Airway Stents for Excessive Dynamic Airway Collapse
Primary Purpose
Tracheobronchomalacia, Excessive Dynamic Airway Collapse
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dynamic Flexible Bronchoscopy
Rigid Bronchoscopy
Stent placement
Sponsored by
About this trial
This is an interventional treatment trial for Tracheobronchomalacia focused on measuring Silicone Airway stent, Metallic Airway stent
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Medical Management Group
Treatment group
Arm Description
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.
The patients assigned to treatment group will undergo flexible bronchoscopy with dynamic maneuvers, rigid bronchoscope , tracheobronchial wash and airway stent placement
Outcomes
Primary Outcome Measures
St. George's Respiratory Questionnaire
Index designed to measure health status in patients with respiratory symptoms
Secondary Outcome Measures
modified Medical Research Council scale of dyspnea
Shortness of breath scale
Cough Quality of life Questionnaire
6 minute walk test
FEV1
Peak flow
Self-reported symptoms
dyspnea, inability to clear secretions, cough, recurrent infection and wheezing.
Complications
Airway infections
Full Information
NCT ID
NCT02982876
First Posted
December 2, 2016
Last Updated
April 14, 2023
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
American Association of Broncology and Interventional Pulmonology, Curetbm.org Fundation, Hood Laboratories, Boston Medical products inc
1. Study Identification
Unique Protocol Identification Number
NCT02982876
Brief Title
Airway Stents for Excessive Dynamic Airway Collapse
Official Title
Airway Stents for Excessive Dynamic Airway Collapse: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
American Association of Broncology and Interventional Pulmonology, Curetbm.org Fundation, Hood Laboratories, Boston Medical products inc
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tracheobronchomalacia, Excessive Dynamic Airway Collapse
Keywords
Silicone Airway stent, Metallic Airway stent
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Medical Management Group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Treatment group
Arm Type
Active Comparator
Arm Description
The patients assigned to treatment group will undergo flexible bronchoscopy with dynamic maneuvers, rigid bronchoscope , tracheobronchial wash and airway stent placement
Intervention Type
Procedure
Intervention Name(s)
Dynamic Flexible Bronchoscopy
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Rigid Bronchoscopy
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Stent placement
Intervention Description
Silicone Y stent or uncovered self-expanding metallic stent will be placed in the standard fashion and good fit will be confirmed visually.
Primary Outcome Measure Information:
Title
St. George's Respiratory Questionnaire
Description
Index designed to measure health status in patients with respiratory symptoms
Time Frame
7-14 days
Secondary Outcome Measure Information:
Title
modified Medical Research Council scale of dyspnea
Description
Shortness of breath scale
Time Frame
7-14 days
Title
Cough Quality of life Questionnaire
Time Frame
7-14 days
Title
6 minute walk test
Time Frame
7-14 days
Title
FEV1
Time Frame
7-14 days
Title
Peak flow
Time Frame
7-14 days
Title
Self-reported symptoms
Description
dyspnea, inability to clear secretions, cough, recurrent infection and wheezing.
Time Frame
7-14 days
Title
Complications
Description
Airway infections
Time Frame
7-14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adnan Majid, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Airway Stents for Excessive Dynamic Airway Collapse
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