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临床试验/NCT01967056
NCT01967056Unknown不适用

Predictors of Respiratory Failure Following Extubation in Teh Surgical Intensive Care Unit (SICU)

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 750 人开始时间: 2013年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
750
试验地点
1
主要终点
Respiratory Failure

研究概览

简要总结

Respiratory failure following extubation causes significant morbidity and increases mortality in teh surgical intensive care unit (SICU). However the causes of respiratory failure following extubation remain poorly understood. The investigators hypothesize that extubation failure can be predicted based on preoperative risk factors as well as ICU acquired morbidities including muscle weakness and renal failure.

详细描述

Both extubation delay and extubation failure are related to adverse outcomes. A spontaneous breathing trial is therefore recommended to predict extubation readiness. However, depending on the disease entity and local culture, a range of 10-20 per cent incidence of extubation failure has been described from tertiary care hospitals. The aim of this trial is to identify additional variables in surgical patients that can be used to support a clinician's decision on whether or not to extubate a patient's trachea.

Te investigators have recently developed and validated the SPORC (Brueckmann, 2013), a score that predicts the risk of extubation failure following surgery based on patients comorbidities and the acuity of the disease leading to surgery, and the investigators hypothesize that the SPORC will also predict extubation failure in the surgical ICU.

In addition, it is likely that ICU acquired morbidity also predicts extubation failure. In fact, the investigators have recently shown that muscle weakness is a predictor of aspiration (Mirzakhani, 2013), and the investigators speculated that muscle weakness may also respiratory failure after extubation.

Finally, it has been suggested that the increased mortality seen in patients with acute kidney injury (AKI) requiring continuous renal replacement therapy (CRRT) versus end stage renal disease (ESRD) patients requiring CRRT can be attributed to an increased need for mechanical ventilation. (Walcher, 2011). Therefore, the investigators also hypothesize that acute kidney injury increases the vulnerability of patients to postextubation respiratory failure.

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

入选标准

  • Adults (18 years of age or greater)
  • Patients who have been extubated following mechanical ventilation in the surgical ICU

排除标准

  • Preexisting end-stage renal disease
  • Neurological disorder associated with severe muscle weakness
  • Goals of care focused on comfort

结局指标

主要结局

Respiratory Failure

时间窗: 30 days

The investigators defined respiratory failure as a composite endpoint including reintubation within 72 hours, use of non-invasive ventilation for treatment of extubation failure, and tracheostomy during hospitalization (expected time of 30 days post extubation)

次要结局

  • Reintubation within 72 hours(72 hours)
  • Non-invasive ventilation for treatment of extubation failure(72 hours)
  • SICU length of stay(180 days)
  • Tracheostomy(Patients will be followed for 30 days of hospitalization)
  • Hospital length of stay(180 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ulrich Schmidt

Associate Professor of Anesthesia

Massachusetts General Hospital

研究点 (1)

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