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

Обзор

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

Подробное описание

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.

Вмешательства

• Устройство Non-Invasive Positive Pressure Ventilation
  Oxygen is delivered with positive pressure through a face mask covering the nose and mouth.
• Устройство High Flow Nasal Oxygen
  Humidified oxygen is delivered to the participant through a specially-designed nasal cannula.

Первичные конечные точки

• Number of Subjects with Major Adverse Pulmonary Event (MAPE) [Срок оценки: a) Hospital Death up to 28 days after randomization b) Maximum of 28 ventilator days c) Maximum of 24 NIRS hours]

Вторичные конечные точки (3)

• Number of Subjects with New or worsening pneumonia/pneumonitis [Срок оценки: Up to hospital discharge or 7 days of randomization, whichever comes first.]
• Number of Subjects with Acute Respiratory Distress Syndrome (ARDS) [Срок оценки: Up to hospital discharge or 7 days of randomization, whichever comes first.]
• Number of Subjects with New or worsening shock [Срок оценки: Up to hospital discharge or 72 hours of randomization, whichever comes first.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Ohio State East Hospital — Columbus
• OSU Wexner Medical Center — Columbus

Идентификаторы

NCT: NCT07558265 · UG3HL175260 · UG3HL175260 · U24HL175258

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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