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WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department (WINDSURFER)

5 maggio 2026 aggiornato da: Henry Wang, MD, Ohio State University

The purpose of this clinical trial is to determine the best initial non-invasive respiratory support (NIRS) strategy for adults who present to the emergency department with acute hypoxemic respiratory failure, a condition in which blood oxygen levels are dangerously low and require urgent treatment. This study compares two commonly used non-invasive respiratory support strategies to evaluate their effectiveness and safety, based on important patient outcomes during hospitalization, including survival, the need for invasive mechanical ventilation, and the duration of respiratory support. Participants will be randomly assigned (with an equal chance) to receive one of the following treatments:

  • Non-Invasive Positive Pressure Ventilation (NIPPV): Oxygen delivered under pressure through a face mask.
  • High-Flow Nasal Oxygen (HFNO): Oxygen delivered at high-flow through a specially designed nasal cannula placed in the nostrils.

Researchers will compare the two treatment strategies using a hierarchical assessment of major pulmonary outcomes, including:

  • Hospital survival
  • Days on mechanical ventilation
  • Duration of non-invasive respiratory support

As part of the study, researchers will collect:

  • Blood and urine samples
  • Physiologic measurements (such as chest movement measured through sensors placed on the skin)
  • Information from participants' medical records

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Acute hypoxemic respiratory failure (AHRF) is a serious medical emergency that frequently presents in the emergency department (ED) and requires immediate respiratory support to prevent further clinical deterioration. Patients with AHRF are at high risk for progression to invasive mechanical ventilation and death, and early management decisions may substantially influence outcomes.

Non-invasive respiratory support (NIRS) is widely used as first-line therapy for AHRF. Two commonly used NIRS strategies are non-invasive positive-pressure ventilation (NIPPV) and high-flow nasal oxygen (HFNO). Both modalities are accepted standards of care; however, their relative effectiveness and safety when applied early in the ED remain uncertain. Prior comparative studies have largely been conducted in intensive care settings, enrolled selected patient populations, or focused on single outcomes such as intubation or mortality. Consequently, equipoise persists regarding the optimal initial NIRS strategy for ED patients with undifferentiated AHRF.

The WINDSURFER trial (WIN ratio analysis to Determine a strategy of non-invasive SUpport for Respiratory Failure in the EmeRgency Department) is designed to compare two strategies of non-invasive respiratory support-NIPPV and HFNO-with respect to clinically meaningful outcomes in adult ED patients with acute hypoxemic respiratory failure.

The trial is conducted at multiple hospitals participating in the NIH funded Strategies to Innovate Emergency Care Clinical Trials Network (SIREN), enabling enrollment across diverse emergency care environments.

The study enrolls adult patients early in their ED course, reflecting the population in which initial respiratory support decisions are most consequential.

Participants are randomly assigned in equal proportions to one of the two study strategies, with allocation managed centrally through a secure electronic system to ensure balance across sites.

The assigned strategy is implemented as the initial approach to non invasive respiratory support for a defined protocolized period, after which ongoing respiratory management is determined by the treating clinical team according to standard clinical practice.

Clinical data are collected from the medical record and study specific assessments to characterize baseline features, treatment course, and in hospital events. Follow up extends through hospitalization and a defined post randomization observation period to ensure complete capture of relevant clinical outcomes.

Ethical Considerations: Because AHRF is a life-threatening emergency requiring immediate intervention and patients frequently lack decision making capacity at presentation, the study is conducted under Exception From Informed Consent (EFIC) in accordance with Food and Drug Administration (FDA) regulations (21 CFR 50.24). Community consultation and public disclosure are completed prior to enrollment at each site. Participants or their Legally Authorized Representatives are informed of enrollment at the earliest feasible opportunity and may withdraw from the study at any time.

Tipo di studio

Interventistico

Iscrizione (Stimato)

500

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

Backup dei contatti dello studio

  • Nome: Valerie L Durkalski-Mauldin, PhD
  • Numero di telefono: 843-876-1911
  • Email: durkalsv@musc.edu

Luoghi di studio

  • Stati Uniti
    • Ohio
      • Columbus, Ohio, Stati Uniti, 43210
        • OSU Wexner Medical Center
        • Contatto:
        • Investigatore principale:
          • Jason Bischof, MD
        • Contatto:
      • Columbus, Ohio, Stati Uniti, 43203
        • Ohio State East Hospital
        • Contatto:
        • Investigatore principale:
          • Jason Bischof, MD
        • Contatto:

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

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Age ≥18 years

  • Presenting to the Emergency Department (ED) with Acute Hypoxemic Respiratory failure (AHRF), defined as:

    • [(respiratory rate ≥25 breaths/min) AND (requiring ≥6 L/min of oxygen required to maintain SpO2 ≥90%), OR SpO2:FiO2 ratio<250] OR
    • Arrival at ED on prehospital Non-Invasive Respiratory Support (NIRS).
  • Clinical need for NIRS
  • Randomization ≤2 hours after identification of need for NIRS
  • Randomization ≤6 hours of ED arrival

Exclusion Criteria:

