EIT- Guided Lung Recruitment in Pediatric Acute Respiratory Distress Syndrome
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Global Inhomogeneity Index (GI)
概览
简要总结
Study Title:
EIT-Guided Lung Recruitment Maneuvers in Pediatric ARDS: Effects on Ventilation Distribution and Respiratory Mechanics
Study Objective:
The primary goal of this clinical trial is to determine whether lung recruitment maneuvers guided by Electrical Impedance Tomography (EIT) result in a more homogeneous ventilation distribution and less injurious ventilation in children with pediatric Acute Respiratory Distress Syndrome (pARDS). The study will assess changes in intrapulmonary gas distribution and respiratory mechanics during recruitment maneuvers using both EIT and partitioned respiratory mechanics.
This is a prospective cohort study involving children diagnosed with pARDS. Eligible participants will be consecutively enrolled over time and will undergo a standardized series of staircase lung recruitment maneuvers under continuous EIT monitoring. The final mechanical ventilation (MV) settings will be individualized and titrated based on the EIT-derived response to recruitment.
Main Research Questions:
How can lung recruitment maneuvers be performed safely in children with pARDS? How can we monitor the physiological effects of recruitment on respiratory mechanics? How does recruitment influence the distribution of ventilation within the lungs?
Eligible participants will undergo a series of staircase lung recruitment maneuvers under continuous EIT monitoring. The final mechanical ventilation (MV) settings will be titrated and individualized based on the EIT-derived response to recruitment.
详细描述
This is a prospective, single-center, interventional physiological study aiming to assess the effects of EIT-guided lung recruitment maneuvers on ventilation distribution and respiratory mechanics in children with pediatric acute respiratory distress syndrome (pARDS).
A total of 8 mechanically ventilated children diagnosed with moderate-to-severe pARDS will be enrolled within 48 hours from intubation. All patients will undergo a standardized staircase recruitment maneuver under continuous monitoring with Electrical Impedance Tomography (EIT). EIT will be used to assess regional ventilation distribution and guide the titration of PEEP to minimize lung collapse and overdistension. Partitioned respiratory mechanics will be measured through esophageal pressure monitoring to assess changes in lung and chest wall compliance, as well as transpulmonary pressure.
Primary outcome is the change in global inhomogeneity index (GI Index) measured before and after recruitment. Secondary outcomes include center of ventilation (CoV), regional ventilation delay (RVD).
Will also considerd overdistension and collapse percentages, changes in lung/chest wall mechanics.
This pilot study will provide physiological data to inform the design of future randomized trials on EIT-guided mechanical ventilation strategies in pediatric ARDS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is a physiological, exploratory study involving real-time monitoring of ventilation using electrical impedance tomography (EIT). Masking is not applicable because the intervention, namely EIT-guided lung recruitment, requires direct observation and real-time adjustment by clinicians based on EIT data. Therefore, no participants, care providers, investigators, or outcome assessors are masked.
入排标准
- 年龄范围
- 1 Month 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged between 1 month and 10 years
- •Diagnosis of pediatric Acute Respiratory Distress Syndrome (pARDS) according to PALICC-2 criteria
- •Invasive mechanical ventilation for less than 48 hours at the time of enrollment
排除标准
- •Evidence or history of barotrauma (e.g., pneumothorax, pneumomediastinum)
- •Presence of congenital heart disease with hemodynamic significance
- •Known or suspected intracranial hypertension
- •Presence of an implantable cardioverter-defibrillator (ICD)
- •Parental o legal guardian refuse
研究组 & 干预措施
EIT-Guided Recruitment
This arm includes all participants undergoing a standardized staircase lung recruitment maneuver under continuous monitoring with Electrical Impedance Tomography (EIT). EIT is used to assess regional ventilation distribution and guide the titration of PEEP. Mechanical ventilation settings are adjusted based on individual EIT-derived responses. Respiratory mechanics, including transpulmonary pressure and compliance partitioning, are also recorded to evaluate physiological effects of recruitment.
干预措施: Electrical Impedance Tomography (EIT)-Guided Lung Recruitment (Device)
结局指标
主要结局
Global Inhomogeneity Index (GI)
时间窗: Baseline (pre-intervention/procedure/surgery) Immediately after the intervention/procedure/surgery
The Global Inhomogeneity Index (GI) is an EIT-derived quantitative measure of ventilation distribution heterogeneity across the lungs. A lower GI index indicates more homogeneous ventilation. GI will be calculated before and after the EIT-guided recruitment maneuver to assess the effect on regional ventilation distribution.
次要结局
- Differences in Tidal Impedence(Baseline (pre-intervention/procedure/surgery) Immediately after the intervention/procedure/surgery)
- Centre of Ventilation (CoV)(Baseline (pre-intervention/procedure/surgery) Immediately after the intervention/procedure/surgery)
- Changes in Regional Ventilation Delay (RVD) Index(Baseline (pre-intervention/procedure/surgery) Immediately after the intervention/procedure/surgery)
研究者
Giovanna Chidini
Principal Investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico