Transthoracic EchocardiographyNCT04488627
Reliability of Ultrasound Examination of the Inferior Caval Vein
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 compare validity of examination and measurement of inferior caval vein from different views in critically ill patients on mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transthoracic Echocardiography
- What is being tested?
- Conventional transthoracic echocardiographic examination at the intensive care unit.
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- 27 Jul 2020to 31 Jul 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
- Adult, Older adult
Study population: Adult intensive care unit patients on mechanical ventilation.
Who may be able to join
- Inpatients
- Patients on mechanical ventilation indicated for transthoracic echocardiographic examination
Who cannot join
- Age <18 years
- Insufficient imaging quality
- Refusal of echocardiographic examination by patient
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, 00420777577497, skulec@email.cz
About this study
Official title: Reliability of Ultrasound Examination of the Inferior Caval Vein From Different Views in Critically Ill Patients on Artificial Lung Ventilation
The purpose of this study is to compare validity of examination and measurement of inferior caval vein from different views in critically ill patients on mechanical ventilation.
Read the detailed description
A maximal and minimal diameter of inferior caval vein will be measured by transthoracic echocardiography in critically ill patients on mechanical ventilation hospitalised in the intensive care unit from four different views:
- Subcostal view on the inferior caval vein in the long axis,
- subcostal view on the inferior caval vein in the short axis,
- right lateral view on the inferior caval vein in the long axis,
- right lateral view on the inferior caval vein in the short axis.
Comparison between the results of measurements in the subcostal view in the long axis and other views will be performed.
- Conditions
- Transthoracic Echocardiography
- Being tested
- Conventional transthoracic echocardiographic examination at the intensive care unit.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional transthoracic echocardiographic examination at the intensive care unit.Diagnostic test
Conventional transthoracic echocardiographic examination at the intensive care unit targeted to inferior caval vein examination from different views.
| Study group | Role | What they receive |
|---|---|---|
| Critically ill patients | Critically ill patients hospitalised in the intensive care unit indicated to echocardiographic examination. Receives: Diagnostic Test: Conventional transthoracic echocardiographic examination at the intensive care unit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between maximal and minimal diameter of the inferior caval vein from subcostal and right lateral view
Inferior caval vein measurements are key parameters for assessment of preload and fluid responsiveness
Measured: During the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start27 Jul 2020
- Primary completion31 May 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
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
- NCT04488627
- Sponsor's protocol ID
- 284/33
- Status last verified
- Aug 2020
- First submitted
- 20 Jul 2020
- Last updated
- 19 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Ultrasound Examination of the Inferior Caval Vein From Different Views in Critically Ill Patients on Artificial Lung Ventilation
- ClinicalTrials.gov ID
- NCT04488627
- Acronym / sponsor ID
- 284/33
- Conditions
- Transthoracic Echocardiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Emergency Medical Service of the Central Bohemian Region, Czech RepublicUniversity, hospital or other
- Collaborators
- Masaryk Hospital Usti nad Labem
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 28 Jul 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 compare validity of examination and measurement of inferior caval vein from different views in critically ill patients on mechanical ventilation.
Detailed description
A maximal and minimal diameter of inferior caval vein will be measured by transthoracic echocardiography in critically ill patients on mechanical ventilation hospitalised in the intensive care unit from four different views:
- Subcostal view on the inferior caval vein in the long axis,
- subcostal view on the inferior caval vein in the short axis,
- right lateral view on the inferior caval vein in the long axis,
- right lateral view on the inferior caval vein in the short axis.
Comparison between the results of measurements in the subcostal view in the long axis and other views will be performed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill patients | – | Diagnostic Test: Conventional transthoracic echocardiographic examination at the intensive care unit.Critically ill patients hospitalised in the intensive care unit indicated to echocardiographic examination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult intensive care unit patients on mechanical ventilation.
Key inclusion criteria (2 listed)
- Inpatients
- Patients on mechanical ventilation indicated for transthoracic echocardiographic examination
Key exclusion criteria (3 listed)
- Age <18 years
- Insufficient imaging quality
- Refusal of echocardiographic examination by patient
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 |
|---|---|---|
| Conventional transthoracic echocardiographic examination at the intensive care unit.Conventional transthoracic echocardiographic examination at the intensive care unit targeted to inferior caval vein examination from different views. | Diagnostic test | Critically ill patients |
Primary outcome
Correlation between maximal and minimal diameter of the inferior caval vein from subcostal and right lateral view
Time frame: During the intervention
Inferior caval vein measurements are key parameters for assessment of preload and fluid responsiveness
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
- 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 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 19 Aug 2020. 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 (00420777577497, skulec@email.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between maximal and minimal diameter of the inferior caval vein from subcostal and right lateral view (time frame: During the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2020.