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临床试验/NCT04333186
NCT04333186已完成不适用

Expiratory Muscle Function in Critically Ill Ventilated Patients

Amsterdam UMC, location VUmc1 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2017年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
113
试验地点
1
主要终点
Abdominal expiratory muscle thickness

研究概览

简要总结

Inspiratory muscle weakness develops rapidly in ventilated critically ill patients and is associated with adverse outcome, including prolonged duration of mechanical ventilation and mortality. Surprisingly, the effects of critical illness on expiratory muscle function have not been studied.

The main expiratory muscles are the abdominal wall muscles, including the external oblique (EO), internal oblique (IO) and transversus abdominis muscles (TRA). These muscles are activated when respiratory drive or load increases, which can be during e.g. exercise, diaphragm fatigue, increased airway resistance, or positive airway pressure ventilation. The abdominal wall muscles are also critical for protective reflexes, such as coughing. Reduced abdominal muscles strength may lead to decreased cough function and thus inadequate airway clearance. This will lead to secretion pooling in the lower airways, atelectasis, and ventilator associated pneumonia (VAP). Studies have shown that decreased cough function is a risk for weaning failure and (re)hospitalization for respiratory complications. Further, high mortality was found in patients with low peak expiratory flow.

Considering the importance of a proper expiratory muscle function in critically ill patients, it is surprising that the prevalence, causes, and functional impact of changes in expiratory abdominal muscles thickness during mechanical ventilation (MV) for critically ill patients are still unknown.

Ultrasound is increasingly used in the ICU for the visualization of respiratory muscles. In a recent pilot study the investigators confirmed the feasibility and reliability of using of ultrasound to evaluate both diaphragm and expiratory abdominal muscle thickness in ventilated critically ill patients (manuscript in preparation). Accordingly, the primary aim of the present study is to evaluate the evolution of abdominal expiratory muscle thickness during MV in adult critically ill patients, using ultrasound data.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Age > 18 years
  • Invasive mechanical ventilation < 48 hours
  • Expected duration of mechanical ventilation > 72 hours

排除标准

  • Past medical history of neuromuscular disorders
  • Mechanical ventilation > 48 hours within the current hospital admission
  • Pregnant women
  • Open abdominal wounds at proposed location of the ultrasound probe, due to recent abdominal surgery

结局指标

主要结局

Abdominal expiratory muscle thickness

时间窗: From the date of inclusion until the date of first extubation or date of death from any cause, whichever came first, assessed up to 6 weeks

Thickness of the abdominal expiratory muscles measured in millimeters

次要结局

  • Extubation failure(From the date of extubation to the date of reintubation, or the date of death from any cause, or the date of ICU discharge, whichever came first, assessed up to 6 weeks)
  • Positive end expiratory pressure(From the date of inclusion until the date of first extubation or date of death from any cause, whichever came first, assessed up to 6 weeks)
  • Diaphragm muscle thickness(From the date of inclusion until the date of first extubation or date of death from any cause, whichever came first, assessed up to 6 weeks)
  • Inflammatory markers(Within 24 hours after inclusion)
  • Applied driving pressure(From the date of inclusion until the date of first extubation or date of death from any cause, whichever came first, assessed up to 6 weeks)
  • Tidal volume(From the date of inclusion until the date of first extubation or date of death from any cause, whichever came first, assessed up to 6 weeks)
  • Readmission to ICU(From the date of ICU diascharge to the date of death from any cause, or the date of hospital discharge, whichever came first, assessed up to 6 weeks)

研究者

发起方
Amsterdam UMC, location VUmc
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof.dr. L.M.A. Heunks

Principal Investigator

Amsterdam UMC, location VUmc

研究点 (1)

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