Airway Stents for Excessive Dynamic Airway Collapse

Launched by BETH ISRAEL DEACONESS MEDICAL CENTER · Dec 2, 2016

Keywords

ClinConnect Summary

Study Design

This randomized controlled trial will be conducted at Beth Israel Deaconess Medical Center (BIDMC) in accordance with Good Clinical Practice Standards and under IRB supervision. We plan to enroll total of 48 patients with EDAC randomized by a computer generated system to either intervention group (airway stent) or medical management group.

Description of the study

Previous to appointment all patients will have Airway CT scan, 6 minute walk test and pulmonary function test as per protocol and standard of care.

Enrollment

Patients with severe EDAC who remain symptomatic desp...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient with sever symptomatic EDAC (collapse \>90% of the airway during exhalation at dynamic CT scan)
• • Age \> 18 years
• Exclusion Criteria:
• • Patients who have not been well managed from their respiratory comorbidities (asthma, COPD, obstructed sleep apnea, GERD, relapsing polychondritis)
• • Current respiratory infection
• • Resting bradycardia (\<50 beats/min), frequent multifocal PVCs, complex ventricular arrhythmia, sustained SVT
• • Dysrhythmia that might pose a risk during exercise or training
• • Any disease or condition that interferes with completion of initial or follow-up assessments