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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2017年2月15日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Mechanical Ventilation
发起方
Amsterdam UMC, location VUmc
入组人数
113
试验地点
1
主要终点
Abdominal expiratory muscle thickness
状态
已完成
最后更新
5年前

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.

注册库
clinicaltrials.gov
开始日期
2017年2月15日
结束日期
2020年10月16日
最后更新
5年前
研究类型
Observational
性别
All

研究者

发起方
Amsterdam UMC, location VUmc
责任方
Principal Investigator
主要研究者

Prof.dr. L.M.A. Heunks

Principal Investigator

Amsterdam UMC, location VUmc

入排标准

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)

研究点 (1)

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