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临床试验/NCT03773874
NCT03773874已完成不适用

Assessment of Analgesia, Sedation, Physical Restraints and Delirium in Patients Admitted to Spanish Intensive Care Units. ASCyD Project

Hospital Universitario Getafe1 个研究点 分布在 1 个国家目标入组 1,574 人开始时间: 2018年2月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,574
试验地点
1
主要终点
Communicative patient's pain with Numeric Rating Scale (NRS) in critical care units.

研究概览

简要总结

This study assess which Spanish intensive care units evaluate and record, in a standardized way, levels of pain, sedation / agitation, use of physical restraints and prevalence of delirium. Also determine the use of validated assessment tools and explore levels of pain and sedation / agitation, use of physical restraints and prevalence of delirium.

详细描述

An observational, descriptive, cross-sectional, prospective and multicenter study was conducted to know the usual practice (audit) in critical care units and about the assessment of pain, sedation, delirium and the use of mechanical restraints.

At the same time, the level of pain, sedation / agitation and presence of delirium were evaluated in all adult patients who were admitted to the participating units with a minimum stay of 24 hours in the unit.

Process In order to obtain the largest representation of Spanish Intensive Care Units, a network of research nurses was created with coordinators in each autonomous community. The function of the coordinators was to contact and recruit units of adult critical patients within their community. Each coordinator contacted the centers (public and private), creating a network of collaborating nurses from those units who expressed their willingness to participate and who obtained the authorization of their Research Ethics Committee. Each unit was asked to contact a collaborating nurse for the project.

Once the national network of collaborating nurses was created, through the community coordinators, each password was given to each nurse to access the platform created for data entry. The platform offered access to all the documents (methodology, timeline, recommended assessment tools, navigation tutorial for the platform).

Data collection The tool used was an ad hoc survey with online access which consisted of 2 blocks. The first block asked about the characteristics of the units, the nurse-patient ratio, the existence of protocols and the usual practice for the control of pain, sedation / agitation, delirium and the use of mechanical restraints in the unit.

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

  • All adult patients who were admitted to the participating units at the time of the audit and had a minimum stay of 24 hours in the unit.

排除标准

  • no criteria

结局指标

主要结局

Communicative patient's pain with Numeric Rating Scale (NRS) in critical care units.

时间窗: one day

Primary assessment of pain. NRS scale's range from 0 to 10. 0: no pain; 1-3: light pain; 4-6: moderate pain; 7-10: severe pain

"Non communicative" patient's pain with Behavioural Indicators of Pain Scale (ESCID) in critical care units.

时间窗: one day

Primary assessment of pain ESCID scale's range from 0 to 10. 0: no pain; 1-3: light pain; 4-6: moderate pain; 7-10: severe pain

Communicative and "no communicative" patient's sedation/agitation level's with Richmond Agitation Sedation Scale (RASS) in critcal care units.

时间窗: one day

Primary assessment of sedation/agitation level' s. RASS scale range from -5 to +5. -4 to -5: depth sedation; -3 to -1: light sedation; 0: aware; +1 to +4: agitation.

Communicative and "no communicative" patient's delirium prevalence with Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) in critical care units

时间窗: one day

Primary assessment of delirium

Use of physical restraints on Communicative and "no communicative" patient's in critical care units

时间窗: one day

Primary assessment of use of physical restraints

次要结局

  • use of validated scale of pain: Visual Analog Scale (VAS)(one day)
  • protocols of pain and sedation(one day)
  • use of validated scale of pain: Behavioural Indicators of Pain Scale (ESCID)(one day)
  • use of validated scales of sedation/agitation (RASS)(one day)
  • use of validated scales of delirium (CAM-ICU)(one day)
  • use of validated scales of pain: Behavioral Pain Scale (BPS)(one day)
  • protocols of use of physical restraints(one day)
  • protocols of management of delirium(one day)
  • use of validated scales of sedation/agitation (Ramsay scale)(one day)
  • use of validated scale of pain: Numeric Rating Scale (NRS)(one day)
  • use of validated scale of pain: Campbell scale(one day)
  • use of validated scales of pain: Critical-Care Pain Observation Tool (CPOT)(one day)
  • use of validated scales of delirium (Intensive Care Delirium Screening Checklist (ICDSC))(one day)

研究者

发起方
Hospital Universitario Getafe
申办方类型
Other
责任方
Principal Investigator
主要研究者

Susana Arias Rivera

Principal Investigator

Hospital Universitario Getafe

研究点 (1)

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