NCT04650412终止不适用
Integrated Care of Co-morbidities vs Standard Care After Acute Hypercapnic Respiratory Failure in the Intensive Care Unit: a Randomized Controlled Trial
CTU6 个研究点 分布在 2 个国家目标入组 188 人开始时间: 2018年5月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 188
- 试验地点
- 6
- 主要终点
- Hospital readmission
研究概览
简要总结
The study will assess the potential benefit of implementing a complex bundle of interventions to treat important - often unrecognized - comorbidities in patients surviving an episode of Acute Hypercapnic Respiratory Failure (AHRF). This study will also provide a comparative analysis of the costs and health consequences of two alternative strategies to inform decision making about healthcare. All interventions are individually evidence-based and seem sound to hypothesize that implementing such interventions might improve patient's outcome and reduce the financial burder of repeated hospitalization in AHRF survivors.
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
- •Consent form signed
- •Acute hypercapnic respiratory failure defined as PaCO2 > 6.3 kPa requiring invasive or non-invasive mechanical ventilation in the ICU
排除标准
- •Age < 18 years old
- •Known or suspected neuromuscular diseases
- •Pregnancy
- •Iatrogenic respiratory failure (i.e. drug overdose, AHRF after starting opiates or increasing opiates dose)
- •Life expectancy < 3 months
- •Confusion or major psychiatric illness
- •Patient unable to be weaned from NIV
结局指标
主要结局
Hospital readmission
时间窗: 1-year observation
Hospital or ICU readmission
次要结局
- Health Related Quality of Life(Measured at regular 3, 6 and 12 months visits following patient's hospital discharge)
- Cost-effectiveness(1-year observation)
研究者
CTU
Principal investigator
University Hospital, Geneva
研究点 (6)
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