Stratification of the Acute Respiratory Distress Syndrome - A Second Phase Study (STANDARDS-2)
STratification AND Outcome of Patients With the Acute Respiratory Distress Syndrome - A Second Phase Study
研究概览
地位
条件
详细说明
In 2012, an update of the ARDS definition (The Berlin criteria) was published and an empirical classification was proposed according to three PaO2/FiO2 cut-off values at ARDS onset: severe (≤100 mmHg), moderate (>100 - ≤200 mmHg), and mild (>200 - ≤300 mmHg) on positive end-expiratory pressure (PEEP) ≥5 cmH2O. However, despite that there is sufficient evidence about the interactions between PEEP and FiO2, these cut-off values did not mandate the assessment of hypoxemia under standardized guidelines.
The PaO2/FiO2 can be easily manipulated. Alterations in PEEP and FiO2 can dramatically change the PaO2/FiO2. Despite recent reports on the effects of standardized ventilator settings on PaO2/FiO2, is still a matter of debate whether the assessment of hypoxemia must be performed at 24 hours instead of at ARDS onset, and whether the assessment of hypoxemia under standardized ventilator settings is the most appropriate tool for stratifying lung severity in patients with ARDS.
The investigators will examine whether the values of relevant variables (including age, plateau pressure, driving pressure, compliance, PaO2/FiO2) at 24 after ARDS diagnosis under standardized ventilator settings have an impact on the stratification and prediction of death in ARDS patients. This study is an extension of the study NCT02288949.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Ciudad Real、西班牙
- Hospital General de Ciudad Real
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Cuenca、西班牙
- Hospital Virgen De La Luz
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La Coruña、西班牙
- Hospital Universitario de A Coruña
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Madrid、西班牙
- Hospital Universitario 12 de Octubre
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Madrid、西班牙
- Hospital Universitario Fundación Jiménez Díaz
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Madrid、西班牙
- Hospital Universitario de La Paz
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Murcia、西班牙
- Hospital Universitario Morales Meseguer
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Murcia、西班牙
- Hospital Universitario de Arrixaca
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Segovia、西班牙
- Hospital General de Segovia
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Valencia、西班牙
- Hospital Clínico de Valencia
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Valladolid、西班牙
- Hospital Clínico Universitario de Valladolid
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Valladolid、西班牙
- Hospital Universitario Río Hortega
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Zamora、西班牙
- Hospital Virgen de la Concha
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Barcelona
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Terrassa、Barcelona、西班牙
- Hospital Universitario Mutua de Terrassa
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León
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Ponferrada、León、西班牙
- Hospital del Bierzo
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Tenerife
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Santa Cruz de Tenerife、Tenerife、西班牙
- Hospital Universitario NS de Candelaria
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Patients meeting the Berlin criteria for moderate and severe ARDS.
Exclusion Criteria:
- None
学习计划
研究是如何设计的?
设计细节
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 |
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variables associated with highest and lowest mortality
大体时间:at 24 hours
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variables associated with highest and lowest mortality
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at 24 hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
stratification by risk of death
大体时间:at 24 hours
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stratification by risk of death
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at 24 hours
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合作者和调查者
合作者
调查人员
- 首席研究员:Jesús Villar, MD, PhD、Hospital Universitario Dr. Negrin
出版物和有用的链接
一般刊物
- Villar J, Gonzalez-Martin JM, Ambros A, Mosteiro F, Martinez D, Fernandez L, Soler JA, Parra L, Solano R, Soro M, Del Campo R, Gonzalez-Luengo RI, Civantos B, Montiel R, Pita-Garcia L, Vidal A, Anon JM, Ferrando C, Diaz-Dominguez FJ, Mora-Ordonez JM, Fernandez MM, Fernandez C, Fernandez RL, Rodriguez-Suarez P, Steyerberg EW, Kacmarek RM; Spanish Initiative for Epidemiology, Stratification and Therapies of ARDS (SIESTA) Network. Stratification for Identification of Prognostic Categories In the Acute RESpiratory Distress Syndrome (SPIRES) Score. Crit Care Med. 2021 Oct 1;49(10):e920-e930. doi: 10.1097/CCM.0000000000005142.
- Villar J, Ambros A, Mosteiro F, Martinez D, Fernandez L, Ferrando C, Carriedo D, Soler JA, Parrilla D, Hernandez M, Andaluz-Ojeda D, Anon JM, Vidal A, Gonzalez-Higueras E, Martin-Rodriguez C, Diaz-Lamas AM, Blanco J, Belda J, Diaz-Dominguez FJ, Rico-Feijoo J, Martin-Delgado C, Romera MA, Gonzalez-Martin JM, Fernandez RL, Kacmarek RM; Spanish Initiative for Epidemiology, Stratification and Therapies of ARDS (SIESTA) Network. A Prognostic Enrichment Strategy for Selection of Patients With Acute Respiratory Distress Syndrome in Clinical Trials. Crit Care Med. 2019 Mar;47(3):377-385. doi: 10.1097/CCM.0000000000003624.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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