Impact of Biphasic Cuirass Ventilation Compared to Non-Invasive Ventilation in High Risk Extubations
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- to assess for non-inferiority of Biphasic cuirass ventilator compared to Non invasive ventilator in high risk extubations.
研究概览
简要总结
subjects on mechanical ventilator who are about to be extubated to Non invasive ventilation because the physician thinks they are high risk for failure will be approached and consented for our study. Once randomized they will either be on the standard of care Non invasive arm or the intervention arm which would mean they are placed on the Biphasic cuirass ventilation.
详细描述
We are planning on conducting a pilot study to assess if Biphasic cuirass ventilator is non inferior to Non invasive ventilation in high risk patients who are usually extubated to Non Invasive ventilation per current standard of care.
We will identify daily in our Medical Intensive care unit patients who have passed their spontaneous breathing trials and are being planned on being extubated to Non invasive ventilation per their treating Physician and will screen them for suitability and if so then one of our study team will approach patient and or their durable power of attorney and explain about our study and possible risks vs benefit and if they are agreeable will get a written consent and then they are randomized to either the Non invasive arm (per current standard of care) vs Biphasic cuirass ventilation arm (intervention arm).
We plan on assessing them per current standard of care with blood gas and other routine standard laboratory and or imaging. The subjects will not be compensated and they will be made aware of this upfront. Also their participation is completely voluntary and they will not get any additonal charge for taking part in the study. Assuming they tolerate the biphasic cuirass ventilator we anticipate them being on it anywere from 1-4 days.
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
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •High risk extubation patients in the Medical Intensive care units who are being thought to be placed on non invasive ventilator post extubation.
排除标准
- •Age <18 or >80
- •Inmate/Prisoner
- •Chest wall defects
- •History of Diaphragmatic paralysis
- •History of Neuromuscular disease
- •Contraindication to study device (open chest wound, flail chest, complex thoracic surgeries in the past)
研究组 & 干预措施
Non Invasive ventilator arm (per current standard of care)
per current standard of care
干预措施: Biphasic cuirass ventilator which is a type of negative pressure ventilator will be applied to patients on the intervention arm (Device)
Biphasic cuirass ventilator arm
patients in this arm will be the intervention arm and will be placed on the Biphasic cuirass ventilator.
干预措施: Biphasic cuirass ventilator which is a type of negative pressure ventilator will be applied to patients on the intervention arm (Device)
结局指标
主要结局
to assess for non-inferiority of Biphasic cuirass ventilator compared to Non invasive ventilator in high risk extubations.
时间窗: 1 year
Primary outcome will try to assess for non-inferiority of Biphasic cuirass ventilator compared to Non invasive ventilator in high risk extubations - In other words we are comparing and calculating the rate of re-intubations in these patients in the two arms viz. Standard of care Non Invasive Positive Pressure ventilation vs intervention arm using the Biphasic Cuirass Ventilation.
次要结局
未报告次要终点
研究者
Dennis Chairman
Associate Professor
University of Missouri-Columbia