A Portable Chromatic Multifocal Pupillometer for Objective Early Detection and Follow-up of Changes in Intracranial Pressure in Patients With Acute Head Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pupillary response at 5 points of Visual field to blue and red light
研究概览
简要总结
Traumatic Brain Injury (TBI) is a common injury in combat, terrorist attacks and sports such as football and hockey. Unnecessary delays in the diagnosis and treatment of brain damage in patients who can benefit from evacuation procedures can lead to worse brain injury, worse outcome and, sometimes, unnecessary death. However, there is no reliable and sensitive method for diagnosis of TBI severity in the field. In this study we will examine the feasibility of using this a multifocal chromatic pupillometer for monitoring TBI, by examining the pupillary response to multifocal chromatic stimuli in intracranial pressure (ICP)-monitored severe TBI patients. As control, normal subjects will be tested for pupillary responses using this device.
详细描述
To examine the feasibility of using the multifocal chromatic pupillometer for monitoring TBI, the pupillary response to multifocal chromatic stimuli will be assessed in 20 healthy subjects and 20 ICP-monitored severe TBI patients.
The portable pupillometer will be tested in 20 healthy volunteers. Their pupillary responses will be measured 3 times/day for 1 week.
Pupillary response of 20 severe TBI patients will be evaluated as detailed below at the following time points:
- At admittance to ICU, prior to insertion of ICP and CT scan
- Prior to CT scans that are routinely performed at day 3 and 7 post injury
- Routinely at the beginning of every medical personnel shift for 7 days (3 times a day).
- With every change in ICP(more than 5 mmHg for more then 15 min) Data will be recorded and analyzed.
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
- 是
入选标准
- •Healthy subjects -
- •Male or female patients, age between 18 and 70 years, inclusive
- •Informed written consent will be obtained from all participants.
- •Normal eye examination
- •Best-corrected visual acuity (BCVA) of 20/20
- •Normal color vision test (Roth-28-hue test)
- •Written informed consent to participate in the study,
- •TBI-patients:
- •Male or female patients, age between 18 and 70 years, inclusive
- •Initiation of study before the insertion of the ICP monitor.
- •TBI diagnosed by history and clinical examination
- •Glasgow Coma Scale (GCS) score between 3 and 8, inclusive
- •Evidence of TBI confirmed by abnormalities consistent with trauma on CT scan upon admission (diffuse injury II-IV, evacuated and non-evacuated mass lesion, Marshall's CT Classification)
- •Indication for ICP monitoring
- •Written informed consent to participate in the study, signed by a family member and independent physician.
排除标准
- •Healthy subjects
- •History of past or present ocular disease
- •Use of any topical or systemic medications that could adversely influence efferent pupil movements
- •TBI-patients
- •High levels of barbiturate medications as they abolish pupillary responsiveness
- •Coma suspected to be primarily due to other causes (e.g. alcohol)
- •Preexisting clinically significant disease or chronic condition that can be ascertained at the time of admission and could affect pupillary response or measurement (such as known retinal dystrophy disease, glaucoma or dense cataract.
结局指标
主要结局
Pupillary response at 5 points of Visual field to blue and red light
时间窗: 7 days
Pupillary response at 5 points of Visual field to blue and red light will be measured 3 times a day for a week for the health subjects. The TBI patients will be monitored for pupillary response: * At admittance to ICU, prior to insertion of ICP and CT scan * Prior to CT scans that are routinely performed at day 3 and 7 post injury * Routinely at the beginning of every medical personnel shift for 7 days (3 times a day). * With every change in ICP(more than 5 mmHg for more then 15 min)
次要结局
- Intra Cranial Pressure(7 days)
研究者
Dr. Ygal Rotenstreich
Head of Electrophysiology Service
Sheba Medical Center