Trans-Nasal Cooling With the RhinoChill Device Following Cardiac Arrest: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 30
- 主要终点
- Achieve Return of Spontaneous Circulation (ROSC)
研究概览
简要总结
The purpose of the study was to demonstrate the safety and feasibility of early intranasal cooling prior to return of spontaneous circulation (ROSC) in the emergency medical services (EMS) environment. It was hypothesized that cooling during the resuscitation attempt would increase ROSC and subsequent survival. The study was not powered to demonstrate statistically-significant differences in any outcome parameter, but was intended as an exploratory study only.
详细描述
Out of hospital cardiac arrest remains a significant cause of death. Mild hypothermia induced after resuscitation from cardiac arrest has been shown to improve neurologically intact survival. Studies in dogs and rodents have demonstrated improved outcomes when cooling is initiated intra-arrest.
The RhinoChill is a non-invasive cooling device through which rapid cooling is achieved via the intranasal delivery of an evaporative coolant into the nasopharynx. Due to its non-invasive and portable nature, the RhinoChill can be used to begin cooling earlier than other cooling devices.
Studies performed using the RhinoChill in a porcine model of cardiac arrest suggest that cooling with the RhinoChill prior to the first defibrillation attempt facilitates resuscitation and improves resuscitation rate and neurologically intact survival.
This study is being performed to assess the feasibility of using the RhinoChill device in the pre-hospital setting to improve resuscitation from cardiac arrest.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years
- •Collapse was witnessed
- •Unresponsive to external stimuli
排除标准
- •Have an etiology of cardiac arrest due to trauma, severe bleeding, drug overdose (OD), cerebrovascular accident (CVA), drowning, smoke inhalation, electrocution, hanging
- •Already hypothermic
- •Head trauma
- •Cannot place intra nasal catheters
- •Do Not Attempt to Resuscitate (DNAR) orders
- •Known or clinically apparent pregnancy
- •Have a known coagulopathy (except therapeutically induced)
- •Are known to have a need for supplemental oxygen
- •Achieve return of spontaneous circulation (ROSC) prior to initiating cooling
- •Are reached by emergency medical services (EMS) personnel more than 20 minutes after collapse
结局指标
主要结局
Achieve Return of Spontaneous Circulation (ROSC)
时间窗: 1-hour after arrest
ROSC was defined as the return of an organized rhythm on electrocardiography (ECG) with a palpable pulse that was maintained for at least 20 minutes.
Survived to Hospital Discharge
时间窗: 30 days after arrest
The study end-point was hospital discharge. This outcome measure is the patient count for those that were discharged alive from the hospital.
Survived Neurologically-Intact
时间窗: 30-days after 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
- Primary Outcomes in Sub-group With VF/VT as First Rhythm(hospital discharge)
- Time to Therapeutic Temperature(within 8 hours after enrollment)
- Length of Stay(Hospital Discharge)
- Serious Adverse Events (SAEs)(7 days after arrest)
- 24-hour Adverse Events (AE)(24 hours after arrest)