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临床试验/NCT04658498
NCT04658498招募中不适用

Improving Our Understanding of Respiratory Muscle Training to Facilitate Weaning From Mechanical Ventilation in the ICU

KU Leuven1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年2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
招募中
发起方
KU Leuven
入组人数
90
试验地点
1
主要终点
Maximal Inspiratory Pressure (PImax)

研究概览

简要总结

Mechanical ventilation is a life-saving treatment frequently applied in intensive care unit (ICU). Nonetheless, by putting at rest the respiratory muscles, it can lead to respiratory muscle weakness and atrophy, which are accompanied by prolonged duration of mechanical ventilation, difficult weaning and increased ICU mortality. Despite a strong theoretical rationale and some evidence supporting the use of inspiratory muscle training (IMT) to address respiratory muscle weakness and atrophy, the optimal approach to IMT remains largely uncertain. In fact, mechanistic studies evaluating physiological adaptations that occur in respiratory muscles of mechanically ventilated patients in response to different training regimens have not been conducted so far.

The aim of this study is to comprehensively investigate changes in respiratory muscle function in response to three different conditions that patients will be exposed to during their period of weaning from mechanical ventilation.

详细描述

A majority of mechanically ventilated patients develop respiratory muscle weakness during critical illness.

The potential value of implementing rehabilitative interventions for respiratory muscle conditioning are supported by observations showing that respiratory muscle weakness is associated with prolonged duration of mechanical ventilation, difficult weaning, and increased ICU mortality.

Despite a strong theoretical rationale and some evidence supporting its use, mechanistic studies evaluating physiological adaptations that occur in respiratory muscles of mechanically ventilated patients in response to different training regimens have not been performed so far. Consequently, the characterization of IMT modalities and of the optimal approach to IMT remain largely uncertain.

To date, the great part of the studies on the topic employed an external mechanical threshold device to perform trainings, in general adopting loads ranging between 10-50% of maximal inspiratory strength (i.e. maximal inspiratory pressure (PImax)). Intermittent spontaneous breathing periods (e.g. using partially assisted or spontaneous modes of ventilation) are also frequently applied as an activating stimulus to the respiratory muscles during periods of mechanical ventilation.

A tapered flow resistive load (TFRL) device (POWERbreathe KH2, HaB International, UK) has been already tested and implemented at University Hospital Leuven as a way of loading respiratory muscles in ICU patients. The TFRL approach represents a potential more optimal way of loading the respiratory muscles in patients on prolonged mechanical ventilation. Such a loading approach allows higher inspiratory tidal volumes to be reached and higher work and power generation during trainings, by adapting to changes in length-tension characteristics of the inspiratory muscles during inspiration.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Difficult and prolonged weaning patients
  • Adequate oxygenation
  • Febrile temperature < 38ºC
  • Hemodynamic stability
  • Stable blood pressure
  • No or minimal vasopressors
  • 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

研究组 & 干预措施

Usual Care (UC)

Experimental

Intermittent spontaneous breathing periods

干预措施: Procedure: Usual Care (UC) (Other)

UC + High-intensity inspiratory muscle training (HI-IMT)

Experimental

干预措施: Procedure: UC + HI-IMT (Other)

UC + Low-intensity inspiratory muscle training (LI-IMT) (sham IMT)

Experimental

干预措施: Procedure: UC + LI-IMT (sham IMT) (Other)

结局指标

主要结局

Maximal Inspiratory Pressure (PImax)

时间窗: Maximal duration of IMT treatment: 28 days

Using a unidirectional valve which will be connected to the patient's tracheostomy tube or endotracheal tube for an uninterrupted period of 25 seconds.

次要结局

  • Change in cell differentiation of sternocleidomastoid muscle(Maximal duration of IMT treatment: 28 days)
  • Change in amount of fibrotic tissue of sternocleidomastoid muscle(Maximal duration of IMT treatment: 28 days)
  • Change in signal amplitude of electromyography of extra-diaphragmatic respiratory muscles(Maximal duration of IMT treatment: 28 days)
  • Change in contractile material and structural alteration of sternocleidomastoid muscle(Maximal duration of IMT treatment: 28 days)
  • Change in fiber proportion of sternocleidomastoid muscle fibers(Maximal duration of IMT treatment: 28 days)
  • Change in cell proliferation of sternocleidomastoid muscle(Maximal duration of IMT treatment: 28 days)
  • Change in Tissue Oxygenation Index (TOI) of ex of extra-diaphragmatic respiratory muscles(Maximal duration of IMT treatment: 28 days)
  • Esophageal and gastric pressure(Maximal duration of IMT treatment: 28 days)
  • Change in amount of satellite cells of sternocleidomastoid muscle(Maximal duration of IMT treatment: 28 days)
  • Change of gene expression of atrophy/hypertrophy related pathways of sternocleidomastoid muscle(Maximal duration of IMT treatment: 28 days)
  • Change in signal amplitude of diaphragm electromyography(Maximal duration of IMT treatment: 28 days)
  • Diaphragm mobility, thickness and thickening fraction by ultrasounds(Maximal duration of IMT treatment: 28 days)
  • Change in size of sternocleidomastoid muscle fibers(Maximal duration of IMT treatment: 28 days)
  • Change in Blood Flow Index (BFI) of extra-diaphragmatic respiratory muscles(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 (1)

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