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临床试验/NCT02071797
NCT02071797已完成不适用

Early Targeted Brain Cooling in the Cath Lab Following Cardiac Arrest. Randomised Controlled Trial of RhinoChill Versus Blanketrol Intra-Hospital Induction of Therapeutic Hypothermia After Cardiac Arrest

Mid and South Essex NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
2
主要终点
Time to reduce tympanic temperature to < 34C

研究概览

简要总结

The objective of the COOLCATH study is to compare the effect of the RhinoChill transnasal cooling system to current standard Blanketrol III cooling blanket in its ability to achieve therapeutic hypothermia (TH) induction for patients undergoing TH after cardiac arrest.

The COOLCATH study will be a prospective, open-label randomized controlled trial comparing induction of TH efficacy and outcomes of patients following cardiac arrest. Any patient with return of spontaneous circulation (ROSC) following a cardiac arrest within the Essex Cardiothoracic Centre (CTC), or who is brought to the Essex CTC and is a candidate for TH will be considered for this study.

详细描述

According to standard practice patients will be fully anaesthetised, intubated and ventilated. Patients will have a baseline tympanic temperature measurement taken and then will be randomized to receive induction of TH by either RhinoChill Transnasal cooling system, or standard care using the Blanketrol III cooling blanket.

All patients will have tympanic and oesophageal temperature measurement every 10 minutes until they reach TH (<34 degrees centigrade). Once TH is achieved, the RhinoChill will be discontinued, and all patients will then receive the Blanketrol III cooling blanket for maintenance of TH for the standard 24 hour period. If a patient achieves a core body temp of 34 degrees centigrade while undergoing RhinoChill cooling and is still on the cath lab table, the device will be turned to low flow to ensure that the temperature is maintained until a transfer to the Blanketrol system is possible. For patients that arrive in the ICU on RhinoChill with a temperature >34 (i.e. have not reached TH), these patients will have RhinoChill and blanket therapy until they reach <34 degrees centigrade when the RhinoChill will be discontinued.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥ 18 years old
  • Post cardiac arrest with Return of Spontaneous Circulation
  • Receiving therapeutic hypothermia as part of post-cardiac arrest care

排除标准

  • Cardiac arrest caused by trauma, head injury, massive haemorrhage, drug overdose, cerebrovascular accident, drowning, electric shock or hanging
  • Already hypothermic
  • Nasal obstruction preventing the insertion of a nasal catheter
  • Do Not Attempt to Resuscitate (DNAR) orders
  • Known terminal illness (eg. malignancy in the end stages)
  • Known or obvious pregnancy
  • Known coagulation disorder (except those induced by medication eg. Thrombolytics)
  • Known O2- dependency

结局指标

主要结局

Time to reduce tympanic temperature to < 34C

时间窗: Day 1

次要结局

  • In hospital and 30 day mortality(Day 30)
  • Length of Intensive Care Unit stay(Day 30)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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