NCT07366541

Predicting High-Flow Nasal Cannula Failure Using an Electrical Impedance Tomography-Derived Index: A Multicenter Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 90 (actual)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

High-Flow Nasal Cannula (HFNC) therapy is widely used to treat acute respiratory failure. However, predicting therapy failure remains challenging as conventional indices rely on intermittent measurements and cannot provide continuous, objective monitoring. Electrical Impedance Tomography (EIT) enables non-invasive, real-time assessment of regional lung ventilation. This study evaluated whether an EIT-derived Flow Index (FI) could predict HFNC therapy failure within 48 hours.

Detailed description

Design: Single-center, prospective observational study. Setting: Ruijin Hospital, Shanghai, China. Population: Adult patients with acute respiratory failure receiving HFNC between December 2023 and March 2024. Intervention: EIT monitoring during spontaneous breathing while on HFNC. FI was calculated from EIT-derived regional ventilation signals using a curve-fitting formula quantifying inspiratory flow-time waveform concavity. Endpoints: Primary - HFNC failure (escalation to mechanical ventilation or persistent hypoxemia within 48 h). ROC analysis compared FI with ROX index, respiratory rate, and SpO₂. Logistic regression models assessed predictive value and odds ratios.

Conditions

• Acute Respiratory Failure
• Oxygen Therapy Failure
• High-flow Nasal Cannula (HFNC) Therapy
• Electrical Impedance Tomography (EIT)

Interventions

Type	Name	Description
DEVICE	Electrical impedance tomography(PulmoVista 500, Dräger Medical)	Outcome Parameters: FI, ROX index, respiratory rate, SpO₂

Timeline

• Start date: 2023-12-01
• Primary completion: 2025-12-31
• Completion: 2026-02-01
• First posted: 2026-01-26
• Last updated: 2026-01-26

Locations

1 site across 1 country: China