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Regional Ventilation Evaluation During Neuro-injury Weaning Study

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07067671
Acronym
ReVENtS
Enrollment
60
Registered
2025-07-16
Start date
2026-03-01
Completion date
2028-03-01
Last updated
2026-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Detailed description

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.

Interventions

OTHERInternal 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.

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Absolute ventral-to-dorsal ventilation differenceFrom 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

MeasureTime frameDescription
Correlation between Absolute V-D Difference and Conventional Ventilatory ParametersFrom the start of the ventilator mode change or spontaneous breathing trial until 30 minutes afterThis 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.
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)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: 1. EELI before the trial (baseline, 5 minutes prior), 2. EELI at the end of the trial (30 minutes), 3. EELI 5 minutes after resumption of mechanical ventilation
Correlation between ΔEELI and Extubation/Decannulation Failure7 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.
Pulmonary Compliance Variation during Ventilator Changes and Spontaneous Breathing TrialsFrom 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.
Absolute V-D Difference and Extubation Failure7 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.

Countries

France

Contacts

CONTACTSamuel Gaugain, MD
samuel.gaugain@aphp.fr+330149958518
CONTACTBenjamin Chousterman, MD PhD
benjamin.chousterman@aphp.fr+330149958518
PRINCIPAL_INVESTIGATORSamuel Gaugain, MD

APHP

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026