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Recruiting NCT07107243

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

No phase Interventional Tracheostomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Speaking valve combined with airway pressure, Bronchoscopy.
Who it may be relevant to
Registry conditions: Tracheostomy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Diagnostic test 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.
  • Diagnostic test Bronchoscopy
    The same examiner performed bronchoscopy on all patients to assess upper airway patency.

Primary outcome measures

  • The sensitivity and specificity of SV with transtracheal end-expiratory pressure measurement in predicting upper airway patency [Time frame: The patients started using the SV with the TTPEE measurement on the day of enrollment. After that, bronchoscopy should be performed within 48 hours.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Crossover
Masking
Single blind
Primary purpose
Diagnostic

Study locations

China · 5 centers
  • Hunan Rehabilitation Hospital — Hunan
  • Jiangbin Hospital of Guangxi Zhuang Autonomous Region — Guangxi
  • Beijing Rehabilitation Hospital of Capital Medical University — Beijing
  • YanBian University Hospital — Jilin City
  • Zhengzhou Central Hospital Affiliated to Zhengzhou University — Henan

Identifiers

NCT: NCT07107243 · 2025-hxkfzx-dzx-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