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NCT Number: NCT07088224

Establishment of Prediction Model for Postoperative Sore Throat

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Observational studies without intervention

Other

Observational studies without intervention

Primary outcomes

  1. incidence of Postoperative Sore rate within 24 hours after surgery

    Time frame: within 24 hours after surgery

Secondary outcomes

  1. incidence of Postoperative Sore Throat rate 1 hour after surgery

    Time frame: 1 hour after surgery

  2. incidence of Postoperative Sore Throat rate 48 hour after surgery

    Time frame: 48 hour after surgery

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2025
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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