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Forudsigelse af svigt ved højflow nasal canule ved brug af et elektrisk impedans tomografi-afledt indeks: Et multicenter studie (EFI-HFNO)

16. juni 2026 opdateret af: Ruijin Hospital

Forudsigelse af fejl ved højflow næsekanyle ved brug af et elektrisk impedanstopografi-afledt indeks: Et multicenterstudie

High-Flow Nasal Cannula (HFNC)-terapi er bredt anvendt til behandling af akut respiratorisk svigt. Forudsigelse af terapi-fiasko forbliver dog udfordrende, da konventionelle indeks er afhængige af intermitterende målinger og ikke kan give kontinuerlig, objektiv overvågning. Electrical Impedance Tomography (EIT) muliggør ikke-invasiv, realtidsvurdering af regional lungeventilation. Denne undersøgelse evaluerede, om et EIT-afledt Flow Index (FI) kunne forudsige HFNC-terapi-fiasko inden for 48 timer.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Design: Enkeltcenter, prospektiv observationsstudie. Setting: Ruijin Hospital, Shanghai, Kina. Population: Voksne patienter med akut respiratorisk svigt, der modtog HFNC mellem december 2023 og marts 2024. Intervention: EIT-overvågning under spontanåndedræt på HFNC. FI blev beregnet fra EIT-afledte regionale ventilationssignaler ved hjælp af en kurvetilpasningsformel, der kvantificerer inspiratorisk flow-tidsbølgeformens konkavitet.

Endepunkter: Primær - HFNC-fejl (eskalering til mekanisk ventilation eller vedvarende hypoksæmi inden for 48 timer). ROC-analyse sammenlignede FI med ROX-indeks, respirationsfrekvens og SpO₂. Logistiske regressionsmodeller vurderede prædiktiv værdi og odds ratioer.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

164

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Voksne patienter med akut respirationssvigt, der modtager HFNC

Beskrivelse

Inklusionskriterier:

  • Alder ≥18 år
  • Akut respirationssvigt, der kræver HFNC
  • Stabil hemodynamik
  • FiO₂ ≤0,6

Eksklusionskriterier:

  • Neuromuskulær sygdom, der påvirker spontanåndedræt
  • Graviditet
  • Kontraindikationer over for EIT
  • Dårlig EIT-signalkvalitet

