Airway Stents for Excessive Dynamic Airway Collapse

NCT02982876 | Completed DMC

• 1 other identifier: 2016P000246
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tracheobronchomalacia; Excessive Dynamic Airway Collapse

Keywords

Silicone Airway stent; Metallic Airway stent

Outcome Measures

Primary Outcomes (1)

• St. George's Respiratory Questionnaire

  Index designed to measure health status in patients with respiratory symptoms

  7-14 days

Secondary Outcomes (7)

• modified Medical Research Council scale of dyspnea

  7-14 days

• Cough Quality of life Questionnaire

  7-14 days

• 6 minute walk test

  7-14 days

• FEV1

  7-14 days

• Peak flow

  7-14 days

Study Arms (2)

Medical Management Group

NO INTERVENTION

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.

Treatment group

ACTIVE COMPARATOR

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; Procedure: Rigid Bronchoscopy; Device: Stent placement

Interventions

Dynamic Flexible Bronchoscopy PROCEDURE

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

Treatment group

Rigid Bronchoscopy PROCEDURE

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.

Treatment group

Stent placement DEVICE

Silicone Y stent or uncovered self-expanding metallic stent will be placed in the standard fashion and good fit will be confirmed visually.

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with sever symptomatic EDAC (collapse \>90% of the airway during exhalation at dynamic CT scan)
• Age \> 18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• American Association of Broncology and Interventional Pulmonology: collaborator
• Curetbm.org Fundation: collaborator
• Hood Laboratories: collaborator
• Boston Medical products inc: collaborator

Related Publications (36)

• Leong P, Bardin PG, Lau KK. What's in a name? Expiratory tracheal narrowing in adults explained. Clin Radiol. 2013 Dec;68(12):1268-75. doi: 10.1016/j.crad.2013.06.017. Epub 2013 Aug 13.

  PMID: 23953005 BACKGROUND

• Murgu S, Colt H. Tracheobronchomalacia and excessive dynamic airway collapse. Clin Chest Med. 2013 Sep;34(3):527-55. doi: 10.1016/j.ccm.2013.05.003. Epub 2013 Jun 27.

  PMID: 23993822 BACKGROUND

• Ridge CA, O'donnell CR, Lee EY, Majid A, Boiselle PM. Tracheobronchomalacia: current concepts and controversies. J Thorac Imaging. 2011 Nov;26(4):278-89. doi: 10.1097/RTI.0b013e3182203342.

  PMID: 22009081 BACKGROUND

• Boiselle PM, O'Donnell CR, Bankier AA, Ernst A, Millet ME, Potemkin A, Loring SH. Tracheal collapsibility in healthy volunteers during forced expiration: assessment with multidetector CT. Radiology. 2009 Jul;252(1):255-62. doi: 10.1148/radiol.2521081958. Epub 2009 May 6.

  PMID: 19420322 BACKGROUND

• Carden KA, Boiselle PM, Waltz DA, Ernst A. Tracheomalacia and tracheobronchomalacia in children and adults: an in-depth review. Chest. 2005 Mar;127(3):984-1005. doi: 10.1378/chest.127.3.984.

  PMID: 15764786 BACKGROUND

• Jokinen K, Palva T, Nuutinen J. Chronic bronchitis. A bronchologic evaluation. ORL J Otorhinolaryngol Relat Spec. 1976;38(3):178-86. doi: 10.1159/000275273.

  PMID: 945891 BACKGROUND

• Palombini BC, Villanova CA, Araujo E, Gastal OL, Alt DC, Stolz DP, Palombini CO. A pathogenic triad in chronic cough: asthma, postnasal drip syndrome, and gastroesophageal reflux disease. Chest. 1999 Aug;116(2):279-84. doi: 10.1378/chest.116.2.279.

  PMID: 10453852 BACKGROUND

• Ikeda S, Hanawa T, Konishi T, Adachi M, Sawai S, Chiba W, Kosaba S, Hatakenaka R, Matsubara Y, Funatsu T. [Diagnosis, incidence, clinicopathology and surgical treatment of acquired tracheobronchomalacia]. Nihon Kyobu Shikkan Gakkai Zasshi. 1992 Jun;30(6):1028-35. Japanese.

  PMID: 1507676 BACKGROUND

• Majid A, Gaurav K, Sanchez JM, Berger RL, Folch E, Fernandez-Bussy S, Ernst A, Gangadharan SP. Evaluation of tracheobronchomalacia by dynamic flexible bronchoscopy. A pilot study. Ann Am Thorac Soc. 2014 Jul;11(6):951-5. doi: 10.1513/AnnalsATS.201312-435BC.

