Predicting Upper Airway Openness in Adults With Long-Term Tracheostomy Using Speaking Valves and Airway Pressure Measurement A Multicenter Study

What this Trial Is About

Researchers are studying patients with prolonged tracheostomy to evaluate a new non-invasive method that predicts whether the upper airway is open or blocked. This method combines the use of a speaking valve and measuring transtracheal end-expiratory pressure. The study is prospective and involves multiple centers to assess the accuracy of this approach compared to the standard bronchoscopy test. Participants will wear speaking valves for 30 minutes while their transtracheal end-expiratory pressure is measured to check upper airway patency. Within 48 hours of this test, they will undergo bronchoscopy performed by the same examiner to confirm airway openness. The study groups are defined based on agreement or disagreement between the speaking valve test and bronchoscopy results. During the study, researchers will monitor how well the speaking valve and pressure measurement predict airway patency by comparing results to bronchoscopy findings. The main outcome is the sensitivity and specificity of this new diagnostic test. Participants must meet specific health criteria and will be observed from enrollment through the bronchoscopy within two days. The study is sponsored by Capital Medical University and runs until late 2026.

SV With TTPEE Measurement Predicts Upper Airway Patency in Prolonged Tracheostomy Patients