Point-pf-Care ultrasound. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Transthoracic Echocardiography
- What is being tested?
- Survey
- How many people
- 52 participants
- Where
- 1 siteCzechia
- Study dates
- 28 Aug 2020to 31 Jan 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Physicians with at least basic knowledge of cardiac Point-of-Care ultrasound.
Who may be able to join
- physician with at least basic knowledge of cardiac Point-of-Care ultrasound who agrees to complete the questionnaire
Who cannot join
- not meet the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reliability of Subjective Qualitative Assessment of the Heart by Cardiac Point-of-Care Ultrasound in Comparison With Conventional Transthoracic Echocardiography
The purpose of this study is to evaluate reliability of subjective qualitative assessment of the basic cardiac parameters by Point-pf-Care ultrasound.
Read the detailed description
Subjective qualitative assessment of ventricular function, diameter of the right ventricle and the size of inferior caval vein using cardiac Point-of-Care ultrasound is commonly performed by intensivists and emergency medicine physicians during the management of the patients with shock and/or acute respiratory failure. However, very little data is available to define the reliability of this qualitative examination. The presented study aims to assess this reliability.
Physicians meeting inclusion and exclusion criteria will be sent by a questionnaire consisting of 19 ultrasound cases. Participants will be asked to perform qualitative evaluation of ultrasound findings of each case. Then, the results will be compared with quantitative measurements made by conventional transthoracic echocardiography and validity testing will be performed.
- Conditions
- Transthoracic Echocardiography
- Being tested
- Survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Each participant completes a questionnaire. In the questionnaire, he performs a subjective qualitative evaluation of Point-of-Care ultrasound records of the heart.
Each participant will complete a questionnaire in which they perform a subjective qualitative evaluation of ultrasonographic recordings of the heart.
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability of subjective qualitative assessment of the heart by Point-of-Care ultrasound in comparison with conventional transthoracic echocardiography
Subjective assessment of Point-of-Care ultrasound records of the heart will be performed by participants via completion of the questionnaire. Thereafter, results of the survey will be compared with the objective measurements taken by conventional transthoracic echocardiography from the same records than presented in the questionnaire.
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start28 Aug 2020
- Primary completion25 Dec 2020
- Study completion31 Jan 2021
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 Transthoracic EchocardiographyStudies 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emergency Medical Service of the Central Bohemian Region, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- Masaryk Hospital Usti nad Labem
- Responsible party
- Principal investigator, Roman Skulec, Masaryk Hospital Usti nad Labem
- Investigators
- Roman Skulec, MD, PhD, Principal investigator, Masaryk Hospital Usti nad Labem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04521933
- Sponsor's protocol ID
- 09/2020
- Status last verified
- Feb 2021
- First submitted
- 18 Aug 2020
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. Eur Heart J Cardiovasc Imaging. 2015 Mar;16(3):233-70. doi: 10.1093/ehjci/jev014.
PubMed 25712077
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Subjective Qualitative Assessment of the Heart by Cardiac Point-of-Care Ultrasound in Comparison With Conventional Transthoracic Echocardiography
- ClinicalTrials.gov ID
- NCT04521933
- Acronym / sponsor ID
- 09/2020
- Conditions
- Transthoracic Echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Emergency Medical Service of the Central Bohemian Region, Czech RepublicUniversity, hospital or other
- Collaborators
- Masaryk Hospital Usti nad Labem
- Study start
- 28 Aug 2020 (actual)
- Primary completion
- 25 Dec 2020 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 21 Aug 2020 (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 subjective qualitative assessment of the basic cardiac parameters by Point-pf-Care ultrasound.
Detailed description
Subjective qualitative assessment of ventricular function, diameter of the right ventricle and the size of inferior caval vein using cardiac Point-of-Care ultrasound is commonly performed by intensivists and emergency medicine physicians during the management of the patients with shock and/or acute respiratory failure. However, very little data is available to define the reliability of this qualitative examination. The presented study aims to assess this reliability.
Physicians meeting inclusion and exclusion criteria will be sent by a questionnaire consisting of 19 ultrasound cases. Participants will be asked to perform qualitative evaluation of ultrasound findings of each case. Then, the results will be compared with quantitative measurements made by conventional transthoracic echocardiography and validity testing will be performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Physicians with at least basic knowledge of cardiac Point-of-Care ultrasound.
Key inclusion criteria (1 listed)
- physician with at least basic knowledge of cardiac Point-of-Care ultrasound who agrees to complete the questionnaire
Key exclusion criteria (1 listed)
- not meet the inclusion criteria
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 |
|---|---|---|
| SurveyEach participant completes a questionnaire. In the questionnaire, he performs a subjective qualitative evaluation of Point-of-Care ultrasound records of the heart. Each participant will complete a questionnaire in which they perform a subjective qualitative evaluation of ultrasonographic recordings of the heart. | Other | – |
Primary outcome
Reliability of subjective qualitative assessment of the heart by Point-of-Care ultrasound in comparison with conventional transthoracic echocardiography
Time frame: four weeks
Subjective assessment of Point-of-Care ultrasound records of the heart will be performed by participants via completion of the questionnaire. Thereafter, results of the survey will be compared with the objective measurements taken by conventional transthoracic echocardiography from the same records than presented in the questionnaire.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Background: PubMed 25712077Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. Eur Heart J Cardiovasc Imaging. 2015 Mar;16(3):233-70. doi: 10.1093/ehjci/jev014.
- Individual participant dataSharing planned: No
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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 Transthoracic Echocardiography, 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 10 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability of subjective qualitative assessment of the heart by Point-of-Care ultrasound in comparison with conventional transthoracic echocardiography (time frame: four weeks). 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 NCT04521933, 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 10 Feb 2021.