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临床试验/NCT02576132
NCT02576132已完成不适用

Pupillometry for Pain Assessment in Critically Ill Patients

Charite University, Berlin, Germany1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2011年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Correlation coefficient of pupillary light reflex amplitude and pain score

研究概览

简要总结

This study was part of a quality improvement project at the Department of Anesthesiology and Intensive Care Medicine, Charité - Universitaetsmedizin Berlin.

Being in pain is reported to be one of the most important stressors in critically ill patients and worsens outcome. The evaluation of pain using validated scores in patients who are able to self-report significantly improves the quality of analgesic therapy and health related outcomes in intensive care patients.

However, behavioral pain score that are used in sedated or delirious patients, often underestimate the severity of pain.

The primary aim of this study is to investigate if measurement of the pupillary light reflex Amplitude correlates with the results of pain assessment using validated pain scores in critically ill patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • critically ill patients
  • aged 18 years or older
  • patients with an expected intensive care unit length of stay of of at least 48 hours.

排除标准

  • not German speaking
  • traumatic brain injury
  • increased intracranial pressure
  • ocular disease or surgery.

结局指标

主要结局

Correlation coefficient of pupillary light reflex amplitude and pain score

时间窗: Participants will be followed up to 6 days during their intensive care unit stay

Pain is measured by Numeric Rating Scale - Visualised or Behavioural Pain Scale or Behavioral Pain Scale - Non Intubated and pupillary light reflex amplitude is measured by pupillometry

次要结局

  • Latency of pupil [ms](Participants will be followed up to 6 days during their intensive care unit stay)
  • Minimal pupil size [mm](Participants will be followed up to 6 days during their intensive care unit stay)
  • Maximal pupil size [mm](Participants will be followed up to 6 days during their intensive care unit stay)
  • Pupillary light reflex [%](Participants will be followed up to 6 days during their intensive care unit stay)
  • Morbidity Scores(Participants will be followed up during their intensive care unit stay, an average of 25 days)
  • Glasgow Coma Scale (GCS)(Participants will be followed up to 6 days during their intensive care unit stay)
  • Delirium(Participants will be followed up to 6 days during their intensive care unit stay)
  • Contraction speed of pupil [mm/s](Participants will be followed up to 6 days during their intensive care unit stay)
  • Duration of mechanical ventilation (hours)(Participants will be followed up during their intensive care unit stay, an average of 25 days)
  • Amount of administered drugs(Participants will be followed up to 6 days during their intensive care unit stay)
  • Richmond Agitation Sedation Scale (RASS)(Participants will be followed up to 6 days during their intensive care unit stay)
  • Intensive care unit length of stay (days)(Participants will be followed up during their intensive care unit stay, an average of 25 days)
  • Hospital length of stay (days)(Participants will be followed up during their hospital length of stay, an average of 5 weeks)
  • Hospital mortality (days)(Participants will be followed up during their hospital length of stay, an average of 5 weeks)
  • Discharge to home [%](Participants will be followed up during their hospital length of stay, an average of 5 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Claudia Spies

Head of Department of Anesthesiology and Intensive Care Medicine CVK/CCM

Charite University, Berlin, Germany

研究点 (1)

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