Proportional Assist Ventilation Versus Volume-Assist-Control After a Failed Spontaneous Breathing Trial: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- proportion of patients who meet criteria for enrollment who are approached in a timely manner
研究概览
简要总结
The primary aim of this research is to determine the feasibility of conducting a randomized controlled trial comparing two ventilation modes in patients admitted to the ICU who require mechanical ventilation. The investigators plan to include patients on mechanical ventilation with low support (PaO2/FiO2 ratio > 200, FiO2 < 0.5 and PEEP < 8) for a period no longer than 48 hrs. There are a number of potential barriers to enroll patients in the study. Importantly patients will have to be enrolled within 48 hours from the time they meet inclusion criteria.
The secondary aims are to determine the impact of proportional assist-ventilation (PAV) versus volume assist-control (VAC) ventilation by evaluating the number of ventilation-free days, development of Intensive Care Unit (ICU) delirium, use of sedative/ analgesic medications, use of antipsychotic medications, length of stay in the intensive care unit and hospital, reintubations within 24 hours, adverse events, and mortality in the two groups of patients.
详细描述
Overview of Design Randomized controlled pilot study comparing mechanical ventilation modes and daily spontaneous trial combination, in patients requiring invasive mechanical ventilation with low ventilator support (PaO2/Fio2 ratio > 200, FiO2 < 0.5 & PEEP <8) for a period not greater than 48 hrs.
Hypothesis The investigators hypothesize that 50 % of patients approached will agree to enrollment in this clinical trial over a period of 4 months. The investigators hypothesize 80% of the patients meeting inclusion criteria will be approached in a timely manner. The investigators also propose that PAV mode ventilation will be superior to ACV based on clinical outcome measurements.
Study Subjects Consecutive adult patients requiring invasive mechanical ventilation on low ventilator support (as mentioned above) for a period not greater than 48 hrs will be enrolled if they or their proxy consent for the study. The study will be performed in the intensive care units of University of Louisville and Jewish Hospital in Louisville, KY.
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
- 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
- •Age >18 yrs old
- •Patient or proxy available in the hospital to consent
- •Receipt of invasive mechanical ventilation on low ventilator support (Po2/Fio2 ratio >200, Fio2 <60% & PEEP <8) for a period not greater than 48 hrs
排除标准
- •Pregnant patients
- •Terminal diseases (e.g. advanced or metastatic malignancy, liver cirrhosis with an estimated 3 month mortality > 50%)
- •Severely depressed respiratory drive
- •Receipt of neuromuscular blocker
- •Bronchopleural fistula
- •Inability to obtain consent from patients or their proxies.
结局指标
主要结局
proportion of patients who meet criteria for enrollment who are approached in a timely manner
时间窗: 1 year
patient enrollment number over time
时间窗: 1 year
compliance with the ventilator settings
时间窗: 1 year
次要结局
- Use of antipsychotic medications(1 year)
- Reintubations within 24 hrs(1 year)
- Adverse events(1 year)
- Ventilation free days from the time patient is enrolled in the study(1 year)
- Development of ICU delirium Based on CAM ICU(1 year)
- Length of stay in the intensive care unit(1 year)
- Use of sedative or analgesic medications(1 year)
- Length of stay in the hospital(1 year)
- In hospital mortality(1 year)
研究者
Rodrigo Cavallazzi
Assistant Professor of Medicine
University of Louisville