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Machine Learning Prediction of Spinal Anaesthesia Block Duration

2026年9月13日 更新者:SalahEldin Ahmed Abdelaziz Ahmed、Specialized Medical Center (SMC)

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

地位

尚未招聘

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

观察性的

注册 (估计的)

255

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

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

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Salaheldin A abdelaziz Ahmed、Specialized Medical Center

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年12月1日

初级完成 (估计的)

2028年7月1日

研究完成 (估计的)

2028年9月1日

研究注册日期

首次提交

2026年9月7日

首先提交符合 QC 标准的

2026年9月7日

首次发布 (实际的)

2026年9月11日

研究记录更新

最后更新发布 (实际的)

2026年9月15日

上次提交的符合 QC 标准的更新

2026年9月13日

最后验证

2026年9月1日

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)?

是的

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

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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