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

NCT07366541 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 164

Last updated 2026-06-17

No results posted yet for this study

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.

Conditions

  • Acute Respiratory Failure
  • Electrical Impedance Tomography (EIT)
  • High-Flow Nasal Oxygen Therapy

Interventions

DEVICE

Mechanical Ventilation Support

Patients received pressure support ventilation at three sequentially adjusted levels (PSmin, PSbase, PSmax). Breathing parameters were continuously monitored using an electrical impedance tomography (EIT) device, and inspiratory effort was invasively measured via an esophageal pressure catheter.

DEVICE

Electrical Impedance Tomography Monitoring

PulmoVista 500 EIT device (Dräger Medical, Lübeck, Germany) was used for continuous real-time monitoring of regional lung ventilation.

OTHER

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.

DEVICE

High-Flow Nasal Oxygen Therapy With EIT Monitoring

Patients received standard-of-care HFNO for AHRF. Additionally, a PulmoVista 500 EIT device was used to monitor lung ventilation and derive the EFI at baseline and 30 minutes.

Sponsors & Collaborators

  • Ruijin Hospital

    lead OTHER

Principal Investigators

  • Hongping Qu · Department of Critical Care Medicine，Ruijin Hospital，Shanghai Jiao Tong University School of Medicine

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07366541 on ClinicalTrials.gov