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Not yet recruiting NCT07088224

Establishment of Prediction Model for Postoperative Sore Throat

Observational Postoperative Sore Throat

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Observational studies without intervention.
Who it may be relevant to
Registry conditions: Postoperative Sore Throat. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other Observational studies without intervention
    Observational studies without intervention

Primary outcome measures

  • incidence of Postoperative Sore rate within 24 hours after surgery [Time frame: within 24 hours after surgery]
Secondary outcome measures (2)
  • incidence of Postoperative Sore Throat rate 1 hour after surgery [Time frame: 1 hour after surgery]
  • incidence of Postoperative Sore Throat rate 48 hour after surgery [Time frame: 48 hour after surgery]

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07088224 · KY20250624-12

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