Evaluation of Pain Levels by Quantitative Pupillometry During the Placement of Deep Venous Catheters in Sedated Patients in Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change in variation of pupillary diameter by quantitative pupillometry
研究概览
简要总结
Pain is common in intensive care and gives rise to multiple consequences that can impact the future of patients. The placement of deep venous catheters are painful gestures of common practice in intensive care. However, some patients are ventilated and sedated and their level of pain is difficult to judge. Quantitative pupillometry seems to be a reliable tool for assessing pain in these patients unable to communicate. The method is already common practice in the operating room for this indication and recent studies increasingly validate its use in intensive care.
The aim of the study is to validate the different levels of pain that can be assessed by pupillometry within this population during catheterization and to identify any non-responding subgroups (in order to conduct future clinical trials evaluating pain therapies).
详细描述
Three groups of patients will be studied : with aminergic drugs / with curare / without aminergic drugs nor curare.
The measurement of pain levels by quantitative pupillometry (NPi®-200 pupillometer, NeurOptics® USA) will be made in intubated, sedated patients, unable to communicate on their level of pain during the placement of a deep venous catheter.
Pain will be evaluated before starting the placement of the catheter, at puncture(s), at dilation(s), and during the suture of the catheter.
Simultaneously, RASS and BPS scores as well as the patient's vital parameters and the cumulative doses of sedation-analgesia, curare and aminergic drugs will be collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 否
入选标准
- •Patient aged over 18 hospitalized in Intensive Care Unit
- •Requiring the placement of a deep venous catheter (central venous catheter or dialysis catheter)
- •Sedated, intubated, unable to communicate about pain
- •No opposition to participation in the study
排除标准
- •Any ophthalmological pathology (lesion of the orbital cavity, edematous soft tissue or with an open lesion)
- •Any intracranial pathology (stroke, subarachnoid hemorrhage, tumour, etc.)
- •Patient post-cardio-respiratory arrest within the first 48 hours
- •Medicines interfering with the pupillary reflex: clonidine dexmedetomidine, droperidol, metoclopramide, nitric oxide, scopolamine, atropine
- •Patient protected within the law
- •Previous participation in the study
结局指标
主要结局
Change in variation of pupillary diameter by quantitative pupillometry
时间窗: During the insertion of the deep venous catheter : before starting the placement of the catheter, at puncture(s), at dilation(s), and during the suture of the catheter (through study completion : an average of 20 minutes)
Pupillary variation (%) = \[maximum pupil diameter (mm) - minimum pupil diameter (mm)\] / maximum pupil diameter (mm)\]
次要结局
- Changes in pupil constriction by quantitative pupillometry(During the insertion of the deep venous catheter : before starting the placement of the catheter, at puncture(s), at dilation(s), and during the suture of the catheter (through study completion : an average of 20 minutes))
- Changes in pupillary reflex latency by quantitative pupillometry(During the insertion of the deep venous catheter : before starting the placement of the catheter, at puncture(s), at dilation(s), and during the suture of the catheter (through study completion : an average of 20 minutes))
- Changes in pupil dilatation by quantitative pupillometry(During the insertion of the deep venous catheter : before starting the placement of the catheter, at puncture(s), at dilation(s), and during the suture of the catheter (through study completion : an average of 20 minutes))
- Changes in NPi by quantitative pupillometry(During the insertion of the deep venous catheter : before starting the placement of the catheter, at puncture(s), at dilation(s), and during the suture of the catheter (through study completion : an average of 20 minutes))
- Changes in BPS scores(During the insertion of the deep venous catheter : before starting the placement of the catheter, at puncture(s), at dilation(s), and during the suture of the catheter (through study completion : an average of 20 minutes))
- Changes in respiratory rate(During the insertion of the deep venous catheter : before starting the placement of the catheter, at puncture(s), at dilation(s), and during the suture of the catheter (through study completion : an average of 20 minutes))
- Changes in heart rate(During the insertion of the deep venous catheter : before starting the placement of the catheter, at puncture(s), at dilation(s), and during the suture of the catheter (through study completion : an average of 20 minutes))
- Changes in blood pressure(During the insertion of the deep venous catheter : before starting the placement of the catheter, at puncture(s), at dilation(s), and during the suture of the catheter (through study completion : an average of 20 minutes))
研究者
Ambre Sauvage
Principal Investigator
Centre Hospitalier Régional Universitaire de Tours