“SWASTHVAYU” – India’s indigenous Ventilator soon to start Human Clinical Trials
“SwasthVayu” - India’s indigenous ventilator will soon start human clinical trials at Manipal Hospitals, Bengaluru. ‘SwasthVayu’ is the first “Made in India” non-invasive ventilator being developed by the National Aerospace Laboratories (NAL), Bengaluru in scientific and medical knowledge collaboration with Dr Satyanarayana Mysore HOD, Pulmonology Respiratory & Sleep Medicine, Lung Transplant Physician at Manipal Hospitals, Bengaluru and Dr Anurag Agarwal, Director of Council of Scientific and Industrial Research (CSIR) - Institute of Genomics and Integrative Biology (IGIB).
The invention of ventilators has saved the lives of numerous patients, suffering from respiratory failure-a medical emergency characterized by low oxygen and high carbon-dioxide levels in the body due to the inability to breathe appropriately as compared to a normal healthy person.
At the beginning of the pandemic, foreseeing the large outbreak of COVID 19 cases in India, there was a clarion call by Prime Minister Narendra Modi to all the entrepreneurs and scientists, to innovate and ramp up health care systems, including increasing the number of ventilators. The number of people who would require such ventilators was expected to be high and this was not going to be met with the existing numbers in India, nor would it be met through imports. Hence there was a compelling need for indigenous ventilators to mitigate the acute shortage of ventilators. Apart from COVID patients, these ventilators could also benefit and support patients suffering from other respiratory disorders like complex sleep-disordered breathing such as the obstructive sleep apnea (OSA), central sleep apnea (CSA) and heart failure (HF).
The National Aerospace Laboratories (NAL), a constituent of Council of Scientific and Industrial Research (CSIR), New Delhi, swung into action and took the challenge to develop SwasthVayu - an indigenous, non-invasive, portable ventilator with clinical inputs from well-known pulmonologist Dr. Satyanarayana and Dr. Anurag Agarwal. SwasthVayu is equipped with advanced features like Bi-level mode (BiPAP), Continuous Positive Airway Mode (CPAP), Spontaneous modes and 3D printed HEPA-T filter adapter connected directly to the non-ventilated mask. “This is of paramount importance in minimizing the risk of virus spread. The device also has a special provision to connect to the oxygen concentrator externally”, added Dr. Satyanarayana.
Dr. C.M. Ananda, Chief scientist and Head Electronics Division of NAL said that the device has been subjected to trials on artificial lung models and has successfully passed stringent electrical safety, performance, calibration, bio-compatibility tests at National Accreditation Board for Testing and Calibration Laboratories (NABL) accredited laboratory. The device is registered with the Central Drug Research Institute (CDRI) and Central Drugs Standard Control Organisation (CDSCO) regulatory authorities. The device is ideal to treat patients with respiratory failure in both COVID and non-COVID situations, either in the ICU or non-intensive medical conditions. Further, this provides an opportunity for scarce ICU beds not to be overburdened and to be used for severely affected patients.
Dr Satyanarayana further added, “Considering the nation’s endeavor of attaining self-reliance, indigenous production of this device, which for long had always been imported, is itself a mile stone.
The Ethics Committee, and the scientific committee at Manipal Hospitals, Bengaluru has scrutinized and approved the device for clinical trials under Dr Satyanarayana, Head of Pulmonology and Sleep Medicine as the Principal Investigator. Dr. Satyanarayana further added that “the device will also be a bonanza post-pandemic for treating sleep-disordered breathing including Obstructive Sleep Apnea and other sleep apnea. The clinical trials will begin shortly and for now, the focus will be limited to the successful completion of the trials only.”