Airway Stents for Excessive Dynamic Airway Collapse

April 14, 2023 updated by: Adnan Majid, MD, Beth Israel Deaconess Medical Center

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

Phase

Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / 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.

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
St. George's Respiratory Questionnaire Time Frame: 7-14 days	Index designed to measure health status in patients with respiratory symptoms	7-14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
modified Medical Research Council scale of dyspnea Time Frame: 7-14 days	Shortness of breath scale	7-14 days
Cough Quality of life Questionnaire Time Frame: 7-14 days		7-14 days
6 minute walk test Time Frame: 7-14 days		7-14 days
FEV1 Time Frame: 7-14 days		7-14 days
Peak flow Time Frame: 7-14 days		7-14 days
Self-reported symptoms Time Frame: 7-14 days	dyspnea, inability to clear secretions, cough, recurrent infection and wheezing.	7-14 days
Complications Time Frame: 7-14 days	Airway infections	7-14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

December 2, 2016

First Submitted That Met QC Criteria

December 2, 2016

First Posted (Estimate)

December 6, 2016

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 14, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

2016P000246

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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Airway Stents for Excessive Dynamic Airway Collapse