Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Protocolizzato Sospensione della Cannula Nasale ad Alto Flusso in Pazienti Adulti: Uno Studio Randomizzato a Cluster a Cuneo Scalato (PRO-WEAN HFNC)

22 settembre 2026 aggiornato da: Jie Li, Rush University Medical Center

Svezzamento Protocollizzato della Cannula Nasale ad Alto Flusso in Pazienti Adulti: Uno Studio Randomizzato a Cluster a Cuneo Scalettato (PRO-WEAN HFNC)

High-flow nasal cannula (HFNC) is a type of oxygen therapy commonly used in adults with breathing problems. While HFNC can help patients avoid breathing tubes and improve oxygen levels, there is no standard method for deciding how and when to reduce and stop this therapy once a patient improves. In many hospitals, these decisions vary from clinician to clinician.

This study will compare usual care with a standardized step-by-step plan for reducing HFNC support. Eight hospitals will participate and will switch from usual care to the standardized plan at different time points during the study.

The main goal is to determine whether the standardized weaning plan increases the number of patients who can successfully stop HFNC within 5 days. The study will also evaluate how long patients remain on HFNC, whether they need additional breathing support, and how long they stay in the hospital.

The results may help develop clearer guidance for safely and efficiently stopping HFNC therapy.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

High-flow nasal cannula (HFNC) therapy has become a standard treatment for acute hypoxemic respiratory failure. Although evidence supports its use for improving oxygenation and reducing intubation risk, guidance on how to discontinue HFNC remains limited. Current weaning practices are highly variable across institutions and clinicians. This variability may contribute to either premature discontinuation, leading to respiratory deterioration, or prolonged therapy, which may delay ICU discharge and increase healthcare utilization.

This trial evaluates implementation of a standardized HFNC weaning protocol across multiple hospitals using a stepped-wedge cluster randomized design. The intervention focuses on structured, progressive reduction of HFNC flow and fraction of inspired oxygen (FiO₂), with predefined criteria for discontinuation and re-escalation of support.

The stepped-wedge approach allows sequential implementation of the protocol across participating hospitals while accounting for secular trends and inter-site practice variability. The study is designed to determine whether protocolized weaning improves efficiency and clinical outcomes compared with usual care.

Findings from this trial are intended to inform evidence-based guidance for HFNC liberation strategies in adult patients with acute hypoxemic respiratory failure.

Tipo di studio

Interventistico

Iscrizione (Stimato)

2000

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Stati Uniti
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60612
        • Rush University Medical Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Adult patients ≥ 18 years

  • Receiving HFNC for ≥12 hours

  • Receiving HFNC to treat acute hypoxemic respiratory failure, defined as requirement of FIO2 ≥ 0.5 to maintain SpO2 at 90-97% and Evidence of increased work of breathing at initiation (e.g., tachypnea with respiratory rate > 20-25/min, or accessory muscle use), including:

    • Patients using HFNC to avoid intubation
    • Post-extubated patients who develop acute hypoxemic respiratory failure, regardless of respiratory support device prior to HFNC use.

  • The bedside clinical team determines that HFNC weaning is clinically appropriate

  • Demonstrates clinical stability, defined as:

    • Respiratory rate ≤ 25 breaths per minute without use of accessory respiratory muscles
    • SpO₂ > 90% on HFNC
    • HFNC FiO₂ ≤ 0.80

Exclusion Criteria:

  • • Planned procedures requiring intubation

    • Hypercapnia (PaCO2 ≥ 45 mmHg)
    • Receiving extracorporeal membrane oxygenation (ECMO)
    • Receiving continuous aerosol therapy via HFNC (e.g., inhaled nitric oxide [iNO], epoprostenol, or continuous albuterol)
    • Receiving chronic home use of HFNC, CPAP, or noninvasive ventilation therapy to treat chronic respiratory failure
    • Receiving HFNC as preventative post-extubation therapy, defined as HFNC use immediately after extubation for less than 48 hr in the absence of clinical signs of respiratory failure.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Usual Care HFNC Weaning

During this phase, high-flow nasal cannula (HFNC) weaning and discontinuation are performed according to local standard practice without a mandated protocol. Decisions regarding reduction of flow and fraction of inspired oxygen (FiO₂), transition to conventional oxygen therapy, and re-escalation of support are made at the discretion of the treating clinical team.
Comportamentale: Usual Care HFNC Weaning

