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NCT Number: NCT07353814

Ventilator-based Inspiratory Muscle Training for Patients With Respiratory Failure

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.

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Key information

Age range

40 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

kasr Al Ainy Hospital

Cairo, Giza Governorate, 11956, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

adjustment of parameters on mechanical ventilation device

Other

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

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

Primary outcomes

  1. Spontaneous breathing trial (SBT)

    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

  2. Burn's Wean Assessment Score

    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.

  3. Duration of MV

    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)

  4. weaning success rate

    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 %).

  5. Extubation success rate

    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 %).

Secondary outcomes

  1. Blood Gas analysis

    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

  2. Negative Inspiratory Force

    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.

  3. Respiratory Rate

    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

  4. Minute Ventilation

    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.

  5. Static Lung-Thorax Compliance

    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.

  6. Rapid Shallow Breathing Index

    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).

  7. 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

    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

  8. Integrative weaning index

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mahmoud E Ragab, MSc

CONTACT

[email protected]

+201001218587

SHYMAA T Mohamed, PhD

CONTACT

[email protected]

+201021088610

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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