A Pragmatic Pilot Trial Evaluating Inspiratory Pressure Adjustment Based on Pressure Muscle Index in Patients Undergoing Pressure Support Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Feasibility of PMI target pressure support level setting strategy
研究概览
简要总结
Pressure support ventilation (PSV) is one of the most frequently used ventilator modes in the intensive care unit (ICU). The successful implementation of PSV depends on matching the patient's inspiratory effort with the ventilator support. In clinical practice, the pressure support level is usually set and adjusted according to tidal volume (VT) and respiratory rate (RR). However, these parameters may not fully represent the patient's effort. Previous studies have shown that pressure muscle index (PMI), which is measured as the difference between the peak and plateau airway pressure during an end-inspiratory airway occlusion, could reliably determine the low and high inspiratory effort during PSV.
However, the comparative effectiveness of these two pressure support level setting strategies remains uncertain. Our aim is to explore clinical and implementation factors relevant to a future definitive randomized controlled trial to evaluate PMI - and VT/RR - pressure support level setting strategies. The Inspiratory effort-targeted pressure support ventilation pragmatic pilot trial will test clinician adherence and to explore clinical outcomes.
Two centers are included in a pragmatic sequential cluster crossover pilot trial. We enrolled all eligible adults with acute respiratory failure requiring mechanical ventilation admitted to ICU. The pressure support level setting strategy was assigned according to the epoch. The first trial epoch will be assigned to VTRR - pressure support level setting strategy for 4 weeks. The washout week between the two epochs will be 4 weeks. Then sequentially, it will be crossed over to PMI - pressure support level setting strategy for 4 weeks.
- In the VT/RR-targeted group, the pressure support is adjusted to obtain a VT between 6 and 8 ml/kg PBW and RR between 20 and 35 breaths/min until day 28 or death or performance of spontaneous breathing trial (SBT).
- In the PMI-targeted group, the pressure support is adjusted according to PMI between 0 and 2 cmH2O until day 28 or death or performance of SBT.
We will also survey clinicians to understand potential facilitators and barriers to conducting a definitive randomized trial.
详细描述
Steering committee (chief investigators): Feng-Xue Zhu, Li Weng, Jian-Xin Zhou
Aim.
Our aim is to explore clinical and implementation factors relevant to a future definitive randomized controlled trial to evaluate PMI - and VT/RR - pressure support level setting strategies. The Inspiratory effort-targeted pressure support ventilation pragmatic pilot trial will test clinician adherence and to explore clinical outcomes.
Study design and Work plan.
Two centers are included in a pragmatic sequential cluster crossover pilot trial. The pressure support level setting strategy will be assigned according to the epoch. The first trial epoch will be assigned to VTRR - pressure support level setting strategy for 4 weeks, because that is the current standard practice in ICU prior to study initiation. The washout week between the two epochs will be 4 weeks. Then sequentially, it will be crossed over to PMI - pressure support level setting strategy for 4 weeks. Before each epoch, a one-week comprehensive training program will be conducted for all staff in the participating ICUs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •PSV initiated during the last 24 hours, whether transition from controlled modes or primary initiation;
- •Mechanical ventilation expected to be required for at least 24-48 hours by responsible physicians;
- •The partial pressure of oxygen in arterial blood (PaO2)/inspired oxygen fraction (FiO2) ≤ 300 mmHg (measuring at clinical FiO2 and positive end-expiratory pressure [PEEP]);
- •No sedation or stable sedation with Richmond Agitation Sedation Scale (RASS) of -2 to +1 or Riker's Sedation-Agitation Scale (SAS) of 3 to 4.
排除标准
- •Age younger than 18 years old;
- •Initiation of PSV before ICU admission;
- •Duration of mechanical ventilation longer than 7 days before enrollment;
- •History of neuromuscular diseases;
- •Clinical suspicion of increased intracranial pressure;
- •Presentation with pneumothorax and/or bronchopleural fistula;
- •Extracorporeal support;
- •Moribund conditions;
- •Refusal by the ICU physicians or the patient.
结局指标
主要结局
Feasibility of PMI target pressure support level setting strategy
时间窗: 1 year
Defined as 75% of the test points in which PMI can reach 0-2 cmH2O.
次要结局
- Feasibility of VT/RR target pressure support level setting strategy(1 year)
- Total duration of mechanical ventilation(1 year)
- Ventilator-free days (VFDs)(1 year)
- Duration of mechanical ventilation before enrollment(1 year)
- The time before the first SBT(1 year)
- Length of stay in the ICU and hospital(1 year)
- ICU mortality, hospital mortality, and 28-day mortality(1 year)
- Weaning time(1 year)
- Frequency of prolonged weaning(1 year)
- Frequency of self-extubation, re-intubation, tracheotomy, and mechanical ventilation longer than 21 days(1 year)
研究者
Jian-Xin Zhou
Professor
Capital Medical University