Progressive Pressure Support Reduction as Inspiratory Muscle Endurance Training in Mechanically Ventilated Patients (inspira-rct)
4. juli 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
60
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Ricardo Miguel Rodrigues-Gomes
- Telefonnummer: +34618060702
- E-mail: ric.mr.gomes@gmail.com
Studiesteder
-
-
-
Vigo, Spanien
- Hospital Alvaro Cunqueiro
-
Kontakt:
- Ricardo Miguel Rodrigues-Gomes, PhD
- Telefonnummer: +34618060702
- E-mail: ric.mr.gomes@gmail.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
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.
|
|
Aktiv komparator: 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.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Maximal Inspiratory Pressure (PImax)
Tidsramme: 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.
|
Day 7 from randomization
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Diaphragm Thickening Fraction (DTF)
Tidsramme: Days 0, 3, 7 and 14 from randomization
|
measured by ultrasound (linear probe 7-15 MHz, zone of apposition, M-mode, average of 3 cycles).
Performed by ICU physician per standardized protocol.
|
Days 0, 3, 7 and 14 from randomization
|
|
P0.1 (Airway Occlusion Pressure at 100ms
Tidsramme: Baseline and days 3, 7 and 14; and at start, mid and end of each training session (intervention group)
|
respiratory drive indicator, read directly from ventilator display
|
Baseline and days 3, 7 and 14; and at start, mid and end of each training session (intervention group)
|
|
Time to Successful Extubation
Tidsramme: From randomization until extubation, up to 14 days
|
hours from randomization to extubation without reintubation within 48 hours
|
From randomization until extubation, up to 14 days
|
|
Weaning Success Rate
Tidsramme: Days 7 and 14 from randomization
|
proportion of patients extubated without reintubation within 48 hours
|
Days 7 and 14 from randomization
|
|
Sustained Pressure Support Reduction
Tidsramme: days 1, 3, 5 and 7 from randomization
|
difference in cmH2O between baseline PS at Day 0 and Day 7
|
days 1, 3, 5 and 7 from randomization
|
|
Total Days on Mechanical Ventilation
Tidsramme: From randomization until ICU discharge, up to 30 days
|
From randomization until ICU discharge, up to 30 days
|
|
|
ICU Mortality
Tidsramme: At the time of ICU discharge (up to 24 weeks)
|
At the time of ICU discharge (up to 24 weeks)
|
|
|
30-day Mortality
Tidsramme: Day 30 from randomization
|
Day 30 from randomization
|
|
|
ICU Readmission at 30 days
Tidsramme: Day 30 from randomization
|
Day 30 from randomization
|
|
|
Borg CR10 Score during training session
Tidsramme: Periprocedural (from the start of the session until 30 minutes post-intervention)
|
perceived respiratory exertion (0-10)
|
Periprocedural (from the start of the session until 30 minutes post-intervention)
|
|
Adverse events during training sessions
Tidsramme: Periprocedural (from the start of the session until 30 minutes post-intervention)
|
episodes of RR >35, SpO2 <90%, HR >120 bpm
|
Periprocedural (from the start of the session until 30 minutes post-intervention)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. oktober 2026
Primær færdiggørelse (Anslået)
31. december 2027
Studieafslutning (Anslået)
30. marts 2028
Datoer for studieregistrering
Først indsendt
23. maj 2026
Først indsendt, der opfyldte QC-kriterier
4. juli 2026
Først opslået (Faktiske)
8. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
8. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- INSPIRA-RCT-2026-HACunqueiro
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .