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NCT Number: NCT05474196

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

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.

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Key information

Conditions

Acute Respiratory Distress Syndrome Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical Intensive Care Unit, Bicêtre Hospital

Le Kremlin-Bicêtre, France

Location status: Recruiting

Location contact

Tài Pham, MD

CONTACT

[email protected]

+33145217245

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

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

    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 PVPI values. We will calculate the correlation coefficient linking these two variables to assess if their association.

  2. Correlation between the transpulmonary driving pressure at admission and the ICU-mortality

    Time frame: 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).

  3. Correlation between the extravascular lung water at admission and the ICU-mortality

    Time frame: 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).

  4. Influence of position on plateau pressure

    Time frame: 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.

  5. Influence of position on plateau pressure on esophageal pressure

    Time frame: 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.

  6. Influence of position on plateau pressure on transpulmonary pressure

    Time frame: 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.

  7. Influence of position on plateau pressure on intra-abdominal pressure

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Tài Pham, MD, PhD.

CONTACT

[email protected]

+33145217245

Sponsors and collaborators

Lead sponsor

Bicetre Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 26, 2022
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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