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Clinical Trials in China / NCT07107243
Recruiting Not applicable

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

NCT07107243 · tracked via the Priya Life Science China tracker
Sponsor
Capital Medical University
Phase
Not applicable
Started
2025-10-01
Last updated
2026-01-21

Condition(s) studied

Tracheostomy

Investigational drug(s) / intervention(s)

Speaking valve combined with airway pressureBronchoscopy

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • The sensitivity and specificity of SV with transtracheal end-expiratory pressure measurement in predicting upper airway patency — The patients started using the SV with the TTPEE measurement on the day of enrollment. After that, bronchoscopy should be performed within 48 hours.
    Patients enrolled in the study will undergo both SV with transtracheal end-expiratory pressure measurement and bronchoscopy. Upper airway non-patency will be defined as positive. Using the results of bronchoscopy as the gold standard, the sensitivity and specificity of SV with transtracheal end-expiratory pressure measurement will be evaluated.

Trial sites (5)

FacilityCityRegionStatus
Hunan Rehabilitation Hospital Hunan Hunan Recruiting
Jiangbin Hospital of Guangxi Zhuang Autonomous Region Guangxi Jiangbin Recruiting
Beijing Rehabilitation Hospital of Capital Medical University Beijing Shijingshan Recruiting
YanBian University Hospital Jilin City Yanbian Recruiting
Zhengzhou Central Hospital Affiliated to Zhengzhou University Henan Zhengzhou Recruiting

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Other trials for the same condition

A Speaking-Valve-Based Decannulation Protoco for Patients With a Prolonged Disorders of Consciousness Enrolling by invitation
Cough Flow as a Criterion Decannulation Threshold in Prolonged Tracheostomy Patients Starting soon
Comparison of Physiological Effects of Two Types of High-Flow Oxygen Therapy in Tracheostomized Patients Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07107243 on ClinicalTrials.gov ↗ ← All trials in China