Airway Stents for Excessive Dynamic Airway Collapse
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|ClinicalTrials.gov Identifier: NCT02982876|
Recruitment Status : Enrolling by invitation
First Posted : December 6, 2016
Last Update Posted : November 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Tracheobronchomalacia Excessive Dynamic Airway Collapse||Procedure: Dynamic Flexible Bronchoscopy Procedure: Rigid Bronchoscopy Device: Stent placement||Not Applicable|
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.
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.
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.
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.
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.
The patients from the treatment arm will be scheduled for a rigid bronchoscopy, stent removal and bronchial lavage under anesthesia in the operating room.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Airway Stents for Excessive Dynamic Airway Collapse: A Randomized Controlled Trial|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
No Intervention: Medical Management Group
The patients assigned to the medical management group will be placed on a scheduled institution protocol using mucolytic and expectorant therapy (nebulizer treatments using mucolytic (N-acetylcysteine) for 15 minutes BID, Guafenesin (Mucinex®) 1200 mg BID, codeine as needed and Flutter valve BID.
Active Comparator: Treatment group
The patients assigned to treatment group will undergo flexible bronchoscopy with dynamic maneuvers, rigid bronchoscope , tracheobronchial wash and airway stent placement
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.
- St. George's Respiratory Questionnaire [ Time Frame: 7-14 days ]Index designed to measure health status in patients with respiratory symptoms
- modified Medical Research Council scale of dyspnea [ Time Frame: 7-14 days ]Shortness of breath scale
- Cough Quality of life Questionnaire [ Time Frame: 7-14 days ]
- 6 minute walk test [ Time Frame: 7-14 days ]
- FEV1 [ Time Frame: 7-14 days ]
- Peak flow [ Time Frame: 7-14 days ]
- Self-reported symptoms [ Time Frame: 7-14 days ]dyspnea, inability to clear secretions, cough, recurrent infection and wheezing.
- Complications [ Time Frame: 7-14 days ]Airway infections
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02982876
|Principal Investigator:||Adnan Majid, MD||Beth Israel Deaconess Medical Center|