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临床试验/NCT05811208
NCT05811208招募中不适用

Use of Automated Pupillometry for Pain Assessment in ICU Patients with Delirium

St. Anne's University Hospital Brno, Czech Republic1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
pupillometry parameters and objective pain scales

研究概览

简要总结

Pain assessment in intensive care patients is a constant challenge. Approximately 50% to 80% of patients report pain at rest or during medical or nursing interventions (for example endotracheal suctioning, mobilization and rehabilitation, presence and care of invasive inputs, etc.). Obstacles to pain assessment and management are most often due to interference with communication due to impaired consciousness, airway support and connection to artificial pulmonary ventilation, or the effect of administered medication.

Patients in intensive care are prone to delirium. Delirium can compromise patients' ability to verbalise pain for a variety of reasons (e.g. due to impaired attention, memory, thinking and language barriers). Also, pain and inadequate analgesia are risk factors for delirium.

Pupillary reflex changes and their identification by automated pupillometry have yielded positive results regarding nociception assessment in adult and pediatric patients and in perioperative and postoperative care. At the same time, the response of these patients to opioid administration was investigated. The aim was to improve their analgesia.

The aim of this study is to find out whether, there is an association between automated pupillometry and selected objective pain measurement scales in The Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) positive patients after surgery.

详细描述

Periodically after 6 hours, the incidence of delirium will be assessed using the CAM ICU questionnaire. Subsequently, the incidence of pain will be assessed using 3 valid scales. The Visual Analogue Scale (VAS), the Behavioral Pain Scale (BPS) and the Critical Care Observational Tool (CPOT) will be used. Finally, automated pupillometry will be measured. The measurement values will be entered in the record sheet. Information about the medications administered and the patient's vital signs will also be recorded.

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

  • patient after surgery
  • possibility to perform CAM - ICU test (patients with Richmond Agitation-Sedation Scale -2 to +2)

排除标准

  • eye diseases
  • brain injury
  • neuromuscular diseases

结局指标

主要结局

pupillometry parameters and objective pain scales

时间窗: up to 4 weeks

correlation of pupillometry parameters and objective pain scales

次要结局

未报告次要终点

研究者

发起方
St. Anne's University Hospital Brno, Czech Republic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ivan Cundrle

Clinical Professor

St. Anne's University Hospital Brno, Czech Republic

研究点 (1)

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