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临床试验/NCT07088224
NCT07088224尚未招募不适用

Analysis of Risk Factors and Establishment of Prediction Model for Postoperative Sore Throat After Thyroid Surgery Under General Anesthesia

Nanjing First Hospital, Nanjing Medical University0 个研究点目标入组 375 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
375
主要终点
incidence of Postoperative Sore rate within 24 hours after surgery

研究概览

简要总结

This observational study aims to identify the risk factors associated with postoperative sore throat (POST) and to develop a clinical prediction model for patients undergoing thyroid surgery under general anesthesia. Despite improvements in surgical and anesthetic techniques, POST remains one of the most common complications following thyroidectomy, with an incidence of up to 80%. POST can significantly impact patient comfort, swallowing function, nutritional intake, and recovery quality, leading to prolonged hospitalization and increased healthcare costs.

The etiology of POST is multifactorial, involving intubation-related factors (e.g., endotracheal tube size, cuff pressure), surgery-related factors (e.g., duration of surgery, neck hyperextension), and patient-related factors (e.g., age, sex, smoking history, pre-existing throat symptoms). However, large-scale, systematic studies in the Chinese population remain limited.

With the increasing adoption of Enhanced Recovery After Surgery (ERAS) principles, the accurate identification of modifiable risk factors and early prediction of POST risk are essential for targeted preventive strategies and improved perioperative management. Recent advancements in machine learning and statistical modeling allow for the development of personalized, multifactorial risk assessment tools.

In this study, clinical data from patients undergoing thyroid surgery at Nanjing First Hospital will be collected and analyzed. The primary goal is to identify key preoperative and intraoperative predictors of POST and to establish a multivariable nomogram-based prediction model. Internal validation using bootstrap methods will be performed to evaluate the model's discrimination, calibration, and clinical utility, ultimately supporting evidence-based interventions to improve postoperative outcomes and patient satisfaction.

研究设计

研究类型
Observational
观察模型
Cohort
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

入选标准

  • Age ≥ 18 years; Undergoing thyroid surgery under general anesthesia, including both open and endoscopic procedures; Complete postoperative follow-up records available (minimum 48 hours); Accessible and complete surgical and anesthesia records; Provision of written informed consent by the patient or their legally authorized representative;

排除标准

  • Failed tracheal intubation or need for emergency tracheotomy during surgery; Reoperation required due to postoperative complications such as bleeding or nerve injury; Severe cardiopulmonary disease (ASA physical status ≥ IV) or long-term use of corticosteroids; Incomplete clinical data;

结局指标

主要结局

incidence of Postoperative Sore rate within 24 hours after surgery

时间窗: within 24 hours after surgery

次要结局

  • incidence of Postoperative Sore Throat rate 1 hour after surgery(1 hour after surgery)
  • incidence of Postoperative Sore Throat rate 48 hour after surgery(48 hour after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

XiaoLiang Wang

Chief Physician

Nanjing First Hospital, Nanjing Medical University

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