Association Between Driving Transpulmonary Pressure and Extravascular Lung Water in Patients with ARDS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Acute Respiratory Distress Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Association between the transpulmonary driving pressure and the extravascular lung water (EVLW) [Time frame: From inclusion up to hospital discharge (maximum day 60)]
Secondary outcome measures (7)
- Association between the transpulmonary driving pressure and the pulmonary vascular permeability index (PVPI) [Time frame: From inclusion up to hospital discharge (maximum day 60)]
- Correlation between the transpulmonary driving pressure at admission and the ICU-mortality [Time frame: From inclusion up to hospital discharge (maximum day 60)]
- Correlation between the extravascular lung water at admission and the ICU-mortality [Time frame: From inclusion up to hospital discharge (maximum day 60)]
- Influence of position on plateau pressure [Time frame: From inclusion up to hospital discharge (maximum day 60)]
- Influence of position on plateau pressure on esophageal pressure [Time frame: From inclusion up to hospital discharge (maximum day 60)]
- Influence of position on plateau pressure on transpulmonary pressure [Time frame: From inclusion up to hospital discharge (maximum day 60)]
- Influence of position on plateau pressure on intra-abdominal pressure [Time frame: From inclusion up to hospital discharge (maximum day 60)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Medical Intensive Care Unit, Bicêtre Hospital — Le Kremlin-Bicêtre
Identifiers
NCT: NCT05474196 · 2022-A01289-34