  • Urgent need for intubation
  • Cardiac arrest
  • Respiratory arrest
  • Patient not located in the ED
  • Craniofacial anatomic features that prohibit either Non-Invasive Positive Pressure Ventilation (NIPPV) or High Flow Nasal Oxygen (HFNO) interface
  • Tracheostomy or laryngectomy stoma
  • Hemodynamic instability requiring >0.2mcg/kg/min of norepinepherine (or equivalent) to maintain mean arterial pressure >65mmHg
  • Pre-existing "do not resuscitate" or "do not intubate" order
  • Home use of non-invasive positive-pressure ventilation for respiratory support of a medical condition other than sleep apnea
  • Transferred from another Emergency Department
  • History of advanced chronic obstructive pulmonary disease
  • History of advanced heart failure
  • Presence of opt-out identification
  • Prisoner
  • Known or apparent pregnant
  • Previous enrollment in WINDSURFER
  • A patient-specific contraindication makes one assigned study intervention unsafe

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: Non-Invasive Positive Pressure Ventilation (NIPPV)
Participants (randomized) who are experiencing acute hypoxemic respiratory failure will be placed on Non-Invasive Positive Pressure Ventilation (NIPPV), by face mask.
Dispositivo: Non-Invasive Positive Pressure Ventilation
Oxygen is delivered with positive pressure through a face mask covering the nose and mouth.
Altri nomi:
  • NIPPV
Comparatore attivo: High Flow Nasal Oxygen (HFNO)
Participants (randomized) who are experiencing acute hypoxemic respiratory failure will be placed on humidified High-Flow Nasal Oxygen (HFNO), delivered to the participant through a specially designed nasal cannula.
Dispositivo: High Flow Nasal Oxygen
Humidified oxygen is delivered to the participant through a specially-designed nasal cannula.
Altri nomi:
  • HFN

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Subjects with Major Adverse Pulmonary Event (MAPE)
Lasso di tempo: a) Hospital Death up to 28 days after randomization b) Maximum of 28 ventilator days c) Maximum of 24 NIRS hours

Composite of:

  1. Hospital Death
  2. Ventilator Days
  3. Non-Invasive Respiratory Support (NIRS) Hours
a) Hospital Death up to 28 days after randomization b) Maximum of 28 ventilator days c) Maximum of 24 NIRS hours

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Subjects with New or worsening pneumonia/pneumonitis
Lasso di tempo: Up to hospital discharge or 7 days of randomization, whichever comes first.
Development or worsening of air-space disease, as identified by radiologist interpretation of chest x-rays and comparison with first chest x-ray.
Up to hospital discharge or 7 days of randomization, whichever comes first.
Number of Subjects with Acute Respiratory Distress Syndrome (ARDS)
Lasso di tempo: Up to hospital discharge or 7 days of randomization, whichever comes first.

Development or worsening of ARDS. Berlin and European Society of Intensive Care Medicine ARDS criteria, both intubated and non-intubated patients:

  • Bilateral opacities on chest x-ray or computed tomography.
  • Decreased PaO2:FiO2 or SpO2:FiO2 ratio
  • Respiratory failure not explained by heart failure or volume overload.
Up to hospital discharge or 7 days of randomization, whichever comes first.
Number of Subjects with New or worsening shock
Lasso di tempo: Up to hospital discharge or 72 hours of randomization, whichever comes first.
Requirement for vasopressors (>0.2 mcg/kg/min norepinephrine or equivalent) for >1 hour to maintain systolic blood pressure ≥90 mm Hg.
Up to hospital discharge or 72 hours of randomization, whichever comes first.

Collaboratori e investigatori

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

Sponsor

Ohio State University

Collaboratori

Medical University of South Carolina
National Heart, Lung, and Blood Institute (NHLBI)
University of Michigan
University of Arizona
Baystate Medical Center

Investigatori

  • Investigatore principale: Henry E Wang, MD, MS, Ohio State University
  • Investigatore principale: Jarrod Mosier, MD, University of Arizona
  • Investigatore principale: Mark Tidswell, MD, Baystate Health
  • Investigatore principale: Lai Wei, PhD, Ohio State University
  • Direttore dello studio: William Meurer, MD, University of Michigan - Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) Clinical Coordinating Center
  • Direttore dello studio: Robert Silbergleit, MD, University of Michigan - SIREN Clinical Coordinating Center
  • Investigatore principale: Valerie Durkalski-Mauldin, PhD, Medical University of South Carolina - SIREN Data Coordinating Center

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

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 luglio 2026

Completamento primario (Stimato)

1 agosto 2031

Completamento dello studio (Stimato)

1 agosto 2031

Date di iscrizione allo studio

Primo inviato

23 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

23 aprile 2026

Primo Inserito (Effettivo)

30 aprile 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

7 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 maggio 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • UG3HL175260 (Sovvenzione/contratto NIH degli Stati Uniti)
  • U24HL175258 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

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

SÌ

Descrizione del piano IPD

After participant enrollment and follow up have been completed and the database has been locked, the Data Coordinating Center (DCC) will prepare a de-identified dataset that will be submitted to the NHLBI data repository managed by the Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) or else where as arranged with the Institute. Requests to access the shared data after the trial is completed will be handled by the BioLINCC Coordinating Center.

Periodo di condivisione IPD

After data set locked and submitted to BioLINCC.

Criteri di accesso alla condivisione IPD

Request to BioLINCC.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF

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

Sì

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 .

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