RecruitingNot ApplicableNCT07107243

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

Speaking Valves With Transtracheal End-expiratory Pressure Measurement Predicts Upper Airway Patency in Prolonged Tracheostomy Patients: A Multicenter, Prospective Study

Sponsor

Capital Medical University

Enrollment

300 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

Tracheostomy

Summary

The aim of this study is to evaluate the feasibility of predicting upper airway patency in patients with prolonged tracheostomy using a non-invasive method combining speaking valve (SV) and transtracheal end-expiratory pressure (TTPEE) through a multicenter study.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

Weaned from ventilator more than 48 hours
No any organ failure
No sepsis
Stable heart rate and blood pressure
Lung infection under control
PCO2\<60mmHg
Patient and family sign informed consent form

Exclusion Criteria5

Serious dysfunction of vital organs
Inability to tolerate cuff deflation
Laryngopharyngeal trauma
Known severe upper airway obstruction before referrer to our department
Endoscopy(bronchoscopy or laryngoscopy) has been performed and the condition of the upper airway has known

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Interventions

DIAGNOSTIC_TESTSpeaking valve combined with airway pressure

All patients wore speaking valves for 30 minutes, during which the transtracheal end-expiratory pressure was measured to assess the patency of the upper airway.

DIAGNOSTIC_TESTBronchoscopy

The same examiner performed bronchoscopy on all patients to assess upper airway patency.