Research and Monitoring of Ventilation-Perfusion Imaging Technology Using Electrical Impedance Tomography for ARDS Patients' PEEP Trial Lung Ventilation Strategies Clinical Study.
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 28-day mortality
研究概览
简要总结
In the treatment of critically ill patients, mechanical ventilation is a key link, and appropriate mechanical ventilation strategies can open the alveoli and improve oxygenation, while inappropriate mechanical ventilation can increase lung injury and seriously affect the prognosis. Ventilator-related lung injury is mainly concentrated in barotrauma, volumetric injury, shear injury, and biological injury, and the monitoring of respiratory ventilation to the level of local ventilation can help to better assess the state of alveolar opening and alveolar collapse, and help to understand the uniformity of gas distribution in the lungs, which is closely related to lung injury. However, how to achieve simple, bedside and real-time lung ventilation and lung volume assessment in clinical work has always been a difficult problem to be overcome. This study intends to explore the changes of local ventilation and blood flow in the lungs during PEEP trail in patients with ARDS monitored by EIT.
详细描述
- Background and Rationale ARDS is associated with heterogeneous lung collapse. The recruitment-to inflation (R/I) ratio has emerged as an index of recruitability, but is usually assessed globally. Electrical impedance tomography (EIT) enables regional assessment of ventilation and may provide more precise determinations of recruitable lung regions, particularly dorsal areas.
- Objectives Primary objective: To compare the predictive value of regional (dorsal and ventral) versus global R/I for recruitment success in moderate-severe ARDS. Secondary objectives: To classify recruitment phenotypes and evaluate associations with oxygenation, compliance improvement, ventilator-free days, ICU length of stay, and 28-day mortality.
- Study Design Prospective, single-centre observational cohort study in ICU patients with moderate-severe ARDS. All eligible patients undergo standardised recruitment maneuver and EIT monitoring.
- Study Setting Ruijin Hospital, Shanghai Jiao Tong University School of Medicine ICU, December 2022 - December 2024.
- Intervention Standardized PEEP step maneuver from 5 → 15 cmH₂O, maintained for 3 minutes. Continuous EIT monitoring of regional compliance, oxygenation, hemodynamics. Dynamic strain cutoff (>0.6) or adverse events terminate the maneuver. Ventilation mode: volume control, tidal volume 4-6 mL/kg predicted body weight, plateau ≤28-30 cmH₂O, FiO₂ titrated for SpO₂ 88-92%.
- Measurements EIT-derived ΔEELI in dorsal and ventral regions Regional and global compliance (Crec and Crs) R/I calculated: Crec/Crs at baseline PEEP Airway opening pressure by low-flow inflation method Primary outcome: recruitment success (≥10% compliance improvement + ≥20 mmHg PaO₂/FiO₂ increase) Secondary: ventilator-free days, ICU LOS, 28-day mortality, dynamic strain
- Statistical Analysis Plan Distribution check by Shapiro-Wilk. Paired tests for within-patient comparisons. ROC curves and Youden index for cut-off selection. Multivariate regression for mortality risk factors. Bonferroni correction for multiple comparisons.
- Safety Monitoring Terminate RM if: MAP <65 mmHg, SpO₂ <88%, arrhythmia onset, dynamic strain >0.6.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet the Berlin definition of ARDS and have been treated with mechanical ventilation (clinical diagnosis of ARDS by the attending ICU physician)
- •PaO₂/FiO₂ ≤150 mmHg
排除标准
- •Age< 18 or >90 years
- •Pneumothorax, pneumomediastinum
- •Hemodynamic instability (rising vasopressor need in <6h)
- •Contraindications to RM or EIT
研究组 & 干预措施
evaluate the feasibility of using EIT to calculate regional recruitment-to-inflation (R/I) ratios
Regional R/I ratios were computed for the global lung, dorsal (dependent), and ventral (non-dependent) regions of interest (ROIs), which were defined as 50% of the ventro-dorsal lung diameter based on EIT imaging.compare the predictive value of regional (dorsal and ventral) versus global R/I for recruitment success in moderate-severe ARDS.
干预措施: 10ml of 10% saline is injected centrally (Drug)
结局指标
主要结局
28-day mortality
时间窗: From enrollment to the end of treatment at 28 days
Statistical analysis of 28-day mortality
recruitment success percent
时间窗: From enrollment to the end of treatment at 7 days
recruitment( ≥10% compliance improvement ) and Re-check the blood gas ≥20 mmHg PaO₂/FiO₂ increase mean success
Correlation between EIT-derived parameters and clinical outcomes
时间窗: From enrollment to the end of treatment at 28-day
Correlation analysis between EIT-derived parameters \[e.g., GI index (100%), ROI (100%), V/Q ratio, percentage of dead space (100%)\] and clinical outcomes\[e.g., 28-day mortality\]
Change in Sequential Organ Failure Assessment (SOFA) score from baseline to day 7
时间窗: From enrollment to the end of treatment at 7 days
Change in Sequential Organ Failure Assessment (SOFA) score from baseline to day 7
Duration of mechanical ventilation from enrollment to successful weaning
时间窗: From enrollment to the end of treatment at 7 days
Duration of mechanical ventilation in days from enrollment to successful weaning
Improvements in lung compliance
时间窗: through study completion, an average of 3 month
Change in lung compliance measured by EIT and Ventilator (C=△V/△P)during PEEP trials from baseline to 30 minutes at each PEEP level (0，5, 10, 15 and 20 cmH2O)
Regional and global compliance (Crec and Crs)
时间窗: through study completion, an average of 3 month
The EIT detection calculates the corresponding results through a continuous monitoring process that lasts approximately 3 minutes.
次要结局
- Changes in regional ventilation-perfusion matching during PEEP trials(From enrollment to the end of treatment at 7 days)
- Change in PaO2/FiO2 ratio(From enrollment to the end of treatment at 7 days)
- Change in dyspnea severity(From enrollment to the end of treatment at 7 days)
- Length of ICU stay(From enrollment to the end of treatment at 7 days)
- Incidence of adverse events(From enrollment to the end of treatment at 7 days)