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临床试验/NCT01411722
NCT01411722已完成2 期

Electrical Activity of the Diaphragm in Mechanically Ventilated Patients During the Weaning Period

University of Turin, Italy2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2008年9月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
50
试验地点
2
主要终点
Electrical activity of the diaphragm as a predictor of weaning outcome

研究概览

简要总结

The study aims to assess 1) the electrical activity of the diaphragm in mechanically ventilated patients during weaning from mechanical ventilation. 2) Whether the electrical activity of the diaphragm may predict the weaning outcome

详细描述

Optimization of the time to liberate the patient from mechanical ventilation should be balanced between the risks associated with failed extubation and those related to prolonged mechanical ventilation. Weaning failure is associated with major complications. Even when weaning protocols and clinical predictors have been used to improve the weaning outcome, there is still a significant proportion of patients who fail to breath spontaneously with significant risks of pneumonia, prolonged mechanical ventilation and increased morbidity and mortality rate. Electrical activity of the diaphragm, a mirror of the respiratory drive and now available on an ICU ventilator may help to predict in a more accurate way the weaning outcome. The patients will be ventilated in NAVA with the titration method (1). As soon as patients passed successfully a daily screening EAdi will be measured during a spontaneous breathing trial.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

入选标准

  • All patients older than 18 years and mechanically ventilated for >= 48 h.
  • In the resolving stage of the disease which brought to mechanical ventilation.
  • Pao2/Fio2 ratio >150 on positive end-expiratory pressure (PEEP) <=8 cm H2O.
  • Sedation discontinued for a minimum of 24 hrs
  • Analgesia provided solely with morphine at a dosage of less or equal to 0.01 mg/kg/hr.
  • Patient fully alert and cooperative.
  • Intact respiratory drive evaluated with Glasgow Coma Scale >=10.

排除标准

  • The attending physician refuses to allow enrolment
  • The patient refuses informed consent
  • Hemodynamic instability despite adequate filling (i.e. need for continuous infusion of epinephrine or vasopressin, or dopamine or dobutamine > 5 mcg/kg/min or norepinephrine > 0.1 mcg/kg/min to maintain systolic arterial blood pressure > 90 mmHg)
  • No collaborative Patient
  • Coagulation or platelets disorders
  • neuromuscular disease
  • phrenic nerve damage/diaphragm paralysis
  • contraindication to exchange naso-gastric tube
  • History of heart or lung transplantation
  • Presence or suspicion of a central nervous system disorder

结局指标

主要结局

Electrical activity of the diaphragm as a predictor of weaning outcome

时间窗: 48 hours

次要结局

  • Comparison of electrical activity of the diaphragm as a predictor versus other predictors(48 hours)
  • Evaluation of respiratory parameters during the weaning process(48 hours)

研究者

发起方
University of Turin, Italy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marco Ranieri

MD Professor

University of Turin, Italy

研究点 (2)

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