Dose Responsiveness as a Measure of Clinical Effectiveness During Neuromonitored Spine Surgery
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Nature of changes in free-run smooth muscle EMG under varying surgical and anesthetic conditions
研究概览
简要总结
Intraoperative Neuromonitoring (IONM) is a tool used by neurophysiologists during spine surgery to prevent irreversible damage to the spinal cord during procedures through a system of alerts. This study investigates the effectiveness of IONM in 300 participants receiving spine surgery. The goal of this study is to refine the alert criteria for procedures in which IONM is used.
详细描述
Intraoperative neurophysiological monitoring (IONM) measures neural function and integrity during surgical procedures. Through IONM, neurodiagnostic procedures can help determine whether any nerves have become compressed or if the brain or spinal cord has any reduced vascular flow, allowing the surgical team to take immediate and corrective actions to prevent a bad outcome. Essentially, IONM acts as an early warning system for surgeons to gain reliable insight into a patient's condition during surgery, adding a layer of safety to the measures already in place that monitor cardiac and respiratory function while a patient is anesthetized.
We propose an observational research study to enhance the evidence-base for IONM. A novel prospective neuromonitoring database will be implemented. In addition to the usual contingency data to assess prediction accuracy, other measures will be examined:
- A "dose effect of injury" assessment. Three categories of injury will be recorded by physicians: (a) No New Deficit; (b) New Minor Deficit; and (c) New Severe Deficit.
- The outcome effect of intraoperative test frequency will be evaluated (infrequent vs average vs very frequent), leading to a "dose effect of neuromonitoring" assessment. Here we hypothesize that within our prospective sample, there is a relationship between the proportion of total new neurological deficits (New Minor Deficit + New Severe Deficit) and the frequency of IONM testing. More frequent testing is associated with fewer total new neurological deficits.
- Patient reported outcomes will be evaluated longitudinally in conjunction with clinical outcomes data. Patient interviews will be conducted by a trained research assistant aided by department technologists. Patient-reported neurological outcome assessments will be supplemented/confirmed by review of in- and outpatient surgical/neurophysiologist physician chart notes.
Data from this proposed observational study will allow real-life outcomes based improvement in the field of IONM.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Must be 18+ years old
- •Patients must be undergoing cervical and/or thoracic spine surgical procedure at Abbott Northwestern Hospital in Minneapolis, MN
排除标准
- •Patients who are non-English speakers
- •Patients with ongoing psychiatric concerns are excluded
- •Patients unwilling to be contacted for a 6-month follow-up
结局指标
主要结局
Nature of changes in free-run smooth muscle EMG under varying surgical and anesthetic conditions
时间窗: 1 day
Free-run smooth muscle EMG will be monitored continuously throughout the duration of surgery. Any changes in the EMG, as indicated by fluctuation in amplitude and/or frequency, will be recorded.
The believable and repeatable smooth muscle EMG response, if any, measured by amplitude and frequency after deliberate spinal/extra-spinal neural stimulations.
时间窗: 1 day
Nature of changes in free-run smooth muscle EMG resulting from the inadvertent effect of intraoperative monitoring stimulation and recording.
时间窗: 1 day
Smooth muscle EMG in response to stimulations and recordings will be monitored. Any changes in the EMG, as indicated by fluctuation in amplitude and/or frequency, will be recorded.
次要结局
- Short Form (36) Health Survey(1 year)