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临床试验/NCT00502489
NCT00502489Unknown不适用

Computer Driven Management of Weaning Following Prolonged Mechanical Ventilation: a Pilot Study

Rabin Medical Center0 个研究点目标入组 50 人开始时间: 2007年10月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
主要终点
Maintenance of spontaneous breathing

研究概览

简要总结

After an episode of acute respiratory failure requiring mechanical ventilation, weaning the patient from the ventilator may be difficult. Discontinuation of ventilation is estimated to take up to 40% of the total duration of ventilatory support. Approximately two- thirds of patients can be disconnected from the ventilator after a spontaneous breathing trial. Prolongation of mechanical ventilation may increase the risk of adverse events such as infections and can increase morbidity and mortality.

Identifying weaning readiness early and reliably is therefore crucial. Weaning protocols developed to assist in identifying weaning readiness have been shown to shorten duration of mechanical ventilation, most notably the weaning period.

Closed loop knowledge-based systems serve as a continuously applied weaning process that automatically reduce ventilatory assistance according to patient ability and indicate when the patient is ready for disconnection. No data on the use of such a computer driven system (CDS) in elderly patients requiring prolonged ventilation in weaning centers (non ICU) have been reported.

The Objective of the present study is to evaluate the ability of a computer driven system to predict weaning readiness and to compare this to a physician-directed protocol. The CDS continuously adapts pressure support, gradually decreasing ventilator assistance according to patient ability, and thus indicates weaning readiness. Patients who maintain spontaneous breathing for 7 days following weaning will be considered to be successfully weaned from mechanical ventilation.

详细描述

Introduction.

After an episode of acute respiratory failure requiring mechanical ventilation, weaning the patient from the ventilator may be difficult. Discontinuation of ventilation is estimated to take up to 40% of the total duration of ventilatory support. Approximately two- thirds of patients can be disconnected from the ventilator after a spontaneous breathing trial. Prolongation of mechanical ventilation may increase the risk of adverse events such as infections and can increase morbidity and mortality.

Identifying weaning readiness early and reliably is therefore crucial. Weaning protocols developed to assist in identifying weaning readiness have been shown to shorten duration of mechanical ventilation, most notably the weaning period.

Closed loop knowledge-based systems serve as a continuously applied weaning process that automatically reduce ventilatory assistance according to patient ability and indicate when the patient is ready for disconnection. No data on the use of such a computer driven system (CDS) in elderly patients requiring prolonged ventilation in weaning centers (non ICU) have been reported.

Objective:

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
60 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Pressure support ventilation (PSV) for at least 48 h,
  • •Plateau pressure less than 30 cmH2O,
  • •PEEP < 6 cmH2O, PaO2/FIO2 ratio > 150 or SaO2 > 94% with FIO2 < than 0.5,
  • •pCO2 <55 mm Hg for normal patients and < 65 m Hg for patients with COPD,
  • •No requirement for inotropic support,
  • •Body temperature > 36.50C and < 38.50 C,
  • •Stable neurological status with Glasgow Coma Score (GCS) > 6, HgB > 8 mg %,
  • •Systolic blood pressure >90 mg Hg,
  • •Mean arterial pressure >65 mg Hg,
  • •Absence of sedative medications and availability of CDS at the time of patient admission or switching to pressure support ventilation (PSV).

排除标准

  • •Patients younger than 60 or older than 85 years of age,
  • •Patients on chronic ventilatory assistance at home; and
  • •Patients with decision to limit life-sustaining treatments

结局指标

主要结局

Maintenance of spontaneous breathing

时间窗: 7 days

次要结局

未报告次要终点

研究者

申办方类型
Other

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