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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
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tracheobronchomalacia focused on measuring Silicone Airway stent, Metallic Airway stent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    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
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    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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