Association Between Driving Transpulmonary Pressure and Extravascular Lung Water in Patients with ARDS

Recruiting

• Conditions: Acute Respiratory Distress Syndrome

• Registration Number: NCT05474196
• Lead Sponsor: Bicetre Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-01
• Study First Submitted: 2022-07-19
• Study First Submitted QC: 2022-07-23
• Study First Posted: 2022-07-26
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-09
• Last Update Posted: 2025-02-11
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Association between the transpulmonary driving pressure and the extravascular lung water (EVLW)	From inclusion up to hospital discharge (maximum day 60)	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.

Secondary Outcome Measures

Name	Time	Method
Correlation between the extravascular lung water at admission and the ICU-mortality	From inclusion up to hospital discharge (maximum day 60)	Multivariable analysis of factors associated with ICU mortality, including initial severity, comorbidities, respiratory mechanics covariates, EVLW and pulmonary vascular permeability index (PVPI).
Influence of position on plateau pressure on transpulmonary pressure	From inclusion up to hospital discharge (maximum day 60)	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.
Influence of position on plateau pressure	From inclusion up to hospital discharge (maximum day 60)	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.
Correlation between the transpulmonary driving pressure at admission and the ICU-mortality	From inclusion up to hospital discharge (maximum day 60)	Multivariable analysis of factors associated with ICU mortality, including initial severity, comorbidities, respiratory mechanics covariates, EVLW and pulmonary vascular permeability index (PVPI).
Association between the transpulmonary driving pressure and the pulmonary vascular permeability index (PVPI)	From inclusion up to hospital discharge (maximum day 60)	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.
Influence of position on plateau pressure on intra-abdominal pressure	From inclusion up to hospital discharge (maximum day 60)	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.
Influence of position on plateau pressure on esophageal pressure	From inclusion up to hospital discharge (maximum day 60)	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.

Trial Locations

Locations (1)

Medical Intensive Care Unit, Bicêtre Hospital; 🇫🇷 Le Kremlin-Bicêtre, France