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Establishment of Prediction Model for Postoperative Sore Throat

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07088224
Enrollment
375
Registered
2025-07-28
Start date
2025-08-01
Completion date
2026-07-31
Last updated
2025-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Sore Throat

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.

Interventions

OTHERObservational studies without intervention

Observational studies without intervention

Sponsors

Nanjing First Hospital, Nanjing Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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;

Design outcomes

Primary

MeasureTime frame
incidence of Postoperative Sore rate within 24 hours after surgerywithin 24 hours after surgery

Secondary

MeasureTime frame
incidence of Postoperative Sore Throat rate 1 hour after surgery1 hour after surgery
incidence of Postoperative Sore Throat rate 48 hour after surgery48 hour after surgery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026