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临床试验/NCT07708506
NCT07708506进行中(未招募)不适用

Is the Degree of Hypoxemia Driving Outcome or is it a Marker of Overall Organ Dysfunction in Acute Hypoxemic Respiratory Failure?

Jesus Villar22 个研究点 分布在 2 个国家目标入组 1,241 人开始时间: 2026年7月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
1,241
试验地点
22
主要终点
Early ICU death

研究概览

简要总结

Acute hypoxemic respiratory failure (AHRF) is the most common cause of admission in the intensive care units (UCIs) worldwide. The investigators will assess the value of mediation analysis (a statistical method to understand the mechanism or process through which an independent variable influences a dependent variable (prediction of early ICU death) via a mediator variable. This allows researcher to see the "how" and "why" of a causal link, respecting the timing relationships" o "maintaining appropriate time constants in patients with AHRF me, We had a database with 2,000,000 anonymized and dissociated demographics and clinical data from 1,241 patients with AHRF enrolled in our PANDORA cohort (Prevalence AND Outcome of acute Respiratory fAilure) registered with ClinicalTrails.gov (NCT013145974) from 22 Spanish hospitals and funded by the ISCIII. The study was approved by the Ethics Committees for Clinical research of participating hospitals and informed consent was waived based on Spanish legislation for biomedical research (Royal Decrees 1090/2015 and 957/2020). The investigators will use mediation analysis (Baron & Kenny techniques) to clarify the association of extrapulmonary organ dysfunction and hypoxemia in the early prediction of ICU mortality. We will analyze 1,241 patients mechanically ventilated with AHRF at the time of diagnosis, 1,193 with data at 24 hours, and 996 patients with data at 48 hours from a epidemiological study in Spain.

详细描述

Background: Acute hypoxemic respiratory failure (AHRF) is the most common cause of admission in the intensive care units (UCIs) worldwide.

Objectives: The investigators will asess the value of mediation analysis (a statistical method to understand the mechanism or process through which an independent variable influences a dependent variable (prediction of early ICU death) via a mediator variable. This allows researcher to see the "how" and "why" of a causal link, respecting the timing relationships" o "maintaining appropriate time constants in patients with AHRF mechanically ventilated.

Methods: The investigators had a database with 2,000,000 anonymized and dissociated demographics and clinical data from 1,241 patients with AHRF enrolled in our PANDORA cohort (Prevalence AND Outcome of acute Respiratory fAilure) from 22 Spanish hospitals and funded by the ISCIII. The study was approved by the Ethics Committees for Clinical research of participating hospitals and informed consent was waived based on Spanish legislation for biomedical research (Royal Decrees 1090/2015 and 957/2020). The investigators will use mediation analysis (Baron & Kenny techniques) to clarify the association of extrapulmonary organ dysfunction and hypoxemia in the early prediction of ICU mortality. The investigators will analyze 1,241 patients mechanically ventilated with AHRF at the time of diagnosis, 1,193 with data at 24 hours, and 996 patients with data at 48 hours from a epidemiological study in Spain.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • intubation and mechanical ventilation PaO2/FiO2 ratio < or = 300 mmHg under MV with PEEP > or = 5 cmH2O, and FiO2 > 0r = 0.3

排除标准

  • Brain death patients

研究组 & 干预措施

Time on admission

The investigators will use 1241 at the time of meeting AHRF (t0)

干预措施: mediation analysis (Diagnostic Test)

Time 24

The investigaotros will use 1193 patients with AHRF, with completed data after 24 hours of mechanical ventilation

干预措施: mediation analysis (Diagnostic Test)

Time 48

The investigaotros will use 996 patients with AHRF with completed data after 48 hours of mechanical ventilation

干预措施: mediation analysis (Diagnostic Test)

结局指标

主要结局

Early ICU death

时间窗: up to 100 weeks

prediction of ICU death

Death in the intensive care unit (ICU)

时间窗: up to 100 weeks

prediction of ICU death

次要结局

未报告次要终点

研究者

发起方
Jesus Villar
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jesus Villar

Principal investigator and scientificc advisor

Hospital Universitario de Gran Canaria Doctor Negrín

研究点 (22)

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