Progressive Pressure Support Reduction as Inspiratory Muscle Endurance Training in Mechanically Ventilated Patients

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study 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.

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.

Eligibility

Primary outcome measure(s)

• Maximal Inspiratory Pressure (PImax) — 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.

Trial sites (1)

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