Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Geprotocolleerde Afbouw van High-Flow Neuscanule bij Volwassen Patiënten: Een Gestapelde Wig-Cluster Gerandomiseerde Studie (PRO-WEAN HFNC)

22 september 2026 bijgewerkt door: Jie Li, Rush University Medical Center

Protocolmatige Afbouw van Hoogdebiet Neuscanule bij Volwassen Patiënten: Een Stapsgewijs Wigcluster Gerandomiseerde 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

2000

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • Illinois
      • Chicago, Illinois, Verenigde Staten, 60612
        • Rush University Medical Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Gedragsmatig: 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.
Experimenteel: 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.
Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Proportion of patients successfully weaned from HFNC on day 5 of study enrollment
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Proportion of participants successfully weaned from HFNC by Day 1
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Rush University Medical Center

Medewerkers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 november 2026

Primaire voltooiing (Geschat)

30 april 2028

Studie voltooiing (Geschat)

28 juni 2028

Studieregistratiedata

Eerst ingediend

28 februari 2026

Eerst ingediend dat voldeed aan de QC-criteria

28 februari 2026

Eerst geplaatst (Werkelijk)

5 maart 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

25 september 2026

Laatste update ingediend die voldeed aan QC-criteria

22 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • HFNC weaning

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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-tijdsbestek voor delen

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

IPD-toegangscriteria voor delen

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.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ANALYTIC_CODE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren