Respiratory Muscle Weaknessinspira-rctNCT07689110
Progressive Pressure Support Reduction as Inspiratory Muscle Endurance Training in Mechanically Ventilated Patients
A study testing Progressive Pressure Support Reduction (IRT-PS) and Standard ICU Care in people with Respiratory Muscle Weakness and Mechanical Ventilation Weaning, run by University of Santiago de Compostela at 1 site in Spain.
Trial summary
Mechanical ventilation causes rapid diaphragm muscle atrophy, detectable within 18 hours of ventilator support, which is a major contributor to weaning failure and prolonged ICU stay. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Muscle Weakness, Mechanical Ventilation Weaning, Physiotherapy
- What is being tested?
- Progressive Pressure Support Reduction (IRT-PS) and Standard ICU Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2026to 30 Mar 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Admitted to ICU with invasive mechanical ventilation for more than 48 hours at the time of randomization
- Expected to remain intubated for at least 24 additional hours, at the discretion of the attending intensivist
- Active pressure support ventilation (PSV) mode with PS level ≥ 5 cmH2O
- Richmond Agitation-Sedation Scale (RASS) score between -1 and +1
- Arterial pH ≥ 7.35 and serum lactate ≤ 2.0 mmol/L
- Peripheral oxygen saturation (SpO2) ≥ 90% with current FiO2
- Informed consent obtained from patient or legal representative
Who cannot join
- Neurological condition affecting central respiratory control (high cervical spinal cord injury, ALS, myasthenia gravis, active Guillain-Barré syndrome)
- Established tracheostomy at the time of inclusion
- Restriction on head-of-bed elevation to ≥ 30 degrees
- Decision to limit therapeutic effort (LET) or life expectancy < 48 hours
- Active hemodynamic instability (requirement for ≥ 2 vasopressors or vasopressor adjustment within the last 6 hours)
- Multiple rib fractures or undrained pneumothorax
- Simultaneous participation in another interventional clinical trial
- Previous inclusion in this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Hospital Álvaro Cunqueiro
Vigo
Ricardo Miguel Rodrigues-Gomes, PhD, +34618060702, ric.mr.gomes@gmail.com
About this study
Official title: Progressive Pressure Support Reduction as Inspiratory Muscle Endurance Training in Mechanically Ventilated Critically Ill Patients: Effect on Maximal Inspiratory Pressure, Diaphragm Thickening Fraction, Weaning Success and Extubation (INSPIRA-RCT)
Mechanical ventilation causes rapid diaphragm muscle atrophy, detectable within 18 hours of ventilator support, which is a major contributor to weaning failure and prolonged ICU stay.
This randomized controlled trial tests whether a physiotherapist-guided inspiratory endurance training program - achieved by progressively reducing pressure support (PS) levels on the ventilator - can preserve or improve inspiratory muscle strength and diaphragm structure in critically ill adults on mechanical ventilation, compared to standard ICU care.
Read more
Participants will be randomly assigned to one of two groups. The intervention group will receive twice-daily training sessions (weekdays only) in which the physiotherapist gradually reduces PS by up to 50% of the baseline level, causing the patient to breathe with greater muscular effort - equivalent to progressive endurance exercise for the diaphragm. The control group will receive standard weaning care as directed by the attending intensivist.
The primary outcome is maximal inspiratory pressure (PImax) at day 7. Secondary outcomes include diaphragm thickening fraction measured by ultrasound, time to successful extubation, weaning success rate, and mortality.
All measurements are performed by the ICU physician (blinded to group allocation) using airway occlusion maneuvers recorded on the ventilator and diaphragm ultrasound, following a standardized protocol.
- Conditions
- Respiratory Muscle Weakness, Mechanical Ventilation Weaning, Physiotherapy, Endurance Training
- Being tested
- Progressive Pressure Support Reduction (IRT-PS), Standard ICU Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Pressure Support Reduction (IRT-PS)Behavioural
Progressive reduction of pressure support (PS) during ventilator-assisted breathing, performed by a physiotherapist twice daily (weekdays only). Sessions consist of 1-3 sets of 5-15 minutes with 2-minute rest intervals at baseline PS. PS is reduced by 25% initially up to a maximum of 50% of baseline (minimum 5 cmH2O) for PS ≥10 cmH2O; by 1-2 cmH2O for PS 5-9 cmH2O; and by 1 cmH2O down to 0 cmH2O for PS <5 cmH2O. Target perceived exertion: Borg CR10 3-5. P0.1 monitored continuously; session stopped if P0.1 >4 cmH2O sustained >2 minutes (Goligher et al. criteria). Safety stop criteria: RR >35 rpm, SpO2 <90%, HR >120 bpm.
