Detection of Right Ventricular Dysfunction by 2D Strain During Acute Respiratory Distress Syndrom (ARDS) (STRAIN)
This study is not yet open for participant recruitment.
Verified January 2013 by University Hospital, Grenoble
Sponsor:
University Hospital, Grenoble
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01757522
First received: December 4, 2012
Last updated: January 3, 2013
Last verified: January 2013
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Purpose
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.
| Condition |
|---|
|
Acute Respiratory Distress Syndrome Right Ventricular Dysfunction Right Heart Failure Acute Cor Pulmonale |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Detection of Right Ventricular Dysfunction by 2D Strain During Acute Respiratory Distress Syndrom (ARDS) |
Resource links provided by NLM:
Further study details as provided by University Hospital, Grenoble:
Primary Outcome Measures:
- Right ventricle 2D strain [ Time Frame: Duration of mechanical ventilation ] [ Designated as safety issue: No ]We will assess whether 2D strain can detect a right ventricular dysfunction as compared to standard echocardiographic parameters
Secondary Outcome Measures:
- Mean right ventricle strain under ventilated patients [ Time Frame: at inclusion ] [ Designated as safety issue: No ]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.
- Reproducibility between transthoracic and transesophageal strain measures [ Time Frame: Time of mechanical ventilation ] [ Designated as safety issue: No ]In ARDS patients, we record a transthoracic and transesophageal echocardiography. We compare RV strain values obtained from transthoracic and transesophageal echocardiography.
- NT pro BNP and pre pro endothelin plasma level [ Time Frame: At inclusion in ARDS patients ] [ Designated as safety issue: No ]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.
Biospecimen Retention: Samples Without DNA
Plasmatic levels of NT proBNP and pre pro endothelin are monitored in ARDS group to determine whether these biomarkers can help detect right ventricular dysfunction.
| Estimated Enrollment: | 290 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients are recruited in our medical intensive care unit at Grenoble University Hospital.
Criteria
ARDS group
Inclusion Criteria:
- 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
Exclusion Criteria:
- Predictable duration of mechanical ventilation shorter than 48 hours
- Contraindication to transesophageal echocardiography
ALI group:
Inclusion Criteria:
- 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
Exclusion Criteria:
- Predictable duration of mechanical ventilation shorter than 48 hours
Control Group:
Inclusion Criteria:
- Need for mechanical ventilation for a non-respiratory cause
Exclusion Criteria:
- Need for FiO2>30%
- Known cardiac abnormalities
- Cardiac drugs intake during last 24 hours
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01757522
Contacts
| Contact: POTTON Leila, MD | 33-476768779 | LPotton@chu-grenoble.fr |
Locations
| France | |
| University Hospital of Grenoble | Not yet recruiting |
| Grenoble, Cedex 09, France, 38043 | |
| Contact: Leila POTTON, ACC 33-476768779 LPotton@chu-grenoble.fr | |
| Contact: Caroline TOURNEGROS, CRA 33-476767109 CTournegros@chu-grenoble.fr | |
| Principal Investigator: Leila POTTON, ACC | |
| Sub-Investigator: Carole SCHWEBEL, PU/PH | |
| Sub-Investigator: Agnes BONADONA, PH | |
| Sub-Investigator: Rebecca HAMIDFAR, PH | |
| Sub-Investigator: Clemence MINET, PH | |
| Sub-Investigator: Claire ARA SOMOHANO, PH | |
| Sub-Investigator: Maxime LUGOSI, ACC | |
| Sub-Investigator: Patrice FAURE, PU/PH | |
| Sub-Investigator: Bertrand TOUSSAINT, PU/PH | |
| Sub-Investigator: Carole SAUNIER, PH | |
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
| Principal Investigator: | Leila POTTON, ACC | University Hospital, Grenoble |
More Information
No publications provided
| Responsible Party: | University Hospital, Grenoble |
| ClinicalTrials.gov Identifier: | NCT01757522 History of Changes |
| Other Study ID Numbers: | 2012-A01204-39 |
| Study First Received: | December 4, 2012 |
| Last Updated: | January 3, 2013 |
| Health Authority: | France: L’Agence nationale de sécurité du médicament et des produits de santé |
Additional relevant MeSH terms:
|
Heart Failure Pulmonary Heart Disease Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Ventricular Dysfunction, Right Ventricular Dysfunction Heart Diseases |
Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Lung Injury |
ClinicalTrials.gov processed this record on May 22, 2013