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临床试验/NCT02946502
NCT02946502已完成不适用

Prognostic Value of Dominant Hand Held Dynamometry in Mechanical Ventilation Weaning: a Prospective, Multicenter Study

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 261 人开始时间: 2017年1月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
261
试验地点
1
主要终点
extubation outcome according to handgrip strength value

研究概览

简要总结

The purpose of this study is to test the association between ICU acquired weakness as evaluated by dominant handheld dynamometry (handgrip) and the mechanical ventilation weaning outcome

详细描述

Previous studies have evidenced that Intensive Care Unit acquired peripheral muscle weakness may lead to delayed mechanical ventilation weaning (i.e difficult or prolonged weaning according to guidelines). Nevertheless, no study has ever tested the association between handgrip strength and extubation outcome. The investigators have generated the hypothesis that ICU acquired weakness, as tested by handgrip strength might be associated with extubation outcome. The investigators have planned to include 240 patients. Handgrip strength will be monitored, along with a full muscular assessment through Medical Research Council score by the attending physiotherapist. Physicians in charge of the patients will be blinded to these values and the weaning protocol will continue according to guidelines.

研究设计

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

  • adult patients
  • under mechanical ventilation for at least 48 hours
  • meeting readiness to wean criteria according to international guidelines
  • with social security
  • informed consent given by the patient or a proxy

排除标准

  • baseline pre existing rheumatologic or neurologic condition preventing the patient to use the tested device
  • confusion (as assessed by Confusion Assessment Method for the Intensive Care Unit )
  • Patients whose extubation is a terminal extubation, or with prior decision not to resort a reintubation in case of post-extubation respiratory distress.
  • known pregnancy
  • Inability to deliver clear patient information (language barrier without an interpreter, for example)
  • Participation in another intervention research

结局指标

主要结局

extubation outcome according to handgrip strength value

时间窗: 7 days

Each mechanical ventilation weaning trial

次要结局

  • Association between handgrip strength and cough strength as assessed through peak expiratory flow evaluated with a portable spirometer(7 days)
  • Association between handgrip strength and maximal inspiratory strength during a brief inspiratory valve occlusion on the ventilator(7 days)
  • Association between handgrip strength defined Intensive Care Unit acquired weakness and Intensive Care Unit and hospital survival(18 months)
  • Association between handgrip strength and difficulty of weaning according to guidelines(7 days)
  • Association between handgrip strength and peripheral muscular strength evaluated by the Medical Research Council score(7 days)
  • Association between handgrip strength and the peripheral muscular strength evaluated by the Medical Research Council score. (Global score and its components)(7 days)
  • Association between handgrip strength defined Intensive Care Unit acquired weakness and Intensive Care Unit and hospital length of stay(18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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