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临床试验/NCT01669486
NCT01669486已完成不适用

The Pain in Intensive Care Unit: An Experimental Research to Compare Behavioural Pain Scale (BPS) and Critical Care Pain Observation Tool (CPOT)

Università degli Studi dell'Insubria1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年6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
The evaluation of pain in critically ill patients

研究概览

简要总结

The purpose of this research is to find the best system for assessing the pain of critically ill patient in Intensive Care Unit (ICU).

At first the investigators assess the sedation of the patient with the scale sedation-agitation scale (SAS) or the delirium with the confusion assessment method, if the patient is too sedated or delirious the investigators consider him unable to use the Visual Analogic Scale (VAS).

The investigators compare two different scales Critical Care Pain Observation Tool (CPOT) and Behavioural Pain Scale (BPS) which include no verbal items. Each items has been evaluated in three different moments: before, during and after the nurses' care.

The investigators compare the scales between them. Then, every time the investigators value the score of these scales with the self-report of patients with the VAS scale (when it is possible) and finally with the physiological parameters (blood pressure, heart rate and respiratory rate).

In the end, the investigators compare two different classes of patient: the surgical and medical one. The investigators search for some differences in the perception of the pain between these two classes.

详细描述

This study has specific aims:

  1. to find the best method to evaluate the pain in critically ill patients;
  2. to compare the perception of pain analysed trough CPOT and BPS;
  3. to compare CPOT and BPS between medical and surgical patients.

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • male and female
  • require of Mechanical Ventilation (MV)
  • Hospitalization on ICU > 24 hours

排除标准

  • Age < 18 years
  • Tetraplegic
  • Neuromuscolar disease
  • Neuromuscolar blocking agents by continuous infusion
  • Spontaneous breathing without Mechanical Ventilation (MV)

结局指标

主要结局

The evaluation of pain in critically ill patients

时间窗: Participants will be followed for 3 days

The measurement of pain with no verbal items of different pain scales: facial expression, movements of the body, muscle tone, compliance of mechanical ventilation, movements of the arms. We'll evaluate the level of pain before and after nurses manoeuvers

次要结局

  • The comparisation beetween the CPOT and the BPS scales(Participants will be followed for 3 days)
  • The comparisation of CPOT and BPS between medical and surgical critically ill patients(Participants will be followed for 3 days)

研究者

发起方
Università degli Studi dell'Insubria
申办方类型
Other
责任方
Principal Investigator
主要研究者

Paolo Severgnini

Prof.

Università degli Studi dell'Insubria

研究点 (1)

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