Clinical trial NCT05474196: Association Between Driving Transpulmonary Pressure and Extravascular Lung Water in Patients with ARDS
Official title: Association Between Driving Transpulmonary Pressure and Extravascular Lung Water in Patients with ARDS
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Respiratory Distress Syndrome
Lead sponsor: Bicetre Hospital
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients intubated in the medical ICU of Bicêtre hospital (Academic hospital), Le Kremlin Bicêtre, France

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Acute respiratory distress syndrome (ARDS)
* Monitoring with a transpulmonary thermodilution device
* Esophageal pressure monitoring

Exclusion Criteria:

* Legal protection measures
* Pregnancy
* Contra-indications of esophageal catheter : esophageal varicose, severe coagulopathy

Primary outcomes:
measure: Association between the transpulmonary driving pressure and the extravascular lung water (EVLW)
timeFrame: From inclusion up to hospital discharge (maximum day 60)
Secondary outcomes:
measure: Association between the transpulmonary driving pressure and the pulmonary vascular permeability index (PVPI)
timeFrame: From inclusion up to hospital discharge (maximum day 60)
measure: Correlation between the transpulmonary driving pressure at admission and the ICU-mortality
timeFrame: From inclusion up to hospital discharge (maximum day 60)
measure: Correlation between the extravascular lung water at admission and the ICU-mortality
timeFrame: From inclusion up to hospital discharge (maximum day 60)
measure: Influence of position on plateau pressure
timeFrame: From inclusion up to hospital discharge (maximum day 60)
measure: Influence of position on plateau pressure on esophageal pressure
timeFrame: From inclusion up to hospital discharge (maximum day 60)
measure: Influence of position on plateau pressure on transpulmonary pressure
timeFrame: From inclusion up to hospital discharge (maximum day 60)
measure: Influence of position on plateau pressure on intra-abdominal pressure
timeFrame: From inclusion up to hospital discharge (maximum day 60)
Other outcomes:
Locations:
city: Le Kremlin-Bicêtre
country: France
facility: Medical Intensive Care Unit, Bicêtre Hospital
Study officials:
affiliation: Hôpital Bicêtre
name: Tài Pham, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: