A Comparative Clinical Trial of a New Rectum Cooling System Versus Temperature-adjusting Blanket on Patients of Hypoxic-ischemic Brain Damage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Rate of Cooling
研究概览
简要总结
This study will try to evaluate the effectiveness and safety of a new method for achieving mild hypothermia, i.e.,mild hypothermia therapy through rectum. Half of participants will be treated by the widely-used hyper-hypothermia blanket method, while the other half will be treated by the investigators' new method.
详细描述
Mild hypothermia therapy has been proved to be beneficial to patients with severe traumatic brain injury. Currently a variety of cooling methods can achieve mild hypothermia,the hyper-hypothermia blanket being the most widely-used one.
Hyper-hypothermia blanket is a waterbed mattress connected to a thermostat-controlled water tank. Water is cooled in the tank and recycled between the tank and the mattress so that the patients sleeping on the mattress can be stably cooled. The operation is basically program-controlled ,but the whole system is quite expensive.
The investigators came up with a new cooling system which is very simple and accessible. A condom inserted with two 10# gastric tube and one 6# gastric tube and ringed with a rubber band is inserted into the patient's rectum, and ice-cold saline is pumped in through one 10# gastric tube and drained out from the other 10# gastric tube, the 6# gastric tube connected to the pressure monitor. Cooling rate is controlled by the flow speed of cold saline. The investigators will evaluate the effectiveness and safety of this new method for achieving mild hypothermia.
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 (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonatal HIE
- •After cardiopulmonary resuscitation (CPR)
- •Severe craniocerebral injury (GCS < 8)
- •Acute central nervous system infection and severe brain edema or lasting convulsion
- •Severe cerebral edema caused by various metabolic factors
排除标准
- •End-stage heart failure
- •Uncorrected serious cardiovascular dysfunction
- •Active intracranial hemorrhage not under control
- •Platelet count < 50 * 10^9 / L
结局指标
主要结局
Rate of Cooling
时间窗: 4 hours
The body temperature is measured every 15 minutes until the target temperature(33-35℃)is reached.
Body Temperature Fluctuations in Maintenance Phase
时间窗: 12 hours
During the maintenance phase,the body temperature is measured every 15 minutes.
Rate of Rewarming
时间窗: 24 to 48 hours
The body temperature is measured every 15 minutes until it rises to 36.5℃.
次要结局
- Incidence of Complications(24 to 72 hours)
- Fecal Occult Blood Testing Results Before and After the Therapy(Within 24 hours before the therapy and 48 to 72 hours after the therapy)
研究者
Zelan Zuo
Head Nurse of Pediatric Intensive Care Unit
Children's Hospital of Chongqing Medical University