Progressive Pressure Support Reduction as Inspiratory Muscle Endurance Training in Mechanically Ventilated Patients (inspira-rct)
4 luglio 2026 aggiornato da: ricardo miguel rodrigues gomes, University of Santiago de Compostela
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.
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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
60
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Ricardo Miguel Rodrigues-Gomes
- Numero di telefono: +34618060702
- Email: ric.mr.gomes@gmail.com
Luoghi di studio
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Vigo, Spagna
- Hospital Alvaro Cunqueiro
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Contatto:
- Ricardo Miguel Rodrigues-Gomes, PhD
- Numero di telefono: +34618060702
- Email: ric.mr.gomes@gmail.com
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Inspiratory Resistance Training (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.
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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.
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Comparatore attivo: Standard Care (Usual Care)
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.
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Maximal Inspiratory Pressure (PImax)
Lasso di tempo: Day 7 from randomization
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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.
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Day 7 from randomization
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Diaphragm Thickening Fraction (DTF)
Lasso di tempo: Days 0, 3, 7 and 14 from randomization
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measured by ultrasound (linear probe 7-15 MHz, zone of apposition, M-mode, average of 3 cycles).
Performed by ICU physician per standardized protocol.
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Days 0, 3, 7 and 14 from randomization
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P0.1 (Airway Occlusion Pressure at 100ms
Lasso di tempo: Baseline and days 3, 7 and 14; and at start, mid and end of each training session (intervention group)
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respiratory drive indicator, read directly from ventilator display
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Baseline and days 3, 7 and 14; and at start, mid and end of each training session (intervention group)
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Time to Successful Extubation
Lasso di tempo: From randomization until extubation, up to 14 days
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hours from randomization to extubation without reintubation within 48 hours
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From randomization until extubation, up to 14 days
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Weaning Success Rate
Lasso di tempo: Days 7 and 14 from randomization
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proportion of patients extubated without reintubation within 48 hours
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Days 7 and 14 from randomization
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Sustained Pressure Support Reduction
Lasso di tempo: days 1, 3, 5 and 7 from randomization
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difference in cmH2O between baseline PS at Day 0 and Day 7
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days 1, 3, 5 and 7 from randomization
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Total Days on Mechanical Ventilation
Lasso di tempo: From randomization until ICU discharge, up to 30 days
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From randomization until ICU discharge, up to 30 days
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ICU Mortality
Lasso di tempo: At the time of ICU discharge (up to 24 weeks)
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At the time of ICU discharge (up to 24 weeks)
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30-day Mortality
Lasso di tempo: Day 30 from randomization
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Day 30 from randomization
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ICU Readmission at 30 days
Lasso di tempo: Day 30 from randomization
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Day 30 from randomization
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Borg CR10 Score during training session
Lasso di tempo: Periprocedural (from the start of the session until 30 minutes post-intervention)
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perceived respiratory exertion (0-10)
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Periprocedural (from the start of the session until 30 minutes post-intervention)
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Adverse events during training sessions
Lasso di tempo: Periprocedural (from the start of the session until 30 minutes post-intervention)
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episodes of RR >35, SpO2 <90%, HR >120 bpm
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Periprocedural (from the start of the session until 30 minutes post-intervention)
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 ottobre 2026
Completamento primario (Stimato)
31 dicembre 2027
Completamento dello studio (Stimato)
30 marzo 2028
Date di iscrizione allo studio
Primo inviato
23 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
4 luglio 2026
Primo Inserito (Effettivo)
8 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
8 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
4 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- INSPIRA-RCT-2026-HACunqueiro
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .