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Predicting High-Flow Nasal Oxygen Failure Within 72 Hours Using a Physiology-Informed Dual-Domain Model at 30 Minutes
Sponsor: Ruijin Hospital
Summary
This is a single-center, ambispective observational cohort study of adults with acute hypoxemic respiratory failure (AHRF) receiving high-flow nasal oxygen (HFNO) as initial respiratory support. The study includes three stages. Stage 1 (retrospective derivation): the first 57 consecutive patients (May-September 2025) were retrospectively included to develop and lock a dual-domain logistic model using baseline EFI, baseline PaCO2, and 0-30 minute changes in respiratory rate (ΔRR) and SpO2 (ΔSpO2). Stage 2 (retrospective temporal validation): the later 58 patients (October 2025-March 2026) were retrospectively included, and the frozen model was directly applied without refitting; results of Stages 1 and 2 have been reported. Stage 3 (prospective validation): an independent prospective validation cohort is currently being enrolled, and the frozen model will be applied without refitting. The primary outcome is endotracheal intubation within 72 hours after HFNO initiation. This registration covers the complete study; the retrospective stages have been reported, and the prospective stage is ongoing.
Official title: A Physiology-Informed Dual-Domain Model for 30-Minute Reassessment to Predict Endotracheal Intubation Within 72 Hours After High-Flow Nasal Oxygen Initiation in Adults With Acute Hypoxemic Respiratory Failure: A Retrospective Derivation and Multicenter Prospective Validation Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
115
Start Date
2025-05-01
Completion Date
2026-12-31
Last Updated
2026-10-08
Healthy Volunteers
No
Conditions
Interventions
High-Flow Nasal Oxygen Therapy
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.
Electrical Impedance Tomography Monitoring
PulmoVista 500 EIT device (Dräger Medical, Lübeck, Germany) was used for continuous real-time monitoring of regional lung ventilation and to derive the EIT-derived flow index (EFI) at baseline and 30 minutes.
Locations (1)
Department of Critical Care Medicine，Ruijin Hospital，Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China