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Effect of CPAP on 6-Minute Walk Test Outcomes in Patients With ECAC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04217603
Recruitment Status : Not yet recruiting
First Posted : January 3, 2020
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
Adnan Majid, Beth Israel Deaconess Medical Center

Brief Summary:
The purpose of this protocol is to perform a prospective, randomized, double-blinded, pacebo-controlled clinical trial to determine the influence of a non-invasive positive pressure ventilation device on exercise capacity and symptoms in adult patients with ECAC. Primary outcome will include the total distance traversed by the study subject during a standard 6-minute walk test, and secondary outcomes will include peak flow measurement and symptom reporting before and after the exercise testing. The study will focus on the use of continuous positive airway pressure (CPAP) device. CPAP is FDA-approved for the treatment of various medical conditions, including obstructive sleep apnea and heart failure, but is not FDA-approved for the treatment of ECAC. The study will enroll 32 ambulatory study subjects with confirmed ECAC at the BIDMC, and each study subject will be monitored for up to 3 months.

Condition or disease Intervention/treatment Phase
Tracheobronchomalacia Excessive Dynamic Airway Collapse Device: Continuous positive airway pressure (CPAP) device Device: Sham-continuous positive airway pressure (CPAP) device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

This prospective, randomized placebo controlled, double-blind clinical 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 a total of 32 patients with ECAC randomized by an opaque envelope technique into two different groups: group 1 (CPAP) and group 2 (sham-CPAP)

  • Group 1: This group will perform a 6MWT with CPAP
  • Group 2: This group will perform a 6MWT with a sham-CPAP
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Randomization will be stratified using the variables sex (Female and male) and age (<60 and >60). Additionally a block 2-4 pattern will be used to assure a random and evenly distributed patient population in the different strata. Randomization will be carried out by the research coordinator; the rest of the personnel will be blinded to the allocation of the patients to the different groups.
Primary Purpose: Treatment
Official Title: Effect of Continuous Positive Airway Pressure (CPAP) on 6-Minute Walk Test Outcomes in Patients With Excessive Central Airway Collapse (ECAC)
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: Group 1
This group will perform a 6MWT with CPAP
Device: Continuous positive airway pressure (CPAP) device
Use of a CPAP during a 6 minute walk test to maintain the airways open during the respiratory cycle

Sham Comparator: Group 2
This group will perform a 6MWT with a sham-CPAP
Device: Sham-continuous positive airway pressure (CPAP) device
An enlarged air leak incorporated into the exhalation valve will be positioned between the mask and the CPAP tubing, allowing airflow resistance of the exhalation port to be almost eliminated by increasing its area, thereby virtually cancelling positive pressure. Also an orifice restrictor in the CPAP circuit will be connected between the CPAP unit and the tubing in order to load the blower with the same airflow resistance as in true CPAP.




Primary Outcome Measures :
  1. Difference in meters walked in 6MWTs [ Time Frame: 3 months ]
    Statistical difference between the 6 MWT results of the CPAP and sham-CPAP groups as compared with the initial results of the 6 MWT and between groups using ANCOVA.


Secondary Outcome Measures :
  1. Modified Borg scale scores for dyspnea [ Time Frame: 3 months ]
  2. Modified Borg scale scores for exertion [ Time Frame: 3 months ]
  3. Subjective assestment of cough during 6MWTs [ Time Frame: 3 months ]


Information from the National Library of Medicine

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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 a diagnosis of ECAC either via bronchoscopy or CT Scan
  • Age > 18 years
  • Patients that will undergo a diagnostic or therapeutic bronchoscopy as part of their standard of care
  • Patients with a baseline 6 MWT
  • Patients that have never used CPAP devices in the past

Exclusion Criteria:

  • Patients with poorly-controlled respiratory comorbidities (asthma, COPD, obstructed sleep apnea, GERD, relapsing polychondritis)
  • No evidence for acute respiratory tract infection, or respiratory tract infection within the prior 3 weeks
  • 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
  • Subject has co-morbidities that may significantly reduce subject's ability to improve exercise capacity (e.g., severe arthritis, planned knee surgery) or baseline limitation on 6MWT is not due to dyspnea.
  • Subject has an inability to walk >140m (150 yd) in 6 minutes
  • Subject has an inability to tolerate bronchoscopy under moderate sedation or general anesthesia.
  • Subject has a known sensitivity to drugs required to perform bronchoscopy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04217603


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Publications:
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
Sala A, Martínez Deltoro A, Martínez Moragón E. Asmática con broncomalacia y buena respuesta al tratamiento con presión positiva continua en la vía aérea. Arch Bronconeumol. http://www.archbronconeumol.org/es/pdf/S030028961300272X/S300/.
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

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Responsible Party: Adnan Majid, MD, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT04217603    
Other Study ID Numbers: 2019P001034
First Posted: January 3, 2020    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Adnan Majid, Beth Israel Deaconess Medical Center:
Continuous Positive Airway Pressure
Tracheobronchomalacia
Excessive Dynamic Airway Collapse
Excessive Central Airway Collapse
Additional relevant MeSH terms:
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Tracheobronchomalacia
Shock
Pathologic Processes
Cartilage Diseases
Musculoskeletal Diseases
Bronchial Diseases
Respiratory Tract Diseases
Tracheal Diseases
Musculoskeletal Abnormalities
Congenital Abnormalities
Connective Tissue Diseases