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

NCT07689110 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-07-08

No results posted yet for this 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.

Conditions

  • Respiratory Muscle Weakness
  • Mechanical Ventilation Weaning
  • Physiotherapy
  • Endurance Training

Interventions

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 \<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.

OTHER

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.

Sponsors & Collaborators

  • University of Santiago de Compostela

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2027-12-31
Completion
2028-03-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07689110 on ClinicalTrials.gov