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 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
148
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Michele Mondoni, MD
- Telefonnummer: +39 0240223025
- E-post: michele.mondoni@unimi.it
Studiesteder
-
-
Lombardy
-
Milan, Lombardy, Italia, 20142
- Rekruttering
- Pulmonology Unit, ASST Santi Paolo e Carlo. Department of Health Sciences, University of Milan, Milan (Italy)
-
-
Sicily
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Catania, Sicily, Italia, 95123
- Har ikke rekruttert ennå
- Pulmonology Unit, University Hospital "G. Rodolico-San Marco"
-
Ta kontakt med:
- Claudia Crimi, MD PhD
- Telefonnummer: +39 095 3781352
- E-post: claudia.crimi@unict.it
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Non-protocolized weaning
Non-protocolized weaning according to standard clinical practice: HFNC assessment every 24 hours and discontinuation based on physician clinical judgment.
|
|
|
Eksperimentell: Protocolized weaning
Protocolized weaning using ROX index + FiO₂
|
HFNC discontinuation based on ROX index ≥9.2 and FiO₂ ≤40%
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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.
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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.
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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)
|
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Predictors of weaning success
Tidsramme: From enrollment through hospital discharge, an average of 10 days.
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Identification of clinical and respiratory variables associated with successful HFNC weaning.
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From enrollment through hospital discharge, an average of 10 days.
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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.
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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.
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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.
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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.
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Before HFNC discontinuation and within 48 hours after weaning attempt
|
Samarbeidspartnere og etterforskere
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Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
15. mai 2026
Primær fullføring (Antatt)
1. mai 2028
Studiet fullført (Antatt)
1. mai 2028
Datoer for studieregistrering
Først innsendt
13. mai 2026
Først innsendt som oppfylte QC-kriteriene
4. juni 2026
Først lagt ut (Faktiske)
10. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
10. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. juni 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- THE WHIP TRIAL
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