Machine Learning Prediction of Spinal Anaesthesia Block Duration
Artificial Intelligence-Based Prediction of Sensory and Motor Block Duration Following Spinal Anaesthesia: A Prospective Observational Prediction Model Development Study
The duration of sensory and motor block after spinal anaesthesia varies widely between patients given the same dose of local anaesthetic. Much of this variability is explained by differences in lumbosacral cerebrospinal fluid volume, which cannot be measured routinely in clinical practice but is related to simple body measurements such as abdominal circumference and vertebral column length. This prospective observational study will develop and internally validate prediction models for the duration of sensory and motor block following spinal anaesthesia in adults undergoing elective surgery. Preoperative clinical and anthropometric variables will be recorded, and block regression will be assessed serially after intrathecal injection. Machine learning methods (lasso regression, ridge regression, random forest, extreme gradient boosting, and support vector regression) will be developed and compared against multivariable linear regression as the reference model. The aim is a practical tool that helps anaesthetists anticipate how long a spinal block will last in an individual patient, supporting decisions about case scheduling, supplementation, and discharge planning.
研究概览
详细说明
Background. Spinal anaesthesia produces block of unpredictable duration. Cerebrospinal fluid volume in the lumbosacral region is the dominant determinant of block spread and regression, and correlates inversely with abdominal circumference and directly with vertebral column length. Existing single-variable rules perform poorly, and no validated multivariable model is in routine clinical use. Objectives. The primary objective is to develop and internally validate models predicting the duration of sensory block and the duration of motor block after single-shot spinal anaesthesia. The secondary objective is to compare the predictive performance of machine learning approaches with conventional multivariable linear regression. Design. Single-centre prospective observational cohort study. No study-directed intervention is applied; anaesthetic technique, drug, and dose are determined by the attending anaesthetist according to routine practice and are recorded as candidate predictors. Assessments. Sensory block level is assessed bilaterally by pinprick with a 25-gauge needle along the mid-clavicular line, over dermatomes T4 to S1. Motor block is assessed using the modified Bromage scale (0-3). Assessments are performed at fixed intervals from intrathecal injection until complete regression of sensory and motor block. Candidate predictors. Age, sex, height, weight, body mass index, abdominal circumference, vertebral column length, ASA physical status, local anaesthetic dose and baricity, and adjuvant use. Sample size. A target of 255 participants was derived using the Riley criteria for continuous-outcome prediction models (pmsampsize), assuming 9 candidate predictors, an outcome standard deviation of 40 minutes, anticipated R-squared of 0.35, shrinkage of at least 0.90, and a multiplicative margin of error of 1.10. The four criteria yielded 183, 183, 234, and 246; the largest requirement of 246 was inflated by approximately 4 per cent for attrition. Analysis. Model development will use nested repeated 10-fold cross-validation with bootstrap optimism correction. Performance will be reported as R-squared, root mean squared error, and mean absolute error, with calibration plots. SHAP values will be used to describe predictor contributions. Reporting will follow TRIPOD+AI.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Salaheldin A Abdelaziz Ahmed
- 电话号码:+966508818713
- 邮箱:saladin28.sa@gmail.com
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
取样方法
研究人群
Consecutive adults scheduled for elective surgery under single-shot spinal anaesthesia at Specialized Medical Center, King Fahad campus, Riyadh.
描述
Inclusion Criteria:
- Adults scheduled for elective surgery under single-shot spinal anaesthesia
- ASA physical status I to III
- Written informed consent obtained
Exclusion Criteria:
- Contraindication to neuraxial anaesthesia (coagulopathy, local or systemic infection, raised intracranial pressure, patient refusal)
- Failed or incomplete block requiring conversion to general anaesthesia
- Repeated or top-up intrathecal injection
- Pregnancy
- Known spinal deformity or previous spine surgery
- Pre-existing neurological or neuromuscular disease affecting sensory or motor assessment
- Inability to cooperate with sensory and motor assessment
学习计划
研究是如何设计的?
设计细节
- 观测模型:COHORT
- 时间观点:PROSPECTIVE
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 |
|---|---|---|
|
Duration of sensory block
大体时间:Up to 8 hours after intrathecal injection
|
Time from completion of intrathecal injection to regression of sensory block to the S1 dermatome, assessed bilaterally by pinprick with a 25-gauge needle along the mid-clavicular line |
Up to 8 hours after intrathecal injection
|
|
Duration of motor block
大体时间:Up to 8 hours after intrathecal injection
|
Time from completion of intrathecal injection to return to modified Bromage score 0 (full ability to flex knee and ankle) |
Up to 8 hours after intrathecal injection
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Predictive performance of machine learning models
大体时间:Through study completion, an average of 20 months
|
R-squared, root mean squared error, mean absolute error, and calibration slope for lasso regression, ridge regression, random forest, extreme gradient boosting, and support vector regression, each compared with multivariable linear regression as the reference model |
Through study completion, an average of 20 months
|
|
Time to peak sensory block level
大体时间:Up to 30 minutes after intrathecal injection
|
Time from intrathecal injection to the highest dermatomal level of sensory block, assessed by pinprick |
Up to 30 minutes after intrathecal injection
|
合作者和调查者
调查人员
- 首席研究员:Salaheldin A abdelaziz Ahmed、Specialized Medical Center
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
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
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
De-identified individual participant data underlying published results, together with the data dictionary and model code, will be made available to researchers whose proposed use has been approved by an independent review committee. Requests should be directed to the principal investigator. Data will be available from 6 months to 36 months after publication of the primary results.
IPD 共享时间框架
Data will become available 6 months after publication of the primary results and will remain available for 36 months
IPD 共享访问标准
Requests should be directed to the principal investigator. Proposals will be reviewed by the principal investigator and the Specialized Medical Center Institutional Review Board. Requesters must provide a methodologically sound proposal and sign a data access agreement.
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 分析代码
药物和器械信息、研究文件
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研究美国 FDA 监管的设备产品
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