Airway Stents for Excessive Dynamic Airway Collapse

• ClinicalTrials.gov Identifier: NCT02982876
• Recruitment Status: Enrolling by invitation
• First Posted: December 6, 2016
• Last Update Posted: November 17, 2020
• Sponsor: Beth Israel Deaconess Medical Center
• 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

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.

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

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

• Principal Investigator: Adnan Majid, MD; Beth Israel Deaconess Medical Center

More Information

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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
• 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:

Tracheobronchomalacia; Shock; Pathologic Processes; Cartilage Diseases; Musculoskeletal Diseases; Bronchial Diseases; Respiratory Tract Diseases; Tracheal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Connective Tissue Diseases