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

NCT05987293 · tracked via the Priya Life Science China tracker

Sponsor

China-Japan Friendship Hospital

Phase

Observational

Started

2023-10-19

Last updated

2024-11-18

Condition(s) studied

Tracheal Tube-related Tongue Injury

Investigational drug(s) / intervention(s)

Tracheal tube-tongue pressure is measured using a computerized occlusal analysis system based on T-Scan® technique, suitable for multi-point real-time monitoring of intraoral pressure.

Tracheal tube-tongue pressure is measured using a computerized occlusal analysis system based on T-Scan® technique, suitable for multi-point real-time monitoring of intraoral pressure.: A flexible film sensor with a thickness of 0.11mm is placed between the tongue and the tracheal tube to measure the distribution, join force and dynamic changes of pressure at different site of the tongue. Five channels of pressure values will be recorded separately: (Ch1) the tip of the tongue, (Ch2) the middle of the tongue, (Ch3) the base of the tongue, (Ch4) the right side at the base of the tongue, (Ch5) the left side at the base of the tongue. The pressure values at the following points during the operation will be recorded: (t1) after intubation, (t2) highest pressure during patient positioning, (t3) after position fixed, (t4) at the end of surgery, (t5) before extubation.

Study 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 lack of qualitative and quantitative risk assessment of tracheal tube-related tongue injury.
3. This is a protocol of a single-center, prospective, paralled-group clinical trial based on the measurement of dynamic changes in pressure between the tracheal tube and the tongue in different position during the surgery.
4. The primary endpoint is tracheal tube-related tongue injury, secondary outcomes include the time to first successful recovery of oral intake of fluids and solid food and airway-related events.
5. This trial aims to find the best indicators for tracheal tracheal tube-related tongue injury and to provide solid basis for optimizing airway protection strategies and surgical positioning.

Eligibility

Sex

ALL

Min age

18 Years

Max age

85 Years

Healthy volunteers

Accepted

Inclusion Criteria: 1. ASA I-III 2. Age 18-85 years old 3. Scheduled for elective surgery with tracheal intubation under general anesthesia, with operation duration ≥2 hours 4. The intended surgical position will be supine, prone, cervical traction or beach chair position 5. Obtained informed consent Exclusion Criteria: 1. Informed consent is not obtained 2. Maxillofacial surgeries or other surgeries involving the oral cavity and upper airway 3. History of head and neck radiotherapy 4. Deformity, trauma, infection and active bleeding exist in the mouth and tongue 5. Airway hyperresponsiveness, active asthma, acute exacerbation of chronic obstructive pulmonary disease, laryngeal osteomalacia 6. Respiratory insufficiency, moderate to severe ventilation or diffusion dysfunction 7. Existing chronic sore throat, recurrent laryngeal nerve injury, dysarthria, dysphagia, severe gastroesophageal reflux, upper esophageal sphincter dysfunction, cardiac stenosis and other basic diseases 8. Postoperative total parenteral nutrition therapy is planned

Primary outcome measure(s)

tracheal tube-related tongue injury — Starting from the time after surgery till post-operative day 7 (POD7)
The primary composite endpoint is assessed as incidence of tracheal tube-related tongue injury, which is either the state of severe sore throat (VAS≥4), dysphagia after extubation, or any of the symptoms of macroglossia.

Trial sites (1)

Facility	City	Region	Status
China-Japan Friendship Hospital	Beijing	Beijing Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05987293 on ClinicalTrials.gov ↗ ← All trials in China