Study of Brain Cools Device in Patients Resuscitated From Cardiac Arrest
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Rate of hypothermia induction
研究概览
简要总结
This submission is a pilot in which the new IQool Warming System device will be used to maintain the temperature of adult patients in cardiac arrest within a range of within a range of 32°C to 38.5°C (89.6°F to 101.3°F). The IQool Warming System has received a 510 K Clearance by the FDA.
详细描述
Subjects will receive temperature management using the IQool. This is an FDA approved device. Managing temperature is part of standard care for this population and surface cooling is commonly employed.
The following phases will be conducted as standard of care, and will be reviewed for this study:
Induction phase: When a subject is included in the study, the IQool will be connected to the patient and activated. The induction period will continue until the patient has reached the upper limit of the target temperature range (defined as 0.5°C above the target temperature).
Maintenance phase: Set target temperature will be maintained for 24 hours. The maintenance phase begins when the subject temperature is within 0.5°C of goal temperature. The maintenance phase is completed 24 hours after first reaching below the upper limit of the target temperature range.
Rewarming phase: After 24 hours of maintenance, gradual rewarming at 0.25 °C/h will commence. When the subject reaches 37°C the TTM period is completed and the IQool will continue to provide fever control.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •In- or out-of-hospital cardiac arrest of all initial rhythms
- •Adult patients (18 years of age and older)
- •Unconscious on admission to hospital, defined as not following commands
- •Indication for targeted temperature management
排除标准
- •Pregnancy
- •Active do not resuscitate order
- •Any patient not expected to survive 72 hours
- •Skin infection
- •Skin wound affecting site of temperature exchange pads
结局指标
主要结局
Rate of hypothermia induction
时间窗: Up to 12 hours
Induction of hypothermia will occur at a rate of at least 1C/hr
Maintenance of hypothermia
时间窗: 24 hours
The IQool system will maintain temperature within 0.5C of goal temperature for 75% of the maintenance phase
Rewarming rate
时间窗: Up to16 hours
When rewarming, the IQool system will rewarm within 0.5C of the goal rate of rewarming
次要结局
- Number of physicians that recommend the IQool system for temperature management(72 hours)
研究者
Adam Frisch
Assistant Professor of Emergency Medicine
University of Pittsburgh