Airway Stents for Excessive Dynamic Airway Collapse

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.

Conditions

• Tracheobronchomalacia
• Excessive 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.

Sponsors & Collaborators

• American Association of Broncology and Interventional Pulmonology

  collaborator UNKNOWN

• Curetbm.org Fundation

  collaborator UNKNOWN

• Hood Laboratories

  collaborator UNKNOWN

• Boston Medical products inc

  collaborator UNKNOWN

• Beth Israel Deaconess Medical Center

  lead OTHER

Principal Investigators

• Adnan Majid, MD · Beth Israel Deaconess Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-12-31

Primary Completion

2024-12-31

Completion

2024-12-31