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Predicting High-Flow Nasal Oxygen Failure Within 72 Hours Using a Physiology-Informed Dual-Domain Model at 30 Minutes

Recruitingn/aAges 18 Years - anyAllRuijin Hospital
NCT07366541 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria (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 Exclusion Criteria: * 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)
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What it tests

  • High-Flow Nasal Oxygen Therapy
  • Electrical Impedance Tomography Monitoring
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Where

1 site
Department of Critical Care Medicine，Ruijin Hospital，Shanghai Jiao Tong University School of Medicine
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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