"The Effect of the Use of an Autotransfusion HemaShock Device on Hemodynamic Parameters During Resuscitation"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- Blood pressure
研究概览
简要总结
The purpose of the research (pilot study) is to determine the impact of the use of the autotransfusion device on hemodynamic parameters during resuscitation.
24 people will be included in the pilot study (12 people will be included in the intervention group - with the usage of "autotransfusion socks" during resuscitation and 12 people in the control group - without "autotransfusion socks"). Investigators will compare the hemodynamic parameters and also neurological outcome between both groups.
详细描述
The purpose of the research (pilot study) is to determine the impact of the use of the autotransfusion device on hemodynamic parameters during resuscitation.
Out-of-hospital cardiac arrest (OHCA) is one of the leading causes of death in Europe.
In order to improve the hemodynamic parameters during resuscitation, device for autotransfusion was developed. Devices are basically a very strong elastic stockings that also block arterial circulation. While "putting on" stockings, blood is being squeezed from the lower extremities (approximately 500 ml of blood for each lower limb). With blood being squeezed from the lower limb into the central circulation the filling of the heart is being improved; thus the device will improve the preload and also cardiac output.
A study done on an animal model showed that during resuscitation using "autotransfusion socks" increases both systolic and diastolic blood pressure during resuscitation, the perfusion of the coronary arteries improves and also the values of the partial pressure of carbon dioxide increases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •OHCA (Out of Hospital Cardiac Arrest)
- •age > 18 years
- •intubated
- •meets criteria for resuscitation
排除标准
- •age < 18 years
- •not intubated
- •clinical signs for DVT (deep vein thrombosis), PE (pulmonary embolism)
- •clinical signs of acute inflammation of limbs, broken limbs etc.
- •known oncological patient
- •trauma patients
结局指标
主要结局
Blood pressure
时间窗: Immediately after ROSC
Noninvasive blood pressure ((both systolic and diastolic blood pressure)) after removal of HemaShock Socks
End tidal CO2 (Carbon dioxide) after intubation
时间窗: Immediately after an intubation
capnography
End tidal CO2 (Carbon dioxide) every 5 minutes after first application of Hemashock Socks
时间窗: 30 minutes after the first application of HemaShock socks
capnography
End tidal CO2 (Carbon dioxide) after application of Hemashock Socks
时间窗: Immediately after an application of Hemashock Socks
capnography
End tidal CO2 (Carbon dioxide) after removal of HemaShock Socks
时间窗: Immediately after the removal of HemaShock socks
capnography
次要结局
- Tissue/skin malfunction under HemaShock Socks(From removal of the HemaShock socks up to 15 weeks)
- Cerebral Performance Category Scale(Through study completion, an average of 1 year)