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NCT Number: NCT07067671

Regional Ventilation Evaluation During Neuro-injury Weaning Study

This study evaluates changes in regional lung ventilation using thoracic electrical impedance tomography (EIT) during the weaning process from mechanical ventilation in ICU patients with acute brain injury. It aims to identify predictive EIT patterns related to extubation outcomes.

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Key information

Conditions

Acute Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Craniocerebral Trauma Hemorrhage Hypoxia Hypoxia, Brain Hypoxia-Ischemia, Brain Hypoxic-Ischemic Brain Injury Intracerebral Hemorrhage Intracranial Hemorrhages Mechanical Ventilation Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Prolonged Weaning Signs and Symptoms Signs and Symptoms, Respiratory Trauma, Nervous System Traumatic Brain Injury Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

This is a prospective, single-center pilot study conducted in the intensive care unit. The study focuses on adult patients with acute brain injury requiring invasive mechanical ventilation for more than 48 hours. The aim is to assess regional alveolar ventilation using thoracic electrical impedance tomography (EIT) during different stages of ventilator weaning, including changes in ventilatory mode, spontaneous breathing trials, and, when feasible, around extubation or decannulation.

EIT provides dynamic, non-invasive real-time imaging of regional pulmonary ventilation. Data will be collected using a 16-electrode thoracic belt and analyzed retrospectively with dedicated software. The primary outcome measure is the Absolute Ventral-to-Dorsal Ventilation Difference, calculated from predefined regions of interest. Secondary outcomes include correlations with traditional ventilatory parameters (tidal volume, respiratory rate, oxygen saturation), end-expiratory impedance variation (ΔEELI), compliance changes, and extubation or decannulation failure defined by the need for reintubation within 7 days.

This study aims to improve understanding of regional ventilation patterns in brain-injured patients and assess the potential of EIT to predict weaning outcomes and guide personalized ventilatory strategies.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 or older
  • Hospitalized in intensive care for an acute brain injury.
  • Mechanical ventilation for more than 48 hours.
  • Ventilator withdrawal planned in the next few days
  • Social security coverage

Exclusion criteria

  • Pregnancy
  • Moribund patient / decision to stop treatment
  • Patient under state medical aid

Treatment and study plan

Internal Thoracic Impedance

Other

Internal Thoracic Impedance is a non-invasive an imaging technique which use low alternative current through electrodes placed on a belt positioned at the level of the patient's rib cage. Images are constructed according to conductivity measured.

Primary outcomes

  1. Absolute ventral-to-dorsal ventilation difference

    Time frame: From the start of the ventilator mode change or spontaneous breathing trial until 30 minutes after.

    The Absolute V-D Difference will be calculated as the average of the ventilation in the ventral regions (ROI1 and ROI2) minus the average of the ventilation in the dorsal regions (ROI3 and ROI4) during mechanical ventilation weaning. This outcome will provide insights into regional pulmonary ventilation distribution and its correlation with extubation outcomes.

    This difference is calculated as follows: (ROI_Value1 + ROI_Value2)/2 - (ROI_Value3 + ROI_Value4)/2 expressed as a percentage.

Secondary outcomes

  1. Correlation between Absolute V-D Difference and Conventional Ventilatory Parameters

    Time frame: From the start of the ventilator mode change or spontaneous breathing trial until 30 minutes after

    This outcome will evaluate how the Absolute V-D Difference correlates with other monitoring parameters, such as tidal volume, respiratory rate, SpO₂, and end-tidal CO₂ (EtCO₂), throughout the weaning process.

  2. End-Expiratory Lung Impedance (ΔEELI)

    Time frame: From 5 minutes before to 5 minutes after the 30-minute spontaneous breathing trial (i.e., total duration of 40 minutes)

    The monitoring of ΔEELI will be continuous throughout the spontaneous breathing trial, which lasts 30 minutes. Monitoring will begin at a stable baseline 5 minutes prior to the start of the trial and will continue until 5 minutes after its completion.

    Three specific time points will be collected and analyzed:

    • EELI before the trial (baseline, 5 minutes prior),
    • EELI at the end of the trial (30 minutes),
    • EELI 5 minutes after resumption of mechanical ventilation

  3. Correlation between ΔEELI and Extubation/Decannulation Failure

    Time frame: 7 days post-extubation or post-deventilation.

    This secondary outcome assesses the relationship between changes in end-expiratory impedance (ΔEELI) and extubation or decannulation failure, defined as reintubation or need for reventilation within 7 days.

  4. Pulmonary Compliance Variation during Ventilator Changes and Spontaneous Breathing Trials

    Time frame: From the start of ventilator mode change or spontaneous breathing trial until 30 minutes after.

    This measure will track the changes in regional pulmonary compliance in response to adjustments in ventilator parameters (e.g., PEEP, tidal volume) and spontaneous breathing trials.

  5. Absolute V-D Difference and Extubation Failure

    Time frame: 7 days post-extubation or post-deventilation.

    This outcome will examine the correlation between the Absolute V-D Difference and extubation failure, defined as reintubation or the need for reventilation within 7 days post-extubation or post-deventilation.

Study contacts

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

Benjamin Chousterman, MD PhD

CONTACT

[email protected]

+330149958518

Samuel Gaugain, MD

CONTACT

[email protected]

+330149958518

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Evaluation of Regional Ventilation in Neuro-injured Patients Undergoing Weaning From Mechanical Ventilation

Acronym: ReVENtS

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 16, 2025
Registry last updated
Feb 19, 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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