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

Study acronym: EFI-HFNO
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion dates: Mar 31, 2026 to Dec 31, 2026 Primary endpoint revised · Sponsor refiled this as recruiting (was completed) · Enrollment target: 164 to 115 · 7 more Show 10 more changesShow less
    • Primary endpoint revised
    • Sponsor refiled this as recruiting (was completed)
    • Enrollment target: 164 to 115
    • Interventions: Electrical Impedance Tomography Monitoring (Device), High-Flow Nasal Oxygen Therapy (Other), High-Flow Nasal Oxygen Therapy With EIT… to Electrical Impedance Tomography Monitoring (Device), High-Flow Nasal Oxygen Therapy (Other)
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: 3 to 4
    • Study description shortened, about 254 words
    • Site details revised
    • Study arms: 5 to 3
    • Study title expanded, about 3 words
  2. Primary endpoint(s) modified Enrollment increased: 90 → 164 participants · Start date: Dec 1, 2023 to May 1, 2025 · Trial completed · 8 morev2 Show 11 more changesShow less
    • Enrollment increased: 90 → 164 participants
    • Start date: Dec 1, 2023 to May 1, 2025
    • Trial completed
    • Primary completion pushed from Dec 31, 2025 to Mar 31, 2026
    • Completion pushed from Feb 1, 2026 to Mar 31, 2026
    • Trial arms changed: 1 → 5
    • Interventions: Electrical impedance tomography(PulmoVista 500, Dräger Medical) (Device) to Electrical Impedance Tomography Monitoring (Device), High-Flow Nasal Oxygen Therapy (Other), High-Flow Nasal Oxygen Therapy With EIT…
    • Eligibility criteria expanded, about 56 words
    • Secondary endpoints: 2 to 3
    • Study description expanded, about 409 words
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Ruijin Hospital
370 trials monitored
See 13 trials at risk
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.
Trial Details
NCT Number NCT07366541
Lead Sponsor Ruijin Hospital
Conditions Acute Respiratory Failure, Electrical Impedance Tomography (EIT), High-Flow Nasal Oxygen Therapy
Enrollment 115 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov