kasr Al Ainy Hospital
Cairo, Giza Governorate, 11956, Egypt
NCT Number: NCT07353814
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.
Trial opening soon.
Get Notified40 year–55 year
All sexes
Interventional
Not applicable
Cairo, Giza Governorate, 11956, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
adjust the parameters of the mode of training on mechanical ventilation according the group of patients
Chest Physiotherapy including: ▪ Postural Drainage ▪ Manual techniques for airway clearance (percussion, vibration, shaking) Adding to range of passive to active movements of the limbs
Time frame: From initiation of the first SBT until successful extubation, up to 48 hours
documenting the frequency (total number) of spontaneous breathing trials for each patient until successful extubation
Time frame: baseline (Day 1, prior to intervention) and immediately before initiation of successful SBT
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: from randomization to successful unassisted breathing, up to 48 hours
defined as the time from study randomization to successful unassisted breathing (in days)
Time frame: Within 48 hours following extubation
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 72 hours following extubation
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: baseline (Day 1, prior to intervention) and within 48 hours after liberation from mechanical ventilation
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
Time frame: Baseline (Day 1, prior to intervention) and immediately following completion of successful SBT
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.
Time frame: Baseline (Day 1, prior to intervention) and immediately following completion of successful SBT
Respiratory rate (breaths/min) will be measured from the mechanical ventilator as an indicator of respiratory load and breathing pattern
Time frame: Baseline (Day 1, prior to intervention) and immediately following completion of successful SBT
Minute ventilation (L/min) will be measured from the mechanical ventilator.
Time frame: Baseline (Day 1, prior to intervention) and immediately following completion of successful SBT
Static lung-thorax compliance (mL/cmH₂O) calculated from ventilator parameters.
Time frame: Baseline (Day 1, prior to intervention) and immediately following completion of successful SBT
The Rapid Shallow Breathing Index (breaths/min/L) is calculated as respiratory rate divided by tidal volume (RSBI).
Time frame: baseline (Day 1, prior to intervention) and within 48 hours after liberation from mechanical ventilation
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
Time frame: baseline (Day 1, prior to intervention) and immediately before initiation of successful SBT
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.
Contact information is provided by the study sponsor or research team.
Mahmoud E Ragab, MSc
CONTACT
SHYMAA T Mohamed, PhD
CONTACT
Cairo University
Other
Ventilator-based Inspiratory Muscle Training: Trigger Sensitivity Adjustment Versus Stepwise Pressure Support Reduction for Patients With Respiratory Failure
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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