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Clinical Trials/NCT07366541
NCT07366541
Active, not recruiting
Not Applicable

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

Ruijin Hospital1 site in 1 country90 target enrollmentStarted: December 1, 2023Last updated:

Overview

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
90
Locations
1
Primary Endpoint
HFNC Failure Rate

Overview

Brief 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age ≥18 years
  • Acute respiratory failure requiring HFNC
  • Stable hemodynamics
  • FiO₂ ≤0.6

Exclusion Criteria

  • Neuromuscular disease affecting spontaneous breathing
  • Pregnancy
  • Contraindications to EIT
  • Poor EIT signal quality

Arms & Interventions

HFNC Oxygen Therapy

Intervention: Electrical impedance tomography(PulmoVista 500, Dräger Medical) (Device)

Outcomes

Primary Outcomes

HFNC Failure Rate

Time Frame: Within 48 hours of HFNC initiation

Secondary Outcomes

  • ROC comparison of FI, ROX index, and conventional parameters(Within 48 hours)
  • Odds ratio and confidence interval for FI predicting HFNC failure(Within 48 hours)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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