Regional Ventilation Evaluation During Neuro-injury Weaning Study

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pregnancy

Moribund patient / decision to stop treatment

Patient under state medical aid

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Internal Thoracic Impedance

    Other intervention

    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.

Treatment groups

No treatment groups listed

Trial outcomes

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.

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

Secondary outcomes

1

Correlation between Absolute V-D Difference and Conventional Ventilatory Parameters

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.

Time frame
From the start of the ventilator mode change or spontaneous breathing trial until 30 minutes after
2

End-Expiratory Lung Impedance (ΔEELI)

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

Time frame
From 5 minutes before to 5 minutes after the 30-minute spontaneous breathing trial (i.e., total duration of 40 minutes)
3

Correlation between ΔEELI and Extubation/Decannulation Failure

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.

Time frame
7 days post-extubation or post-deventilation.
4

Pulmonary Compliance Variation during Ventilator Changes and Spontaneous Breathing Trials

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.

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

Other outcomes

Sponsors and contacts

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