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Physiological Validation Cohort
Mechanically ventilated patients with acute respiratory distress syndrome (ARDS) receiving pressure support ventilation. Intervention: Simultaneous electrical impedance tomography (EIT) and esophageal pressure monitoring at three sequential pressure support levels (PSmin, PSbase, PSmax). Outcome measures: EIT-derived Flow Index (EFI), esophageal pressure swing (ΔPes), pressure-time product per minute (PTP/min). No HFNO administered.
Enhed: 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.
Enhed: Electrical Impedance Tomography Monitoring
PulmoVista 500 EIT device (Dräger Medical, Lübeck, Germany) was used for continuous real-time monitoring of regional lung ventilation.
Derivation Cohort - HFNO Success
High-risk patients with acute hypoxemic respiratory failure (AHRF) initiated on high-flow nasal oxygen (HFNO) who achieved clinical stabilization without requiring escalation to noninvasive ventilation or endotracheal intubation within 72 hours. Intervention: EIT monitoring and bedside data collection (heart rate, respiratory rate, arterial blood gases, SpO₂, ROX index, EMOX index) at baseline (HFNO initiation) and at 30 minutes. No additional device intervention.
Andet: 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.
Enhed: 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.
Derivation Cohort - HFNO Failure
High-risk patients with AHRF initiated on HFNO who required escalation to noninvasive ventilation or endotracheal intubation within 72 hours due to refractory hypoxemia, progressive respiratory acidosis, severe respiratory distress, or hemodynamic instability. Intervention: EIT monitoring and bedside data collection (same variables as success group) at baseline and 30 minutes. Escalation decision guided by predefined objective criteria, not by EIT data.
Andet: 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.
Enhed: 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.
Validation Cohort - HFNO Success
Independent temporally separate cohort of high-risk AHRF patients initiated on HFNO who achieved clinical stabilization without escalation. Same inclusion/exclusion criteria as derivation cohort. Intervention: Identical 30-minute reassessment protocol: EIT monitoring and bedside data collection at baseline and 30 minutes. Model tested prospectively without coefficient refitting.
Enhed: 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.
Validation Cohort - HFNO Failure
Independent temporally separate cohort of high-risk AHRF patients initiated on HFNO who required escalation to noninvasive ventilation or endotracheal intubation. Same escalation criteria as derivation cohort. Intervention: EIT monitoring and bedside data collection at baseline and 30 minutes. The fixed dual-domain model (baseline PaCO₂, 30-min EFI, ΔRR, ΔSpO₂) derived from the derivation cohort was applied without refitting to assess discrimination.
Enhed: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
HFNC Failure Rate(Early Reassessment at 30 Minutes)
Tidsramme: within 30 minutes after HFNO initiation (with monitoring of outcomes up to hospital discharge)
HFNO failure was defined as escalation to noninvasive ventilation (NIV) or endotracheal intubation due to refractory hypoxemia, progressive respiratory acidosis, severe respiratory distress, or hemodynamic instability. Within-tier adjustments (increasing flow or FiO₂ without changing support modality) were NOT considered failure.
within 30 minutes after HFNO initiation (with monitoring of outcomes up to hospital discharge)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Physiological Validation of EFI
Tidsramme: During physiological measurements in mechanically ventilated patients (performed before the clinical HFNO cohort; within 48 hours of ICU admission)
EFI was compared with esophageal pressure swing (ΔPes) and pressure-time product per minute (PTP/min) across pressure support levels using regression analysis and repeated within-subject comparisons.Unit of Measure No unit for R² (dimensionless ratio); Arbitrary units (a.u.) for EFI; cm H₂O for ΔPes; cm H₂O·s/min for PTP/min.
During physiological measurements in mechanically ventilated patients (performed before the clinical HFNO cohort; within 48 hours of ICU admission)
Persistent Abnormality at 30 Minutes
Tidsramme: within 30 minutes after HFNO initiation
ANCOVA-adjusted 30-minute values of EFI, PaCO₂, heart rate, respiratory rate, pH, PaO₂ were compared between HFNO success and failure groups to identify persistent physiological burden.Unit of Measure EFI: arbitrary units (a.u.); PaCO₂ and PaO₂: mmHg; Heart rate: beats/min; Respiratory rate: breaths/min; pH: dimensionless (pH units);
within 30 minutes after HFNO initiation
Divergent Short-Term Response Trajectories
Tidsramme: Baseline to 30 minutes after HFNO initiation
Generalized estimating equations (GEE) evaluated time-by-group interactions for EFI, respiratory rate, PaO₂, PaCO₂, pH, heart rate, ROX, to identify divergent early response trajectories.Measure of Central Tendency / Measure of Dispersion Time-by-group interaction P values; Estimated marginal means at baseline and 30 minutes for each group; Within-patient change scores (Δ values) between the two time points for each variable Unit of Measure EFI: arbitrary units (a.u.); Heart rate: beats/min; Respiratory rate: breaths/min; pH: dimensionless (pH units); PaCO₂ and PaO₂: mm Hg; ROX: dimensionless index.
Baseline to 30 minutes after HFNO initiation

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ruijin Hospital

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. maj 2025

Primær færdiggørelse (Faktiske)

31. marts 2026

Studieafslutning (Faktiske)

31. marts 2026

Datoer for studieregistrering

Først indsendt

16. januar 2026

Først indsendt, der opfyldte QC-kriterier

16. januar 2026

Først opslået (Faktiske)

26. januar 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. juni 2026

Sidst verificeret

1. januar 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • [2025]232 and [2025] 30

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