Standard ICU CareOther
Conventional weaning managed by the attending intensivist according to standard clinical practice, without a structured inspiratory muscle training protocol. Conventional physiotherapy (early mobilization, chest physiotherapy) permitted in both groups.
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory Resistance Training (IRT-PS) | Experimental | Physiotherapist-guided inspiratory endurance training by progressive pressure support reduction (25-50% of baseline PS), 1-3 sets of 5-15 minutes, twice daily on weekdays, for up to 14 days or until extubation. Target: Borg CR10 score 3-5. P0.1 monitored continuously; sessions stopped if P0.1 > 4 cmH2O sustained > 2 minutes. Receives: Behavioral: Progressive Pressure Support Reduction (IRT-PS) |
| Standard Care (Usual Care) | Active comparator | Conventional weaning as directed by the attending intensivist, without a structured inspiratory muscle training program. Conventional physiotherapy (early mobilization, chest physiotherapy) is permitted in both groups. Receives: Other: Standard ICU Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Inspiratory Pressure (PImax)
Measured by manual airway occlusion at end-expiration with pressure curve recorded on the ventilator. Standardized verbal instruction given to the patient. Best of 3 valid maneuvers recorded. Performed by the ICU physician blinded to group allocation.
Measured: Day 7 from randomization
Secondary outcomes (11)
Diaphragm Thickening Fraction (DTF)
measured by ultrasound (linear probe 7-15 MHz, zone of apposition, M-mode, average of 3 cycles). Performed by ICU physician per standardized protocol.
Measured: Days 0, 3, 7 and 14 from randomization
P0.1 (Airway Occlusion Pressure at 100ms
respiratory drive indicator, read directly from ventilator display
Measured: Baseline and days 3, 7 and 14; and at start, mid and end of each training session (intervention group)
Time to Successful Extubation
hours from randomization to extubation without reintubation within 48 hours
Measured: From randomization until extubation, up to 14 days
Weaning Success Rate
proportion of patients extubated without reintubation within 48 hours
Measured: Days 7 and 14 from randomization
Sustained Pressure Support Reduction
difference in cmH2O between baseline PS at Day 0 and Day 7
Measured: days 1, 3, 5 and 7 from randomization
Total Days on Mechanical Ventilation
Measured: From randomization until ICU discharge, up to 30 days
ICU Mortality
Measured: At the time of ICU discharge (up to 24 weeks)
30-day Mortality
Measured: Day 30 from randomization
ICU Readmission at 30 days
Measured: Day 30 from randomization
Borg CR10 Score during training session
perceived respiratory exertion (0-10)
Measured: Periprocedural (from the start of the session until 30 minutes post-intervention)
Adverse events during training sessions
episodes of RR >35, SpO2 <90%, HR >120 bpm
Measured: Periprocedural (from the start of the session until 30 minutes post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Muscle WeaknessStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Santiago de Compostela
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ricardo miguel rodrigues gomes, University of Vigo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07689110
- Sponsor's protocol ID
- INSPIRA-RCT-2026-HACunqueiro
- Acronym
- inspira-rct
- Status last verified
- Jul 2026
- First submitted
- 23 May 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progressive Pressure Support Reduction as Inspiratory Muscle Endurance Training in Mechanically Ventilated Critically Ill Patients: Effect on Maximal Inspiratory Pressure, Diaphragm Thickening Fraction, Weaning Success and Extubation (INSPIRA-RCT)
- ClinicalTrials.gov ID
- NCT07689110
- Acronym / sponsor ID
- inspira-rct / INSPIRA-RCT-2026-HACunqueiro
- Conditions
- Respiratory Muscle Weakness, Mechanical Ventilation Weaning, Physiotherapy, Endurance Training
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Santiago de CompostelaUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 8 Jul 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.
Mechanical ventilation causes rapid diaphragm muscle atrophy, detectable within 18 hours of ventilator support, which is a major contributor to weaning failure and prolonged ICU stay.
This randomized controlled trial tests whether a physiotherapist-guided inspiratory endurance training program - achieved by progressively reducing pressure support (PS) levels on the ventilator - can preserve or improve inspiratory muscle strength and diaphragm structure in critically ill adults on mechanical ventilation, compared to standard ICU care.
Participants will be randomly assigned to one of two groups. The intervention group will receive twice-daily training sessions (weekdays only) in which the physiotherapist gradually reduces PS by up to 50% of the baseline level, causing the patient to breathe with greater muscular effort - equivalent to progressive endurance exercise for the diaphragm. The control group will receive standard weaning care as directed by the attending intensivist.
The primary outcome is maximal inspiratory pressure (PImax) at day 7. Secondary outcomes include diaphragm thickening fraction measured by ultrasound, time to successful extubation, weaning success rate, and mortality.
