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)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Maximal Inspiratory Pressure (PImax)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Maximal Inspiratory Pressure (PImax)
时间窗: 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.
次要结局
- Diaphragm Thickening Fraction (DTF)(Days 0, 3, 7 and 14 from randomization)
- P0.1 (Airway Occlusion Pressure at 100ms(Baseline and days 3, 7 and 14; and at start, mid and end of each training session (intervention group))
- Time to Successful Extubation(From randomization until extubation, up to 14 days)
- Weaning Success Rate(Days 7 and 14 from randomization)
- Sustained Pressure Support Reduction(days 1, 3, 5 and 7 from randomization)
- Total Days on Mechanical Ventilation(From randomization until ICU discharge, up to 30 days)
- ICU Mortality(At the time of ICU discharge (up to 24 weeks))
- 30-day Mortality(Day 30 from randomization)
- ICU Readmission at 30 days(Day 30 from randomization)
- Borg CR10 Score during training session(Periprocedural (from the start of the session until 30 minutes post-intervention))
- Adverse events during training sessions(Periprocedural (from the start of the session until 30 minutes post-intervention))
研究者
ricardo miguel rodrigues gomes
Asociate Profesor
University of Vigo