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临床试验/NCT06443697
NCT06443697招募中不适用

A Machine Learning-based Prediction Model for Delayed Clinically Important Postoperative Nausea and Vomiting in High-risk Patients Undergoing Laparoscopic Gastrointestinal Surgery

Sixth Affiliated Hospital, Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 1,154 人开始时间: 2024年4月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,154
试验地点
1
主要终点
Delayed clinically important postoperative nausea and vomiting

研究概览

简要总结

Postoperative nausea and vomiting (PONV) can lead to serious postoperative complications, but most symptoms are mild. Clinically important PONV (CIPONV) refers to PONV symptoms that have a significant impact on the patient's well-being and recovery. Present predictive systems for PONV are mainly concentrated on early PONV. However, there is currently no suitable prediction model for delayed PONV, particularly delayed CI-PONV. This study aims to develop and validate a prediction model for delayed CI-PONV using machine learning algorithms utilizing perioperative data from patients undergoing laparoscopic gastrointestinal surgery.

All 1154 patients in the FDP-PONV trial will be enrolled in this study. Delayed CIPONV is defined as experiencing CIPONV between 25-120 hours after surgery. After selecting the modeling variables from 81 perioperative clinical features, six machine learning models are established to generate the risk prediction models for delayed CIPONV. The area under the receiver operating characteristic curve, accuracy, sensitivity, specificity, positive predictive value, negative predictive value, F1 score and Brier score are used to evaluate the model performance. Shape Additive explanation analysis was conducted to evaluate feature importance.

详细描述

The website https://mvansmeden.shinyapps.io/BeyondEPV/ was used for sample size calculation, considering 6 candidate predictors, an event fraction of 0.14, and a criterion value for reduced mean predictive squared error of 0.03. The calculated sample size is 1080, with a minimally required expected event per variable of 25.1. Therefore, a sample size of 1154 patients is deemed sufficient to support the inclusion of 6 predictors in the development of the predictive model.

A total of 81 variables, including demographics, comorbidities, laboratory findings, as well as information related to anesthesia and surgery, are prospectively collected in the FDP-PONV trial and considered as potential predictive factors in this study. The least absolute shrinkage and selection operator method is used to identify clinically significant variables. Further selection of the final predictors is performed using stepwise regression based on the Akaike Information Criterion.

The entire dataset is randomly divided into a training set and a validation set in a ratio of 7:3. Six machine learning models, namely logistic regression, random, extreme gradient boosting, k-nearest neighbor, gradient boosting decision, and multi-layer perceptron, were developed to create risk prediction models for delayed CIPONV. The performance of the models is assessed by comparing the area under the receiver operating characteristic curve, accuracy, sensitivity, specificity, positive predictive value, negative predictive value, F1 score, Brier score and calibration curve. Bootstrap resamples is conducted 1000 times on the training cohort to evaluate the predictive model's performance. Decision curve analysis is conducted to assess the clinical applicability of the model. The SHapley Additive Explanations library (SHAP) is used to interpret the prediction model.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • a) age between 18 and 75 years, b) having 3 or 4 Apfel risk factors, and c) scheduled to undergo laparoscopic gastrointestinal surgical procedures under general anesthesia.

排除标准

  • a) American Society of Anesthesiologists (ASA) physical status greater than 3, b) severe hepatic dysfunction, c) contraindications to fosaprepitant, 5-HT3 receptor antagonist, or dexamethasone, d) preoperative use of medications known to have antiemetic properties, e) presence of mental disorders or inability to communicate, and f) pregnant or nursing women.

结局指标

主要结局

Delayed clinically important postoperative nausea and vomiting

时间窗: Every 24 hours after surgery (at 2-day, 3-day, 4-day and 5-day)

A postoperative nausea and vomiting severity score of ≥ 5 based on the simplified postoperative nausea and vomiting impact scoring system, assessed between 25 and 120 hours after surgery.

次要结局

未报告次要终点

研究者

发起方
Sixth Affiliated Hospital, Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhi-Nan Zheng

Attending doctor

Sixth Affiliated Hospital, Sun Yat-sen University

研究点 (1)

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