Effect of Continuous Positive Airway Pressure (CPAP) on 6-Minute Walk Test Outcomes in Patients With Excessive Central Airway Collapse (ECAC)
Beth Israel Deaconess Medical Center
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.
Description
Basal 6MWT performed as a standard of care in these patients will be compared to intervention ones to see if there is an improvement of at least 24 meters in their 6MWT distance, then both groups will be compared to see if there is a statistically significant difference between groups. Subjects, treating physicians and the research fellow performing the 6MWT will be blinded to the intervention; the only un-blinded personnel to the intervention will be the study coordinator who will be in charge of setting the CPAP before every intervention. As part of the standard of care of our institution,…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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/m…
Interventions
- DeviceContinuous positive airway pressure (CPAP) device
Use of a CPAP during a 6 minute walk test to maintain the airways open during the respiratory cycle
- DeviceSham-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.
Location
- Beth Israel Deaconess Medical CenterBoston, Massachusetts