RecruitingNot ApplicableNCT04658498

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


Sponsor

KU Leuven

Enrollment

90 participants

Start Date

Feb 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria11

  • 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

Exclusion Criteria9

  • 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

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Interventions

OTHERProcedure: Usual Care (UC)

Intermittent spontaneous breathing periods

OTHERProcedure: UC + HI-IMT

UC + Supervised daily sessions of training including 4 sets of 6-10 full vital capacity breaths against an external load using a tapered flow resistive device (POWERbreathe KH2, HaB International, UK). The maximum tolerable resistance allowing patients to inhale at least 70% of their inspiratory vital capacity will be chosen and progressively increased throughout the training period.

OTHERProcedure: UC + LI-IMT (sham IMT)

UC + superrvised daily sessions of training including 4 sets of 6-10 breaths at the lowest external imposable load with the tapered flow resistive device (POWERbreathe KH2, HaB International, UK) (i.e. 3 cmH2O).


Locations(1)

University Hospital Leuven

Leuven, Belgium

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NCT04658498


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