BEST (Burn Center Evaluation of Standard Therapies) Ventilator Mode Study: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Ventilator-free Days During the First 28 Days
研究概览
简要总结
The purpose of this study is to compare High Frequency Pressure Ventilation (HFPV) to conventional mechanical ventilation.
Hypothesis: Patients placed on HFPV will have significantly higher number of ventilator-free days compared to patients placed on a conventional volume mode.
详细描述
This is a prospective, randomized, controlled trial comparing HFPV to conventional ventilator modes in the support of burn patients with respiratory failure. Burn patients who develop the need for mechanical ventilation present a variety of challenges that call for innovative therapeutic options. Even in the absence of smoke inhalation injury,decreased chest wall compliance from full thickness burns as well as massive fluid requirements are just a few variables that make it difficult to achieve gas exchange goals when attempting to apply conventional lung protective strategies recommended by the ARDS Net investigators.
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
- •Patients who are deemed to require ventilatory support for more than 24 hours from the time of screening.
排除标准
- •Anticipated extubation within 24 hours of screening
- •Patients who are pregnant Patients not expected to survive for more than 24 hours
结局指标
主要结局
Ventilator-free Days During the First 28 Days
时间窗: 28 days
The primary end point was ventilator-free days in the first 28 days, defined as the number of days after randomization from day 0 to day 28 alive without ventilator assistance for at least 48 consecutive hrs.
次要结局
- Days Free From Nonpulmonary Organ Failure(28)
- Death(during hospitalization)
- Ventilator Associated Pneumonia(28 days)
- Need for Rescue Ventilator(28 days)
- Barotrauma(28 days)
- Ventilator Associated Tracheobronchitis (VATB)(checked daily)
研究者
Elsa Coates
Administrator
United States Army Institute of Surgical Research