Human clinical trial of ‘SwasthVayu’, India’s first ‘Made in India’ non-invasive ventilator, will soon start at Manipal Hospitals, Bengaluru.
It is 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 trial of ‘SwasthVayu’ to treat COVID-19 patients would begin at the Manipal Hospital, which also collaborated in its development in ‘record’ 36 days, the NAL said in a statement here.
The device can be used for COVID patients and also support those suffering from other respiratory disorders and heart failure, it said.
NAL had in May last announced the development of the ventilator which was simple to use without any specialised nursing and cost effective, compact and configured with majority of indigenous components.
Since then it had been tested on artificial lung models with successful results, the institute said.
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.
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.”
