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临床试验/NCT02909010
NCT02909010Unknown不适用

Bispectral Index Monitoring To Guide Sedation In Patients With Non-Neurological Pathology Over 65 Years, Admitted To Intensive Care Unit: Randomized Control Trial

Hospital Universitari de Bellvitge0 个研究点目标入组 150 人开始时间: 2015年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
150
主要终点
Total Dose of sedation

研究概览

简要总结

A randomized, control trial to compare the total dose of sedatives use in patients over 65 years admitted to the intensive care unit, guiding sedation by monitoring with BIS® versus monitoring with the exclusive use of sedation scales.

The study will include all patients over 65 years who enter the intensive care unit of the University Hospital of Bellvitge affected with medical or surgical pathology of non neurological etiology who require sedation for more than 24 hours to maintain adaptation to mechanical ventilation.

详细描述

Patients admitted to the intensive care unit (ICU) usually require use of hypnotics and sedatives to ensure comfort and proper adaptation to mechanical ventilation. An important requirement for an adequate sedation is frequent and proper assessment of its depth. Inadequate sedation can lead to problems of over-sedation, under-sedation and/or delirium in ICU, especially in elderly patients. The main objective od the study is To compare the total dose of sedative use and the rate of over-sedation in patients over 65 years admitted to the ICU, adjusting sedation by monitoring with BIS® versus monitoring with the exclusive use of sedation scales. METHODS. A randomized, clinical trial including patients over 65 years who were admitted to the ICU affected with medical or surgical pathology of non neurological etiology who required sedation for more than 24 hours to maintain adaptation to mechanical ventilation. Patients were randomized into two groups: the intervention group using BIS monitoring to adjust sedation in order to maintain values between 50-60 and; the control group in which sedation was adjusted with the exclusive use of Richmond Agitation-Sedation Scale (RASS) to maintain RASS -2. The study was approved by the institution's Research Ethics Committee.

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
65 Years 至 100 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients over 65 yers
  • Patients admitted to teintensive care unit of the University Hospital of Bellvitge medical or surgical pathology of neurological etiology
  • Patiens requiring sedation for more than 24 hours

排除标准

  • Patients less than 65 years
  • Patients admitted to the ICU with Neurological condition.
  • Postoperative patients admitted and extubation is expected within 24 hours.

结局指标

主要结局

Total Dose of sedation

时间窗: Two years

Total dose of sedatives administered in the intervention group compared with the control group.

次要结局

未报告次要终点

研究者

发起方
Hospital Universitari de Bellvitge
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sofia Contreras Medina

Intensivist

Hospital Universitari de Bellvitge

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