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Clinical Trials/NCT05474196
NCT05474196
Recruiting
Not Applicable

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

Bicetre Hospital1 site in 1 country100 target enrollmentFebruary 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Respiratory Distress Syndrome
Sponsor
Bicetre Hospital
Enrollment
100
Locations
1
Primary Endpoint
Association between the transpulmonary driving pressure and the extravascular lung water (EVLW)
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2022
End Date
September 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Bicetre Hospital
Responsible Party
Principal Investigator
Principal Investigator

Tai PHAM

Principal Investigator

Bicetre Hospital

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

Outcomes

Primary Outcomes

Association between the transpulmonary driving pressure and the extravascular lung water (EVLW)

Time Frame: 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 Outcomes

  • Correlation between the extravascular lung water at admission and the ICU-mortality(From inclusion up to hospital discharge (maximum day 60))
  • Influence of position on plateau pressure on transpulmonary pressure(From inclusion up to hospital discharge (maximum day 60))
  • Influence of position on plateau pressure(From inclusion up to hospital discharge (maximum day 60))
  • Correlation between the transpulmonary driving pressure at admission and the ICU-mortality(From inclusion up to hospital discharge (maximum day 60))
  • Association between the transpulmonary driving pressure and the pulmonary vascular permeability index (PVPI)(From inclusion up to hospital discharge (maximum day 60))
  • Influence of position on plateau pressure on intra-abdominal pressure(From inclusion up to hospital discharge (maximum day 60))
  • Influence of position on plateau pressure on esophageal pressure(From inclusion up to hospital discharge (maximum day 60))

Study Sites (1)

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