Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07359586

Laryngopharyngeal Injury After Endotracheal Intubation Under General Anesthesia

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Postoperative hoarseness

    Time frame: Perioperative,up to150 days

    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.

Secondary outcomes

  1. Incidence of Hoarseness

    Time frame: Perioperative,up to150 days

    (Number of patients with postoperative hoarseness） / (Total number of patients undergoing general anesthesia tracheal intubation) × 100%

  2. the severity of hoarseness

    Time frame: Perioperative,up to150 days

    Hoarseness was assessed as follows: 0 = none (no hoarseness), 1 = noticed by patient, 2 = obvious to observer, 3 = aphonia.

  3. Postoperative Vocal Fold Injury

    Time frame: Perioperative,up to150 days

    Based on patients' hoarseness symptoms and laryngoscopic findings, an otolaryngologist conducted clinical assessment and grading, classifying vocal fold injury into four levels. The classification criteria were: Grade 0 (Normal): Non-hoarsenes; Grade 1 (Mild): hoarseness with negative laryngoscopic findings or vocal fold closure gap; Grade 2 (Moderate): hoarseness with vocal fold mobility impairment; Grade 3 (Severe): hoarseness with vocal cord paralysis or fixation.

  4. Incidence of Arytenoid Dislocation

    Time frame: Perioperative,up to150 days

    (Number of patients with postoperative arytenoid dislocation)/ (Total number of patients undergoing general anesthesia tracheal intubation) × 100%

Study contacts

Contact information is provided by the study sponsor or research team.

Diansan Su

CONTACT

[email protected]

+8618616514088

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Official study title

Incidence,Perioperative Risk Factors and Prognosis Associated With Laryngopharyngea Injury After Endotracheal Intubation Under General Anesthesia：A Retrospective Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 22, 2026
Registry last updated
Jan 22, 2026

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.