Using a speaking valve and transtracheal end‑expiratory pressure to predict upper airway openness
Official title: Speaking Valves With Transtracheal End-expiratory Pressure Measurement Predicts Upper Airway Patency in Prolonged Tracheostomy Patients: A Multicenter, Prospective Study
Run by Capital Medical University · NCT07107243 · Data updated 2026-11-12
This trial tests whether using a speaking valve together with a transtracheal end‑expiratory pressure (TTPEE) measurement can tell if the upper airway is open in people with prolonged tracheostomies.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Capital Medical University Academic / other |
| Locations | 5 sites (Hunan, Hunan and 4 other locations) |
| Status | Recruiting |
| Started | October 1, 2025 |
| Main results expected | September 30, 2026 |
| Study ends | October 31, 2026 |
| Registry record updated | January 21, 2026 |
| Trial ID | NCT07107243 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are prolonged tracheostomy patients who have been off the ventilator for more than 48 hours, are stable without sepsis or organ failure, have PCO2 <60 mmHg, and can tolerate cuff deflation.
✕Probably not a fit
Patients with known severe upper airway obstruction, inability to tolerate cuff deflation, laryngopharyngeal trauma, active sepsis or major organ failure, or those whose airway has already been assessed by endoscopy are unlikely to benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter interventional trial applies a bedside, noninvasive method combining a speaking valve (SV) with transtracheal end‑expiratory pressure (TTPEE) measurement to predict upper airway patency in prolonged tracheostomy patients. Eligible participants are those weaned from the ventilator for more than 48 hours, hemodynamically stable, without sepsis or organ failure, and with PCO2 below 60 mmHg; bronchoscopy may be used as a comparator when clinically indicated. The protocol excludes patients with known severe upper airway obstruction, laryngopharyngeal trauma, inability to tolerate cuff deflation, or prior endoscopic airway assessment. Data will be collected at three Chinese rehabilitation hospitals to determine feasibility and diagnostic accuracy for guiding decannulation decisions.
Why it matters
Potential benefit: If successful, this method could provide a simple bedside test to help identify patients who can safely have their tracheostomy decannulated.
How similar studies have gone: Speaking valves and pressure measurements have been used previously to infer airway patency, but combining SV with transtracheal end‑expiratory pressure measurement is relatively novel and not yet widely validated.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Hunan Rehabilitation Hospital
Hunan, Hunan, China Recruiting -
Jiangbin Hospital of Guangxi Zhuang Autonomous Region
Guangxi, Jiangbin, China Recruiting -
Beijing Rehabilitation Hospital of Capital Medical University
Beijing, Shijingshan, China Recruiting -
YanBian University Hospital
Jilin City, Yanbian, China Recruiting -
Zhengzhou Central Hospital Affiliated to Zhengzhou University
Henan, Zhengzhou, China Recruiting
Study contacts
- Study coordinator: Hongying Jiang, MD
- Email: 6jhy@163.com
- Phone: +8656981555
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.