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

January 16, 2026 updated by: Ruijin Hospital
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200025
        • Department of Critical Care Medicine，Ruijin Hospital，Shanghai Jiao Tong University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients with acute respiratory failure receiving HFNC

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HFNC Oxygen Therapy
Device: Electrical impedance tomography(PulmoVista 500, Dräger Medical)
Outcome Parameters: FI, ROX index, respiratory rate, SpO₂

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HFNC Failure Rate
Time Frame: Within 48 hours of HFNC initiation
Within 48 hours of HFNC initiation

Secondary Outcome Measures

Outcome Measure
Time Frame
ROC comparison of FI, ROX index, and conventional parameters
Time Frame: Within 48 hours
Within 48 hours
Odds ratio and confidence interval for FI predicting HFNC failure
Time Frame: Within 48 hours
Within 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Actual)

December 31, 2025

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

January 16, 2026

First Submitted That Met QC Criteria

January 16, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 20250232

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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