Ventilator-based Inspiratory Muscle Training for Patients With Respiratory Failure

Official title

Ventilator-based Inspiratory Muscle Training: Trigger Sensitivity Adjustment Versus Stepwise Pressure Support Reduction for Patients With Respiratory Failure

Overview

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.

Detailed 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.

Interventions

• Other adjustment of parameters on mechanical ventilation device
  adjust the parameters of the mode of training on mechanical ventilation according the group of patients
• Other routine plan of weaning and Conventional Chest Physiotherapy
  Chest Physiotherapy including: ▪ Postural Drainage ▪ Manual techniques for airway clearance (percussion, vibration, shaking) Adding to range of passive to active movements of the limbs

Primary outcome measures

• Spontaneous breathing trial (SBT) [Time frame: From initiation of the first SBT until successful extubation, up to 48 hours]
• Burn's Wean Assessment Score [Time frame: baseline (Day 1, prior to intervention) and immediately before initiation of successful SBT]
• Duration of MV [Time frame: from randomization to successful unassisted breathing, up to 48 hours]
• weaning success rate [Time frame: Within 48 hours following extubation]
• Extubation success rate [Time frame: Within 72 hours following extubation]

Secondary outcome measures (8)

• Blood Gas analysis [Time frame: baseline (Day 1, prior to intervention) and within 48 hours after liberation from mechanical ventilation]
• Negative Inspiratory Force [Time frame: Baseline (Day 1, prior to intervention) and immediately following completion of successful SBT]
• Respiratory Rate [Time frame: Baseline (Day 1, prior to intervention) and immediately following completion of successful SBT]
• Minute Ventilation [Time frame: Baseline (Day 1, prior to intervention) and immediately following completion of successful SBT]
• Static Lung-Thorax Compliance [Time frame: Baseline (Day 1, prior to intervention) and immediately following completion of successful SBT]
• Rapid Shallow Breathing Index [Time frame: Baseline (Day 1, prior to intervention) and immediately following completion of successful SBT]
• The Horowitz index (also known as the oxygenation or Carrico index) [Time frame: baseline (Day 1, prior to intervention) and within 48 hours after liberation from mechanical ventilation]
• Integrative weaning index [Time frame: baseline (Day 1, prior to intervention) and immediately before initiation of successful SBT]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Egypt · 1 center

• kasr Al Ainy Hospital — Cairo

Identifiers

NCT: NCT07353814 · VENTILATOR-BASED TRAINING

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