ARDSARDStrainNCT02638844
Assessment of Right Ventricular 2d-strain in Acute Respiratory Distress Syndrome
An observational study of ARDS, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Assessment of right ventricular (RV) function in patients with acute respiratory syndrome (ARDS) is warranted because RV failure is frequent and associated with worse outcome. Transthoracic echocardiography is the cornerstone of RV assessment but it remains challenging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS
- How many people
- 49 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2015to Aug 2017
- 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: ICU patients with moderate or severe ARDS receiving invasive mechanical ventilation
Who may be able to join
- patients with moderate or severe ARDS (Berlin definition)
- receiving mechanical ventilation (>48h estimated length)
- Transthoracic echocardiography performed during the first 36h after ICU admission
Who cannot join
- pregnancy
- protected or deprived of Liberty major
- chronic respiratory disease
- history of clinical right heart failure
- chronic heart failure with LVEF < 35%
- severe valvular heart disease
- under 18 or protected-adults
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ARDStrain : Assessment of Right Ventricular 2d-strain in Acute Respiratory Distress Syndrome
Assessment of right ventricular (RV) function in patients with acute respiratory syndrome (ARDS) is warranted because RV failure is frequent and associated with worse outcome. Transthoracic echocardiography is the cornerstone of RV assessment but it remains challenging. Quantification of RV deformation by speckle-tracking imaging echocardiography (STE) is a widely available and reproducible technique that readily provides an integrated analysis of all segments of the RV. This study aims to investigate the accuracy of STE-derived strain parameters in assessing RV function during ARDS.
- Conditions
- ARDS
- Keywords
- echocardiography
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of longitudinal peak systolic strain
Measured: up to 36 hours after Intensive Care Unit admission
Secondary outcomes (3)
Measure of PaO2/FiO2 ratio
Measured: up to 36 hours after Intensive Care Unit admission
Ventilator-free days
Measured: 28 days
Mortality
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionJul 2017
- Study completionAug 2017
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 ARDSStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02638844
- Sponsor's protocol ID
- CPRC2013 ARDStrain
- Acronym
- ARDStrain
- Status last verified
- Jul 2017
- First submitted
- 16 Dec 2015
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lemarie J, Maigrat CH, Kimmoun A, Dumont N, Bollaert PE, Selton-Suty C, Gibot S, Huttin O. Feasibility, reproducibility and diagnostic usefulness of right ventricular strain by 2-dimensional speckle-tracking echocardiography in ARDS patients: the ARD strain study. Ann Intensive Care. 2020 Feb 13;10(1):24. doi: 10.1186/s13613-020-0636-2.
PubMed 32056017
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARDStrain : Assessment of Right Ventricular 2d-strain in Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT02638844
- Acronym / sponsor ID
- ARDStrain / CPRC2013 ARDStrain
- Conditions
- ARDS
- Keywords
- echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Jul 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 23 Dec 2015 (estimated)
- 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.
Assessment of right ventricular (RV) function in patients with acute respiratory syndrome (ARDS) is warranted because RV failure is frequent and associated with worse outcome. Transthoracic echocardiography is the cornerstone of RV assessment but it remains challenging. Quantification of RV deformation by speckle-tracking imaging echocardiography (STE) is a widely available and reproducible technique that readily provides an integrated analysis of all segments of the RV. This study aims to investigate the accuracy of STE-derived strain parameters in assessing RV function during ARDS.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU patients with moderate or severe ARDS receiving invasive mechanical ventilation
Key inclusion criteria (3 listed)
- patients with moderate or severe ARDS (Berlin definition)
- receiving mechanical ventilation (>48h estimated length)
- Transthoracic echocardiography performed during the first 36h after ICU admission
Key exclusion criteria (7 listed)
- pregnancy
- protected or deprived of Liberty major
- chronic respiratory disease
- history of clinical right heart failure
- chronic heart failure with LVEF < 35%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measure of longitudinal peak systolic strain
Time frame: up to 36 hours after Intensive Care Unit admission
3 secondary outcomes
Measure of PaO2/FiO2 ratio
Time frame: up to 36 hours after Intensive Care Unit admission
Ventilator-free days
Time frame: 28 days
Mortality
Time frame: 28 days
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 5 Feb 2018.
- Derived from this study: PubMed 32056017Lemarie J, Maigrat CH, Kimmoun A, Dumont N, Bollaert PE, Selton-Suty C, Gibot S, Huttin O. Feasibility, reproducibility and diagnostic usefulness of right ventricular strain by 2-dimensional speckle-tracking echocardiography in ARDS patients: the ARD strain study. Ann Intensive Care. 2020 Feb 13;10(1):24. doi: 10.1186/s13613-020-0636-2.
- 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.
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 ARDS, run by Central Hospital, Nancy, France 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 3 inclusion and 7 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 5 Feb 2018. 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?
Measure of longitudinal peak systolic strain (time frame: up to 36 hours after Intensive Care Unit admission). 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 NCT02638844, 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 5 Feb 2018.