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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Chest Physiotherapy | Placebo Comparator | 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. |
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| Trigger Sensitivity IMT | Experimental | 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. |
|
| Stepwise Pressure Support Reduction IMT | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adjustment of parameters on mechanical ventilation device | Other | adjust the parameters of the mode of training on mechanical ventilation according the group of patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Spontaneous breathing trial (SBT) | documenting the frequency (total number) of spontaneous breathing trials for each patient until successful extubation | 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. | 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) | 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 %). | 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 %). | Within 72 hours following extubation |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Gas analysis | Measure the results of the arterial blood gas analysis before beginning the intervention and follow up on its progression through the study and get the final results once weaning occurs. Lower PaCO₂ during MV is independently associated with successful weaning, while higher levels are linked to weaning failure | baseline (Day 1, prior to intervention) and within 48 hours after liberation from mechanical ventilation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mahmoud E Ragab, MSc | Contact | +201001218587 | mr.syndrome.264@gmail.com | |
| SHYMAA T Mohamed, PhD | Contact | +201021088610 | Shimaa.taha395@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mahmoud E Ragab, M.Sc. | Kasr Al Ainy hospital, Cairo University | Principal Investigator |
| Nesreen G' EL-NAHAS, PhD | Cairo University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| kasr Al Ainy Hospital | Cairo | Giza Governorate | 11956 | Egypt |
data is available with the corresponding author on reasonable request
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only the investigator knows the applied training method, once randomization is happened and the patient enrolled in his specific group
| routine plan of weaning and Conventional Chest Physiotherapy | Other | Chest Physiotherapy including: ▪ Postural Drainage ▪ Manual techniques for airway clearance (percussion, vibration, shaking) Adding to range of passive to active movements of the limbs |
|
| Negative Inspiratory Force | Negative inspiratory force (cmH₂O) will be measured via the mechanical ventilator as an index of global inspiratory muscle strength, consistent with ATS/ERS recommendations for weaning assessment. | Baseline (Day 1, prior to intervention) and immediately following completion of successful SBT |
| Respiratory Rate | Respiratory rate (breaths/min) will be measured from the mechanical ventilator as an indicator of respiratory load and breathing pattern | Baseline (Day 1, prior to intervention) and immediately following completion of successful SBT |
| Minute Ventilation | Minute ventilation (L/min) will be measured from the mechanical ventilator. | Baseline (Day 1, prior to intervention) and immediately following completion of successful SBT |
| Static Lung-Thorax Compliance | Static lung-thorax compliance (mL/cmH₂O) calculated from ventilator parameters. | Baseline (Day 1, prior to intervention) and immediately following completion of successful SBT |
| Rapid Shallow Breathing Index | The Rapid Shallow Breathing Index (breaths/min/L) is calculated as respiratory rate divided by tidal volume (RSBI). | Baseline (Day 1, prior to intervention) and immediately following completion of successful SBT |
| The Horowitz index (also known as the oxygenation or Carrico index) | The PaO₂/FiO₂ ratio is a key indicator of hypoxemia severity and pulmonary recruitment in respiratory failure. Normal values range from 400 to 500 mmHg, while values below 300 mmHg indicate pulmonary dysfunction | baseline (Day 1, prior to intervention) and within 48 hours after liberation from mechanical ventilation |
| Integrative weaning index | It is a composite parameter that was calculated as the product of static compliance (Cst), arterial oxygen saturation, and the RR/TV "RSBI": IWI = Cst × SaO2/RSBI (mL/cm H2O breath/minute/L). It is a reliable and accurate tool for predicting SBT outcomes and determining readiness for spontaneous breathing as an initial weaning step. An oxygen concentration of 0.35 will be preset prior to calculation, as it influences the outcome based on the formula. A value above 25 indicates a likelihood of successful weaning. | baseline (Day 1, prior to intervention) and immediately before initiation of successful SBT |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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