SV With TTPEE Measurement Predicts Upper Airway Patency in Prolonged Tracheostomy Patients
NCT ID: NCT07107243
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2025-10-01
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
DIAGNOSTIC
SINGLE
Study Groups
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True positive group
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.
Speaking 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.
Bronchoscopy
The same examiner performed bronchoscopy on all patients to assess upper airway patency.
False positive group
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.
Speaking 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.
Bronchoscopy
The same examiner performed bronchoscopy on all patients to assess upper airway patency.
True negative group
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.
Speaking 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.
Bronchoscopy
The same examiner performed bronchoscopy on all patients to assess upper airway patency.
False negative group
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.
Speaking 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.
Bronchoscopy
The same examiner performed bronchoscopy on all patients to assess upper airway patency.
Interventions
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Speaking 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.
Bronchoscopy
The same examiner performed bronchoscopy on all patients to assess upper airway patency.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Capital Medical University
OTHER
Responsible Party
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Hongying Jiang
Sponsor-Investigator
Principal Investigators
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Hongying Jiang, MD
Role: STUDY_CHAIR
Beijing Rehabilitation Hospital of Capital Medical University
Locations
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Beijing Rehabilitation Hospital of Capital Medical University
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025-hxkfzx-dzx-001
Identifier Type: -
Identifier Source: org_study_id