Emergency Ventilator Splitting Between Two or More Patients Using a Single Ventilator to Address Critical Ventilator Shortages During a Pandemic
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Completion of 24-hour test
研究概览
简要总结
The purpose of this study is to develop a safe, easily scalable, and simple method to split a single ventilator for use amongst two or more patients, thus serving as a capacity bridge to save patient lives until manufacturers can produce enough ventilators.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Device Feasibility
- 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
- •Undergoing routine thoracic surgery which will include the use of a dual lumen endotracheal tube at Stanford.
- •Able to give consent
- •On venovenous extracorporeal membrane oxygenation for reason other than COVID-19
- •Phase III
- •Able to give consent
- •Infected with COVID-19 and will likely require mechanical ventilation.
排除标准
- •Significant cardiac comorbidities
- •Liver disease
- •Significant cardiac comorbidities
- •Pre or Post-transplant patient
- •Infection with COVID-19
- •Phase III
- •Co-infection with disease aside from COVID-19
- •Severely ill requiring high ventilator requirements and not stable for ventilator splitting
研究组 & 干预措施
Phase 1: Routine surgery
As part of routine cardio-thoracic surgery, endotracheal tubes split from ventilator delivering oxygen independently to each lung for up to 1 minute.
干预措施: Emergency Ventilator Splitter (Device)
Phase 2: ECHO treatment
During care with Extracorporeal Membrane Oxygenation (ECMO) for non-SARS-CoV-2, endotracheal tubes split from ventilator delivering oxygen independently to each lung for up to 24 hours.
干预措施: Emergency Ventilator Splitter (Device)
Phase 3: COVID-19 treatment
Endotracheal tubes split from ventilator delivering oxygen independently to two patients with COVID-19 disease for up to 1 hour.
干预措施: Emergency Ventilator Splitter (Device)
结局指标
主要结局
Completion of 24-hour test
时间窗: Up to 1 hour
This outcome will measure whether the device will function for respiratory support for 1 hour (yes or no; phase 3 only)
Completion of 1-minute test
时间窗: Up to 1 minute
This outcome will measure whether the device will function for respiratory support for 1 minute (yes or no; phase 1 only)
Completion of 24-hour test
时间窗: Up to 1 minute
This outcome will measure whether the device will function for respiratory support for 24 hours (yes or no; phase 2 only)
次要结局
未报告次要终点