Inferior Vena Cava DiameterVCI ECHONCT03587090
Comparison of Subcostal and Transhepatic Views to Assess Inferior Vena Cava by Echocardiography
An observational study of Inferior Vena Cava Diameter, run by University Hospital, Caen at 1 site in France.
Trial summary
Comparison of subcostal and transhepatic views to measure inferior vena cava diameter by echocardiography in intensive care unit patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inferior Vena Cava Diameter
- What is being tested?
- echocardiography
- How many people
- 131 participants
- Where
- 1 siteFrance
- Study dates
- 14 May 2018to 4 Oct 2019
- 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: intensive care unit patients
Who may be able to join
- patient hospitalised in ICU
Who cannot join
- gardianship
- contraindication to transthoracic echocardiography
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparaison échographique Des Voies Sous Costale et Trans hépatique Dans l'évaluation de la Veine Cave inférieure
Comparison of subcostal and transhepatic views to measure inferior vena cava diameter by echocardiography in intensive care unit patients
- Conditions
- Inferior Vena Cava Diameter
- Being tested
- echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echocardiographyDiagnostic test
echocardiography by subcostal and transhepatic views
What is being measured
The primary outcome is the main question the study is designed to answer.
inferior vena cava diameter
measurement of inferior vena cava diameter by 2D et TM mode
Measured: up to 1 day after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2018
- Study start14 May 2018
- Primary completion4 Oct 2019
- Study completion4 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inferior Vena Cava DiameterStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03587090
- Sponsor's protocol ID
- caenUH 18-034
- Acronym
- VCI ECHO
- Status last verified
- Jun 2019
- First submitted
- 8 Jun 2018
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparaison échographique Des Voies Sous Costale et Trans hépatique Dans l'évaluation de la Veine Cave inférieure
- ClinicalTrials.gov ID
- NCT03587090
- Acronym / sponsor ID
- VCI ECHO / caenUH 18-034
- Conditions
- Inferior Vena Cava Diameter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 14 May 2018 (actual)
- Primary completion
- 4 Oct 2019 (actual)
- Study completion
- 4 Oct 2019 (actual)
- First posted
- 16 Jul 2018 (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.
Comparison of subcostal and transhepatic views to measure inferior vena cava diameter by echocardiography in intensive care unit patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- intensive care unit patients
Key inclusion criteria (1 listed)
- patient hospitalised in ICU
Key exclusion criteria (2 listed)
- gardianship
- contraindication to transthoracic echocardiography
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 |
|---|---|---|
| echocardiographyechocardiography by subcostal and transhepatic views | Diagnostic test | – |
Primary outcome
inferior vena cava diameter
Time frame: up to 1 day after inclusion
measurement of inferior vena cava diameter by 2D et TM mode
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 22 Jan 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Inferior Vena Cava Diameter, run by University Hospital, Caen at 1 site in France.
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 2 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 22 Jan 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 France. 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?
inferior vena cava diameter (time frame: up to 1 day after inclusion). 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 22 Jan 2020.