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

NCT05474196 | Recruiting

• 1 other identifier: 2022-A01289-34
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Association between the transpulmonary driving pressure and the pulmonary vascular permeability index (PVPI)

  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)

• 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

  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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients intubated in the medical ICU of Bicêtre hospital (Academic hospital), Le Kremlin Bicêtre, France

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bicetre Hospital: lead

Study Sites (1)

Medical Intensive Care Unit, Bicêtre Hospital

Le Kremlin-Bicêtre, France

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Tài Pham, MD, PhD

  Hôpital Bicêtre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tài Pham, MD, PhD.

CONTACT

+33145217245; tai.pham@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: July 26, 2022
• Study Start: February 1, 2022
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: February 11, 2025

Record last verified: 2025-02

Locations

FR (1)