基于电阻抗断层扫描衍生指数预测高流量鼻导管氧疗失败：一项多中心研究 (EFI-HFNO)
2026年6月16日 更新者：Ruijin Hospital
使用电阻抗断层扫描衍生指数预测高流量鼻导管失败：一项多中心研究
高流量鼻导管（HFNC）疗法被广泛应用于治疗急性呼吸衰竭。
然而，预测治疗失败仍然具有挑战性，因为传统指标依赖于间歇性测量，无法提供连续、客观的监测。
电阻抗断层扫描（EIT）能够实现区域肺通气的无创、实时评估。
本研究评估了EIT衍生的流量指数（FI）是否能在48小时内预测HFNC治疗失败。
研究概览
地位
完全的
详细说明
设计：单中心、前瞻性观察性研究。 设置：中国上海瑞金医院。 人群：2023年12月至2024年3月期间接受高流量鼻导管氧疗的急性呼吸衰竭成年患者。 干预：在HFNC治疗期间进行自主呼吸时的EIT监测。 FI通过使用曲线拟合公式量化吸气流量-时间波形凹度，从EIT衍生的区域通气信号计算得出。
终点：主要终点 - HFNC失败（48小时内升级至机械通气或持续低氧血症）。 ROC分析将FI与ROX指数、呼吸频率和SpO₂进行比较。 逻辑回归模型评估预测价值和比值比。
研究类型
观察性的
注册 (实际的)
164
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200025
- Department of Critical Care Medicine，Ruijin Hospital，Shanghai Jiao Tong University School of Medicine
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
接受经鼻高流量氧疗的急性呼吸衰竭成年患者
描述
纳入标准：
- 年龄 ≥18 岁
- 需要高流量鼻导管氧疗的急性呼吸衰竭
- 血流动力学稳定
- 吸入氧浓度 ≤0.6
排除标准：
- 影响自主呼吸的神经肌肉疾病
- 妊娠期
- 电阻抗断层扫描禁忌症
- 电阻抗断层扫描信号质量差
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Physiological Validation Cohort
Mechanically ventilated patients with acute respiratory distress syndrome (ARDS) receiving pressure support ventilation.
Intervention: Simultaneous electrical impedance tomography (EIT) and esophageal pressure monitoring at three sequential pressure support levels (PSmin, PSbase, PSmax).
Outcome measures: EIT-derived Flow Index (EFI), esophageal pressure swing (ΔPes), pressure-time product per minute (PTP/min).
No HFNO administered.
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Patients received pressure support ventilation at three sequentially adjusted levels (PSmin, PSbase, PSmax).
Breathing parameters were continuously monitored using an electrical impedance tomography (EIT) device, and inspiratory effort was invasively measured via an esophageal pressure catheter.
PulmoVista 500 EIT device (Dräger Medical, Lübeck, Germany) was used for continuous real-time monitoring of regional lung ventilation.
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Derivation Cohort - HFNO Success
High-risk patients with acute hypoxemic respiratory failure (AHRF) initiated on high-flow nasal oxygen (HFNO) who achieved clinical stabilization without requiring escalation to noninvasive ventilation or endotracheal intubation within 72 hours.
Intervention: EIT monitoring and bedside data collection (heart rate, respiratory rate, arterial blood gases, SpO₂, ROX index, EMOX index) at baseline (HFNO initiation) and at 30 minutes.
No additional device intervention.
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Patients received HFNO as part of standard clinical care for acute hypoxemic respiratory failure.
The treatment was titrated by the clinical team based on physiological parameters (SpO₂, RR, ABG), aiming to maintain SpO₂ ≥ 92% and reduce signs of respiratory distress.
Patients received standard-of-care HFNO for AHRF.
Additionally, a PulmoVista 500 EIT device was used to monitor lung ventilation and derive the EFI at baseline and 30 minutes.
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Derivation Cohort - HFNO Failure
High-risk patients with AHRF initiated on HFNO who required escalation to noninvasive ventilation or endotracheal intubation within 72 hours due to refractory hypoxemia, progressive respiratory acidosis, severe respiratory distress, or hemodynamic instability.
Intervention: EIT monitoring and bedside data collection (same variables as success group) at baseline and 30 minutes.
Escalation decision guided by predefined objective criteria, not by EIT data.
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Patients received HFNO as part of standard clinical care for acute hypoxemic respiratory failure.
The treatment was titrated by the clinical team based on physiological parameters (SpO₂, RR, ABG), aiming to maintain SpO₂ ≥ 92% and reduce signs of respiratory distress.
Patients received standard-of-care HFNO for AHRF.
