Regional Ventilation Evaluation During Neuro-injury Weaning Study

NCT07067671 | Not Yet Recruiting

• 2 other identifiers: APHP2507002025-A01069-40
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Electrical Impedance Tomography; Ventilator Weaning; Neurocritical Care; ICU Monitoring; Spontaneous Breathing Trial; Extubation Failure; Respiratory Mechanics; PulmoVista; EIT; Brain-Injured Patients

Outcome Measures

Primary Outcomes (1)

• Absolute ventral-to-dorsal ventilation difference

  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.

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

Secondary Outcomes (5)

• Correlation between Absolute V-D Difference and Conventional Ventilatory Parameters

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

• End-Expiratory Lung Impedance (ΔEELI)

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

• Correlation between ΔEELI and Extubation/Decannulation Failure

  7 days post-extubation or post-deventilation.

• Pulmonary Compliance Variation during Ventilator Changes and Spontaneous Breathing Trials

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

• Absolute V-D Difference and Extubation Failure

  7 days post-extubation or post-deventilation.

Interventions

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.

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

Adult patients hospitalized in intensive care for an acute brain injury under invasive mechanical ventilation for more than 48 hours.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Lariboisière - APHP

Paris, France, 75010, France

Location

MeSH Terms

Conditions

Brain Injuries; Brain Injuries, Traumatic; Hypoxia-Ischemia, Brain; Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Brain Ischemia; Cerebrovascular Disorders; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes

Study Officials

• Samuel Gaugain, MD

  APHP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samuel Gaugain, MD

CONTACT

+330149958518; samuel.gaugain@aphp.fr

Benjamin Chousterman, MD PhD

CONTACT

+330149958518; benjamin.chousterman@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: July 16, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)