Establishment of Prediction Model for Postoperative Sore Throat

NCT ID: NCT07088224

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 375 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-07-31

Brief Summary

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.

Conditions

Postoperative Sore Throat

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Observational studies without intervention

Observational studies without intervention

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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；

Exclusion Criteria

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；

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

XiaoLiang Wang

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

KY20250624-12

Identifier Type: -

Identifier Source: org_study_id