Tracheal Tube-related Tongue Injury Clinical Trial
Official title:
Mechanism and Risk Factors of Tracheal Tube-related Tongue Injury
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.
Background Tracheal tube-related tongue injury can lead to post-intubation pharyngeal dysfunction, postoperative macroglossia, or stridor after extubation. Possible mechanisms include increased oral pressure, obstruction of venous and lymphatic return in the neck, leading to severe throat pain, dysphagia, and respiratory function impairment. There is a lack of indicators and clinical awareness of this issue. Therefore we have designed this study to accurately monitor the tracheal tube-tongue pressure in different surgical position during general anesthesia. Method This is a prospective, single-center observational study. Fifty-four patients undergoing elective surgery in general anesthesia for more than 2 hours with endotracheal tube applied will be enrolled. Patients will be divided into supine position (Supine group) and the high-risk positions (Flexion group) groups. Dynamic changes in pressure between the tracheal tube and the tongue are measured. All patients will be followed up until 7 days after operation. 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. Discussion The study aims to explore the risk factors and pressure thresholds for tracheal tracheal tube-related tongue injury. ;