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Effect of High Flow Nasal Therapy (HFNC) Weaning Protocols vs Standard of Care on Respiratory Outcomes in Patients With Acute Respiratory Failure (WHIP)

4. juni 2026 opdateret af: Michele Mondoni, University of Milan

Effect of High Flow Nasal Therapy (HFNC) Weaning Protocols vs Standard of Care on Respiratory Outcomes in Patients With Acute Respiratory Failure: A Randomized Clinical Trial

High-flow nasal cannula (HFNC) is a widely used noninvasive respiratory support technique for patients with acute respiratory failure (ARF). It provides heated and humidified oxygen at high flow rates, improving oxygenation, reducing respiratory effort, and enhancing patient comfort. International guidelines recommend HFNC over conventional oxygen therapy in hypoxemic ARF. However, there is significant variability in clinical practice regarding HFNC discontinuation, and no standardized weaning criteria currently exist. Prolonged HFNC use may increase hospital stay and healthcare costs, while premature discontinuation may lead to respiratory deterioration and the need for further ventilatory support. Previous studies suggest that successful HFNC weaning may be predicted by a Fraction of inspired oxygen (FiO₂) ≤40% and a Respiratory rate-Oxygenation index (ROX index) ≥9.2. The ROX index is calculated as the ratio of peripheral oxygen saturation (SpO₂) divided by fraction of inspired oxygen (FiO₂) to respiratory rate. The primary objective of this study is to compare a standardized HFNC weaning strategy based on ROX index and FiO₂ thresholds with usual clinical practice based on physician judgment. The primary outcome is weaning failure at the first attempt, defined as the need for HFNC reinstitution, noninvasive or invasive mechanical ventilation, or death within 48 hours after discontinuation.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

148

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiekontakt

Studiesteder

  • Italien
    • Lombardy
      • Milan, Lombardy, Italien, 20142
        • Rekruttering
        • Pulmonology Unit, ASST Santi Paolo e Carlo. Department of Health Sciences, University of Milan, Milan (Italy)
    • Sicily
      • Catania, Sicily, Italien, 95123
        • Ikke rekrutterer endnu
        • Pulmonology Unit, University Hospital "G. Rodolico-San Marco"
        • Kontakt:

Deltagelseskriterier

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Beskrivelse

Inclusion Criteria:

  • Age ≥18 years
  • Presence of acute respiratory failure (ARF)
  • Receiving HFNC treatment for ≥24 hours

Exclusion Criteria:

  • Post-extubation HFNC use or tracheostomized patients
  • Respiratory acidosis (pH <7.35) or clinically significant acute hypercapnia (pCO₂ >50 mmHg with worsening from baseline)
  • Long-term home NIV or home CPAP use
  • Do-not-intubate (DNI) orders precluding escalation to invasive mechanical ventilation
  • Life expectancy ≤48-72 hours due to terminal non-respiratory disease
  • Neurological impairment or deep sedation preventing safe HFNC use (e.g. coma or severe uncontrolled delirium)
  • Technical contraindications to HFNC (i.e. facial trauma, maxillofacial surgery, severe nasal obstruction)
  • Refusal to participate or inability to provide informed consent

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Non-protocolized weaning
Non-protocolized weaning according to standard clinical practice: HFNC assessment every 24 hours and discontinuation based on physician clinical judgment.
Eksperimentel: Protocolized weaning
Protocolized weaning using ROX index + FiO₂
Andet: Protocolized HFNC weaning
HFNC discontinuation based on ROX index ≥9.2 and FiO₂ ≤40%

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Weaning failure
Tidsramme: Within 48 hours after the first separation attempt
To compare the percentage of patients who fail HFNC weaning within 48 hours after the first separation attempt using a protocolized HFNC weaning strategy based on ROX index and FiO₂ cut-offs versus standard clinical practice guided by physician judgment.
Within 48 hours after the first separation attempt

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Second-attempt weaning success
Tidsramme: Within 48 hours after the second separation attempt
To compare the percentage of patients who fail HFNC weaning within 48 hours after the second separation attempt using a protocolized HFNC weaning strategy based on ROX index and FiO₂ cut-offs versus standard clinical practice guided by physician judgment.
Within 48 hours after the second separation attempt
Length of hospital stay
Tidsramme: From the day of hospital admission until the day of hospital discharge, assessed up to 60 days; and from the day of HFNC discontinuation until the day of hospital discharge, assessed up to 60 days.
Comparison of total hospital stay and post-weaning hospital stay between the two study arms.
From the day of hospital admission until the day of hospital discharge, assessed up to 60 days; and from the day of HFNC discontinuation until the day of hospital discharge, assessed up to 60 days.
In-hospital and 30-day mortality
Tidsramme: From the day of admission to the day of discharge or death (in-hospital mortality) and from the day of admission to 30-day after discharge (30-day mortality)
Comparison of in-hospital mortality and 30-day mortality after discharge between the two study arms.
From the day of admission to the day of discharge or death (in-hospital mortality) and from the day of admission to 30-day after discharge (30-day mortality)
Predictors of weaning success
Tidsramme: From enrollment through hospital discharge, an average of 10 days.
Identification of clinical and respiratory variables associated with successful HFNC weaning.
From enrollment through hospital discharge, an average of 10 days.
Number of days of HFNC treatment from initiation to definitive discontinuation
Tidsramme: From the date and time of HFNC initiation until the date and time of definitive HFNC discontinuation, assessed up to 30 days.
Number of days of HFNC treatment from initiation to definitive discontinuation
From the date and time of HFNC initiation until the date and time of definitive HFNC discontinuation, assessed up to 30 days.
Predictors of HFNC treatment duration
Tidsramme: From HFNC initiation through hospital discharge, an average of 10 days
Demographic, clinical, radiological and laboratory variables associated with HFNC treatment duration
From HFNC initiation through hospital discharge, an average of 10 days
Prevalence of diaphragmatic dysfunction assessed by diaphragm thickening fraction (DTF) and diaphragmatic excursion measured by ultrasound between the two study arms.
Tidsramme: 30 minutes before HFNC weaning initiation and 24 hours after weaning completion.
Comparison of the prevalence of diaphragmatic dysfunction assessed by diaphragmatic ultrasound between patients with successful HFNC weaning and those with weaning failure. Diaphragmatic function will be evaluated using diaphragm thickening fraction (DTF) and diaphragmatic excursion measured by ultrasound.
30 minutes before HFNC weaning initiation and 24 hours after weaning completion.
Changes in diaphragmatic function
Tidsramme: Before HFNC discontinuation and within 48 hours after weaning attempt
Evaluation of diaphragmatic ultrasound parameters before and after HFNC discontinuation.
Before HFNC discontinuation and within 48 hours after weaning attempt

Samarbejdspartnere og efterforskere

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Sponsor

University of Milan

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 (Anslået)

15. maj 2026

Primær færdiggørelse (Anslået)

1. maj 2028

Studieafslutning (Anslået)

1. maj 2028

Datoer for studieregistrering

Først indsendt

13. maj 2026

Først indsendt, der opfyldte QC-kriterier

4. juni 2026

Først opslået (Faktiske)

10. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • THE WHIP TRIAL

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Kliniske forsøg med Akut respirationssvigt (ARF)

Kliniske forsøg med Protocolized HFNC weaning

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