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Protokollisiertes Entwöhnen von High-Flow-Nasalkanülen bei erwachsenen Patienten: Eine gestufte Keil-Cluster-Randomisierte Studie (PRO-WEAN HFNC)

22. September 2026 aktualisiert von: Jie Li, Rush University Medical Center

Protokolliertes Absetzen von High-Flow-Nasenkanülen bei erwachsenen Patienten: Eine gestufte Keil-Cluster-randomisierte Studie (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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

2000

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Vereinigte Staaten
    • Illinois
      • Chicago, Illinois, Vereinigte Staaten, 60612
        • Rush University Medical Center

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: 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.
Verhalten: 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.
Experimental: 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.
Verhalten: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Proportion of patients successfully weaned from HFNC on day 5 of study enrollment
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Proportion of participants successfully weaned from HFNC by Day 1
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Rush University Medical Center

Mitarbeiter

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. November 2026

Primärer Abschluss (Geschätzt)

30. April 2028

Studienabschluss (Geschätzt)

28. Juni 2028

Studienanmeldedaten

Zuerst eingereicht

28. Februar 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

28. Februar 2026

Zuerst gepostet (Tatsächlich)

5. März 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

25. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

22. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • HFNC weaning

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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.

IPD-Sharing-Zeitrahmen

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

IPD-Sharing-Zugriffskriterien

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.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ANALYTIC_CODE

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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