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

5. Mai 2026 aktualisiert von: 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

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

500

Phase

  • Unzutreffend

Kontakte und Standorte

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

Studienkontakt

Studieren Sie die Kontaktsicherung

  • Name: Valerie L Durkalski-Mauldin, PhD
  • Telefonnummer: 843-876-1911
  • E-Mail: durkalsv@musc.edu

Studienorte

  • Vereinigte Staaten
    • Ohio
      • Columbus, Ohio, Vereinigte Staaten, 43210
        • OSU Wexner Medical Center
        • Kontakt:
        • Hauptermittler:
          • Jason Bischof, MD
        • Kontakt:
      • Columbus, Ohio, Vereinigte Staaten, 43203
        • Ohio State East Hospital
        • Kontakt:
        • Hauptermittler:
          • Jason Bischof, MD
        • Kontakt:

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

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

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: 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.
Gerät: Non-Invasive Positive Pressure Ventilation
Oxygen is delivered with positive pressure through a face mask covering the nose and mouth.
Andere Namen:
  • NIPPV
Aktiver Komparator: 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.
Gerät: High Flow Nasal Oxygen
Humidified oxygen is delivered to the participant through a specially-designed nasal cannula.
Andere Namen:
  • HFNO

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Subjects with Major Adverse Pulmonary Event (MAPE)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Subjects with New or worsening pneumonia/pneumonitis
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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.

Mitarbeiter und Ermittler

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

Sponsor

Ohio State University

Mitarbeiter

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

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

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. Juli 2026

Primärer Abschluss (Geschätzt)

1. August 2031

Studienabschluss (Geschätzt)

1. August 2031

Studienanmeldedaten

Zuerst eingereicht

23. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

23. April 2026

Zuerst gepostet (Tatsächlich)

30. April 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

7. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

5. Mai 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • UG3HL175260 (US NIH Stipendium/Vertrag)
  • U24HL175258 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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.

IPD-Sharing-Zeitrahmen

After data set locked and submitted to BioLINCC.

IPD-Sharing-Zugriffskriterien

Request to BioLINCC.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Ja

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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