N/A
N=10
PEEP Mask for Tracheobronchomalacia-Induced Cough
Tracheobronchomalacia
Bottom Line
View on ClinicalTrials.gov: NCT04169282 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Change in Cough Severity as Measured by the Cough Visual Analog Scale (VAS) — -50.67 units on a scale — p=0.108
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- nPEP (non-invasive positive expiratory pressure) mask (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Cough Severity as Measured by the Cough Visual Analog Scale (VAS) |
-50.67 | 0.108 |
| PRIMARY Change in Quality of Life as Measured by the Cough-Specific Quality-of-Life Questionnaire (CQLQ) |
-14.63 | 0.003 sig |
| PRIMARY Change in Quality of Life as Measured by the Leicester Cough Questionnaire (LCQ) |
2.53 | 0.025 sig |
| SECONDARY Proximal Airway Reactance at 5 Hz (X5) as Assessed by Impulse Oscillometry |
-3.19; -3.08 | — |
Summary
This study aims to determine if an expiratory resistance device that delivers non-invasive positive expiratory pressure (nPEP) will reduce or stop coughing, reduce airway resistance and improve quality of life in patients with tracheobronchomalacia (TBM) who are not candidates for tracheal stenting.
Eligibility Criteria
Inclusion Criteria
- Age ≥18 years
- Visualization of ≥50% collapse of the trachea or mainstem bronchus on CT scan or bronchoscopy
- No upper or lower respiratory infection within 4 weeks
- Having capacity to provide legal written informed consent
Exclusion Criteria
- History of tracheobronchoplasty or chronic tracheal stenting
- Current tracheostomy
- History of external chest trauma
- History of:
- Active treatment for Lung cancer
- Lung transplantation
- Unstable congestive heart failure
- History of spontaneous pneumothorax
- Other medical conditions that interfere with participation in the study
- Pregnant women
Data sourced from ClinicalTrials.gov (NCT04169282). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.