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

Capital Medical University

Status: Enrolling

Conditions: Tracheostomy

Treatments: Diagnostic Test: Bronchoscopy; Diagnostic Test: Speaking valve combined with airway pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT07107243

2025-hxkfzx-dzx-001

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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300 participants in 4 patient groups

True positive group

Experimental group

Description:

Upper airway non-patency is defined as positive; otherwise, it is negative. The true positive group is defined as those for whom both the results of the speaking valve (SV) with the transtracheal end-expiratory pressure (TTPEE) measurement protocol and the bronchoscopy are positive.

Treatment:

Diagnostic Test: Speaking valve combined with airway pressure

Diagnostic Test: Bronchoscopy

False positive group

Experimental group

Description:

Upper airway non-patency is defined as positive; otherwise, it is negative. The false positive group is defined as the group in which the result of the speaking valve (SV) with the transtracheal end-expiratory pressure (TTPEE) measurement protocol is positive, and the result of the bronchoscopy is negative.

Treatment:

Diagnostic Test: Speaking valve combined with airway pressure

Diagnostic Test: Bronchoscopy

True negative group

Experimental group

Description:

Upper airway non-patency is defined as positive; otherwise, it is negative. The true negative group is defined as those for whom both the results of the speaking valve (SV) with the transtracheal end-expiratory pressure (TTPEE) measurement protocol and the bronchoscopy are negative.

Treatment:

Diagnostic Test: Speaking valve combined with airway pressure

Diagnostic Test: Bronchoscopy

False negative group

Experimental group

Description:

Upper airway non-patency is defined as positive; otherwise, it is negative. The false negative group is defined as the group in which the result of the speaking valve (SV) with the transtracheal end-expiratory pressure (TTPEE) measurement protocol is negative, and the result of the bronchoscopy is positive.

Treatment:

Diagnostic Test: Speaking valve combined with airway pressure

Diagnostic Test: Bronchoscopy