CompletedNot Applicable

PEEP Mask for Tracheobronchomalacia-Induced Cough

United States10 participantsStarted 2021-08-30

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in Cough Severity as Measured by the Cough Visual Analog Scale (VAS)

Timeframe: Baseline, two weeks

Change in Quality of Life as Measured by the Cough-Specific Quality-of-Life Questionnaire (CQLQ)

Timeframe: Baseline, two weeks

Change in Quality of Life as Measured by the Leicester Cough Questionnaire (LCQ)

Timeframe: Baseline, two weeks

Trial details

NCT IDNCT04169282

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08-15

Results submitted2023-07-25

View on ClinicalTrials.gov More Tracheobronchomalacia trials