Pragmatic Investigation of Volume Targeted Ventilation-1 (PIVOT-1)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 2
- 主要终点
- Percentage of patients receiving Assist Volume Control
研究概览
简要总结
This proposal will test the feasibility of implementing an assist volume control ventilation protocol in patients receiving mechanical ventilation in the medical intensive care unit. The trial will consist of a before-and-after trial design of block assignment to either adaptive pressure control (baseline) or assist volume control .
This is a feasibility study looking at the management of patients in the ventilator.
详细描述
Over the course of 6 weeks, a before-and-after trial design of adaptive pressure control and assist volume control will be conducted.
Pre-trial planning phase: study protocols will be reviewed with key stakeholders (respiratory therapy providers and medical teams)
Weeks 1-2: data will be collected on our current adaptive pressure control ventilator protocol.
Week 3: The investigators will implement an assist volume control protocol. . Patients already on mechanical ventilation will be converted to assist volume control; however, these patients will not be included in the primary analysis.In accordance with the Consolidated Framework For Implementation Research (CFIR) approach, after 1 week of assist volume control the investigators will engage in quantitative and qualitative feedback with care providers to identify facilitators and barriers of assist volume control implementation.
Week 4-6: If the investigators identify substantial barriers, the investigators will pause and alter the protocol. If not, the investigators will continue assist volume control for an additional 2 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Acute Respiratory Failure requiring mechanical ventilation medical intensive care unit admission
排除标准
- •chronic mechanical ventilation clinician use of non-volume-targeted ventilation as initial mode
结局指标
主要结局
Percentage of patients receiving Assist Volume Control
时间窗: 1 hour
The primary outcome for the PIVOT-1 pilot is feasibility of Assist Volume Control implementation. We define feasibility in this study as 80% of patients receiving Assist Volume Control within 1 hour of initiation of intensive care unit mechanical ventilation
次要结局
- exhaled tidal volume(2 weeks)
- intensive care length of stay(28 days)
- assist volume control duration(24 hours)
- Number of ventilator free days(28 days)
- Percentage of mode crossover(2 weeks)