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临床试验/NCT03832764
NCT03832764已完成不适用

Observational Study for the Evaluation of a New Non-invasive Painmonitor Used in Clinic in Awakening, Postoperative Patients

University Ghent1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2018年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
1
主要终点
Evaluation of a new non-invasive painmonitor used in clinic awakening, postoperative patients.

研究概览

简要总结

During the current pain monitoring system the patient is awake and he/she is asked to give a numerical scale rating from 0 (no pain) to 10 (extreme pain). The purpose is to correlate the non-invasive measurements of the prototype device ANSPEC-PRO with these numbers to develop later a method/algorithm for automatic evaluation of pain (objective measurement of pain). The measurement is done using standard ECG electrodes placed in the hand palm of the patient. The patient feels nothing during the observations, perhaps irritation of skin may occur as result of long time measurement. As a comparison to the investigators prototype, a commercial device is also used in (randomly selected) patients, i.e. the MedStorm device.

The study will try to answer the following questions:

  • Are the measurements with the ANSPEC-PRO correlated with the NRS values?
  • What is the (mathematical) relationship between the measured values and the NRS?
  • Is there difference between the two devices in measuring pain levels? And what is this difference if pain alleviation medication is given to the patient?
  • A number of 26 patients is envisaged for this study, equally distributed to be evaluated with the two devices.

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

入选标准

  • patients postoperative of a painfull operation
  • between 18 and70 years old

排除标准

  • day surgery patients
  • chronic pain patients
  • taken medication : anticonvulsants

结局指标

主要结局

Evaluation of a new non-invasive painmonitor used in clinic awakening, postoperative patients.

时间窗: 140 minutes each patient

Pain monitoring of awake patients which are standardly treated for pain using the numerical rating scale. The main outcome is a correlation between ANSPEC-PRO device and the numerical rating scale.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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