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

NCT07107243 | Recruiting DMC

• 1 other identifier: 2025-hxkfzx-dzx-001
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 5

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.

Conditions

Tracheostomy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The sensitivity and specificity of SV with transtracheal end-expiratory pressure measurement in predicting upper airway patency

  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.

Study Arms (4)

True positive group

EXPERIMENTAL

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: Speaking valve combined with airway pressure; Diagnostic Test: Bronchoscopy

False positive group

EXPERIMENTAL

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: Speaking valve combined with airway pressure; Diagnostic Test: Bronchoscopy

True negative group

EXPERIMENTAL

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: Speaking valve combined with airway pressure; Diagnostic Test: Bronchoscopy

False negative group

EXPERIMENTAL

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: Speaking valve combined with airway pressure; Diagnostic Test: Bronchoscopy

Interventions

Bronchoscopy DIAGNOSTIC_TEST

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

False negative group; False positive group; True negative group; True positive group

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.

False negative group; False positive group; True negative group; True positive group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (5)

Hunan Rehabilitation Hospital

Hunan, Hunan, 410000, China

RECRUITING

Jiangbin Hospital of Guangxi Zhuang Autonomous Region

Guangxi, Jiangbin, 530012, China

RECRUITING

Beijing Rehabilitation Hospital of Capital Medical University

Beijing, Shijingshan, 100144, China

RECRUITING

YanBian University Hospital

Jilin, Yanbian, 133000, China

RECRUITING

Zhengzhou Central Hospital Affiliated to Zhengzhou University

Henan, Zhengzhou, 450007, China

RECRUITING

MeSH Terms

Interventions

Bronchoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Hongying Jiang, MD

  Beijing Rehabilitation Hospital of Capital Medical University

  STUDY CHAIR

Central Study Contacts

Hongying Jiang, MD

CONTACT

+8656981555; 6jhy@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor-Investigator

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

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: August 6, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: January 21, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)