Laryngopharyngeal Injury After Endotracheal Intubation Under General Anesthesia

NCT07359586 | Recruiting

• 1 other identifier: ZJU2025B0596
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 2

Brief Summary

This study retrospectively analyzed patients who underwent tracheal intubation under general anesthesia at the First Affiliated Hospital of Zhejiang University School of Medicine between October 1, 2015, and September 30, 2025, with a focus on issues related to postoperativelaryngopharyngeal complaints. Patients requiring otolaryngological consultation due to postoperative laryngopharyngeal complaints were identified via the case consultation system. Relevant patient data were collected through the Medison Anesthesia Information Management System and electronic medical record system, and telephone follow-up was conducted to assess patient prognosis. The primary outcome measures were the risk factors of postoperative hoarseness, while the secondary outcome measures included the incidence of postoperative hoarseness, the severity of vocal fold injury and its related risk factors. Additionally, the prognosis of patients and its related risk factors were evaluated. This study aims to reduce the incidence of perioperative laryngopharyngeal injury and provide a reference for the optimization of perioperative anesthetic regimens.

Conditions

Hepatic Carcinoma; Pancreatic Carcinoma; Cholangiocarcinoma; Thyroid Carcinoma; Gastric Cancer; Pulmonary Carcinoma

Keywords

hoarseness; Vocal cord injury; Incidence; Prognosis

Outcome Measures

Primary Outcomes (1)

• Postoperative hoarseness

  The patients underwent general anesthesia with tracheal intubation and required otolaryngological consultation for hoarseness between October 1, 2015, and September 30, 2025.Hoarseness is characterized by alterations in voice quality, pitch (how high or low the voice is), volume (loudness), or vocal effort that impair effective communication, as judged by a healthcare provider, and may adversely affect quality of life.

  Perioperative,up to150 days

Secondary Outcomes (4)

• Incidence of Hoarseness

  Perioperative,up to150 days

• the severity of hoarseness

  Perioperative,up to150 days

• Postoperative Vocal Fold Injury

  Perioperative,up to150 days

• Incidence of Arytenoid Dislocation

  Perioperative,up to150 days

Study Arms (1)

hoarseness

We collected perioperative clinical data from the cohort, analyzed the associated risk factors for the occurrence of relevant symptoms, and investigated the prognosis.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent endotracheal intubation under general anesthesia at the First Affiliated Hospital of Zhejiang University between October 1, 2015, and September 30, 2025

You may qualify if:

• Patients who underwent general anesthesia with tracheal intubation at the First Affiliated Hospital of Zhejiang University School of Medicine between October 2015 and September 2025
• Patients who required otolaryngological consultation due to laryngopharyngeal complaints (including hoarseness, sore throat, cough, choking on drinking water, etc.) postoperatively
• The surgical type was non-otolaryngological surgery

You may not qualify if:

• Patients with a history of laryngopharyngeal lesions (e.g., granuloma, polyp, tumour, vocal cord paralysis
• Patients with a preexisting tracheotomy
• Patients requiring postoperative tracheotomy
• Patients with incomplete medical records
• Patients who underwent multiple surgeries but for whom the specific surgical episode responsible for the laryngopharyngeal complaints could not be identified

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (2)

he First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

COMPLETED

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms; Carcinoma, Hepatocellular; Lung Neoplasms; Pancreatic Neoplasms; Cholangiocarcinoma; Thyroid Neoplasms; Hoarseness

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Liver Neoplasms; Liver Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Head and Neck Neoplasms; Thyroid Diseases; Voice Disorders; Laryngeal Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory

Study Officials

• Diansan Su

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diansan Su

CONTACT

+8618616514088; diansansu@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of the Department of Anesthesiology

Study Record Dates

• First Submitted: January 2, 2026
• First Posted: January 22, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 25, 2026
• Study Completion (Estimated): December 25, 2026
• Last Updated: January 22, 2026

Record last verified: 2025-12

Locations

CN (2)