Establishment of Prediction Model for Postoperative Sore Throat

NCT07088224 | Not Yet Recruiting DMC

• 1 other identifier: KY20250624-12
• Study Type: observational
• Target: 375
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• incidence of Postoperative Sore rate within 24 hours after surgery

  within 24 hours after surgery

Secondary Outcomes (2)

• 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

Interventions

Observational studies without intervention OTHER

Observational studies without intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with postoperative thyroid surgery pain

You may qualify if:

• 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；

You may not qualify if:

• 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；

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: July 20, 2025
• First Posted: July 28, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: July 28, 2025

Record last verified: 2025-07