Ventilator-based Inspiratory Muscle Training for Patients With Respiratory Failure

Cairo University (CU)

Status: Not yet enrolling

Conditions: Respiratory Failure; Mechanical Ventilation Complication

Treatments: Other: adjustment of parameters on mechanical ventilation device; Other: routine plan of weaning and Conventional Chest Physiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07353814

VENTILATOR-BASED TRAINING

Details and patient eligibility

About

This study will be conducted to compare the effectiveness of progressive inspiratory flow trigger sensitivity rising versus stepwise pressure support reduction as ventilator-based inspiratory muscle training methods on weaning and extubation success in mechanically ventilated patients with respiratory failure.

Full description

Acute respiratory failure (ARF) remains a leading contributor to morbidity and mortality in intensive care settings. It accounts for approximately 10% to 15% of medical ICU admissions and up to 50% to 75% of prolonged ICU stays exceeding seven days, with a reported mortality rate of around 40%. Inspiratory muscle weakness is common in mechanically ventilated patients, particularly with prolonged ventilation. Inspiratory muscle training could limit or reverse these detrimental effects and promote quicker, successful weaning. Unfortunately, especially when the weaning process started late, the significant loss of muscle strength means that between 5% and 15% of patients being weaned repeatedly fail to regain respiratory autonomy. Several strategies aim to reduce weaning duration and MV time in patients requiring prolonged ventilation, including inspiratory muscle training (IMT); however, evidence for its effectiveness remains limited and inconsistent. Alternatively, ventilator-based approaches such as trigger sensitivity optimization or gradual pressure support (PS) reduction offer valid equipment-free methods that may preserve muscle activity and enhance synchrony. Despite their potential, these strategies have not been rigorously evaluated in randomized controlled trials.

Enrollment: 60 estimated patients

Sex: All

Ages: 40 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Acute respiratory failure patients in the ICU are receiving MV for 48 h or more in a controlled mode.
• Their ages will range from 40 to 55 years old, and both sexes will be included.
• Conscious and oriented patients with a Glasgow coma score ≥13 (≥9T).
• Alertness score with a Richmond Agitation-Sedation Scale (RASS) will be from 0 to -1.
• All patients in this study must be hemodynamically and medically stable.
• Patients must be able to trigger spontaneous breaths on the ventilator but couldn't generate maximum inspiratory pressure more than -15 mbar.

Exclusion criteria

• Persistent hemodynamic instability as life-threatening conditions or comorbidities interfere with and compromise weaning, like cardiac arrhythmia, pericardial effusion, congestive heart failure, or acute coronary syndrome.
• Severe breathlessness when spontaneously breathing.
• Any progressive neuromuscular disease, such as myopathy or neuropathy, that would interfere with responding to inspiratory muscle training due to inadequate training performance of the inspiratory muscle.
• Spinal cord injury.
• Skeletal pathology (scoliosis, flail chest, spinal instrumentation) that would seriously impair the movement of the chest wall and ribs.
• Patients in a coma or under heavy sedation (RASS ≤ -2) and with respiratory muscle paralysis.
• High peak airway pressure (barotrauma), high PEEP >10, or active pneumothorax.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups, including a placebo group

Conventional Chest Physiotherapy

Placebo Comparator group

Description:

twenty mechanically ventilated patients with acute respiratory failure, who will receive the routine plan of weaning and conventional chest physiotherapy from MV twice a day with a 4-6 hour gap between for 4-5 days a week till extubation.

Treatment:

Other: routine plan of weaning and Conventional Chest Physiotherapy

Trigger Sensitivity IMT

Experimental group

Description:

twenty mechanically ventilated patients with acute respiratory failure, who will receive inspiratory muscle training by gradual inspiratory flow trigger sensitivity optimization in addition to the routine plan of weaning and conventional chest physiotherapy from MV, twice a day with a 4-6 hour gap between, for 4-5 days a week till extubation.

Treatment:

Other: routine plan of weaning and Conventional Chest Physiotherapy

Other: adjustment of parameters on mechanical ventilation device

Stepwise Pressure Support Reduction IMT

Experimental group

Description:

twenty mechanically ventilated patients with acute respiratory failure, who will receive inspiratory muscle training via stepwise pressure support reduction in addition to the routine plan of weaning and conventional chest physiotherapy from MV, twice a day with a 4-6 hour gap between, for 4-5 days a week till extubation.

Treatment:

Other: routine plan of weaning and Conventional Chest Physiotherapy

Other: adjustment of parameters on mechanical ventilation device