Predicting High-Flow Nasal Oxygen Failure at 30 Minutes Using a Physiology-Informed Dual-Domain Model
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- HFNC Failure Rate
研究概览
简要总结
This prospective, single-center, two-stage translational study develops and validates a physiology-informed dual-domain model for ultra-early (30-minute) prediction of high-flow nasal oxygen (HFNO) failure in patients with acute hypoxemic respiratory failure. The study includes a physiological validation cohort (n=24) to anchor the EIT-derived Flow Index (EFI) as a marker of inspiratory effort, followed by a temporally separated clinical derivation cohort (n=57) and independent validation cohort (n=58). Candidate predictors are screened from 1,328 clinical features. The final dual-domain model integrates persistent physiological burden (baseline PaCO₂ and 30-minute EFI) with short-term dynamic adaptation (ΔRR and ΔSpO₂ over 30 minutes). The model's discrimination is tested prospectively without refitting.
详细描述
Detailed Description
This was a single-center, prospective, two-stage translational study conducted at Ruijin Hospital, Shanghai Jiao Tong University School of Medicine. The study comprised three integrated components:
- Physiological validation cohort (n = 24) Mechanically ventilated patients with acute respiratory distress syndrome (ARDS) receiving pressure support ventilation underwent simultaneous electrical impedance tomography (EIT) and esophageal pressure monitoring. Measurements were performed at three sequentially adjusted pressure support levels: baseline clinical setting (PSbase), maximal tolerated level (PSmax), and minimal level (PSmin). The EIT-derived Flow Index (EFI) was calculated from the global impedance-time signal. Relationships between EFI and esophageal pressure swing (ΔPes) as well as pressure-time product per minute (PTP/min) were assessed using regression analysis. Changes in EFI across pressure support levels were evaluated by repeated within-subject comparisons.
- Clinical derivation cohort (n = 57) High-risk adult patients with acute hypoxemic respiratory failure (AHRF) initiated on high-flow nasal oxygen (HFNO) were prospectively enrolled between May 2025 and September 2025. Inclusion required at least one of the following high-risk criteria: PaO₂/FiO₂ ≤ 200 mmHg or FiO₂ ≥ 0.40 to maintain SpO₂ ≥ 92%; respiratory rate ≥ 25 breaths/min; APACHE II score ≥ 12; or bilateral infiltrates on chest imaging. EIT and bedside variables (heart rate, respiratory rate, arterial blood gases, ROX index) were recorded at baseline (HFNO initiation) and at 30 minutes. HFNO failure was defined a priori as clinically meaningful escalation to noninvasive ventilation (NIV) or endotracheal intubation due to sustained hypoxemia, progressive respiratory acidosis, respiratory muscle fatigue, or hemodynamic instability. Within-tier adjustments (increasing flow or FiO₂ without changing support modality) were not considered failure.
Patient-level analyses were performed to identify two prespecified domains of early HFNO failure:
Persistent abnormality (physiological burden that remained abnormal after accounting for baseline): evaluated by analysis of covariance (ANCOVA) for 30-minute variables adjusted for baseline values.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(must meet all):
- •Age ≥18 years
- •Acute hypoxemic respiratory failure (AHRF) requiring HFNO initiation
- •At least one of the following high-risk criteria: a) PaO₂/FiO₂ ≤200 mmHg or FiO₂ ≥0.40 to maintain SpO₂ ≥92%; b) Respiratory rate ≥25/min; c) APACHE II score ≥12; d) Bilateral infiltrates on chest imaging
排除标准
- •Neuromuscular disease affecting spontaneous breathing
- •Pregnancy
- •Contraindication to EIT (e.g., chest wall wounds, pacemaker)
- •Do-not-intubate order
- •Hypercapnic respiratory failure as primary diagnosis (PaCO₂ >50 mmHg with pH <7.30 at baseline, unless mixed mechanism)
结局指标
主要结局
HFNC Failure Rate
时间窗: Within 48 hours of HFNC initiation
次要结局
- ROC comparison of FI, ROX index, and conventional parameters(Within 48 hours)
- Odds ratio and confidence interval for FI predicting HFNC failure(Within 48 hours)