Evaluation of Effectiveness of Cardiopulmonary Resuscitation With Manual and Mechanical Chest Compression Systems During In-hospital (at the Emergency Department) Witnessed Cardiac Arrests Using Cerebral Oximetry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Regional cerebral tissue oxygen saturation level
研究概览
简要总结
Post-resuscitation neurological impairment is associated with morbidity and especially with late mortality. Thus, because good neurological outcome is vital for a successful resuscitation, it is essential to have sufficient cerebral tissue perfusion and oxygenation during its application. Near-Infrared Spectroscopy (NIRS) is used to evaluate such conditions. NIRS is a non-invasive technique which provides real-time, continuous information about regional cerebral tissue oxygen saturation levels (regional SO2/rSO2). Research on NIRS has been done in many studies including cardiovascular surgery, neurosurgery and their intensive care processes and its effectiveness has been approved. However, there is limited data on its use in cardiac arrests.
As stated in the current guidelines, sufficient speed and depth of chest compressions, few interruptions of compressions are key to a successful outcome of resuscitation. The studies with the mechanical chest compression devices showed that the earlier it was applied in out-of-hospital cases, the higher the rates of survival until hospitalization. There is not sufficient number of studies on the routine use of mechanical chest compression devices for in-hospital cases. In case the application of manual resuscitation is not convenient (during patient relocation, procedure at the angiography laboratory, and rush hours of emergency services when staff might fall short), alternative methods will be required.
The aim of our study is to compare rSO2 levels measured during resuscitation with manual and mechanical devices in in-hospital (at the emergency department) witnessed cardiac arrest cases and to analyze the impact of both application method and perfusion levels on survival and neurological outcome.
详细描述
The study will be a single-center, prospective and randomized study. It will be conducted at the Emergency Department of Eskisehir Osmangazi University Education, Application and Research Hospital.
Patients will be allocated to treatment groups by blocked randomization (www.randomizer.org). Advanced cardiac life support algorithm will be initiated as outlined in the current resuscitation guidelines and cardiopulmonary resuscitation (CPR) will be continued either manually or mechanically (with the chest compression system), according to the randomization scheme. Due to the nature of the interventions carried out in the study process, blinding of healthcare providers was not possible.
Before the initiation of the study, the team members participating in the study will receive theoretical and practical training on CPR, mechanical chest compression system utilization and NIRS.
Patients who develop cardiopulmonary arrest during their clinical evaluation in the emergency department will receive CPR, and the chest compression method will be determined by the senior physician according to the randomization scheme.
- The manual CPR group will receive chest compressions, respiratory support and medical treatment in accordance with the recommendations of current guidelines. If return of spontaneous circulation (ROSC) is achieved, post-resuscitation care will be provided. If ROSC is not achieved, CPR will be terminated in accordance with the recommendations of current guidelines.
- The patients on the mechanical chest compression group will receive manual chest compressions until the mechanical compression device is installed (about 15-20 seconds). In this time interval, thorax and sternum measurements will be evaluated for suitability for the study, and mechanical compression device will be installed on patients who are deemed suitable. The patients will receive chest compressions, respiratory support and medical treatment in accordance with the recommendations of current guidelines. If ROSC is achieved, post-resuscitation care will be provided. If ROSC is not achieved, CPR will be terminated in accordance with the recommendations of current guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •18 years or older.
- •In hospital (emergency service) witnessed cardiac arrest.
- •Cardiac arrest caused reasons other than trauma.
- •Length of sternum between 170- 303 mm (devise requirements).
- •Patients' chest width not more than 449 mm (devise requirements).
- •Informed consent of first-degree relatives of patients.
排除标准
- •Younger than 18 years old.
- •Out-of-hospital cardiac arrest.
- •Exposure to trauma.
- •Length of sternum not between 170- 303 mm (devise requirements).
- •Patients' chest width more than 449 mm (devise requirements).
- •Intracranial mass, large infarct or bleeding in the frontal part of the head (rSO2 monitoring area) which might effect the evaluation.
- •Lack of informed consent of first-degree relatives of patients.
结局指标
主要结局
Regional cerebral tissue oxygen saturation level
时间窗: 20-45 second
Comparison of regional cerebral tissue oxygen saturation levels between two groups during cardiopulmonary resuscitation
次要结局
- Survival at the 6th hour and 24th hour after resuscitation,(6th hour and 24th hours)
- Hospital discharge(1- 30 days)
- Additional pathology(1- 30 days)
研究者
Filiz Baloglu Kaya
Ass.Prof.
Eskisehir Osmangazi University