[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646534":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":52,"collaborators":26,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":26,"enrollmentInfo":67,"targetDuration":26,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":26,"overallStatus":79,"whyStopped":26,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"University of Santiago de Compostela","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Behavioral: Progressive Pressure Support Reduction (IRT-PS)",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[19],"Other: Standard ICU Care",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","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 \\\u003C5 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 \\\u003C90%, HR \\>120 bpm.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Standard ICU Care","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.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Ricardo Miguel Rodrigues-Gomes","CONTACT","+34618060702","ric.mr.gomes@gmail.com",[38],{"facility":39,"status":26,"city":40,"state":26,"zip":26,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Hospital Álvaro Cunqueiro","Vigo","Spain","ES",{"type":44,"coordinates":45},"Point",[46,47],-8.72264,42.23282,{"lat":47,"lon":46},[50],{"name":51,"role":34,"phone":35,"phoneExt":26,"email":36},"Ricardo Miguel Rodrigues-Gomes, PhD",{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":56,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","ricardo miguel rodrigues gomes","Asociate Profesor","University of Vigo","100646534","progressive-pressure-support-reduction-as-inspiratory-muscle-endurance-training-in-mechanically-ventilated-patients-100646534",false,"NCT07689110","Progressive Pressure Support Reduction as Inspiratory Muscle Endurance Training in Mechanically Ventilated Patients","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)","inspira-rct","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Admitted to ICU with invasive mechanical ventilation for more than 48 hours at the time of randomization\n3. Expected to remain intubated for at least 24 additional hours, at the discretion of the attending intensivist\n4. Active pressure support ventilation (PSV) mode with PS level ≥ 5 cmH2O\n5. Richmond Agitation-Sedation Scale (RASS) score between -1 and +1\n6. Arterial pH ≥ 7.35 and serum lactate ≤ 2.0 mmol\u002FL\n7. Peripheral oxygen saturation (SpO2) ≥ 90% with current FiO2\n8. Informed consent obtained from patient or legal representative\n\nExclusion Criteria:\n\n1. Neurological condition affecting central respiratory control (high cervical spinal cord injury, ALS, myasthenia gravis, active Guillain-Barré syndrome)\n2. Established tracheostomy at the time of inclusion\n3. Restriction on head-of-bed elevation to ≥ 30 degrees\n4. Decision to limit therapeutic effort (LET) or life expectancy \\\u003C 48 hours\n5. Active hemodynamic instability (requirement for ≥ 2 vasopressors or vasopressor adjustment within the last 6 hours)\n6. Multiple rib fractures or undrained pneumothorax\n7. Simultaneous participation in another interventional clinical trial\n8. Previous inclusion in this study","ALL","18 Years",{"count":68,"type":69},60,"ESTIMATED","INTERVENTIONAL",[72],"NA","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.\n\nThis 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.\n\nParticipants 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.\n\nThe 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.\n\nAll 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.",[75,76,77,78],"Respiratory Muscle Weakness","Mechanical Ventilation Weaning","Physiotherapy","Endurance Training","NOT_YET_RECRUITING","2026-07-04",{"date":82,"type":83},"2026-07-08","ACTUAL",{"date":85,"type":69},"2026-10-01",{"date":87,"type":69},"2028-03-30",{"name":5,"class":6},1]