Airway Stents for Excessive Dynamic Airway Collapse
- Conditions
- TracheobronchomalaciaExcessive Dynamic Airway Collapse
- Interventions
- Procedure: Dynamic Flexible BronchoscopyProcedure: Rigid BronchoscopyDevice: Stent placement
- Registration Number
- NCT02982876
- Lead Sponsor
- Beth Israel Deaconess Medical Center
- Brief 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.
- Detailed Description
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 despite optimal medical management will be informed about the trial and if interested will be recruited for the study.
Operative Technique
Patients in the treatment group (stent) will undergo bronchoscopy under light sedation and rigid bronchoscopy under general anesthesia. The treatment group will undergo a bronchial wash and placement of an airway stent.Patients assigned to the medical management group will not undergo bronchoscopy.
Stents
Based on the patient's airway anatomy an uncovered self-expanding metallic stent (Ultraflex™ Single-Use Tracheobronchial Stent System) or a silicone Y-stent(Endoxane, Novatech S.A., Aubagne-France or Channick Hood Laboratories, Pembroke, MA, 02359) will be used in the study.
During Stent Trial
After bronchoscopy, patients in the treatment group will receive a standardized medication regimen to include mucolytics, cough suppressors and expectorants in order to decrease the risk of potential complications following the procedure.
Follow-up
All participants will be scheduled for a follow-up visit in the following 14 days either after rigid bronchoscopy (treatment group) or after first visit (medical management group) with 6MWTs and PFTs. In this visit all patients will be asked to complete the SGRQ, CQLQ and mMRC questionnaires by the research team. All this data will be recorded in an encrypted database. Afterwards, the patients in the medical management arm will be offered a stent trial as part of standard of care.
Stent removal
The patients from the treatment arm will be scheduled for a rigid bronchoscopy, stent removal and bronchial lavage under anesthesia in the operating room.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 50
- Patient with sever symptomatic EDAC (collapse >90% of the airway during exhalation at dynamic CT scan)
- Age > 18 years
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment group Dynamic Flexible Bronchoscopy The patients assigned to treatment group will undergo flexible bronchoscopy with dynamic maneuvers, rigid bronchoscope , tracheobronchial wash and airway stent placement Treatment group Stent placement The patients assigned to treatment group will undergo flexible bronchoscopy with dynamic maneuvers, rigid bronchoscope , tracheobronchial wash and airway stent placement Treatment group Rigid Bronchoscopy The patients assigned to treatment group will undergo flexible bronchoscopy with dynamic maneuvers, rigid bronchoscope , tracheobronchial wash and airway stent placement
- Primary Outcome Measures
Name Time Method St. George's Respiratory Questionnaire 7-14 days Index designed to measure health status in patients with respiratory symptoms
- Secondary Outcome Measures
Name Time Method 6 minute walk test 7-14 days FEV1 7-14 days Cough Quality of life Questionnaire 7-14 days Peak flow 7-14 days Self-reported symptoms 7-14 days dyspnea, inability to clear secretions, cough, recurrent infection and wheezing.
modified Medical Research Council scale of dyspnea 7-14 days Shortness of breath scale
Complications 7-14 days Airway infections