ADHERE-LPV Advancing Delivery of High-Quality Evidence-Based Respiratory Efforts in Lung-Protective Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,125
- 试验地点
- 2
- 主要终点
- lung-protective ventilation
研究概览
简要总结
This study is a cluster randomized trial across 10 hospitals, stratified by hospital size (hospitals with greater than 100 mechanically ventilated patients a year will be classified as large, while those with 100 or fewer will be classified as small). Randomization will occur at the hospital level, ensuring an even distribution of large and small hospitals between study arms. Hospitals assigned to the intervention group will implement an EHR-based strategy designed to enhance adherence to lung-protective ventilation (LPV) for a 9-month intervention period, after which the strategy will be rolled out to all hospitals. The intervention focuses on modifying the ventilator order within the Electronic Health Record (EHR) to encourage default settings aligned with LPV principles. This study design allows for comparison of patient outcomes before and after implementation within each hospital while also enabling simultaneous comparisons between hospitals that have and have not yet received the intervention. The cluster randomization approach is necessary, given the order is controlled at the hospital level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Aged 18 and over
- •Requires mechanical ventilation
排除标准
- •The patient opted out of research
- •The mode ordered does not require a set tidal volume
- •Requires ECMO prior to ICU admission
- •Data during the use of ECMO
- •Hospitalization was for an elective surgery
- •The duration of mechanical ventilation was less than 12 hours (these are not the patients that would benefit from LPV)
- •Admission code documentation of Do Not Intubate. While rare, in situations where a patient was intubated but whose preferences are contradictory to the current care, mechanical ventilation is managed differently while undergoing goals of care conversations.
- •Height was documented as less than 4 feet given the PBW formula was not validated below this height.
研究组 & 干预措施
Standard of Care Ventilator
Patients in one of the 10 participating hospitals who require mechanical ventilation randomized to the current ventilator order that is used across the health system.
干预措施: control ventilator (Device)
Experimental Ventilator
Patients in one of the 10 participating hospitals who require mechanical ventilation randomized to a new ventilation order
干预措施: New ventilator (Device)
结局指标
主要结局
lung-protective ventilation
时间窗: 4 hours
The primary outcome is a binary indicator of lung-protective ventilation (ventilator set at ≤ 8 cc/kg) at the first documented set tidal volume after 4 hours.
次要结局
- Rate (hours) with set tidal volume < 6cc/kg PBW(72 hours)
- Rate (hours) exposure to >8 cc/kg PBW(72 hours)
- Rate (hours) exposure to >10 cc/kg PBW(72 hours)
- Time to adhere to ≤ 8 cc/kg per day: Of all patients set to >8 cc/kg per day, how long did it take for the patient to receive ≤ 8 cc/kg per day?(72 hours)