Acute Respiratory Distress SyndromeSTRAINNCT01757522
Detection of Right Ventricular Dysfunction by 2D Strain During Acute Respiratory Distress Syndrom (ARDS)
An observational study of Acute Respiratory Distress Syndrome and Right Ventricular Dysfunction, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Acute respiratory distress syndrome (ARDS) and mechanical ventilation can lead to right ventricular dysfunction and ultimately right ventricular failure by increasing pulmonary vascular resistances and pressure load. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Right Ventricular Dysfunction, Right Heart Failure
- How many people
- 47 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jan 2013to 25 Oct 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: Patients are recruited in our medical intensive care unit at Grenoble University Hospital.
Who may be able to join
- Need for mechanical ventilation
- ARDS criteria met: Respiratory failure not fully explained by cardiac failure, Pao2/FiO2<200, bilateral opacities on Chest imaging, all symptoms appeared within 1 week
- Need for mechanical ventilation
- ALI criteria met: Respiratory failure not fully explained by cardiac failure, Pao2/FiO2<300, bilateral opacities on Chest imaging, all symptoms appeared within 1 week
- Need for mechanical ventilation for a non-respiratory cause
Who cannot join
- Predictable duration of mechanical ventilation shorter than 48 hours
- Contraindication to transesophageal echocardiography
- ALI group:
- Predictable duration of mechanical ventilation shorter than 48 hours
- Control Group:
- Need for FiO2>30%
- Known cardiac abnormalities
- Cardiac drugs intake during last 24 hours
Trial locations and contacts
1 site in 1 country.
About this study
Acute respiratory distress syndrome (ARDS) and mechanical ventilation can lead to right ventricular dysfunction and ultimately right ventricular failure by increasing pulmonary vascular resistances and pressure load. This can be prevented by modifying ventilator settings, using vasopressors or inotropes or even by prone positionning.But to do so, right ventricular dysfonction has to be detected. Echocardiography has emerged as a first line tool to diagnose right heart failure. Recently, strain analysis showed promising results to detect early right ventricle abnormalities in other settings such as pulmonary hypertension or scleroderma. We therefore decided to determine whether 2D strain could help detect early right ventricular dysfunction in ARDS.
- Conditions
- Acute Respiratory Distress Syndrome, Right Ventricular Dysfunction, Right Heart Failure, Acute Cor Pulmonale
- Medical subject headings
- Respiratory Distress Syndrome, Ventricular Dysfunction, Right, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ARDS group | Patients under mechanical ventilation since less than 24 hours at inclusion and presenting acute respiratory distress syndrome criteria. | |
| ALI group | Patients under mechanical ventilation and presenting acute lung injury criteria. | |
| Control Group | Patients under mechanical ventilation for a non-respiratory cause |
What is being measured
The primary outcome is the main question the study is designed to answer.
Right ventricle 2D strain
We will assess whether 2D strain can detect a right ventricular dysfunction as compared to standard echocardiographic parameters
Measured: Duration of mechanical ventilation
Secondary outcomes (3)
Mean right ventricle strain under ventilated patients
We measure right ventricle strain (RV strain) in patients under mechanical ventilation for a non-respiratory cause. This allows us to determine the mean value of RV strain under ventilation when there is no respiratory failure.
Measured: at inclusion
Reproducibility between transthoracic and transesophageal strain measures
In ARDS patients, we record a transthoracic and transesophageal echocardiography. We compare RV strain values obtained from transthoracic and transesophageal echocardiography.
Measured: Time of mechanical ventilation
NT pro BNP and pre pro endothelin plasma level
These assays are made based on the hypothesis they could help discriminate between patients who will develop a right ventricular dysfunction from those who will not. A blood sample is withdrawn at the same time as echocardiography only in the ARDS group.
Measured: At inclusion in ARDS patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2012 (estimated)
- Study start3 Jan 2013
- Primary completion17 Mar 2015
- Study completion25 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carole SCHWEBEL, PU/PH, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01757522
- Sponsor's protocol ID
- 2012-A01204-39
- Acronym
- STRAIN
- Status last verified
- May 2022
- First submitted
- 4 Dec 2012
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Right Ventricular Dysfunction by 2D Strain During Acute Respiratory Distress Syndrom (ARDS)
- ClinicalTrials.gov ID
- NCT01757522
- Acronym / sponsor ID
- STRAIN / 2012-A01204-39
- Conditions
- Acute Respiratory Distress Syndrome, Right Ventricular Dysfunction, Right Heart Failure, Acute Cor Pulmonale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 3 Jan 2013 (actual)
- Primary completion
- 17 Mar 2015 (actual)
- Study completion
- 25 Oct 2017 (actual)
- First posted
- 31 Dec 2012 (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.
Acute respiratory distress syndrome (ARDS) and mechanical ventilation can lead to right ventricular dysfunction and ultimately right ventricular failure by increasing pulmonary vascular resistances and pressure load. This can be prevented by modifying ventilator settings, using vasopressors or inotropes or even by prone positionning.But to do so, right ventricular dysfonction has to be detected. Echocardiography has emerged as a first line tool to diagnose right heart failure. Recently, strain analysis showed promising results to detect early right ventricle abnormalities in other settings such as pulmonary hypertension or scleroderma. We therefore decided to determine whether 2D strain could help detect early right ventricular dysfunction in ARDS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ARDS group | – | –Patients under mechanical ventilation since less than 24 hours at inclusion and presenting acute respiratory distress syndrome criteria. |
| ALI group | – | –Patients under mechanical ventilation and presenting acute lung injury criteria. |
| Control Group | – | –Patients under mechanical ventilation for a non-respiratory cause |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are recruited in our medical intensive care unit at Grenoble University Hospital.
Key inclusion criteria (5 listed)
- Need for mechanical ventilation
- ARDS criteria met: Respiratory failure not fully explained by cardiac failure, Pao2/FiO2<200, bilateral opacities on Chest imaging, all symptoms appeared within 1 week
- Need for mechanical ventilation
- ALI criteria met: Respiratory failure not fully explained by cardiac failure, Pao2/FiO2<300, bilateral opacities on Chest imaging, all symptoms appeared within 1 week
- Need for mechanical ventilation for a non-respiratory cause
Key exclusion criteria (8 listed)
- Predictable duration of mechanical ventilation shorter than 48 hours
- Contraindication to transesophageal echocardiography
- Predictable duration of mechanical ventilation shorter than 48 hours
- Need for FiO2>30%
- Known cardiac abnormalities
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
Right ventricle 2D strain
Time frame: Duration of mechanical ventilation
We will assess whether 2D strain can detect a right ventricular dysfunction as compared to standard echocardiographic parameters
3 secondary outcomes
Mean right ventricle strain under ventilated patients
Time frame: at inclusion
Reproducibility between transthoracic and transesophageal strain measures
Time frame: Time of mechanical ventilation
NT pro BNP and pre pro endothelin plasma level
Time frame: At inclusion in ARDS patients
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 8 Nov 2022.
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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.
Carole SCHWEBEL, PU/PH principal investigator
University Hospital, Grenoble
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 Acute Respiratory Distress Syndrome and Right Ventricular Dysfunction, run by University Hospital, Grenoble 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 5 inclusion and 8 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 8 Nov 2022. 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?
Right ventricle 2D strain (time frame: Duration of mechanical ventilation). 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 8 Nov 2022.