WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 试验地点
- 19
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Known or apparent pregnant
- •Previous enrollment in WINDSURFER
- •A patient-specific contraindication makes one assigned study intervention unsafe
研究组 & 干预措施
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.
干预措施: Non-Invasive Positive Pressure Ventilation (Device)
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.
干预措施: High Flow Nasal Oxygen (Device)
研究者
Henry Wang, MD
Principal Investigator
Ohio State University