Predicting High-Flow Nasal Oxygen Failure at 30 Minutes Using a Physiology-Informed Dual-Domain Model

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.

NCT Number	NCT07366541
Lead Sponsor	Ruijin Hospital
Conditions	Acute Respiratory Failure, Electrical Impedance Tomography (EIT), High-Flow Nasal Oxygen Therapy
Enrollment	164 participants
Start Date	2025-05-01
Primary Completion	2026-03-31 (estimated)
Study Completion	2026-03-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-17