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RecruitingNCT07359586Updated Jan 22, 2026

Laryngopharyngeal Injury After Endotracheal Intubation Under General Anesthesia

An observational study in Gastric Cancer, Hepatic Carcinoma and Pulmonary Carcinoma, sponsored by Zhejiang University. Recruiting at 2 sites in China. Per ClinicalTrials.gov, last updated 2026-01-22.

Sponsored by Zhejiang University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,200
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • hoarseness
  • Vocal cord injury
  • Incidence
  • Prognosis
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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

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

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
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,200 participants (estimated)
Patient registry
No

Groups and cohorts

  • hoarseness

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

05

What researchers measure

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.

    Time frame: Perioperative,up to150 days

Secondary outcomes

  1. Incidence of Hoarseness

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

    Time frame: Perioperative,up to150 days

  2. the severity of hoarseness

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

    Time frame: Perioperative,up to150 days

  3. Postoperative Vocal Fold Injury

    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.

    Time frame: Perioperative,up to150 days

  4. Incidence of Arytenoid Dislocation

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

    Time frame: Perioperative,up to150 days

06

Study locations

1 of 2 sites recruiting
  • 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
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07359586
Lead sponsor
Zhejiang University
Responsible party
Diansan Su (Chair of the Department of Anesthesiology, Zhejiang University) — Principal investigator
First posted
Jan 22, 2026
Start date
Nov 1, 2025
Primary completion
Dec 25, 2026 (estimated)
Completion
Dec 25, 2026 (estimated)
Last update
Jan 22, 2026

Study contacts

Diansan Su
Contact
diansansu@yahoo.com
+8618616514088
Diansan Su
principal investigator · Zhejiang University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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