High-flow nasal cannula (HFNC) weaning and discontinuation are performed according to local standard clinical practice without a mandated protocol. Decisions regarding reduction of flow and fraction of inspired oxygen (FiO₂), transition to conventional oxygen therapy, and escalation of respiratory support are made at the discretion of the treating clinical team.
Sperimentale: Protocolized HFNC Weaning

Participants receive a standardized HFNC weaning protocol consisting of structured, stepwise reduction of flow and FiO₂ with predefined criteria for discontinuation and criteria for treatment failure requiring re-escalation of respiratory support. The protocol is implemented at the hospital level during the intervention phase of the stepped-wedge design.
Comportamentale: Protocolized HFNC Weaning Strategy

A standardized high-flow nasal cannula (HFNC) weaning protocol consisting of structured, stepwise reduction of flow and fraction of inspired oxygen (FiO₂) with predefined criteria for discontinuation and predefined criteria for treatment failure requiring re-escalation of respiratory support. The protocol is implemented at the hospital level during the intervention phase of the stepped-wedge cluster randomized design.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of patients successfully weaned from HFNC on day 5 of study enrollment
Lasso di tempo: Up to 5 days after study enrollment

HFNC weaning success is defined as discontinuation of high-flow nasal cannula therapy with the participant alive and breathing on conventional oxygen therapy or room air without need for noninvasive ventilation, CPAP, invasive mechanical ventilation, or re-initiation of HFNC within 24 hours of discontinuation. Participants remaining on HFNC beyond Day 5 are considered weaning failures.
Up to 5 days after study enrollment

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of participants successfully weaned from HFNC by Day 1
Lasso di tempo: Up to 1 day after study enrollment

HFNC weaning success is defined as discontinuation of high-flow nasal cannula therapy with the participant alive and without need for noninvasive ventilation, CPAP, invasive mechanical ventilation, or re-initiation of HFNC within 24 hours of discontinuation.
Up to 1 day after study enrollment
Proportion of participants successfully weaned from HFNC by Day 2
Lasso di tempo: Up to 2 days after study enrollment

HFNC weaning success is defined as discontinuation of high-flow nasal cannula therapy with the participant alive and without need for noninvasive ventilation, CPAP, invasive mechanical ventilation, or re-initiation of HFNC within 24 hours of discontinuation.
Up to 2 days after study enrollment
Proportion of participants successfully weaned from HFNC by Day 3
Lasso di tempo: Up to 3 days after study enrollment

HFNC weaning success is defined as discontinuation of high-flow nasal cannula therapy with the participant alive and without need for noninvasive ventilation, CPAP, invasive mechanical ventilation, or re-initiation of HFNC within 24 hours of discontinuation.
Up to 3 days after study enrollment
Proportion of participants successfully weaned from HFNC by Day 4
Lasso di tempo: Up to 4 days after study enrollment

HFNC weaning success is defined as discontinuation of high-flow nasal cannula therapy with the participant alive and without need for noninvasive ventilation, CPAP, invasive mechanical ventilation, or re-initiation of HFNC within 24 hours of discontinuation.
Up to 4 days after study enrollment
Proportion of participants successfully weaned from HFNC by Day 7
Lasso di tempo: Up to 7 days after study enrollment

HFNC weaning success is defined as discontinuation of high-flow nasal cannula therapy with the participant alive and without need for noninvasive ventilation, CPAP, invasive mechanical ventilation, or re-initiation of HFNC within 24 hours of discontinuation.
Up to 7 days after study enrollment
HFNC duration (hours)
Lasso di tempo: From HFNC initiation until hospital discharge, up to 28 days

Total duration of high-flow nasal cannula (HFNC) therapy measured in hours from initiation of HFNC until permanent discontinuation of HFNC during the hospitalization.
From HFNC initiation until hospital discharge, up to 28 days
Oxygen-free days through Day 28
Lasso di tempo: Up to 28 days after study enrollment

Number of days alive and not receiving any supplemental oxygen (including HFNC, conventional oxygen therapy, noninvasive ventilation, or invasive mechanical ventilation) during the first 28 days after study enrollment. Participants who die before Day 28 will be assigned zero oxygen-free days.
Up to 28 days after study enrollment
HFNC Weaning Duration
Lasso di tempo: From study enrollment until HFNC discontinuation, up to 28 days

