Airway Stents for Excessive Dynamic Airway Collapse

NACompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

December 31, 2016

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2024

Conditions
TracheobronchomalaciaExcessive Dynamic Airway Collapse
Interventions
PROCEDURE

Dynamic Flexible Bronchoscopy

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

PROCEDURE

Rigid Bronchoscopy

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.

DEVICE

Stent placement

Silicone Y stent or uncovered self-expanding metallic stent will be placed in the standard fashion and good fit will be confirmed visually.

All Listed Sponsors
collaborator

American Association of Broncology and Interventional Pulmonology

UNKNOWN

collaborator

Curetbm.org Fundation

UNKNOWN

collaborator

Hood Laboratories

UNKNOWN

collaborator

Boston Medical products inc

UNKNOWN

lead

Beth Israel Deaconess Medical Center

OTHER