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临床试验/NCT01541462
NCT01541462已完成不适用

Weaning From Prolonged Mechanical Ventilation

RML Specialty Hospital2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2000年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
500
试验地点
2
主要终点
Weaning duration

研究概览

简要总结

Patients requiring the use of artificial ventilation (also called mechanical ventilation) for more than 21 days account for more than 37% of all ICU costs. As such, these patients are now transferred to centers that specialize in weaning patients from the respirator; these units are referred to as long-term acute care (LTAC) facilities. Despite the increase of LTAC facilities, research on the fastest method for disconnecting the patient from the respirator is lacking. In addition, little information is available regarding the long-term survival and quality of life after a prolonged course of artificial ventilation. The purpose of this study is to determine the fastest method for disconnecting the patient from the respirator at a LTAC facility and its effect on long-term survival and quality of life.

详细描述

Patients requiring prolonged mechanical ventilation (defined as more than 21 days) account for more than 37% of all ICU costs. As such, these patients are now transferred to centers that specialize in weaning from mechanical ventilation, so called long-term acute care (LTAC) facilities. Despite the proliferation of LTAC facilities, research on methods for expediting weaning is lacking. In addition, little information is available regarding long-term survival and patient's perception of quality of life after a prolonged course of mechanical ventilation.

In patients receiving mechanical ventilation in an ICU, randomized trials have revealed that ventilator duration was significantly influenced by weaning methods. The two most common weaning methods are pressure support and spontaneous breathing trials. Unlike the ICU, the relative efficacy of these two techniques in weaning patients requiring prolonged ventilation at a LTAC facility is largely unknown. The aim of this proposal is to determine whether the length of time required for weaning from prolonged ventilation differs with pressure support versus spontaneous breathing trials. The second aim is to determine the long-term impact of prolonged ventilation on survival, functional status and quality of life.

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
Single (Investigator)

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

  • Mechanical Ventilation for at least 21 days

排除标准

  • Hypoxemia (oxygen saturation < 90% with fractional inspired O2 concentration > 0.40, and positive end-expiratory pressure > 5 cm H2O
  • Hemodynamic instability (requiring intravenous vasoactive agents, such as dopamine > 5 mg/kg/min)
  • Profound neurological deficits (large stroke)
  • Documented bilateral phrenic nerve injury
  • Previous admission to RML Hospital
  • Life expectancy less than 3 months

结局指标

主要结局

Weaning duration

时间窗: From the first day of randomization to the day the patient was successfully weaned up to 5 days

次要结局

  • mortality(6 and 12 month)

研究者

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

Amal Jubran

Attending Physician

RML Specialty Hospital

研究点 (2)

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