Duration in hours from study enrollment to permanent discontinuation of high-flow nasal cannula therapy among participants who meet criteria for weaning success.
From study enrollment until HFNC discontinuation, up to 28 days
Proportion of participants requiring noninvasive ventilation within 48 hours after HFNC discontinuation
Lasso di tempo: Within 48 hours after HFNC discontinuation

Proportion of participants who require initiation of noninvasive ventilation (e.g., BiPAP or CPAP for respiratory failure) within 48 hours after HFNC discontinuation.
Within 48 hours after HFNC discontinuation
Proportion of participants requiring re-initiation of HFNC within 48 hours after discontinuation
Lasso di tempo: Within 48 hours after HFNC discontinuation

Proportion of participants who require re-initiation of high-flow nasal cannula therapy within 48 hours after initial discontinuation.
Within 48 hours after HFNC discontinuation
Proportion of participants requiring invasive mechanical ventilation within 48 hours after HFNC discontinuation
Lasso di tempo: Within 48 hours after HFNC discontinuation

Proportion of participants who require endotracheal intubation and invasive mechanical ventilation within 48 hours after HFNC discontinuation.
Within 48 hours after HFNC discontinuation
Duration of invasive mechanical ventilation (hours)
Lasso di tempo: During hospitalization, up to 28 days after enrollment

Total duration of invasive mechanical ventilation measured in hours from initiation of endotracheal intubation until successful extubation during hospitalization.
During hospitalization, up to 28 days after enrollment
ICU Length of Stay
Lasso di tempo: During index hospitalization, up to 28 days after enrollment

Number of days from ICU admission to ICU discharge during the index hospitalization
During index hospitalization, up to 28 days after enrollment
Hospital length of stay (days)
Lasso di tempo: During index hospitalization, up to 28 days after enrollment

Number of days from hospital admission to hospital discharge during the index hospitalization.
During index hospitalization, up to 28 days after enrollment
ICU mortality
Lasso di tempo: During ICU stay, up to 28 days after enrollment

Proportion of participants who die during the ICU stay.
During ICU stay, up to 28 days after enrollment
Hospital mortality
Lasso di tempo: During hospitalization, up to 28 days after enrollment

Proportion of participants who die during the index hospitalization.
During hospitalization, up to 28 days after enrollment
Adverse events related to HFNC therapy
Lasso di tempo: During hospitalization, up to 28 days after enrollment

Incidence of adverse events during HFNC therapy, including but not limited to skin breakdown, nasal or facial injury, epistaxis, or other clinically significant complications documented during hospitalization.
During hospitalization, up to 28 days after enrollment

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Rush University Medical Center

Collaboratori

Changhai Hospital
Shanghai Zhongshan Hospital
First Hospital of China Medical University
First Affiliated Hospital of Chongqing Medical University
The First Affiliated Hospital of Xiamen University
Binzhou Medical University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 novembre 2026

Completamento primario (Stimato)

30 aprile 2028

Completamento dello studio (Stimato)

28 giugno 2028

Date di iscrizione allo studio

Primo inviato

28 febbraio 2026

Primo inviato che soddisfa i criteri di controllo qualità

28 febbraio 2026

Primo Inserito (Effettivo)

5 marzo 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

25 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

22 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • HFNC weaning

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

De-identified individual participant data underlying the results reported in the publication (including data dictionaries) will be made available to qualified researchers upon reasonable request and with appropriate institutional ethics approval after publication of the primary results. Requests must include a methodologically sound research proposal and will require approval by the study investigators and participating institutions. Data will be shared under a data use agreement to ensure participant confidentiality and compliance with institutional and regulatory policies.

Periodo di condivisione IPD

Data will be available beginning 6 months after publication of the primary results and will remain available for 5 years thereafter.

Criteri di accesso alla condivisione IPD

Access to de-identified individual participant data, data dictionaries, statistical analysis plan, and analytic code will be granted to qualified researchers who submit a methodologically sound research proposal. Requests must receive approval from the study investigators and participating institutions and obtain appropriate institutional ethics approval. Data will be shared under a data use agreement to ensure participant confidentiality and compliance with institutional and regulatory requirements.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • CODICE_ANALITICO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Sottoscrivi