近红外光谱光学监测脊髓损伤试验
“OMNI-SCI”试验——“近红外光谱光学监测脊髓损伤”试验
The study involves the 'first-in-human' evaluation of a novel optical sensor which uses near-infrared spectroscopy (NIRS) technology to assess oxygenation and hemodynamics of the injured spinal cord. The NIRS sensor is laid on top of the dura, at the site of the SCI, and emits near-infrared light signals into the cord to measure tissue oxygenation and tissue hemodynamics in real-time. Our testing of this novel NIRS sensor in patients with acute SCI represents the first step in translating this technology for human use.
研究概览
详细说明
This single-center, prospective observational study will enroll 10 patients admitted to Vancouver General Hospital (VGH) for treatment of an acute traumatic spine injury.
Promising preclinical data demonstrates that the oxygenation and hemodynamic measures of our Near Infra-Red Spectroscopy (NIRS) system closely match the invasive intraparenchymal measures obtained within the injured spinal cord. Further, the NIRS sensor is responsive and reflective of systemic hemodynamic changes. This clinical protocol represents the first application of this novel NIRS sensor in human SCI. Following operative decompression of the spinal cord via a posterior approach, the NIRS sensor will be placed over the dura for 7 days to monitor spinal cord oxygenation and tissue hemodynamics. Patients will be followed for 6 months and data collection for safety, feasibly and efficacy of the NIRS System.
The specific aims of this project are to:
- Establish the safety, feasibility, and efficacy of our NIRS system in monitoring tissue oxygenation and hemodynamics of the injured spinal cord in human participants.
- Complete the technical refinement of the NIRS system utilizing an iterative process guided by participant recruitment and data accrual during the trial.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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-
British Columbia
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Vancouver、British Columbia、加拿大、V5Z1M9
- Vancouver General Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Male or female aged 17 years or older
- Spinal injury between bony levels C3 and L1 inclusive
- Motor complete acute traumatic SCI (AIS A or B) or motor incomplete SCI (AIS C) with a total lower extremity motor score of less than 5
- Blunt (non-penetrating) SCI requiring posterior laminectomy with stabilization/fusion surgery within 72 hours of injury
- Able to communicate in English and provide informed consent
Exclusion Criteria:
- Isolated radiculopathy or cauda equina injury
- Spinal cord impairment secondary to tumour, infection, epidural bleeding, or ischemia (in
- Any condition or injury (e.g. Morel-Lavellee lesion) that would interfere with the application or readings of the NIRS sensor
- Associated traumatic condition that would interfere with the informed consent process or outcome assessments (e.g. traumatic brain injury, pelvic, abdominal, or thoracic injuries)
- Any other medical condition that, in the investigator's opinion, would render the protocol procedures dangerous
- Female patients who are pregnant
学习计划
研究是如何设计的？
设计细节
- 主要用途：设备可行性
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Arm 1
NIRS monitoring of spinal cord oxygenation and hemodynamics |
The NIRS sensor is laid on top of the dura, at the site of the SCI, and emits near-infrared light signals into the cord to measure tissue oxygenation and tissue hemodynamics in real-time. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Feasibility Assessment - Overall
大体时间：Day 7
|
Study specific questionnaire will collected data on the the ease of sensor application, NIRS monitoring and sensor removal is recorded with this form. Series of questions requiring the assessment of the NIRS system using yes/no and 10-point scoring scale |
Day 7
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Feasibility Assessment: Sensor Application
大体时间：Day 1
|
Study specific form will be used record data associated with application of the NIRS sensor, such as the laminectomy and instrumentation data, location of the sensor and ease of application (score out of 10). |
Day 1
|
|
Feasibility Assessment: Sensor Removal
大体时间：Day 7
|
Study specific form will be used to record the condition of the sensor and participants' experience (score out of 10) at the time of sensor removal |
Day 7
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Safety Assessment - Neurologic Function
大体时间：6 Month
|
Neurologic function will be assessed using the International Standards for Neurologic Classification of Spinal Cord Injury (ISNCSCI) to determine if the application, 7-day placement, or removal of the NIRS sensor is associated with any deterioration in spinal cord function. |
6 Month
|
|
Safety Assessment - Wound Assessment
大体时间：Day 7
|
The externalization of a foreign body may lead to an increased risk of surgical site infection. Any incidence of wound infection will be monitored and document on a wound assessment form. |
Day 7
|
|
Safety Assessment - Adverse Events
大体时间：6 Months
|
The incidence of AEs in the acute SCI patient population is significant. For the purposes of this study, and in keeping with standard of care on the Acute Spine Unit at study site, all AEs will be recorded utilizing the Spine Adverse Event (SAVES) form, a well-established system for prospectively documenting AEs in spine patients |
6 Months
|
合作者和调查者
调查人员
- 首席研究员：Brian Kwon, MD, PhD、University of British Columbia
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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