ClinicalTrials.gg
CompletedNCT01757522STRAINUpdated Nov 8, 2022

Detection of Right Ventricular Dysfunction by 2D Strain During Acute Respiratory Distress Syndrom (ARDS)

An observational study in Acute Respiratory Distress Syndrome, Right Ventricular Dysfunction and Right Heart Failure, sponsored by University Hospital, Grenoble. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-08.

Sponsored by University Hospital, Grenoble · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
47
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Acute Respiratory Distress Syndrome
  • Right Ventricular Dysfunction
  • Right Heart Failure
  • Acute Cor Pulmonale
03

In context

Respiratory Distress Syndrome

1,387 studies on the registry are indexed under Respiratory Distress Syndrome; 283 are open to participants now.

This study's enrollment of 47 is below the median of 100 across 475 observational studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

University Hospital, Grenoble is the lead sponsor of 837 studies on the registry; 207 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients are recruited in our medical intensive care unit at Grenoble University Hospital.

Eligibility 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
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
47 participants (actual)
Biospecimen retention
Samples without dna

Groups and 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

06

What researchers measure

Primary outcomes

  1. Right ventricle 2D strain

    We will assess whether 2D strain can detect a right ventricular dysfunction as compared to standard echocardiographic parameters

    Time frame: Duration of mechanical ventilation

Secondary outcomes

  1. 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.

    Time frame: at inclusion

  2. 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.

    Time frame: Time of mechanical ventilation

  3. 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.

    Time frame: At inclusion in ARDS patients

07

Study locations

1 site
  • University Hospital of Grenoble
    Grenoble, Cedex 09 38043, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01757522
Responsible party
Sponsor
First posted
Dec 31, 2012
Start date
Jan 3, 2013
Primary completion
Mar 17, 2015
Completion
Oct 25, 2017
Last update
Nov 8, 2022

Study contacts

Carole SCHWEBEL, PU/PH
principal investigator · University Hospital, Grenoble

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion