Airway Stents for Excessive Dynamic Airway Collapse

Brief Title

Airway Stents for Excessive Dynamic Airway Collapse

Official Title

Airway Stents for Excessive Dynamic Airway Collapse: A Randomized Controlled Trial

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.
    


Study Type

Interventional


Primary Outcome

St. George's Respiratory Questionnaire

Secondary Outcome

 modified Medical Research Council scale of dyspnea

Condition

Tracheobronchomalacia

Intervention

Dynamic Flexible Bronchoscopy

Study Arms / Comparison Groups

 Medical Management Group
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

50

Start Date

December 2016

Completion Date

December 2021

Primary Completion Date

December 2021

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Adnan Majid, MD, , 



Administrative Informations


NCT ID

NCT02982876

Organization ID

2016P000246


Responsible Party

Principal Investigator

Study Sponsor

Beth Israel Deaconess Medical Center

Collaborators

 American Association of Broncology and Interventional Pulmonology

Study Sponsor

Adnan Majid, MD, Principal Investigator, Beth Israel Deaconess Medical Center


Verification Date

November 2020