All measurements are performed by the ICU physician (blinded to group allocation) using airway occlusion maneuvers recorded on the ventilator and diaphragm ultrasound, following a standardized protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inspiratory Resistance Training (IRT-PS) | Experimental | Behavioral: Progressive Pressure Support Reduction (IRT-PS)Physiotherapist-guided inspiratory endurance training by progressive pressure support reduction (25-50% of baseline PS), 1-3 sets of 5-15 minutes, twice daily on weekdays, for up to 14 days or until extubation. Target: Borg CR10 score 3-5. P0.1 monitored continuously; sessions stopped if P0.1 > 4 cmH2O sustained > 2 minutes. |
| Standard Care (Usual Care) | Active comparator | Other: Standard ICU CareConventional weaning as directed by the attending intensivist, without a structured inspiratory muscle training program. Conventional physiotherapy (early mobilization, chest physiotherapy) is permitted in both groups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years
- Admitted to ICU with invasive mechanical ventilation for more than 48 hours at the time of randomization
- Expected to remain intubated for at least 24 additional hours, at the discretion of the attending intensivist
- Active pressure support ventilation (PSV) mode with PS level ≥ 5 cmH2O
- Richmond Agitation-Sedation Scale (RASS) score between -1 and +1
Key exclusion criteria (8 listed)
- Neurological condition affecting central respiratory control (high cervical spinal cord injury, ALS, myasthenia gravis, active Guillain-Barré syndrome)
- Established tracheostomy at the time of inclusion
- Restriction on head-of-bed elevation to ≥ 30 degrees
- Decision to limit therapeutic effort (LET) or life expectancy < 48 hours
- Active hemodynamic instability (requirement for ≥ 2 vasopressors or vasopressor adjustment within the last 6 hours)
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 |
|---|---|---|
| Progressive Pressure Support Reduction (IRT-PS)Progressive reduction of pressure support (PS) during ventilator-assisted breathing, performed by a physiotherapist twice daily (weekdays only). Sessions consist of 1-3 sets of 5-15 minutes with 2-minute rest intervals at baseline PS. PS is reduced by 25% initially up to a maximum of 50% of baseline (minimum 5 cmH2O) for PS ≥10 cmH2O; by 1-2 cmH2O for PS 5-9 cmH2O; and by 1 cmH2O down to 0 cmH2O for PS <5 cmH2O. Target perceived exertion: Borg CR10 3-5. P0.1 monitored continuously; session stopped if P0.1 >4 cmH2O sustained >2 minutes (Goligher et al. criteria). Safety stop criteria: RR >35 rpm, SpO2 <90%, HR >120 bpm. | Behavioural | Inspiratory Resistance Training (IRT-PS) |
| Standard ICU CareConventional weaning managed by the attending intensivist according to standard clinical practice, without a structured inspiratory muscle training protocol. Conventional physiotherapy (early mobilization, chest physiotherapy) permitted in both groups. | Other | Standard Care (Usual Care) |
Primary outcome
Maximal Inspiratory Pressure (PImax)
Time frame: Day 7 from randomization
Measured by manual airway occlusion at end-expiration with pressure curve recorded on the ventilator. Standardized verbal instruction given to the patient. Best of 3 valid maneuvers recorded. Performed by the ICU physician blinded to group allocation.
11 secondary outcomes
Diaphragm Thickening Fraction (DTF)
Time frame: Days 0, 3, 7 and 14 from randomization
P0.1 (Airway Occlusion Pressure at 100ms
Time frame: Baseline and days 3, 7 and 14; and at start, mid and end of each training session (intervention group)
Time to Successful Extubation
Time frame: From randomization until extubation, up to 14 days
Weaning Success Rate
Time frame: Days 7 and 14 from randomization
Sustained Pressure Support Reduction
Time frame: days 1, 3, 5 and 7 from randomization
Total Days on Mechanical Ventilation
Time frame: From randomization until ICU discharge, up to 30 days
ICU Mortality
Time frame: At the time of ICU discharge (up to 24 weeks)
30-day Mortality
Time frame: Day 30 from randomization
ICU Readmission at 30 days
Time frame: Day 30 from randomization
Borg CR10 Score during training session
Time frame: Periprocedural (from the start of the session until 30 minutes post-intervention)
Adverse events during training sessions
Time frame: Periprocedural (from the start of the session until 30 minutes post-intervention)
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 8 Jul 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Pressure Support Reduction (IRT-PS) and Standard ICU Care in people with Respiratory Muscle Weakness and Mechanical Ventilation Weaning, run by University of Santiago de Compostela at 1 site in Spain.
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 8 inclusion and 8 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 8 Jul 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 Spain. 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. 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 Ricardo Miguel Rodrigues-Gomes (+34618060702, ric.mr.gomes@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Inspiratory Pressure (PImax) (time frame: Day 7 from randomization). 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 8 Jul 2026.