Prospective Evaluation of Non-invasive Intracranial Pressure (ICP) Monitoring in Pediatric Patients Undergoing Invasive ICP Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- ICP recordings from the HS-1000 device compared to those from the invasive ICP monitor
研究概览
简要总结
The purpose of this study is to prospectively evaluate the accuracy and safety of non-invasive intracranial pressure (ICP) measurements using the HeadSense-1000 (HS-1000) device compared to the current invasive external ventricular device (EVD) or parenchymal (bolt) monitoring devices in the pediatric population.
详细描述
The HS-1000 is an innovative non-invasive intracranial pressure (ICP) monitoring device that employs advanced acoustic signal analysis to derive ICP on a continuous basis. The first version of the device was clinically validated in trials in Italy, India, and Armenia. Overall, more than 10,000 ICP measurements were collected from both patients and healthy subjects. The device is currently undergoing FDA validation in an adult cohort across eight sites in the United States.
This will be a pilot study conducted at Akron Children's Hospital. A maximum of 40 patients with severe traumatic brain injury (TBI) or neurological conditions requiring ICP monitoring will be studied over 2 years. All patients treated with either surgical ICP monitor (external ventricular drain [EVD] or subarachnoid manometer [Bolt]) are eligible for study enrollment. The HS-1000 device will be deployed as soon as possible after surgical ICP monitor placement to record and collect data in parallel with the surgical device.
To assess the accuracy and safety of the HS-1000 device as an alternative to the invasive ICP procedure, the investigators will compare ICP readings obtained by the HS-1000 monitoring system to measurements recorded by the surgical device during 15-30 minute recording sessions.
ICP readings will be recorded from both the invasive and HeadSense non-invasive ICP monitor for an aggregate of 30 minutes. During the recording sessions, a webcam will take periodic snapshots of the ICP monitor and/or bedside monitor picturing the ICP values and other clinical parameters that are displayed on screen, with a focus on blood pressure and heart rate (HR). Recording sessions will be done until an aggregate of at least 30 minutes of data are collected, depending on the patient's clinical condition. Recording sessions may be repeated over several days until the 30 minute target is reached.
The HeadSense headset is removed between recordings. Recording should be done only in case the patient's clinical condition allows it (i.e. patient is in supine position and does not require any clinical intervention or treatment at the time of the recording). In case the patient requires some clinical intervention the recording will be stopped and will be resumed only after the intervention is done and the patient's clinical condition allows resuming of the recording.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females <= 18 years old admitted to the PICU whose treatment includes a surgical ICP monitor.
- •Subject or legal authorized representative (per local regulation) is able and willing to comply with the requirements of the protocol
- •Subject or legal authorized representative (per local regulation) is able to understand and sign written informed consent to participate in the study
排除标准
- •Subject with an invasive ICP monitor placed Ten (10) days or before the date of recording for EVD monitor OR Five (5) days or before the date of recording for Bolt monitor
- •Subjects with more than one invasive ICP monitor in place at the time of recording
- •Ear disease/ear trauma
- •Subjects with severe head trauma in which the location and/or severity of the skull fracture(s), i.e. frank skull fracture or major joint dislocations with parenchyma exposed to room pressure, may jeopardize HeadSense monitoring procedure [Post-craniotomy patients with intact dura and accurate ICP values from the invasive EVD are eligible.]
- •Severe TBI that jeopardizes HS-1000 monitoring procedure
- •Cerebral spinal fluid (CSF) otorrhea
- •Allergy/Hypersensitivity to test materials
- •Pregnant or breast feeding
- •Current enrollment (or within 30 days) in another investigational device or drug study, OR receiving an investigational agent
- •Any condition that jeopardizes study participation (abnormal clinical/lab finding)
研究组 & 干预措施
HS-1000 recording
ICP readings will be recorded from both the invasive and HeadSense non-invasive ICP monitor for an aggregate of 30 minutes. During the recording sessions, a webcam will take periodic snapshots of the ICP monitor and/or bedside monitor picturing the ICP values and other clinical parameters that are displayed on screen, with a focus on blood pressure and heart rate (HR). Recording sessions will be done until an aggregate of at least 30 minutes of data are collected, depending on the patient's clinical condition. Recording sessions may be repeated over several days until the 30 minute target is reached.
干预措施: HS-1000 recording (Device)
结局指标
主要结局
ICP recordings from the HS-1000 device compared to those from the invasive ICP monitor
时间窗: 5 days of bolt insertion or 10 days of EVD insertion
次要结局
- Safety of the HS-1000 as determined by number of reported device-related adverse events(Up to 48hours after last recording)