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

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05474196
• Other study ID #: 2022-A01289-34
• Status: Recruiting
• Start date: February 1, 2022
• Est. completion date: September 2024

Study information

• Verified date: September 2023
• Source: Bicetre Hospital
• Contact: Tài Pham, MD, PhD.
• Phone: +33145217245
• Email: tai.pham[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Locations

Country	Name	City	State
France	Medical Intensive Care Unit, Bicêtre Hospital	Le Kremlin-Bicêtre

Sponsors (1)

Lead Sponsor	Collaborator
Bicetre Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From inclusion up to hospital discharge (maximum day 60)
Secondary	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.	From inclusion up to hospital discharge (maximum day 60)
Secondary	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).	From inclusion up to hospital discharge (maximum day 60)
Secondary	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).	From inclusion up to hospital discharge (maximum day 60)
Secondary	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.	From inclusion up to hospital discharge (maximum day 60)
Secondary	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.	From inclusion up to hospital discharge (maximum day 60)
Secondary	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.	From inclusion up to hospital discharge (maximum day 60)
Secondary	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.	From inclusion up to hospital discharge (maximum day 60)