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

January 17, 2026 updated by: Hongying Jiang, MD, Capital Medical University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Hongying Jiang, MD
  • Phone Number: +8656981555
  • Email: 6jhy@163.com

Study Locations

  • China
    • Hunan
      • Hunan, Hunan, China, 410000
        • Recruiting
        • Hunan Rehabilitation Hospital
        • Contact:
    • Jiangbin
      • Guangxi, Jiangbin, China, 530012
        • Recruiting
        • Jiangbin Hospital of Guangxi Zhuang Autonomous Region
        • Contact:
    • Shijingshan
      • Beijing, Shijingshan, China, 100144
        • Recruiting
        • Beijing Rehabilitation Hospital of Capital Medical University
        • Contact:
    • Yanbian
      • Jilin, Yanbian, China, 133000
        • Recruiting
        • Yanbian University Hospital
        • Contact:
    • Zhengzhou
      • Henan, Zhengzhou, China, 450007
        • Recruiting
        • Zhengzhou Central Hospital Affiliated to Zhengzhou University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Diagnostic test: Bronchoscopy
The same examiner performed bronchoscopy on all patients to assess upper airway patency.
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.
Experimental: 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.
Diagnostic test: Bronchoscopy
The same examiner performed bronchoscopy on all patients to assess upper airway patency.
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.
Experimental: 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.
Diagnostic test: Bronchoscopy
The same examiner performed bronchoscopy on all patients to assess upper airway patency.
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.
Experimental: 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.
Diagnostic test: Bronchoscopy
The same examiner performed bronchoscopy on all patients to assess upper airway patency.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The patients started using the SV with the TTPEE measurement on the day of enrollment. After that, bronchoscopy should be performed within 48 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Capital Medical University

Investigators

  • Study Chair: Hongying Jiang, MD, Beijing Rehabilitation Hospital of Capital Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

July 22, 2025

First Submitted That Met QC Criteria

July 30, 2025

First Posted (Actual)

August 6, 2025

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 17, 2026

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-hxkfzx-dzx-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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