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

5 de mayo de 2026 actualizado por: 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

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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 de estudio

Intervencionista

Inscripción (Estimado)

500

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Henry E Wang, MD, MS
  • Número de teléfono: 614-648-1372
  • Correo electrónico: Henry.wang@osumc.edu

Copia de seguridad de contactos de estudio

  • Nombre: Valerie L Durkalski-Mauldin, PhD
  • Número de teléfono: 843-876-1911
  • Correo electrónico: durkalsv@musc.edu

Ubicaciones de estudio

  • Estados Unidos
    • Ohio
      • Columbus, Ohio, Estados Unidos, 43210
        • OSU Wexner Medical Center
        • Contacto:
        • Investigador principal:
          • Jason Bischof, MD
        • Contacto:
      • Columbus, Ohio, Estados Unidos, 43203
        • Ohio State East Hospital
        • Contacto:
        • Investigador principal:
          • Jason Bischof, MD
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: 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.
Otros nombres:
  • VPPNI
Comparador activo: 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.
Otros nombres:
  • HFNO

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Subjects with Major Adverse Pulmonary Event (MAPE)
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Subjects with New or worsening pneumonia/pneumonitis
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Ohio State University

Colaboradores

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

Investigadores

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

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de julio de 2026

Finalización primaria (Estimado)

1 de agosto de 2031

Finalización del estudio (Estimado)

1 de agosto de 2031

Fechas de registro del estudio

Enviado por primera vez

23 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

23 de abril de 2026

Publicado por primera vez (Actual)

30 de abril de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

7 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

5 de mayo de 2026

Última verificación

1 de abril de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • UG3HL175260 (Subvención/contrato del NIH de EE. UU.)
  • U24HL175258 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan 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.

Marco de tiempo para compartir IPD

After data set locked and submitted to BioLINCC.

Criterios de acceso compartido de IPD

Request to BioLINCC.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

Sí

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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