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A Single-center, Prospective Study for Mechanism and Risk Factors of Tracheal Tube-related Tongue Injury
Sponsor: China-Japan Friendship Hospital
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.
Official title: Mechanism and Risk Factors of Tracheal Tube-related Tongue Injury
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
OBSERVATIONAL
Enrollment
94
Start Date
2023-10-19
Completion Date
2025-12-31
Last Updated
2024-11-18
Healthy Volunteers
Yes
Conditions
Interventions
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.
Locations (1)
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China