Initiation of Cooling by Emergency Medical Services to Promote the Adoption of In-hospital Therapeutic Hypothermia in Cardiac Arrest Survivors: the ICE-PACS Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 585
- 试验地点
- 3
- 主要终点
- Success of in-hospital cooling
研究概览
简要总结
This is a large pragmatic, randomized controlled trial comparing pre-hospital initiation of therapeutic hypothermia by Emergency Medical Services (EMS) providers to conventional post-resuscitation care. The goal of this trial is to increase the proportion of cardiac arrest patients that are appropriately treated in-hospital with therapeutic hypothermia to reach the target body temperature within 6 hours of hospital arrival. The investigators believe that EMS-initiation of cooling will be a powerful reminder to in-hospital clinicians to continue therapeutic hypothermia, and will lead to care improvements across a health system.
详细描述
This is a large pragmatic, randomized controlled trial comparing pre-hospital initiation of therapeutic hypothermia by Emergency Medical Services (EMS) providers to conventional post-resuscitation care. The goal of this trial is to increase the proportion of cardiac arrest patients that are appropriately treated in-hospital with therapeutic hypothermia to reach the target body temperature within 6 hours of hospital arrival. The investigators believe that EMS-initiation of cooling will be a powerful reminder to in-hospital clinicians to continue therapeutic hypothermia, and will lead to care improvements across a health system. This study builds on our previous work using large hospital networks hospitals to improve the delivery of evidence-based practice.
The primary research question is as follows: Does pre-hospital initiation of therapeutic hypothermia by EMS providers increase the proportion of comatose out of hospital cardiac arrest patients with return of spontaneous circulation (ROSC) that are successfully cooled to a target temperature of 32 to 34 degrees Celsius within 6 hours of emergency department arrival, compared to usual post-resuscitation care provided in the field? The primary outcome is the proportion of included patients that are successfully cooled to reach target temperature of 32 to 34 degrees Celsius within 6 hours of emergency department arrival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
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
- •Pulseless OHCA in the study communities (any rhythm, initial rhythm will be recorded)
- •Age equal to or greater than 18 years
- •Defibrillation and/or chest compressions by EMS providers (including fire fighters)
- •Return of spontaneous circulation (ROSC) sustained for greater than or equal to 5 minutes
- •Patient is unresponsive to verbal stimulus using AVPU (Alert, Voice, Pain, Unresponsive) scale
- •Patient is endotracheally intubated
- •SBP equal to or greater than 100 mm Hg (even if needing dopamine)
排除标准
- •Trauma (including burns) associated with cardiac arrest
- •Sepsis or serious infection suspected as cause of cardiac arrest
- •Clinical evidence of active severe bleeding
- •Suspected hypothermic cardiac arrest
- •Known coagulopathy (medical history or medications; ASA and clopidogrel are permitted)
- •Any verbal or written do-not-resuscitate (DNR)
- •Obviously pregnant
- •Known Prisoner
研究组 & 干预措施
Pre-hospital cooling
Patients in this arm will receive pre-hospital cooling by paramedics. This treatment includes placement of surface ice-pacs, initiation of an intravenous infusion of cold saline, and wrist and ankle bands with text to remind in-hospital clinicians to continue therapeutic hypothermia.
干预措施: Pre-hospital cooling (Behavioral)
Usual pre-hospital care
Patients in this arm will receive usual post-resuscitation care by paramedics. Usual post-resuscitation care does not include initiation of cooling in the pre-hospital setting.
结局指标
主要结局
Success of in-hospital cooling
时间窗: within 6 hours of emergency department arrival
The primary outcome is the proportion of included patients that are successfully cooled to reach target temperature of 32 to 34 degrees Celsius within 6 hours of emergency department arrival.
次要结局
- Mortality at hospital discharge(Hospital discharge)
- Mortality during transport(During transport to hospital)
- Mortality during 6 hours(Within 6 hours of emergency department arrival)
- Cooling ever in hospital(within 24 hours of emergency department arrival)
- Median Modified Rankin score at hospital discharge(hospital discharge)
- Good neurological outcome(hospital discharge)
- Time of transport to hospital(During transport to hospital)