PRINCESS - Prehospital Resuscitation Intra Nasal Cooling Effectiveness Survival Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 700
- 试验地点
- 3
- 主要终点
- Neurologically intact survival (CPC-cerebral performance categories scale 1-2)
研究概览
简要总结
Promising result of intra-arrest cooling on neurological intact survival in cardiac arrest patients has recently been published in the PRINCE-study in Circulation 2010.
The main purpose of this study is to determine whether prehospital intra-nasal cooling initiated during resuscitation, in addition to systemic cooling at hospital, increases neurological intact survival measured as cerebral performance category score (CPC-score)at 90 days in witnessed cardiac arrests outside hospital.
详细描述
Background:
The RhinoChill Device is a non-invasive, portable cooling device through which rapid cooling is achieved via the trans-nasal delivery of an evaporative coolant into the nasopharynx. Animal studies suggest a life-saving benefit for intra-arrest cooling.
Results from a European multicenter randomized trial (PRINCE - Pre Rosc Intra Nasal Cooling Effectiveness), published in Circulation in August 2010, demonstrate that intra-arrest trans-nasal evaporative cooling can be used safely and effectively in prehospital cardiac arrest without interfering with advanced cardiac life support protocols.
The outcome results among patients admitted to hospital showed a trend towards improved survival to hospital discharge in the treatment group (43.8% versus 31.0, p=0.26). The difference in neurologically intact survival was 34.4% vs 21.4%). In the subgroup of patients where cardiopulmonary resuscitation (CPR) was started by Emergency Medical Services personnel within 10 minutes (78 % of total number of patients) the difference in total survival between the groups was (56.5 versus 29.4, p=0.03). Neurologically intact survival for the corresponding subgroup was 43.5% vs 17.6%. In the treatment group, time to tympanic temperature of 34º was reached 3 hours faster (102 min versus 291 min, p=0.03) and time to core temperature 2 hours faster (155 min versus 284 min, p=0.13).
This study is powered to detect clinically significant changes in neurologically intact survival at 90 days after cardiac arrest. An interim analysis for safety and futility will be performed by an external committee after the first 200 patients have provided endpoint data. Conditional power for meeting the primary endpoint will if needed, be computed at that time, and if the interim results do not correspond to the primary endpoint, termination of the study for futility will be considered. Early stopping for efficacy reasons will only be considered if major outcome differences are seen between the groups according to the Haybittle rule with a p-value ≤0,001.
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
- Single (Outcomes Assessor)
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
- •Age ≥18 years
- •Collapse was witnessed (heard or seen)
- •Do not have a pulse
- •Are unresponsive to external stimuli
排除标准
- •Age ≥80 years
- •Have an etiology of cardiac arrest due to trauma, severe bleeding, drug overdose, cerebrovascular accident, drowning, smoke inhalation, electrocution, hanging
- •Already hypothermic (e.g., avalanche victim; found in the snow)
- •Have an obvious barrier to placing intra nasal catheters (e.g., intranasal obstruction)
- •Do Not Attempt to Resuscitate (DNAR) orders
- •Have a terminal disease
- •Known or clinically apparent pregnancy
- •Have a known coagulopathy (except therapeutically induced)
- •Are known to have a need for supplemental oxygen
- •Achieve ROSC prior to randomization
- •Response time (call to arrival) of the ambulance > 15 minutes
研究组 & 干预措施
Control
Patients in the control group standard advanced cardiac life support care. Patients that achieve return of spontaneous circulation will be treated with hypothermia according to current guidelines upon arrival at the intensive care unit.
Intervention
Intra-arrest trans-nasal cooling with RhinoChill will be initiated during advanced cardiac life support. In patients achieving return of spontaneous circulation, trans-nasal cooling will continue until systemic cooling is started at the intensive care unit.
干预措施: Prehospital intra-nasal cooling with RhinoChill (Device)
结局指标
主要结局
Neurologically intact survival (CPC-cerebral performance categories scale 1-2)
时间窗: 90 days after cardiac arrest
The Cerebral Performance Categories (CPC) are used to describe neurological outcome. A CPC of 1 or 2 is considered "neurologically intact." 1. - Good cerebral performance: little to no deficit. 2. - Moderate cerebral disability: capable of independent activities of daily life 3. - Severe cerebral disability: conscious, but dependent on others for daily support 4. - Coma or vegetative state 5. - Death or brain death
次要结局
- Total survival(90 days)
- Time to target temperature of 32-34º Celsius(8-10 hours)
- Proportion of patients achieving Return of Spontaneous Circulation (ROSC).(1 hour)
- Admitted alive to hospital(2-4 hours)
研究者
Leif Svensson
Leif Svensson, MD, PhD. Associate Professor in Cardiology. Karolinska Institutet, Södersjukhuset.
Karolinska Institutet