Additionally, a PulmoVista 500 EIT device was used to monitor lung ventilation and derive the EFI at baseline and 30 minutes.
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Validation Cohort - HFNO Success
Independent temporally separate cohort of high-risk AHRF patients initiated on HFNO who achieved clinical stabilization without escalation.
Same inclusion/exclusion criteria as derivation cohort.
Intervention: Identical 30-minute reassessment protocol: EIT monitoring and bedside data collection at baseline and 30 minutes.
Model tested prospectively without coefficient refitting.
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Patients received standard-of-care HFNO for AHRF.
Additionally, a PulmoVista 500 EIT device was used to monitor lung ventilation and derive the EFI at baseline and 30 minutes.
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Validation Cohort - HFNO Failure
Independent temporally separate cohort of high-risk AHRF patients initiated on HFNO who required escalation to noninvasive ventilation or endotracheal intubation.
Same escalation criteria as derivation cohort.
Intervention: EIT monitoring and bedside data collection at baseline and 30 minutes.
The fixed dual-domain model (baseline PaCO₂, 30-min EFI, ΔRR, ΔSpO₂) derived from the derivation cohort was applied without refitting to assess discrimination.
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Patients received standard-of-care HFNO for AHRF.
Additionally, a PulmoVista 500 EIT device was used to monitor lung ventilation and derive the EFI at baseline and 30 minutes.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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HFNC Failure Rate(Early Reassessment at 30 Minutes)
大体时间：within 30 minutes after HFNO initiation (with monitoring of outcomes up to hospital discharge)
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HFNO failure was defined as escalation to noninvasive ventilation (NIV) or endotracheal intubation due to refractory hypoxemia, progressive respiratory acidosis, severe respiratory distress, or hemodynamic instability.
Within-tier adjustments (increasing flow or FiO₂ without changing support modality) were NOT considered failure.
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within 30 minutes after HFNO initiation (with monitoring of outcomes up to hospital discharge)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Physiological Validation of EFI
大体时间：During physiological measurements in mechanically ventilated patients (performed before the clinical HFNO cohort; within 48 hours of ICU admission)
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EFI was compared with esophageal pressure swing (ΔPes) and pressure-time product per minute (PTP/min) across pressure support levels using regression analysis and repeated within-subject comparisons.Unit of Measure No unit for R² (dimensionless ratio); Arbitrary units (a.u.) for EFI; cm H₂O for ΔPes; cm H₂O·s/min for PTP/min.
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During physiological measurements in mechanically ventilated patients (performed before the clinical HFNO cohort; within 48 hours of ICU admission)
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Persistent Abnormality at 30 Minutes
大体时间：within 30 minutes after HFNO initiation
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ANCOVA-adjusted 30-minute values of EFI, PaCO₂, heart rate, respiratory rate, pH, PaO₂ were compared between HFNO success and failure groups to identify persistent physiological burden.Unit of Measure EFI: arbitrary units (a.u.); PaCO₂ and PaO₂: mmHg; Heart rate: beats/min; Respiratory rate: breaths/min; pH: dimensionless (pH units);
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within 30 minutes after HFNO initiation
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Divergent Short-Term Response Trajectories
大体时间：Baseline to 30 minutes after HFNO initiation
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Generalized estimating equations (GEE) evaluated time-by-group interactions for EFI, respiratory rate, PaO₂, PaCO₂, pH, heart rate, ROX, to identify divergent early response trajectories.Measure of Central Tendency / Measure of Dispersion Time-by-group interaction P values; Estimated marginal means at baseline and 30 minutes for each group; Within-patient change scores (Δ values) between the two time points for each variable Unit of Measure EFI: arbitrary units (a.u.); Heart rate: beats/min; Respiratory rate: breaths/min; pH: dimensionless (pH units); PaCO₂ and PaO₂: mm Hg; ROX: dimensionless index.
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Baseline to 30 minutes after HFNO initiation
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Hongping Qu、Department of Critical Care Medicine，Ruijin Hospital，Shanghai Jiao Tong University School of Medicine
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年5月1日
初级完成 (实际的)
2026年3月31日
研究完成 (实际的)
2026年3月31日
研究注册日期
首次提交
2026年1月16日
首先提交符合 QC 标准的
2026年1月16日
首次发布 (实际的)
2026年1月26日
研究记录更新
最后更新发布 (实际的)
2026年6月17日
上次提交的符合 QC 标准的更新
2026年6月16日
最后验证
2026年1月1日
更多信息
与本研究相关的术语
其他研究编号
- [2025]232 and [2025] 30
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