Status:

ACTIVE_NOT_RECRUITING

A Single-center, Prospective Study for Mechanism and Risk Factors of Tracheal Tube-related Tongue Injury

Lead Sponsor:

China-Japan Friendship Hospital

Conditions:

Tracheal Tube-related Tongue Injury

Eligibility:

All Genders

18-85 years

Brief Summary

Article Summary 1. Tracheal tube-related tongue injury is a common clinical complication that would lead to serious events such as dysphagia, respiratory dysfuncion and macroglossia. 2. There is a la...

Detailed Description

Background Tracheal tube-related tongue injury can lead to post-intubation pharyngeal dysfunction, postoperative macroglossia, or stridor after extubation. Possible mechanisms include increased oral p...

Eligibility Criteria

Inclusion

  • ASA I-III
  • Age 18-85 years old
  • Scheduled for elective surgery with tracheal intubation under general anesthesia, with operation duration ≥2 hours
  • The intended surgical position will be supine, prone, cervical traction or beach chair position
  • Obtained informed consent

Exclusion

  • Informed consent is not obtained
  • Maxillofacial surgeries or other surgeries involving the oral cavity and upper airway
  • History of head and neck radiotherapy
  • Deformity, trauma, infection and active bleeding exist in the mouth and tongue
  • Airway hyperresponsiveness, active asthma, acute exacerbation of chronic obstructive pulmonary disease, laryngeal osteomalacia
  • Respiratory insufficiency, moderate to severe ventilation or diffusion dysfunction
  • Existing chronic sore throat, recurrent laryngeal nerve injury, dysarthria, dysphagia, severe gastroesophageal reflux, upper esophageal sphincter dysfunction, cardiac stenosis and other basic diseases
  • Postoperative total parenteral nutrition therapy is planned

Key Trial Info

Start Date :

October 19 2023

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

December 31 2025

Estimated Enrollment :

94 Patients enrolled

Trial Details

Trial ID

NCT05987293

Start Date

October 19 2023

End Date

December 31 2025

Last Update

November 18 2024

Active Locations (1)

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China-Japan Friendship Hospital

Beijing, Beijing Municipality, China, 100029