Evaluation of Regional Ventilation in Neuro-injured Patients Undergoing Weaning From Mechanical Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Absolute ventral-to-dorsal ventilation difference
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Pregnancy
- •Moribund patient / decision to stop treatment
- •Patient under state medical aid
结局指标
主要结局
Absolute ventral-to-dorsal ventilation difference
时间窗: 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.
次要结局
- 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.)