  PMID: 24960030 BACKGROUND

• Lee KS, Sun MRM, Ernst A, Feller-Kopman D, Majid A, Boiselle PM. Comparison of Dynamic Expiratory CT With Bronchoscopy for Diagnosing Airway Malacia: A Pilot Evaluation. Chest. 2007 Mar;131(3):758-764. doi: 10.1378/chest.06-2164.

  PMID: 17356090 BACKGROUND

• Ernst A, Majid A, Feller-Kopman D, Guerrero J, Boiselle P, Loring SH, O'Donnell C, Decamp M, Herth FJ, Gangadharan S, Ashiku S. Airway stabilization with silicone stents for treating adult tracheobronchomalacia: a prospective observational study. Chest. 2007 Aug;132(2):609-16. doi: 10.1378/chest.06-2708.

  PMID: 17699133 BACKGROUND

• Litmanovich D, O'Donnell CR, Bankier AA, Ernst A, Millett ME, Loring SH, Boiselle PM. Bronchial collapsibility at forced expiration in healthy volunteers: assessment with multidetector CT. Radiology. 2010 Nov;257(2):560-7. doi: 10.1148/radiol.10100219. Epub 2010 Sep 9.

  PMID: 20829540 BACKGROUND

• Majid A, Sosa AF, Ernst A, Feller-Kopman D, Folch E, Singh AK, Gangadharan S. Pulmonary function and flow-volume loop patterns in patients with tracheobronchomalacia. Respir Care. 2013 Sep;58(9):1521-6. doi: 10.4187/respcare.02277. Epub 2013 Mar 12.

  PMID: 23481440 BACKGROUND

• Tamura Y, Sakatani K, Yamakoshi N, Terada H, Honda H, Komori C, Kuhara H, Morishita N, Shishido K, Matsuoka H, Shishido N, Ishihara H. [A case of severe COPD associated with tracheo-bronchial stenosis, treated with non-invasive positive pressure ventilation]. Nihon Kokyuki Gakkai Zasshi. 2008 Nov;46(11):915-20. Japanese.

  PMID: 19068766 BACKGROUND

• Ferguson GT, Benoist J. Nasal continuous positive airway pressure in the treatment of tracheobronchomalacia. Am Rev Respir Dis. 1993 Feb;147(2):457-61. doi: 10.1164/ajrccm/147.2.457.

  PMID: 8430971 BACKGROUND

• Adliff M, Ngato D, Keshavjee S, Brenaman S, Granton JT. Treatment of diffuse tracheomalacia secondary to relapsing polychondritis with continuous positive airway pressure. Chest. 1997 Dec;112(6):1701-4. doi: 10.1378/chest.112.6.1701.

  PMID: 9404780 BACKGROUND

• Wright CD. Tracheomalacia. Chest Surg Clin N Am. 2003 May;13(2):349-57, viii. doi: 10.1016/s1052-3359(03)00036-x.

  PMID: 12755319 BACKGROUND

• Gangadharan SP, Bakhos CT, Majid A, Kent MS, Michaud G, Ernst A, Ashiku SK, DeCamp MM. Technical aspects and outcomes of tracheobronchoplasty for severe tracheobronchomalacia. Ann Thorac Surg. 2011 May;91(5):1574-80; discussion 1580-1. doi: 10.1016/j.athoracsur.2011.01.009. Epub 2011 Mar 5.

  PMID: 21377650 BACKGROUND

• Majid A, Guerrero J, Gangadharan S, Feller-Kopman D, Boiselle P, DeCamp M, Ashiku S, Michaud G, Herth F, Ernst A. Tracheobronchoplasty for severe tracheobronchomalacia: a prospective outcome analysis. Chest. 2008 Oct;134(4):801-807. doi: 10.1378/chest.08-0728.

  PMID: 18842912 BACKGROUND

• Ernst A, Odell DD, Michaud G, Majid A, Herth FFJ, Gangadharan SP. Central airway stabilization for tracheobronchomalacia improves quality of life in patients with COPD. Chest. 2011 Nov;140(5):1162-1168. doi: 10.1378/chest.10-3051. Epub 2011 Aug 25.

  PMID: 21868463 BACKGROUND

• Murgu SD, Colt HG. Complications of silicone stent insertion in patients with expiratory central airway collapse. Ann Thorac Surg. 2007 Dec;84(6):1870-7. doi: 10.1016/j.athoracsur.2007.07.026.

  PMID: 18036901 BACKGROUND

• Machuzak M, Santacruz JF, Gildea T, Murthy SC. Airway complications after lung transplantation. Thorac Surg Clin. 2015;25(1):55-75. doi: 10.1016/j.thorsurg.2014.09.008.

