Laryngopharyngeal Injury After Endotracheal Intubation Under General Anesthesia

January 13, 2026 updated by: Diansan Su, Zhejiang University

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • The First Affiliated Hospital, Zhejiang University School of Medicine
      • Hangzhou, Zhejiang, China, 310000
        • Completed
        • he First Affiliated Hospital, Zhejiang University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Perioperative,up to150 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%
Perioperative,up to150 days
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.
Perioperative,up to150 days
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.
Perioperative,up to150 days
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%
Perioperative,up to150 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang University

Investigators

  • Principal Investigator: Diansan Su, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2025

Primary Completion (Estimated)

December 25, 2026

Study Completion (Estimated)

December 25, 2026

Study Registration Dates

First Submitted

January 2, 2026

First Submitted That Met QC Criteria

January 13, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZJU2025B0596

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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