Using a speaking valve and transtracheal end‑expiratory pressure to predict upper airway openness
Speaking Valves With Transtracheal End-expiratory Pressure Measurement Predicts Upper Airway Patency in Prolonged Tracheostomy Patients: A Multicenter, Prospective Study
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Capital Medical University Academic / other |
| Locations | 5 sites (Hunan, Hunan and 4 other locations) |
| Trial ID | NCT07107243 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Hunan, Hunan and 4 other locations
- 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, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.