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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07107243

Enrollment

300

Registered

2025-08-06

Start date

2025-10-01

Completion date

2026-10-31

Last updated

2026-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tracheostomy

Keywords

transtracheal end-expiratory pressure, speaking valve, upper airway, prolonged tracheostomized patients

Brief 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.

Interventions

DIAGNOSTIC_TESTSpeaking 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_TESTBronchoscopy

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Outcomes Assessor)

Intervention model description

All patients received the speaking valve combined with the transtracheal end-expiratory pressure measurement protocol and bronchoscopy.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

China

Contacts

CONTACTHongying Jiang, MD

6jhy@163.com+8656981555

STUDY_CHAIRHongying Jiang, MD

Beijing Rehabilitation Hospital of Capital Medical University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026