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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
Sponsor:
Collaborators:
American Association of Broncology and Interventional Pulmonology
Curetbm.org Fundation
Hood Laboratories
Boston Medical products inc
Information provided by (Responsible Party):
Adnan Majid, 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.

Condition or disease Intervention/treatment Phase
Tracheobronchomalacia Excessive Dynamic Airway Collapse Procedure: Dynamic Flexible Bronchoscopy Procedure: Rigid Bronchoscopy Device: Stent placement Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. St. George's Respiratory Questionnaire [ Time Frame: 7-14 days ]
    Index designed to measure health status in patients with respiratory symptoms


Secondary Outcome Measures :
  1. modified Medical Research Council scale of dyspnea [ Time Frame: 7-14 days ]
    Shortness of breath scale

  2. Cough Quality of life Questionnaire [ Time Frame: 7-14 days ]
  3. 6 minute walk test [ Time Frame: 7-14 days ]
  4. FEV1 [ Time Frame: 7-14 days ]
  5. Peak flow [ Time Frame: 7-14 days ]
  6. Self-reported symptoms [ Time Frame: 7-14 days ]
    dyspnea, inability to clear secretions, cough, recurrent infection and wheezing.

  7. Complications [ Time Frame: 7-14 days ]
    Airway infections



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Sponsors and Collaborators
Beth Israel Deaconess Medical Center
American Association of Broncology and Interventional Pulmonology
Curetbm.org Fundation
Hood Laboratories
Boston Medical products inc
Investigators
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Principal Investigator: Adnan Majid, MD Beth Israel Deaconess Medical Center
Publications:
Odell DD, Majid A, Gangadharan SP, Ernst A. Adoption of a standardized protocol decreases serious complications of airway stenting in patients with tracheobronchomalacia. Chest. 2010; 138(suppl 4):A784

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Responsible Party: Adnan Majid, MD, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT02982876    
Other Study ID Numbers: 2016P000246
First Posted: December 6, 2016    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Adnan Majid, Beth Israel Deaconess Medical Center:
Silicone Airway stent
Metallic Airway stent
Additional relevant MeSH terms:
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Tracheobronchomalacia
Shock
Pathologic Processes
Cartilage Diseases
Musculoskeletal Diseases
Bronchial Diseases
Respiratory Tract Diseases
Tracheal Diseases
Musculoskeletal Abnormalities
Congenital Abnormalities
Connective Tissue Diseases