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临床试验/NCT04356625
NCT04356625已完成不适用

Maximum Expiratory Pressure in Induced Cough as a Predictor of Extubation Failure in Intensive Care Unit Patients on Mechanical Ventilation Ready to Extubate. A Single-arm Open Clinical Trial.

Hospital Nacional Profesor Alejandro Posadas1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Extubation failure

研究概览

简要总结

Clinical trial for the evaluation of diagnostic tests. The sample was composed of adults under mechanical ventilation who passed the spontaneous breathing trial and was ready to be extubated. The maximum expiratory pressure measured in the usual way and the maximum expiratory pressure generated during the induced cough were taken as predictor variables. The outcome variable was extubation failure, measured at 72 hours and at 7 days.

详细描述

After completing the spontaneous breathing trial (SBT), with the extubation decision defined by the physician in charge of the patient and maximal expiratory pressure (MEP) as usually measured greater than 30 centimeters of water (cmH2O). Following this, the patient was allowed to rest for 5 minutes in the same condition. With the patient in the supine position sitting 45 ° to 60 °, the closed suction catheter was removed, an elbow was placed at 90 ° and a bacterial filter in series with the endotracheal tube (ET), an adapter was also coupled with a outlet port to the aneroid pressure gauge. In series an inspiratory unidirectional valve was placed that did not allow expiration. Immediately 2 ml of physiological solution was slowly instilled through the port in the 90º elbow to trigger the cough reflex. The presence or absence of reflex cough and the MEP during induced cough (MEPic) value were verified.

As a safety method, the procedures were stopped if the patient presented signs of intolerance such as respiratory rate (RF)> 35 breaths per minute, saturation <90%, heart rate (HR)> 140 beats per minute or increase of 20 % of resting levels.

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
否

入选标准

  • •Under mechanical ventilation via endotracheal tube in a period greater than 48 hours
  • •Passing the spontaneous breathing trial an be ready for extubation.
  • •Agree to participate in the study and sign the informed consent by the patient or family member

排除标准

  • •tracheostomized prior to admission to mechanical ventilation
  • •history of neuromuscular disease
  • •presence of unstable heart disease
  • •received upper digestive surgery
  • •presence of uncontained enterocutaneous fistula
  • •candidates for non-invasive ventilation as a modality of interface exchange for extubation or as a preventive modality
  • •patients who did not reach a MEP (habitual) of 30 cmH20 since they are not extubated by the extubation protocol of our institution.

研究组 & 干预措施

MEPic

Other
  • Ready for extubation (pass SBT)
  • Measurement of maximum expiratory pressure during the induced cough (MEPic)

干预措施: MEPic (Diagnostic Test)

结局指标

主要结局

Extubation failure

时间窗: 7 days

Endotracheal tube removal failure

Extubation failure

时间窗: 72 hours

Endotracheal tube removal failure

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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