Ventilator-based Inspiratory Muscle Training for Patients With Respiratory Failure

N/ANot Yet RecruitingNCT07353814

Cairo University60 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Respiratory Failure Mechanical Ventilation Complication

Interventions

adjustment of parameters on mechanical ventilation deviceOTHER

adjust the parameters of the mode of training on mechanical ventilation according the group of patients

routine plan of weaning and Conventional Chest PhysiotherapyOTHER

Chest Physiotherapy including: ▪ Postural Drainage ▪ Manual techniques for airway clearance (percussion, vibration, shaking) Adding to range of passive to active movements of the limbs

Eligibility

Sex: ALLMin age: 40 YearsMax age: 55 Years

Medical Language ↔ Plain English

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.

Locations (1)

kasr Al Ainy Hospital

Cairo, Giza Governorate, Egypt

Outcomes

Primary Outcomes

Spontaneous breathing trial (SBT)

documenting the frequency (total number) of spontaneous breathing trials for each patient until successful extubation

Time frame: From initiation of the first SBT until successful extubation, up to 48 hours

Burn's Wean Assessment Score

Calculate the percentage of the total score to indicate the extent of improvement and the probable readiness for weaning (in %). The 26-item checklist assigns 1 point for "yes" responses, with a total score up to 26. Scores below 17 (65%) suggest insufficient readiness for weaning, while scores ≥ 17 indicate probable readiness for weaning.

Time frame: baseline (Day 1, prior to intervention) and immediately before initiation of successful SBT

Duration of MV

defined as the time from study randomization to successful unassisted breathing (in days)

Time frame: from randomization to successful unassisted breathing, up to 48 hours

weaning success rate

absence of ventilatory support 48 hours after discontinuation of MV. Inability to tolerate or pass SBT or to be liberated from invasive ventilatory support indicates weaning failure (in %).

Time frame: Within 48 hours following extubation

Extubation success rate

defined as the proportion of subjects who did not die and were not re-intubated 48-72 hours after the scheduled extubation. The inability to sustain spontaneous breathing after removal of the endotracheal tube, requiring either reintubation or the use of NIV within this specified period, indicates extubation failure (in %).

Time frame: Within 72 hours following extubation

Secondary Outcomes

Blood Gas analysis

Central Contacts

Mahmoud E Ragab, MSc

CONTACT

+201001218587 mr.syndrome.264@gmail.com

SHYMAA T Mohamed, PhD

CONTACT

+201021088610 Shimaa.taha395@gmail.com

Data from ClinicalTrials.gov

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