At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Airway Stents for Excessive Dynamic Airway Collapse: A Randomized Controlled Trial
In Brief
A clinical study evaluating Dynamic Flexible Bronchoscopy, Rigid Bronchoscopy, and 1 other intervention for Tracheobronchomalacia and Excessive Dynamic Airway Collapse. Completed, enrolled 50 participants.
Detailed Summary
Airway stents are used as standard of care to identify which patients with excessive dynamic airway collapse will benefit from a definitive surgical treatment. However, the specific way in which these stents are effective has not been tested. The purpose of this research study is to determine the effectiveness of airway stents when used in the airways of patients with severe symptomatic excessive dynamic airway collapse compared to patients with severe symptomatic excessive dynamic airway collapse that do not receive airway stent.
Study Details
Timeline
Interventions
The bronchoscope will be introduced into the proximal trachea at the level of the cricoid. At that point, patients will be instructed to take a deep breath, hold it and then blow it out (forced expiratory maneuver). Maneuvers will be done at the following six sites: proximal trachea at the level of the cricoid; mid-trachea 5 cm proximal to the carina; distal trachea 2 cm proximal to the carina; right main stem bronchus at the right tracheobronchial angle; bronchus intermedius and left main bronchus at the left tracheobronchial angle
Under general anesthesia, a rigid bronchoscope (Bryan-Dumon Series II; Bryan Corporation; Woburn, MA) will be introduced, and respiration will be maintained through jet ventilation.
Silicone Y stent or uncovered self-expanding metallic stent will be placed in the standard fashion and good fit will be confirmed visually.