Evaluating Two Novel Near-infrared Spectroscopy Devices for Non-invasive Monitoring of Traumatic Brain Injury in the Neuro Critical Care Unit.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 主要终点
- Glasgow Outcome Score Extended
研究概览
简要总结
This project seeks to evaluate the capabilities of new Near Infrared Spectroscopy (NIRS) devices, which use light to measure brain activity, for monitoring how the brain and body react after a serious head injury (TBI), particularly in the immediate and shortly following periods. Data recorded from these devices will help determine if they can effectively monitor additional complications and outcomes in adults over 18 with severe TBIs in a specialised intensive care unit for brain injuries (NCCU) at Addenbrooke's Hospital (Cambridge, UK). We will use two different NIRS devices similar to those currently used in the NCCU but with extra improvements. Both devices are proven to be safe and do not require surgery or internal procedures.
Participants will be recruited based on several criteria and monitored early in their NCCU admission. Monitoring will be daily for 6 hours, lasting from half a week to two weeks, depending on recovery progress. After the initial 10 patients, we will perform an interim analysis and may adjust the recording duration. We aim to recruit a maximum of 50 participants in total. Due to their condition, participants will not be able to give permission to participate, so we will seek it from their next of kin within 24 hours of admission. The study will only observe and not influence treatment. We will also collect additional clinical data, such as scans, the patient's condition six months after the injury, and other medical information for analysis.
The data collection period for this study will last up to 2 years. We will remove any personal details from the patient data. The body function data, with personal details removed, will be transferred and stored on the Brain Physics Lab server (segregated) and University of Cambridge computers for analysis. Any data not saved in dedicated long-term storage will be deleted after use.
详细描述
This study will apply novel near-infrared spectroscopy (NIRS) devices within the neurocritical care unit (NCCU) in Addenbrooke's Hospital (Cambridge, UK). The devices are non-invasive and are shown to be safe. The study is expected to last around year. It will not be used to inform treatment, and patient care is to remain identical regardless of study inclusion.
This study will use two NIRS devices, both of which have enhancements over systems used within the NCCU currently. We aim to develop NIRS-based biomarkers that could be used to support the treatment of those suffering from traumatic brain injury (TBI).
Upon receiving advice from the patient's consultee, the participant will be recorded with two different NIRS devices for a total of six hours daily (three hours per device). Recordings will occur daily for the duration of the participant's admission to the NCCU. We request access to clinical data, for example, blood pressure, heart rate, injuries suffered, CT and MRI scans and six-month outcomes for analytical purposes. As the devices are light-based, skin tone or ethnicity data is requested as is age-band for subject-specific modelling. This data will then be used to develop metrics based on existing literature that describe the brain health of the participant.
Participants will be unable to provide informed consent. Therefore, we will seek advice from their next of kin or in the event they cannot be identified within 24 hours, the treating clinician.
Participants will be those in the NCCU. They will be suffering from moderate or severe TBI. It is very likely they will be in an unconscious state. The study is limited to adults (defined as ≥18 years of age).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Those in the Neuro Critical Care Unit at Addenbrooke's (Cambridge, UK) AND
- •Patients with moderate or severe head trauma AND
- •Over 18 AND
- •Those with intracranial pressure monitoring probes."
排除标准
- •We will not monitor anyone aged under 18 OR
- •We will not monitor anyone with penetrating wounds in the area we want to monitor OR
- •Patients who are enrolled on >2 other research studies, as per local guidelines OR
- •Moribund at presentation OR
- •Those with infectious diseases.
结局指标
主要结局
Glasgow Outcome Score Extended
时间窗: 6 months after admission
The Glasgow Outcome Scale-Extended (GOSE) is a detailed assessment tool used to evaluate the functional status and recovery of patients following traumatic brain injury (TBI), categorizing outcomes into eight levels ranging from death to full recovery. It helps clinicians and researchers understand the long-term impact of TBI on a patient's daily life and guides treatment and rehabilitation efforts. Lower numbers are worse (1=dead). Higher numbers are better (8=Good recovery).
次要结局
未报告次要终点
研究者
Peter J. Hutchinson MD
Professor
University of Cambridge