Study Summary
This trial will test whether a CPAP machine can help improve the exercise capacity and symptoms of people with ECAC. 32 people will be monitored for 3 months.
Eligible Conditions
- Tracheobronchomalacia
- Excessive Dynamic Airway Collapse
Treatment Effectiveness
Phase-Based Effectiveness
N/A
Study Objectives
1 Primary · 3 Secondary · Reporting Duration: 3 months
3 months
Difference in meters walked in 6MWTs
Modified Borg scale scores for dyspnea
Modified Borg scale scores for exertion
Subjective assestment of cough during 6MWTs
Trial Safety
Phase-Based Safety
Trial Design
2 Treatment Groups
Group 1
1 of 2
Group 2
1 of 2
Experimental Treatment
Non-Treatment Group
32 Total Participants · 2 Treatment Groups
Primary Treatment: Group 1 · Has Placebo Group · N/A
Group 1
Device
Experimental Group · 1 Intervention: Continuous positive airway pressure (CPAP) device · Intervention Types: DeviceGroup 2
Device
ShamComparator Group · 1 Intervention: Sham-continuous positive airway pressure (CPAP) device · Intervention Types: DeviceTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months
Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
790 Previous Clinical Trials
849,483 Total Patients Enrolled
4 Trials studying Tracheobronchomalacia
361 Patients Enrolled for Tracheobronchomalacia
Eligibility Criteria
Age 18+ · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have never used a CPAP machine before.
You are scheduled to have a bronchoscopy for diagnostic or treatment purposes as part of your regular medical care.
Patients who have completed a 6-minute walk test before starting the trial.
References
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- Murgu, Septimiu D.. 2014. “Pneumatic Stenting for Tracheobronchomalacia”. Journal of Bronchology & Interventional Pulmonology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/lbr.0000000000000053.
- Patout, Maxime, Laura Mylott, Ruth Kent, Gill Arbane, Patrick B. Murphy, and Nicholas Hart. 2016. “Trial of Portable Continuous Positive Airway Pressure for the Management of Tracheobronchomalacia”. American Journal of Respiratory and Critical Care Medicine. American Thoracic Society. doi:10.1164/rccm.201511-2243im.
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- JIANG, AI-GUI, XIAO-YAN GAO, and HUI-YU LU. 2013. “Diagnosis and Management of an Elderly Patient with Severe Tracheomalacia: A Case Report and Review of the Literature”. Experimental and Therapeutic Medicine. Spandidos Publications. doi:10.3892/etm.2013.1195.
- Murgu, Septimiu, and Henri G. Colt. 2009. “Morphometric Bronchoscopy in Adults with Central Airway Obstruction: Case Illustrations and Review of the Literature”. The Laryngoscope. Wiley. doi:10.1002/lary.20478.
- Park JG, Edell ES. Dynamic Airway Collapse: Distinct From Tracheomalacia. J Bronchol. 2005;12(3):143-146. doi:10.1097/01.laboratory.0000171764.65217.f8
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- Kaltsakas G, Patout M, Arbane G, et al. Review of adult tracheomalacia and its relationship with chronic obstructive pulmonary disease. December 2017:A80-A81. doi:10.1136/thoraxjnl-2017-210983.140
- 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.
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- Farre R, Hernandez L, Montserrat JM, Rotger M, Ballester E, Navajas D. Sham continuous positive airway pressure for placebo-controlled studies in sleep apnoea. Lancet. 1999 Apr 3;353(9159):1154. doi: 10.1016/S0140-6736(99)01056-9. No abstract available.
- 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.
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- 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.
- Murgu S, Colt HG. Morphometric bronchoscopy in adults with central airway obstruction: case illustrations and review of the literature. Laryngoscope. 2009 Jul;119(7):1318-24. doi: 10.1002/lary.20478.
- Rodway GW, Weaver TE, Mancini C, Cater J, Maislin G, Staley B, Ferguson KA, George CF, Schulman DA, Greenberg H, Rapoport DM, Walsleben JA, Lee-Chiong T, Kuna ST. Evaluation of sham-CPAP as a placebo in CPAP intervention studies. Sleep. 2010 Feb;33(2):260-6. doi: 10.1093/sleep/33.2.260.
- Majid A, Fernandez L, Fernandez-Bussy S, Herth F, Ernst A. [Tracheobronchomalacia]. Arch Bronconeumol. 2010 Apr;46(4):196-202. doi: 10.1016/j.arbres.2009.10.011. Epub 2009 Dec 9. Spanish.
- Smith TC, Marini JJ. Impact of PEEP on lung mechanics and work of breathing in severe airflow obstruction. J Appl Physiol (1985). 1988 Oct;65(4):1488-99. doi: 10.1152/jappl.1988.65.4.1488.
- Murgu SD. Pneumatic stenting for tracheobronchomalacia. J Bronchology Interv Pulmonol. 2014 Apr;21(2):109-12. doi: 10.1097/LBR.0000000000000053. No abstract available.
- Martin JG, Shore S, Engel LA. Effect of continuous positive airway pressure on respiratory mechanics and pattern of breathing in induced asthma. Am Rev Respir Dis. 1982 Nov;126(5):812-7. doi: 10.1164/arrd.1982.126.5.812.
- Patout M, Mylott L, Kent R, Arbane G, Murphy PB, Hart N. Trial of Portable Continuous Positive Airway Pressure for the Management of Tracheobronchomalacia. Am J Respir Crit Care Med. 2016 May 15;193(10):e57. doi: 10.1164/rccm.201511-2243IM. No abstract available.
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- Kandaswamy C, Balasubramanian V. Review of adult tracheomalacia and its relationship with chronic obstructive pulmonary disease. Curr Opin Pulm Med. 2009 Mar;15(2):113-9. doi: 10.1097/MCP.0b013e328321832d.
- 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.
- 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.
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- 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.
- Adnan Majid, MD 2023. "Effect of CPAP on 6-Minute Walk Test Outcomes in Patients With ECAC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04217603.
Frequently Asked Questions
Is there presently an opportunity to participate in this experiment?
"According to clinicaltrials.gov, this study is no longer actively recruiting patients and the last edits were made on November 17th 2022. Nonetheless, there are presently 138 other medical trials currently searching for participants." - Anonymous Online Contributor
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