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

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.

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Key information

Conditions

Tracheostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hunan Rehabilitation Hospital, Hunan, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

speaking valve combined with airway pressure

Diagnostic Test

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

Diagnostic Test

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

Primary outcomes

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.

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hongying Jiang, MD

CONTACT

[email protected]

+8656981555

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Aug 6, 2025
Registry last updated: Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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