Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Sevrage protocolisé de la canule nasale à haut débit chez les patients adultes : un essai randomisé en grappes en escalier (PRO-WEAN HFNC)

22 septembre 2026 mis à jour par: Jie Li, Rush University Medical Center

Sevrage protocolisé de la canule nasale à haut débit chez les patients adultes : Un essai randomisé en grappes en marches d'escalier (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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

2000

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Jie Li, PhD
  • Numéro de téléphone: 13125634643
  • E-mail: Jie_Li@rush.edu

Lieux d'étude

  • États-Unis
    • Illinois
      • Chicago, Illinois, États-Unis, 60612
        • Rush University Medical Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 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.
Comportemental: 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.
Expérimental: 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.
Comportemental: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Proportion of patients successfully weaned from HFNC on day 5 of study enrollment
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Proportion of participants successfully weaned from HFNC by Day 1
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Rush University Medical Center

Collaborateurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 novembre 2026

Achèvement primaire (Estimé)

30 avril 2028

Achèvement de l'étude (Estimé)

28 juin 2028

Dates d'inscription aux études

Première soumission

28 février 2026

Première soumission répondant aux critères de contrôle qualité

28 février 2026

Première publication (Réel)

5 mars 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

25 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

22 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • HFNC weaning

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime 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.

Délai de partage IPD

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

Critères d'accès au partage 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.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • ANALYTIC_CODE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner