An observational study in Acute Respiratory Distress Syndrome, sponsored by Bicetre Hospital. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-11.
Sponsored by Bicetre Hospital · Observational
Intubated patients with the acute respiratory distress syndrome (ARDS) are usually treated with protective ventilation limiting plateau pressure below 30 centimeter of water (cmH2O) and, if possible, a driving pressure under 15 cmH2O. However, these airway pressures might not reflect the actual pressure applied to the lung. Transpulmonary pressure is the difference between airway pressure and pleural pressure, the latter is estimated by the esophageal pressure, and so it better reflects the ventilatory induced lung injury (VILI).
One of the consequences of the VILI is a increase of pulmonary edema and it could be estimated by the extravascular lung water, obtained by trans-pulmonary thermodilution.
So it could exist a link between the driving trans-pulmonary pressure and the extravascular lung water.
1,387 studies on the registry are indexed under Respiratory Distress Syndrome; 283 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 475 observational studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →Bicetre Hospital is the lead sponsor of 25 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients intubated in the medical ICU of Bicêtre hospital (Academic hospital), Le Kremlin Bicêtre, France
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Association between the transpulmonary driving pressure and the extravascular lung water (EVLW)
On the first day of patient's respiratory and hemodynamics monitoring, we will collect transpulmonary driving pressure and extra-vascular lung water values. We will calculate the correlation coefficient linking these two variables to assess if their association.
Time frame: From inclusion up to hospital discharge (maximum day 60)
Association between the transpulmonary driving pressure and the pulmonary vascular permeability index (PVPI)
On the first day of patient's respiratory and hemodynamics monitoring, we will collect transpulmonary driving pressure and PVPI values. We will calculate the correlation coefficient linking these two variables to assess if their association.
Time frame: From inclusion up to hospital discharge (maximum day 60)
Correlation between the transpulmonary driving pressure at admission and the ICU-mortality
Multivariable analysis of factors associated with ICU mortality, including initial severity, comorbidities, respiratory mechanics covariates, EVLW and pulmonary vascular permeability index (PVPI).
Time frame: From inclusion up to hospital discharge (maximum day 60)
Correlation between the extravascular lung water at admission and the ICU-mortality
Multivariable analysis of factors associated with ICU mortality, including initial severity, comorbidities, respiratory mechanics covariates, EVLW and pulmonary vascular permeability index (PVPI).
Time frame: From inclusion up to hospital discharge (maximum day 60)
Influence of position on plateau pressure
Plateau pressure will be measured at 0°, 30° and 45° position and we will compare the values to assess if the position impacts this pressure.
Time frame: From inclusion up to hospital discharge (maximum day 60)
Influence of position on plateau pressure on esophageal pressure
Esophageal pressure will be measured at 0°, 30° and 45° position and we will compare the values to assess if the position impacts this pressure.
Time frame: From inclusion up to hospital discharge (maximum day 60)
Influence of position on plateau pressure on transpulmonary pressure
Transpulmonary pressure will be measured at 0°, 30° and 45° position and we will compare the values to assess if the position impacts this pressure.
Time frame: From inclusion up to hospital discharge (maximum day 60)
Influence of position on plateau pressure on intra-abdominal pressure
Intra-abdominal pressure will be measured at 0°, 30° and 45° position and we will compare the values to assess if the position impacts this pressure.
Time frame: From inclusion up to hospital discharge (maximum day 60)
Started Feb 2022 (actual). Primary completion is estimated for Sep 2025, 43 months after the start.
Of 225 non-industry observational studies under Respiratory Distress Syndrome, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 43 months is above that.
Counting every sponsor, half of 231 studies reached it within 24 months; a quarter within 12 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
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Respiratory Distress Syndrome →
Bicetre Hospital