Resuscitation Outcomes Consortium (ROC) Prehospital Resuscitation Using an Impedance Valve and Early Versus Delayed Analysis
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 11,738
- 试验地点
- 18
- 主要终点
- Survival to Hospital Discharge With Satisfactory Function (Modified Rankin Scale [MRS] of Less Than or Equal to 3).
研究概览
简要总结
The purpose of this study is to look at two different treatments during a cardiac arrest that occurs outside of the hospital and whether either or both treatments will increase the number of people who live to hospital discharge. A cardiac arrest is when the heart stops pumping blood to the body.
详细描述
The first treatment involves using a device called the Impedance Threshold Device (ITD). The ITD is a small hard plastic device about the size of a fist that is attached to the face mask or airway tube used during CPR (cardiopulmonary resuscitation). The ITD provides increased blood flow back to the heart during chest compressions until the heart starts beating on its own again.
The other treatment involves the amount of CPR given before the emergency medical services (EMS) providers first look at the heart rhythm to determine if a shock is needed. A person would receive either about 30 seconds of chest compressions or about 3 minutes of compressions before checking the heart rhythm. Giving some compressions before checking the heart rhythm increases the blood being circulated to the body. Researchers do not know how many compressions before the rhythm check are necessary to save more lives.
Depending on the circumstances of the cardiac arrest a person may receive only one of these treatments or both of these treatments. The purpose of the research study is to determine if more people live when either the real ITD is used or if additional CPR is given before looking at the heart rhythm the first time. This study is being conducted in 9 different areas throughout the United States and Canada by the Resuscitation Outcomes Consortium (ROC). About 15,000 patients will be enrolled in this research study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •All persons of local age of consent or older who suffer non-traumatic cardiopulmonary arrest outside of the hospital in the study communities with defibrillation and/or delivery of chest compressions provided by emergency medical service (EMS) providers dispatched to the scene and do not meet any of the exclusion criteria.
排除标准
- •Do not attempt resuscitation (DNAR) orders
- •Blunt, penetrating, or burn-related injury
- •Patients with exsanguinations
- •Known prisoners
- •Known pregnancy
- •Non-ROC EMS agency/provider
- •For Analyzing Late versus Early
- •EMS-witnessed arrests
- •Non-EMS rhythm analysis (AED placed by police or lay responder is an exclusion but CPR by lay or other non-EMS responders is not)
- •Tracheostomy present
- •CPR performed with the mechanical compression "Autopulse" device.
研究组 & 干预措施
1
Use of Impedance Threshold Device (ITD)
干预措施: Impedance Threshold Device (ITD) (Device)
2
Sham ITD
干预措施: Sham ITD (Device)
3
Analyze early. Upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR (cardiopulmonary resuscitation) may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.
干预措施: Analyze early (Other)
4
Analyze late. Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.
干预措施: Analyze later (Other)
结局指标
主要结局
Survival to Hospital Discharge With Satisfactory Function (Modified Rankin Scale [MRS] of Less Than or Equal to 3).
时间窗: Hospital discharge or death prior to discharge
The modified Rankin Score (mRS) measures the ability of patients to function independently. The scale goes from 0 (no symptoms) to 6 (death). Subjects with a mRS scores of three or less (i.e. better) at the time of hospital discharge were considered to have a positive outcome, resulting in a binary measure.
次要结局
- Adult Lifestyle and Function Version of Mini-Mental Status Exam at 6 Months(6 months post hospital discharge)
- Modified Rankin Score at 6 Months After Hospital Discharge(6 months post hospital discharge)
- Survival to Hospital Discharge(Survival to hospital discharge or death before discharge)
- Health Utilities Index III Score and Geriatric Depression Scale Score 6 Months(6 months post hospital discharge)
研究者
Susanne May
Principal Investigator
University of Washington