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

Официальное название

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)

Обзор

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.

Вмешательства

• Поведенческое 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 stop
• Другое 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.

Первичные конечные точки

• Maximal Inspiratory Pressure (PImax) [Срок оценки: Day 7 from randomization]

Вторичные конечные точки (11)

• Diaphragm Thickening Fraction (DTF) [Срок оценки: Days 0, 3, 7 and 14 from randomization]
• P0.1 (Airway Occlusion Pressure at 100ms [Срок оценки: Baseline and days 3, 7 and 14; and at start, mid and end of each training session (intervention group)]
• Time to Successful Extubation [Срок оценки: From randomization until extubation, up to 14 days]
• Weaning Success Rate [Срок оценки: Days 7 and 14 from randomization]
• Sustained Pressure Support Reduction [Срок оценки: days 1, 3, 5 and 7 from randomization]
• Total Days on Mechanical Ventilation [Срок оценки: From randomization until ICU discharge, up to 30 days]
• ICU Mortality [Срок оценки: At the time of ICU discharge (up to 24 weeks)]
• 30-day Mortality [Срок оценки: Day 30 from randomization]
• ICU Readmission at 30 days [Срок оценки: Day 30 from randomization]
• Borg CR10 Score during training session [Срок оценки: Periprocedural (from the start of the session until 30 minutes post-intervention)]
• Adverse events during training sessions [Срок оценки: Periprocedural (from the start of the session until 30 minutes post-intervention)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Hospital Álvaro Cunqueiro — Vigo

Идентификаторы

NCT: NCT07689110 · INSPIRA-RCT-2026-HACunqueiro

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