Vector A40 EU Registry
Research type
Research Study
Full title
A40 EFL Registry: A Multicenter Prospective Study to Determine the Role of EFL in Patients with Chronic Obstructive Pulmonary Disease (COPD) Receiving Home Mechanical Ventilation
IRAS ID
280883
Contact name
M Polkey
Contact email
Sponsor organisation
Philips Respironics Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
Patients who have chronic obstructive pulmonary disease (COPD), with increased daytime carbon dioxide levels, requiring noninvasive mechanical ventilation (equipment that assists with breathing) in the home will be provided with a the new Philips BiPAP A40 EFL noninvasive ventilator, as part of standard clinical care.
This new device works by detecting expiratory flow limitation (EFL) due to narrowing of the airways, which is a key physiologic feature of COPD. The BiPAP A40 EFL device is specifically designed to detect and the adjust pressures settings to abolish EFL. However very little is known about how severe EFL is in patients with COPD, but the study will elucidate for the first time the progression and variation in EFL in relation to exacerbation
Participants while using the home ventilator, will be asked to share their medical history, including medications, demographic information, weight, body mass index (BMI), blood measurements specific to breathing function with COPD patients such as blood oxygen and carbon dioxide levels and their current oxygen usage.
Importantly participants will be asked to share the data collected from the device (via SD card) on a monthly basis and at the time of any sickness or hospitalisation should they occur.
Participants will also receive monthly follow-up phone call from the study staff to discuss any issues and medication changes.
The primary objective is to determine the overall commonness (prevalence) of EFL in patients being treated with non-invasive ventilation to manage their hypercapnic COPD.
REC name
London - London Bridge Research Ethics Committee
REC reference
20/PR/0102
Date of REC Opinion
3 Sep 2020
REC opinion
Further Information Favourable Opinion