Respiratory FailureNCT07353814
Ventilator-based Inspiratory Muscle Training for Patients With Respiratory Failure
A study testing adjustment of parameters on mechanical ventilation device and routine plan of weaning and Conventional Chest Physiotherapy in people with Respiratory Failure and Mechanical Ventilation Complication, run by Cairo University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 55 years
- Conditions the study is for
- Respiratory Failure, Mechanical Ventilation Complication
- What is being tested?
- adjustment of parameters on mechanical ventilation device and routine plan of weaning and Conventional Chest Physiotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Ventilator-based Inspiratory Muscle Training: Trigger Sensitivity Adjustment Versus Stepwise Pressure Support Reduction 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.
Read the 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.
- Being tested
- adjustment of parameters on mechanical ventilation device, routine plan of weaning and Conventional Chest Physiotherapy
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: routine plan of weaning and Conventional Chest Physiotherapy |
| 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. Receives: Other: adjustment of parameters on mechanical ventilation device; Other: routine plan of weaning and Conventional Chest Physiotherapy |
| 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. Receives: Other: adjustment of parameters on mechanical ventilation device; Other: routine plan of weaning and Conventional Chest Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous breathing trial (SBT)
documenting the frequency (total number) of spontaneous breathing trials for each patient until successful extubation
Measured: 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.
Measured: 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)
Measured: 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 %).
Measured: 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 %).
Measured: Within 72 hours following extubation
Secondary outcomes (8)
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
Measured: baseline (Day 1, prior to intervention) and within 48 hours after liberation from mechanical ventilation
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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.
Measured: baseline (Day 1, prior to intervention) and immediately before initiation of successful SBT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud El-Sayed Abduh Ragab, Cairo University
- Investigators
- Mahmoud E Ragab, M.Sc., Principal investigator, Kasr Al Ainy hospital, Cairo UniversityNesreen G' EL-NAHAS, PhD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07353814
- Sponsor's protocol ID
- VENTILATOR-BASED TRAINING
- Status last verified
- Jan 2026
- First submitted
- 1 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data is available with the corresponding author on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventilator-based Inspiratory Muscle Training: Trigger Sensitivity Adjustment Versus Stepwise Pressure Support Reduction for Patients With Respiratory Failure
- ClinicalTrials.gov ID
- NCT07353814
- Acronym / sponsor ID
- VENTILATOR-BASED TRAINING
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional Chest Physiotherapy | Placebo comparator | Other: routine plan of weaning and Conventional Chest Physiotherapytwenty 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. |
| Trigger Sensitivity IMT | Experimental | Other: adjustment of parameters on mechanical ventilation device, Other: routine plan of weaning and Conventional Chest Physiotherapytwenty 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 | Other: adjustment of parameters on mechanical ventilation device, Other: routine plan of weaning and Conventional Chest Physiotherapytwenty 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. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adjustment of parameters on mechanical ventilation deviceadjust the parameters of the mode of training on mechanical ventilation according the group of patients | Other | Stepwise Pressure Support Reduction IMT, Trigger Sensitivity IMT |
| routine plan of weaning and Conventional Chest PhysiotherapyChest Physiotherapy including: ▪ Postural Drainage ▪ Manual techniques for airway clearance (percussion, vibration, shaking) Adding to range of passive to active movements of the limbs | Other | Conventional Chest Physiotherapy, Stepwise Pressure Support Reduction IMT, Trigger Sensitivity IMT |
Primary outcome
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
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.
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)
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 %).
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 %).
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: No. data is available with the corresponding author on reasonable request
Related trials for Respiratory Failure
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Regional Lung Ventilation During Prone Position in in Intubated Children
Pediatric Acute Respiratory Failure
Not yet recruiting
Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
Not yet recruiting
Mechanical Ventilator Adjustments and Patient Dyspnea
Respiratory Failure, Dyspnea During Mechanical Ventilation
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mahmoud E Ragab, M.Sc. principal investigator
Kasr Al Ainy hospital, Cairo University
Nesreen G' EL-NAHAS, PhD study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adjustment of parameters on mechanical ventilation device and routine plan of weaning and Conventional Chest Physiotherapy in people with Respiratory Failure and Mechanical Ventilation Complication, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud E Ragab, MSc (+201001218587, mr.syndrome.264@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spontaneous breathing trial (SBT) (time frame: From initiation of the first SBT until successful extubation, up to 48 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.