Prehospital Resuscitation Intranasal Cooling Effectiveness Survival Study 2 (PRINCESS2)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,022
- 试验地点
- 20
- 主要终点
- Proportion of patients surviving with complete neurologic recovery at 90 days defined as modified Rankin scale (mRs) of 0-1.
研究概览
简要总结
The aim of this clinical trial is to study the impact of ultra-early transnasal evaporative cooling after cardiac arrest and subsequent hypothermia at hospital, on survival with complete neurologic recovery, compared to currently recommended normothermia. The study population will consist of patients 18-79 years old, with out-of-hospital cardiac arrest with initial shockable rhythm.
The main research question it aims to answer is whether there is a difference in survival with complete neurologic recovery at 90 days after cardiac arrest between the group of patients that received ultra-early cooling, compared to the group that was treated with normothermia.
Participants will be randomized to two groups. One group (the intervention group) will receive ultra-early trans-nasal evaporative cooling initiated by EMS personnel at the scene of the cardiac arrest, and subsequent systemic hypothermia for 24 hours at hospital arrival. The other group (the control group), will receive standard of care (advanced cardiac life support and normal body temperature (normothermia)).
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Patients in the intervention group will be treated with hypothermia, which makes blinding for care provider and next of kin difficult in the intervention phase (first 36 h). Participants will be informed of which group the were assigned to if they regained consciousness. The study personnel assessing neurologic outcome at discharge and at 90 days will be blinded for which study group the participant belongs to. In addition, the physician performing the prognostication at 72 hours from cardiac arrest will be a neurologist, intensivist or other specialist experienced and will be blinded for group allocation, but not for relevant clinical data.
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥18 years that meet all of the following inclusion criteria:
- •Adult out-of-hospital cardiac arrest patients with initial shockable rhythm
- •Unconsciousness defined as Glasgow Coma Scale < 8
- •Inclusion within 20 minutes from EMS arrival
排除标准
- •Patients are not eligible if they meet one or more of the following criteria:
- •Age ≥ 80 years
- •Obvious non-cardiac causes to cardiac arrest
- •Obvious already hypothermic
- •Obvious barrier to placing intra nasal catheters
- •Have a known Do Not Attempt to Resuscitate (DNAR) order or other limitations in care
- •Have a known terminal disease
- •Known or clinically apparent pregnancy
研究组 & 干预措施
Early transnasal evaporative cooling with the RhinoChill device
Early transnasal evaporative cooling initiated during ACLS at the scene of the cardiac arrest within 20 minutes from EMS arrival and subsequent hypothermia at 33ºC for 24 hours and fever control for 72 hours at the ICU
干预措施: Early transnasal evaporative cooling with the RhinoChill device (Device)
Standard of care
Standard advanced cardiac life support, subsequent fever control (Normothermia) for 72 hours at ICU
结局指标
主要结局
Proportion of patients surviving with complete neurologic recovery at 90 days defined as modified Rankin scale (mRs) of 0-1.
时间窗: Day 90
The modified Rankin Scale is a scoring system on neurologic function ranging from 0-6, where 0 means no symtoms at all, higher numbers indicating increasing neurologic disabilities and 6 equals death.
次要结局
- Proportion of patients alive at hospital discharge(Day 1-90)
- Proportion of patients with sustained ROSC (return of spontaneous circulation) and admitted alive to hospital(Day 1)
- Proportion of patients alive at 90 days(Day 90)
- Proportion of patients with Modified Rankin scale 0-3 at hospital discharge(Day 1-90)
- Proportion of patients with Modified Rankin scale 0-3 at 90 days(Day 90)
- Device related adverse event rate within the first 24 hours(Day 1)
- Proportion of patients with new cardiac arrest prior to hospital admission(Day 1)
- Composite serious adverse event rate within the first 7 days(Day 1-7)
研究者
Per Nordberg
Senior consultant in cardiology and intensive care, Associate Professor
Karolinska Institutet