Airway Stents for Excessive Dynamic Airway Collapse: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tracheobronchomalacia
- Sponsor
- Beth Israel Deaconess Medical Center
- Enrollment
- 50
- Primary Endpoint
- St. George's Respiratory Questionnaire
- Status
- Completed
- Last Updated
- 9 months ago
Overview
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.
Investigators
Adnan Majid, MD
MD
Beth Israel Deaconess Medical Center
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
Outcomes
Primary Outcomes
St. George's Respiratory Questionnaire
Time Frame: 7-14 days
Index designed to measure health status in patients with respiratory symptoms
Secondary Outcomes
- Peak flow(7-14 days)
- 6 minute walk test(7-14 days)
- FEV1(7-14 days)
- Cough Quality of life Questionnaire(7-14 days)
- Self-reported symptoms(7-14 days)
- modified Medical Research Council scale of dyspnea(7-14 days)
- Complications(7-14 days)