Transcutaneous Pulse Oximetry Brain Monitoring Study (US): T-POT Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Agreement of the brain oximeter levels compared with invasive ICP levels
研究概览
简要总结
This is a study of adult patients with a severe and sudden brain injury who have a drain placed in their brain to measure pressure. The purpose of the study is to monitor the pressure in the brain using a monitor placed on the forehead, and compare this to a drain placed in the brain.
详细描述
The device is a non-invasive brain pulse oximeter. It uses red and near-infrared light and provides a signal which represents the change in blood volume associated with each heartbeat.
The brain signal allows a number of clinically important end-points to be determined, including brain blood flow, oxygen and pressure levels.
The T-Pot (US) Study will be undertaken in patients that require invasive brain monitoring.
The primary aim of the study is to assess the accuracy of the brain pulse oximeter compared with the traditional invasive intracranial pressure (ICP) monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Adult brain-injured patients who have undergone external ventricular drain insertion for cerebrospinal fluid drainage and invasive intracranial pressure monitoring as part of standard medical care
- •Adult brain-injured patients who have undergone external ventricular drain insertion for cerebrospinal fluid drainage and invasive intracranial pressure monitoring that have concomitant continuous electroencephalography (EEG) monitoring as part of standard medical care
排除标准
- •Inability to obtain the brain pulse oximeter signal from at least one brain hemisphere due to interface issue such as severe agitation, head dressing, severe skin or bone trauma, or skull removal preventing brain pulse detection for the initial monitoring session.
- •a. Note: If unable to obtain brain pulse oximeter signal for subsequent monitoring sessions, the only the recordings that were obtained will be used for analysis
- •Hemodynamically unstable patients (defined as increasing vasopressors requirements)
- •Patients with unstable mechanical ventilation support defined as increasing fractional inspired oxygen (FiO2) requirements
研究组 & 干预措施
Enrolled patients
All enrolled patients will have brain pulse monitoring
干预措施: Brain Pulse Oximeter (Device)
结局指标
主要结局
Agreement of the brain oximeter levels compared with invasive ICP levels
时间窗: Daily recordings for up to 30 days while the patient has an invasive ICP probe in situ
Correlation of the optical signal waveforms with the invasive ICP waveforms and level
次要结局
- Optical signal changes associated with periods of brain hypoxia and surrogate ICP waveform(Daily recordings for up to 30 days while the patient has an invasive ICP probe in situ)
- Optical signal changes associated with non-convulsive seizures via EEG monitoring (Alpha, Beta, Theta)(Daily recordings for up to 30 days while the patient has an invasive ICP probe in situ)