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Completed

NCT Number: NCT05337059

Feasabilty and Physiological Effects of a Ventilation Strategy Combining PEEP and Tidal Volume Titration According to Inspiratory and Expiratory Transpulmonary Pressures in ARDS Patients.

Expiratory or inspiratory transpulmonary pressures have been proposed to optimize ventilator settings in patients with ARDS. The aim of this study is to assess the feasibility and the physiological effects of a new method based on both expiratory and inspiratory transpulmonary pressures.

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Key information

Conditions

ARDS, Human Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Angers

Angers, 49000, France

About this study

Expiratory or inspiratory transpulmonary pressures have been proposed to optimize ventilator settings in patients with ARDS. A positive expiratory transpulmonary pressure may be considered as a target to limt the risk of collapse in dependant lung regions. Some authors propose to titrate PEEP to target an inspiratory transpulmonary pressure of 20cmH20 to limit the risk of overdistension in non-dependant regions.The aim of this study is to assess the feasibility and the physiological effects of a new method based on both expiratory and inspiratory transpulmonary pressures.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 years or older
  • Moderate to severe ARDS
  • Written informed consent obtained from patient' surrogates

Exclusion criteria

  • Pneumothorax
  • Known pregnancy
  • Contraindication to electrical impedance tomography or esophageal pressure measurements

Treatment and study plan

PEEP and Tidal Volume Titration

Other

PEEP and Tidal Volume Titration According to Inspiratory and Expiratory Transpulmonary Pressures

Primary outcomes

  1. Ventilation strategy failure

    Time frame: 48 hours

    Number of patients with failure criteria (barotrauma, hemodynamic failure, rescue therapy or acidemia)

Secondary outcomes

  1. Short term physiologicals effects on hemodynamics

    Time frame: 45 minutes

    Cardiac index assed by Echocardiography (L/min/m^2)

  2. All-cause mortality at day 28

    Time frame: 28 days

    All-cause mortality

  3. Ventilator-free days at day 28

    Time frame: 28 days

    Number of alive ventilator free days

  4. Short term physiologicals effects on respiratory mechanics

    Time frame: 45 minutes

    recruited lung volume (mL)

  5. Short term physiologicals effects on gas exchange

    Time frame: 45 minutes

    PaO2/FiO2 ratio (mmHg)

  6. Short term physiologicals effects on gas exchange

    Time frame: 45 minutes

    VD/VT

  7. Short term physiologicals effects on gas exchange

    Time frame: 45 minutes

    PaCO2 (mmHg)

  8. Short term physiologicals effects on respiratory mechanics

    Time frame: 45 minutes

    distribution of ventilation assed by electrical impedance tomography (COV, %)

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

Feasabilty and Physiological Effects of a Ventilation Strategy Combining PEEP and Tidal Volume Titration According to Inspiratory and Expiratory Transpulmonary Pressures in ARDS Patients..

Acronym: PULMOESO

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2022
Registry last updated
Apr 14, 2026

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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