Pilot study of flutter valve device (Acapella) among COPD patients in India- Part 1

Ashish Rai, M.D.

Chief Resident, North Shore Medical Center

PGY-4

February 15, 2019

Chronic obstructive pulmonary disease (COPD) accounts for 5% of global deaths with 80% of these deaths occurring in low to middle income countries as per the recent WHO global burden of disease report. Flutter valve devices could be a low resource tool that could decrease the mortality and morbidity associated with this disease.

Explaining the use of acapella device.

With this background I travelled to Chest Research Foundation (CRF), Pune, India to undertake a pilot study looking into the efficacy of flutter valve devices among individuals with severe COPD living with low to middle income. CRF is an autonomous institution that provides outpatient care to patients suffering from pulmonary disease, with specialization in treating asthma and COPD. The institution was set up in 2002 by group of pulmonologists and internists practicing in Pune, India with aids from the Indian government and pharmaceuticals companies with a goal to bridge the gap between the health care provider and patients and to provide a platform for researchers interested in Asthma and COPD.

Giving informed consent.

Prior to my arrival, physicians at CRF, Dr. Govinda Narke (attending preventive and social medicine) and Dr. Sudeep Salvi (attending pulmonologist and chief of CRF) had arranged for a list of potential patients with severe COPD based on the inclusion and exclusion criteria of the study and received the respective institutional ethics committee approvals.

On the day of my arrival at CRF we started with the process of recruitment which included donating, explaining the potential benefits and risk and demonstrating the use of the Acapella device signing of informed consent and filling out lifestyle indices in the local language with help of Dr. Govinda Narke.

Measuring pulmonary function.

Every day we were able to recruit two to four people depending on the availability and by the time of my departure we were able to recruit 20 patients with a plan to recruit 10 more in this week. Prior to the departure patients were requested to demonstrate the use of Acapella and ask any queries they may have related to its use. 

and pulmonary function tests.

Everyone with their device.

Most patients that were recruited were from the rural areas which were on average 30-40 miles away from institution and were driven with the help of transport arranged from the institution and were provided with a meal and lost wages by CRF.

After explaining to the participant about the potential for decrease in the frequency of COPD exacerbation and hence avoiding hospital admissions, patients appeared to be more accepting for the use of the device and agreed to use it as per the directions. They have been advised to revisit CRF in 15 days for a repeat measurement of pulmonary function test and documenting lifestyle indices, which will be performed by the team at CRF.

Our hypothesis from this project is that outpatient use of a flutter valve device improves pulmonary function and quality of life among severe COPD patients and can be used as an adjunct to pulmonary rehabilitation especially in low to middle income countries.