Regional Ventilation Evaluation During Neuro-injury Weaning Study

NCT ID: NCT07067671

Last Updated: 2026-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-03-31

Study Completion Date

2028-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Brain Injury Mechanical Ventilation Prolonged Weaning Traumatic Brain Injury Hypoxic-Ischemic Brain Injury Intracerebral Hemorrhage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Internal Thoracic Impedance

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Samuel Gaugain, MD

Role: PRINCIPAL_INVESTIGATOR

APHP

Locations

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Hôpital Lariboisière - APHP

Paris, France, France

Site Status

Countries

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France

Central Contacts

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Samuel Gaugain, MD

Role: CONTACT

+330149958518

Benjamin Chousterman, MD PhD

Role: CONTACT

+330149958518

Facility Contacts

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Samuel G Gaugain, Doctor of medicine

Role: primary

+330149958518

Other Identifiers

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2025-A01069-40

Identifier Type: OTHER

Identifier Source: secondary_id

APHP250700

Identifier Type: -

Identifier Source: org_study_id

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