此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

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

2026年5月5日 更新者：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

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

500

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

  • 姓名：Valerie L Durkalski-Mauldin, PhD
  • 电话号码：843-876-1911
  • 邮箱：durkalsv@musc.edu

学习地点

  • 美国
    • Ohio
      • Columbus、Ohio、美国、43210
        • OSU Wexner Medical Center
        • 接触：
        • 首席研究员：
          • Jason Bischof, MD
        • 接触：
      • Columbus、Ohio、美国、43203
        • Ohio State East Hospital
        • 接触：
        • 首席研究员：
          • Jason Bischof, MD
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：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.
设备：Non-Invasive Positive Pressure Ventilation
Oxygen is delivered with positive pressure through a face mask covering the nose and mouth.
其他名称：
  • NIPPV
有源比较器：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.
设备：High Flow Nasal Oxygen
Humidified oxygen is delivered to the participant through a specially-designed nasal cannula.
其他名称：
  • 高频氮氧化物

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of Subjects with Major Adverse Pulmonary Event (MAPE)
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Number of Subjects with New or worsening pneumonia/pneumonitis
大体时间：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)
大体时间：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
大体时间：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.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Ohio State University

合作者

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

调查人员

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

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月1日

初级完成 (估计的)

2031年8月1日

研究完成 (估计的)

2031年8月1日

研究注册日期

首次提交

2026年4月23日

首先提交符合 QC 标准的

2026年4月23日

首次发布 (实际的)

2026年4月30日

研究记录更新

最后更新发布 (实际的)

2026年5月7日

上次提交的符合 QC 标准的更新

2026年5月5日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • UG3HL175260 (美国 NIH 拨款/合同)
  • U24HL175258 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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 共享时间框架

After data set locked and submitted to BioLINCC.

IPD 共享访问标准

Request to BioLINCC.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