  PMID: 25430430 BACKGROUND

• Chhajed PN, Malouf MA, Tamm M, Spratt P, Glanville AR. Interventional bronchoscopy for the management of airway complications following lung transplantation. Chest. 2001 Dec;120(6):1894-9. doi: 10.1378/chest.120.6.1894.

  PMID: 11742919 BACKGROUND

• Zhang J, Hasegawa I, Feller-Kopman D, Boiselle PM. 2003 AUR Memorial Award. Dynamic expiratory volumetric CT imaging of the central airways: comparison of standard-dose and low-dose techniques. Acad Radiol. 2003 Jul;10(7):719-24. doi: 10.1016/s1076-6332(03)80117-4.

  PMID: 12862281 BACKGROUND

• 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

  BACKGROUND

• Jones PW, Quirk FH, Baveystock CM. The St George's Respiratory Questionnaire. Respir Med. 1991 Sep;85 Suppl B:25-31; discussion 33-7. doi: 10.1016/s0954-6111(06)80166-6.

  PMID: 1759018 BACKGROUND

• Bestall JC, Paul EA, Garrod R, Garnham R, Jones PW, Wedzicha JA. Usefulness of the Medical Research Council (MRC) dyspnoea scale as a measure of disability in patients with chronic obstructive pulmonary disease. Thorax. 1999 Jul;54(7):581-6. doi: 10.1136/thx.54.7.581.

  PMID: 10377201 BACKGROUND

• French CT, Irwin RS, Fletcher KE, Adams TM. Evaluation of a cough-specific quality-of-life questionnaire. Chest. 2002 Apr;121(4):1123-31. doi: 10.1378/chest.121.4.1123.

  PMID: 11948042 BACKGROUND

• Jones PW. St. George's Respiratory Questionnaire: MCID. COPD. 2005 Mar;2(1):75-9. doi: 10.1081/copd-200050513.

  PMID: 17136966 BACKGROUND

• Donohue JF. Minimal clinically important differences in COPD lung function. COPD. 2005 Mar;2(1):111-24. doi: 10.1081/copd-200053377.

  PMID: 17136971 BACKGROUND

• Puhan MA, Chandra D, Mosenifar Z, Ries A, Make B, Hansel NN, Wise RA, Sciurba F; National Emphysema Treatment Trial (NETT) Research Group. The minimal important difference of exercise tests in severe COPD. Eur Respir J. 2011 Apr;37(4):784-90. doi: 10.1183/09031936.00063810. Epub 2010 Aug 6.

  PMID: 20693247 BACKGROUND

• de Torres JP, Pinto-Plata V, Ingenito E, Bagley P, Gray A, Berger R, Celli B. Power of outcome measurements to detect clinically significant changes in pulmonary rehabilitation of patients with COPD. Chest. 2002 Apr;121(4):1092-8. doi: 10.1378/chest.121.4.1092.

  PMID: 11948037 BACKGROUND

• Fletcher KE, French CT, Irwin RS, Corapi KM, Norman GR. A prospective global measure, the Punum Ladder, provides more valid assessments of quality of life than a retrospective transition measure. J Clin Epidemiol. 2010 Oct;63(10):1123-31. doi: 10.1016/j.jclinepi.2009.09.015. Epub 2010 Mar 19.

  PMID: 20303709 BACKGROUND

• Nouraei SM, Franco RA, Dowdall JR, Nouraei SA, Mills H, Virk JS, Sandhu GS, Polkey M. Physiology-based minimum clinically important difference thresholds in adult laryngotracheal stenosis. Laryngoscope. 2014 Oct;124(10):2313-20. doi: 10.1002/lary.24641. Epub 2014 Apr 4.

  PMID: 25265276 BACKGROUND

• Shlomi D, Peled N, Shitrit D, Bendayan D, Amital A, Kramer MR. Protective effect of immunosuppression on granulation tissue formation in metallic airway stents. Laryngoscope. 2008 Aug;118(8):1383-8. doi: 10.1097/MLG.0b013e318172d686.

  PMID: 18496158 BACKGROUND

• Jones PW. Interpreting thresholds for a clinically significant change in health status in asthma and COPD. Eur Respir J. 2002 Mar;19(3):398-404. doi: 10.1183/09031936.02.00063702.

  PMID: 11936514 BACKGROUND

MeSH Terms

Conditions

Tracheobronchomalacia

Condition Hierarchy (Ancestors)

Cartilage Diseases; Musculoskeletal Diseases; Bronchial Diseases; Respiratory Tract Diseases; Tracheal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Adnan Majid, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 2, 2016
• First Posted: December 6, 2016
• Study Start: December 1, 2016
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 28, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share