COVID-19 And Geko Evaluation: The CAGE Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Protocol Adherence
研究概览
简要总结
The primary objectives of this pilot study protocol are to assess safety and feasibility of using the geko™ device in COVID-19.
Regarding safety to patients, we will measure the rate of adverse events, primarily local site irritation or discomfort. Feasibility will be measured on the basis of recruitment; ability to enroll sufficient number of patients meeting criteria. Protocol adherence will be observed as the ability to deliver the study intervention to the patients randomized to the treatment arm within the prescribed timeline and ability to complete the course of treatment. Additionally, we plan to measure patient outcomes such as ICU admission and death. The findings of this study have the potential to decrease the complications seen in COVID-19 infections.
详细描述
On March 11, 2020, a global pandemic was declared by the World Health Organization. A novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified as the cause of the COVID-19 pandemic. SARS-CoV-2 infection has quickly become one of the fastest growing and deadliest diseases to surface due to its high death rate and ability to replicate and spread readily from people without symptoms. Recent evidence indicates that critically ill patients with COVID-19 experience a high risk of blood clots. Deep leg vein blood clots can travel to the lungs and cause severe lung failure and death. The geko™ device is a simple device that increases the return of blood flow from the lower legs and potentially decrease the risk of lung blood clots. Investigators believe the geko™ device may have an important benefit in COVID-19 patients by decreasing the risk of lung clots and decrease the risk of respiratory failure which is often the cause of death in COVID-19 patients. In this study, Investigators plan to study the effect of using the geko™ device in COVID-19 patients and measure patient outcomes such as ICU admission and death. The findings of this study have the potential to decrease the complications seen in COVID-19 infections.
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 test positive for Covid-19
排除标准
- •Patients who are unlikely to be adherent or cannot tolerate the therapy (self-report)
- •Prior above or below knee amputation
- •A history of prior Deep Venous Thrombosis (DVT) or Venous Thromboembolism (VTE),
- •Those patients being treated with full dose therapeutic anticoagulation.
- •Patients with pacemakers
结局指标
主要结局
Protocol Adherence
时间窗: From ICU admission to discharge or death in ICU up to 28 days whichever comes first.
We will assess our ability to deliver the study intervention to the patients randomized to the treatment arm within the prescribed timeline and ability to complete the course of treatment
Feasibility of recruitment
时间窗: Within a two year period
Feasibility will be measured on the basis of recruitment; ability to enroll sufficient number of patients meeting criteria
Safety of device: AE
时间窗: From ICU admission to discharge or death in ICU up to 28 days whichever comes first.
We will measure the rate of adverse events, primarily local site irritation or discomfort
次要结局
- Mortality(From date of admission to discharge from ICU or death in hospital assessed up to a 28 days whichever comes first.)
- Morbidity(From date of admission to discharge from ICU assessed up to a 28 days whichever comes first.)