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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKU Leuven

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Difficult and prolonged weaning patients

Adequate oxygenation

Febrile temperature < 38ºC

Hemodynamic stability

Disqualifiers

Pre-existing neuromuscular disease

Agitation

Hemodynamically instable (arrhythmia, decompensated heart failure, coronary insufficiency)

Hemoptysis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Procedure: Usual Care (UC)

    Other intervention

    Intermittent spontaneous breathing periods

  • Procedure: UC + HI-IMT

    Other intervention

    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.

  • Procedure: UC + LI-IMT (sham IMT)

    Other intervention

    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).

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Usual Care (UC)Experimental treatment 1 intervention
Group B: UC + High-intensity inspiratory muscle training (HI-IMT)Experimental treatment 1 intervention
Group C: UC + Low-intensity inspiratory muscle training (LI-IMT) (sham IMT)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maximal Inspiratory Pressure (PImax)

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

Time frame
Maximal duration of IMT treatment: 28 days

Secondary outcomes

1

Diaphragm mobility, thickness and thickening fraction by ultrasounds

Assessment by diaphragm ultrasounds

Time frame
Maximal duration of IMT treatment: 28 days
2

Change in contractile material and structural alteration of sternocleidomastoid muscle

By analyzing muscle microbiopsies using Hematoxylin \& Eosin (H\&E) staining.

Time frame
Maximal duration of IMT treatment: 28 days
3

Change in fiber proportion of sternocleidomastoid muscle fibers

By analyzing muscle microbiopsies with immunostaining of the myosin heavy chain.

Time frame
Maximal duration of IMT treatment: 28 days
4

Change in size of sternocleidomastoid muscle fibers

By analyzing muscle microbiopsies with immunostaining of the myosin heavy chain.

Time frame
Maximal duration of IMT treatment: 28 days

Other outcomes

Sponsors and contacts

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