NCT07366541

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

2.1 years

First QC Date

January 16, 2026

Last Update Submit

January 16, 2026

Conditions

High-flow Nasal Cannula (HFNC) TherapyElectrical Impedance Tomography (EIT)Acute Respiratory FailureOxygen Therapy Failure

Outcome Measures

Primary Outcomes (1)

  • HFNC Failure Rate

    Within 48 hours of HFNC initiation

Secondary Outcomes (2)

  • 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

Study Arms (1)

HFNC Oxygen Therapy

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

Interventions

Electrical impedance tomography(PulmoVista 500, Dräger Medical)DEVICE

Outcome Parameters: FI, ROX index, respiratory rate, SpO₂

HFNC Oxygen Therapy

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with acute respiratory failure receiving HFNC

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Critical Care Medicine，Ruijin Hospital，Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Study Officials

  • Hongping Qu

    Department of Critical Care Medicine，Ruijin Hospital，Shanghai Jiao Tong University School of Medicine

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2026

First Posted

January 26, 2026

Study Start

December 1, 2023

Primary Completion

December 31, 2025

Study Completion

February 1, 2026

Last Updated

January 26, 2026

Record last verified: 2026-01

Locations

CN(1)