A Cluster Randomized Trial on Inspiratory Effort-Based Pressure Support Adjustment Strategy in Patients Undergoing Assisted Mechanical Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 640
- 试验地点
- 1
- 主要终点
- Total duration of mechanical ventilation
研究概览
简要总结
The Inspiratory effort-Targeted Pressure Support Ventilation (IT-PSV) is a cluster randomized controlled trial. Its main aim is to determine whether an inspiratory effort-targeted pressure support setting strategy, compared to the traditional tidal volume and respiratory rate target, can improve clinical outcomes in adult participants undergoing pressure support ventilation.
The investigators propose a physiological-oriented assisted ventilation management that, if found effective, could potentially change the clinical practice for mechanical ventilation.
详细描述
Pressure-support ventilation (PSV) is widely used in the intensive care unit (ICU). The successful implementation of PSV depends on matching the patient's inspiratory effort with the ventilator support. Traditionally, pressure support levels are set according to tidal volume (VT) and respiratory rate (RR). However, previous studies have shown that over-assistance under PSV is not uncommon based on this setting strategy. Pressure muscle index (PMI) is an inspiratory effort monitoring, which can be easily obtained on the ventilator screen at the bedside.
Aim:
The aim is to determine whether an inspiratory effort-targeted pressure support setting strategy, compared to the traditional approach, can improve clinical outcomes in adult participants undergoing PSV.
Design:
This is a two-arm cluster randomized trial in 16 clusters randomized 1:1 to pressure support setting by a PMI-targeted strategy or a traditional VT/RR-targeted strategy.
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
- •Mechanically ventilated patients, who are admitted to the ICU with acute hypoxic respiratory failure, will be consecutively screened daily at 08:00-10:00 morning rounds.
- •Inclusion criteria:
- •PSV initiated during the last 24 hours;
- •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);
- •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;
- •Extracorporeal support;
- •Moribund conditions;
- •Refusal by the ICU physicians or the patient.
结局指标
主要结局
Total duration of mechanical ventilation
时间窗: 28 days
Defined as the time intervals from intubation and mechanical ventilation to successful weaning. For patients with re-intubation or restoration of mechanical ventilation via tracheostomy within seven days after extubation and discontinuation of ventilation, the thereafter duration will be added.
次要结局
- Weaning time(28 days)
- ICU mortality(28 days)
- Length of stay in the hospital(28 days)
- Duration of mechanical ventilation after enrollment(28 days)
- The time before the first spontaneous breathing trial(28 days)
- Frequency of prolonged weaning(28 days)
- Hospital mortality(28 days)
- Length of stay in the ICU(28 days)
研究者
Jian-Xin Zhou
Professor
Capital Medical University