About this trial
Restrictive lung diseases (RLD) represent a significant cause of morbidity, often necessitating intensive interventions such as mechanical ventilation due to diminished lung compliance (LC) and reduced total lung capacity (TLC). Mechanical ventilation, while vital, is associated with ventilator-induced diaphragmatic dysfunction (VIDD), leading to rapid muscle atrophy and impeding patient recovery.
This proposed study aims to evaluate the clinical impact of IMT and PEP on improving respiratory muscle strength, lung compliance and mobilizing secretions (effective cough reflex) in patients with RLD who require mechanical ventilation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged between 18 and 60 years.
Diagnosed with restrictive lung disease (RLD), including interstitial lung diseases, idiopathic pulmonary fibrosis, chest wall deformities, or neuromuscular diseases.
Admitted to the ICU and requiring invasive mechanical ventilation for more than 48 hours.
Glasgow Coma Scale score over 13, inspiratory pressures below -20 cmH2O, oxygen saturation above 90%, tidal volumes exceeding 5ml/kg, respiratory rates under 35 breaths per minute
Disqualifiers
Pre-existing chronic obstructive pulmonary disease (COPD) or other primary obstructive pathologies.
Hemodynamic instability (e.g., requiring high-dose vasopressors).
Active pneumothorax or untreated bronchopleural fistula.
History of cranial or facial trauma, recent thoracic or abdominal surgery contraindicating the intervention.
Trial design
Parallel
Treatments tested in this trial
Inspiratory muscle training
DeviceInspiratory Muscle Training (IMT): Patients will be positioned at a 45° angle in bed. The IMT device will be individually calibrated and connected to the endotracheal tube. Initial intensity will be set at 40% of the patient's maximal inspiratory pressure (MIP), progressing daily by 10%. Positive Expiratory Pressure (PEP) Training: Patients will be positioned laterally. The PEP device will be set at 7 cm H₂O resistance and will be connected to the endotracheal tube. Training will continue daily. Sessions will be paused if signs of respiratory or hemodynamic instability appear (e.g., altered respiratory rate, SpO₂, BP, HR, mental status, hemoptysis, arrhythmias, or diaphoresis). In such cases, training intensity will be maintained at the previous level.
Conventional Chest Physical Therapy
Other interventionParticipants will receive standard physiotherapy consisting of passive and active range-of-motion exercises for the upper and lower limbs, chest physiotherapy (including chest percussion), and therapeutic positioning. Each treatment session will last 15 minutes and will be administered by a qualified physiotherapist according to the institutional standard of care.
Treatment groups
Trial outcomes
Primary outcomes
Lung compliance
It will be assessed daily using ventilator-derived parameters. Static and dynamic compliance values will be recorded directly from the ventilator settings, providing objective measures of lung mechanics improvements throughout the intervention period.
Sponsors and contacts
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