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Completed
NCT07366541
Predicting High-Flow Nasal Oxygen Failure at 30 Minutes Using a Physiology-Informed Dual-Domain Model
Conditions: Acute Respiratory Failure, Electrical Impedance Tomography (EIT), High-Flow Nasal Oxygen Therapy
Sex: All
Ages: 18 Years – 90 Years
Healthy volunteers: No
Enrollment: 164
Sponsor: Ruijin Hospital
Location: Department of Critical Care Medicine,Ruijin Hospital,Shanghai Jiao Tong University School of Medicine Shanghai Shanghai Municipality
Summary
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.
Eligibility Criteria
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 \
Source: ClinicalTrials.gov (NCT07366541). StuddyBuddy aggregates publicly available trial information.