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临床试验/NCT03240263
NCT03240263已完成不适用

Inspiratory Muscle Training in Difficult to Wean Patients: a Randomised Controlled Trial

KU Leuven2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2017年9月1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
KU Leuven
入组人数
90
试验地点
2
主要终点
Weaning Success

研究概览

简要总结

Prolonged mechanical ventilation secondary to weaning failure demands a significant amount of intensive care unit (ICU) resources, thus increasing the economic burden of public healthcare costs. One of the proposed mechanisms accounting for weaning failure is the concept that excessive work of breathing for weak respiratory muscles during the liberation from mechanical ventilation compromises cerebral blood flow, thereby predisposing the brain to dysfunction. Restriction in brain perfusion could have an adverse impact on the function of the respiratory muscles by impairing the output of the respiratory centre thus promoting respiratory muscle fatigue, leading to weaning failure. Inspiratory muscle training (IMT) has been shown to improve the functional capacity of the inspiratory muscles in patients with respiratory muscle weakness whilst has been recently proposed as a possible additional component of weaning strategies. Therefore, this project aims to identify both a mechanism that might be linked to prolong ICU length of stay and that at the same time might be amenable to treatment.

详细描述

  1. Introduction.

Weaning covers the entire process of liberating the patient from mechanical ventilation (MV) support and the endotracheal tube or tracheostomy. For the majority of mechanically-ventilated patients spontaneous breathing (weaning) can be successfully accomplished quickly and easily, however, this is not the case for 15-30% of ventilated patients. The most common factors leading to weaning failure are i) respiratory muscle fatigue ii) hypercapnia iii) dyspnoea and iv) anxiety. Along these lines, a proposed a mechanism that may contribute to weaning failure namely the ''stealing effect'' theory. More specifically, the ''stealing effect'' theory hypothesizes that during the weaning process the energy demand of the respiratory muscles can increase to such an extent that respiratory muscles may deprive oxygen and blood of other tissues such as the brain. In fact, at least for the brain, the decrease in blood and oxygen delivery could theoretically predispose this organ to dysfunction. Restriction in oxygen delivery to the brain could have an adverse impact on the function of the respiratory muscles per se by impairing the output of the respiratory centre and of neuromuscular competence of the ventilatory pump, rendering the ventilatory pump incapable of inflating the lungs thus exaggerating respiratory muscle fatigue and leading to weaning failure. Inspiratory muscle training (ΙΜΤ) is a non-pharmacological and cost-effective treatment which has been shown to improve the functional capacity of the inspiratory muscles in patients with respiratory muscle weakness whilst has been recently proposed as a possible additional component of weaning strategies. Implementation of an IMT program may decrease the energy demands of inspiratory muscles by improving inspiratory muscles breathing efficiency on the one hand and by optimizing the respiratory muscle oxygen utilization on the other hand. Enhancement in muscle strength and contractile function, as well as oxidative capacity in response to IMT that have been documented in patients with chronic lung diseases in response to IMT, may increase the oxygen utilization by the inspiratory muscles thus decreasing the demand of blood flow and oxygen in favour of the cerebral cortex.

The aims of the project are:

In an observational study design:

  1. To investigate whether the inspiratory muscles steal blood and oxygen from the cerebral cortex (''stealing effect'').
  2. To investigate the effect of the ''stealing effect'' theory on weaning outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Difficult and prolonged weaning patients
  • Simple weaning patients
  • Adequate oxygenation
  • Febrile temperature < 38ºC
  • Hemodynamic stability
  • Stable blood pressure
  • No or minimal pressors
  • No myocardial ischemia
  • Adequate hemoglobin and mentation
  • Resolution of disease acute phase
  • Able to follow simple verbal commands related to IMT
  • Mechanically ventilated via a tracheostomy or endotracheal tube

排除标准

  • Pre-existing neuromuscular disease
  • Agitation
  • Hemodynamically instable (arrhythmia, decompensated heart failure, coronary insufficiency)
  • Hemoptysis
  • Diaphoresis
  • Spinal cord injury above T8
  • Use of any type of home MV support prior to hospitalization
  • Skeletal pathology that impairs chest wall movements
  • Poor general prognosis or fatal outcome

结局指标

主要结局

Weaning Success

时间窗: Maximal duration of IMT treatment: 28 days

Number of patients who were successfully weaned within 28 days after inclusion. Day of inclusion: 1st day of start of inspiratory muscle training) Weaning success defined for intubated patients as extubation without death or reintubation within 7 days or ICU discharge without invasive mechanical ventilation within 7days. Tracheotomized patients achieved successful weaning by sustaining spontaneous ventilation without ventilatory support for 7 days or being discharged with spontaneous breathing within 7 days.

次要结局

  • ICU mortality(Maximal duration of IMT treatment: 28 days)
  • 28-day ventilator-free days(Maximal duration of IMT treatment: 28 days)
  • Length of stay in the ICU(Maximal duration of IMT treatment: 28 days)
  • Weaning duration after inclusion(Maximal duration of IMT treatment: 28 days)
  • Duration of mechanical ventilation(Maximal duration of IMT treatment: 28 days)
  • Weaning Success at ICU discharge(Through study completion, an average of 70 days)
  • Weaning duration(Maximal duration of IMT treatment: 28 days)
  • Length of stay in the hospital(Maximal duration of IMT treatment: 28 days)
  • Hospital mortality(Maximal duration of IMT treatment: 28 days)
  • Maximal inspiratory pressure(Maximal duration of IMT treatment: 28 days)
  • Vital Capacity(Maximal duration of IMT treatment: 28 days)
  • Peak inspiratory flow(Maximal duration of IMT treatment: 28 days)
  • rapid shallow breathing index(Maximal duration of IMT treatment: 28 days)
  • Inspiratory muscles fractional oxygen availability(Maximal duration of IMT treatment: 28 days)

研究者

发起方
KU Leuven
申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Langer

PT, PhD

KU Leuven

研究点 (2)

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