Stimulation Anda Validation of the Pupillary Dilation for the Detection of Pain in Analgosedated Patients Under Mechanically in Intensive Care Unit
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Propotion of patient with pain on experimental group versus control group
研究概览
简要总结
This project has 2 phases. Phase 1: diagnostic test study, to evaluate the efficacy of the variation of pupillary size (PDR) to detect pain in ICU patients regarding to Behavioural Pain Scale (BPS) and ESCID (Conductual Scale Pain Index). Phase 2: controlled and aleatorized clinical trial to evaluate efficacy in PDR monitoring after painful assessed minimum stimulus with the best diagnostic efficiency on phase 1, as a need of analgesia indicator tool.
The sample will be patients over 18 years, sedated and mechanically ventilated, with an initial BPS of 3, RASS between -1 and -4, not able not to communicate , with inform consent signed. Exclusion criteria will be: ophtalmologic pathology and administration of drugs interfering pupillary reflexes. Measurements before/during pain/non-pain situations, aspiration of secretions and calibrated intensity stimulus through the pupilometer Algiscan. The investigators will study association between pain according to BPS/ESCID and pupillary dilatation according to pupillometry and percentage of patients with pain and preanalgesia according to pupillometry and standard clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years.
- •Analgosedated patients under mechanical ventilation.
- •Unable to communicate (verbal or motor).
- •Patients with initial BPS of 3, and RASS from -1 to -
- •Familiar prior informed consent.
排除标准
- •Patients treated with muscle relaxants.
- •Severe Critical Polyneuropathy.
- •Pupillary reflex affectation in diabetic patients (diabetic papillopathy,glaucomatous optic neuropathy) or any other pathologies like Adie´s Syndrome, Argyl-Robertson pupil.
- •Patients with tansmisible ocular infections.
- •Patients with possible injury of the third carnial nerve (Horner´s syndrome) due to injury to the brainstem, cervical cord, cancer of the upper lobe the lung, dissection of the carotid and/or cluster headache.
- •Acute cerbrovascular conditions with Glasgow Coma Scale less than 6, or increased intracranial pressure, or pontine base infarction.
- •Drugs that interfere with the pupillary reflex (clonidine, dexmedetomidine, metoclopramide, tramadol, droperidol, ketamine, nitrous oxide).
- •Patients under metoclopramide, if given 10 minutes prior the measurement of the pupillary reflex (PDR).
- •Patients during the first 24 hours after Cardiac Arrest (CRP).
- •Severe unestable comorbidity with doses of norepinephrine> 0.6 microg/kg/min and/or dobutamine>10 microg/kg/min or drenalin any doses.
- •Patients with untreated pheochromocytomas.
- •Refuse to participate in the trial.
结局指标
主要结局
Propotion of patient with pain on experimental group versus control group
时间窗: An average of 1 year
To compare the proprtion of patients with pain according to Behavioral Pain Scale (BPS), pupillometry and Scale of Behaviour Indicators of Pain (escid)
Proportion of patient who require anesthesia on experimental group versus control group
时间窗: An average of 1 year
The proportion of patients who require anesthesia on experimental group (previous analgesia according to pupillometry during endotracheal aspiration) versus control group (previous analgesia according to standard clinical practice).
次要结局
未报告次要终点
研究者
Ana Vallejo de la Cueva
Principal Investigator
Basque Health Service