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临床试验/NCT03024021
NCT03024021已完成不适用

The Effect of Cerebral Oxymetry in Determining Neurological Outcome in Patients Treated With Therapeutic Hypothermia

Tepecik Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Measure of cerebral oximetry

研究概览

简要总结

This study is designed to assess the effect of cerebral oxygen saturation as an early predictor of neurological outcomes in patients undergoing therapeutic hypothermia after cardiac arrest

详细描述

Our study is planned as a prospective observational study. Patients undergoing therapeutic hypothermia in our intensive care unit after cardiac arrest will be enrolled. Each patient's cerebral oxygenation will be monitored with near-infrared spectroscopy (NIRS) in every 6 hours during our 24 hour lasting hypothermia period. Afterwards, patients will be monitorised in every 6 hours during the first day of hypothermia and than the mean values of daily cerebral oxygen values will be noted in the third, fourth and fifth days of nomothermia. Regional oxygen saturation (rSO2) will be noted from left and right probes. Full Outline of Unresponsiveness (FOUR) Score, Glasgow Coma Score (GCS) and cerebral performance category scale (CPC) will be noted at the beginning of therapeutic hypothermia and each day during normothermia, day 21 and the day of discharge from ICU.

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

入选标准

  • Patients at least 18 years old
  • Patients undergoing therapeutic hypothermia

排除标准

  • Patients under 18 years
  • Patients unsuitable for therapeutic hypothermia

结局指标

主要结局

Measure of cerebral oximetry

时间窗: 8 times during the first 48 hours of hospitalization

During the first 48 hours of hospitalization, we will collect the cerebral oximetry values in the two cerebral. hemispheres.

次要结局

  • The cerebral oximetry values (average of the two hemispheres) will be compared between patients with good and poor neurological outcome according with CPC score(Participants will be followed for 8 times during the first 48 hours of hospitalization, the third day, fourth day and fifth day and the duration of hospital stay, an expected average of 2-4 weeks and a 12 month follow up will be performed)

研究者

发起方
Tepecik Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aykut Saritas

principal investigator

Tepecik Training and Research Hospital

研究点 (1)

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