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

Description

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.

Conditions

Tracheobronchomalacia, Excessive Dynamic Airway Collapse

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Study Overview

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Study Details

Study overview

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.

Effect of Continuous Positive Airway Pressure (CPAP) on 6-Minute Walk Test Outcomes in Patients With Excessive Central Airway Collapse (ECAC)

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

Condition
Tracheobronchomalacia
Intervention / Treatment

-

Contacts and Locations

Boston

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States, 02215

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Beth Israel Deaconess Medical Center,

Study Record Dates

2026-01-31