EndotyPIng PreHospitAl de Novo Acute hYpoxemic Respiratory Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- Identification of dynamic endotypes of acute hypoxemic respiratory failure
研究概览
简要总结
We attempt to perform dynamic endotyping of critically ill patients presenting in the emergency department with de novo acute hypoxemic respiratory failure (AHRF). We also attempt to identify what clinical, radiological, physiological and biological variables collected early in the course of AHRF correlate with subsequent mortality and/or persistent severe hypoxemia.
详细描述
Rationale:
Even before the pandemic of the new coronavirus disease (COVID-19), acute respiratory distress syndrome (ARDS), the most severe form of acute hypoxemic respiratory failure (AHRF), constituted a public health challenge. Despite the intense research on identifying targeted pharmacological therapies for ARDS, there is no available treatment for the syndrome.
The failure of clinical trials exploring pharmacological therapies for ARDS has been attributed to incomplete understanding of the pathogenesis and heterogeneity of the syndrome. As examples of the heterogeneity of ARDS, our recent work has identified differential outcomes of patients with ARDS depending on whether hypoxemia is rapidly improving or persistent severe or associated with non-identifiable risk factors or associated with neutropenia. It is advocated that the heterogeneity of ARDS can be tangled by a precision approach, which identifies endotypes of ARDS; i.e., subtypes characterized by a distinct biological profile that might share mortality risk, clinical course, or treatment responsiveness.
Notwithstanding their contributions, current research efforts on endotyping ARDS might be limited by the fact that they are based on the current conceptual framework of the syndrome, which has been widely questioned. Indeed, for reasons such as high interobserver variability of radiological criteria of ARDS and exclusion of patients requiring high-flow nasal oxygen, influential experts have even suggested to completely abandon the term.
Objective:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult patients (aged >18 years) presenting in the emergency department
- •De novo acute hypoxemic respiratory failure (requiring oxygen flow rate of 5 liters per minute or more to maintain SpO2 of 90% or more)
排除标准
- •Age <18 years
- •Not admitted to the hospital
- •Postoperative acute respiratory failure (within one week from surgery)
- •Chronic hypoxemic respiratory failure (requiring long term oxygen therapy at home)
- •Hypercapnic respiratory failure
- •Transferred from another hospital or facility
- •Pregnant women
- •Admitted to the hospital purely to facilitate comfort care
- •Lack of informed consent
研究组 & 干预措施
Patients with de novo acute hypoxemic respiratory failure
We will consider for inclusion patients presenting in the emergency department with de novo acute hypoxemic respiratory failure (AHRF). De novo AHRF is defined as the requirement of oxygen flow rate of 5 liters per minute or more to maintain SpO2 of 90% or more in a patient who does not receive long term oxygen therapy.
结局指标
主要结局
Identification of dynamic endotypes of acute hypoxemic respiratory failure
时间窗: Until death or hospital discharge, assessed up to 28 days following presentation to the emergency department
Mutually exclusive subgroups of patients (clusters) characterized by a distinct biological profile that might share mortality risk, clinical course, and/or treatment responsiveness.
次要结局
- Persistent severe hypoxemia(Until 28 days following presentation to emergency department)
- Intensive care unit-free days(Until 28 days following presentation to emergency department)
- Ventilator-free days(Until 28 days following presentation to emergency department)
- Bacteremia(Until 28 days following presentation to emergency department)
- All-cause mortality(Until death or hospital discharge, assessed up to 28 days following presentation to the emergency department)
- Vasopressor-free days(Until 28 days following presentation to emergency department)
- Continuous renal replacement therapy-free days(Until 28 days following presentation to emergency department)
研究者
Ilias Siempos
Assistant Professor in Critical Care and Pulmonary Medicine
Evangelismos Hospital