Product design and development company Wideblue is accelerating production of a new medical device which could help the NHS quickly discover which COVID-19 patients are deteriorating and need a ventilator.
The device, N-Tidal, developed for Wideblue client Cambridge Respiratory Innovations (CRI), is a fully automated, small battery powered personal capnometer which is used to measure the amount of CO2 in exhaled breath during normal relaxed breathing. The changes in CO2 concentration as a patient breathes in and out through the device are measured and can be used to assess the health of a patient's lungs and general condition. Amid a shortage of ventilators, the device could enable clinicians to prioritise their use based on firm data. The device may also be useful to track progress of patients as they recover after ventilator use.
Normally a device called a spirometer is used to assess lung function, but this requires the patient to blow long and hard into a tube; COVID-19 patients do not have the energy to do this. Also, blowing hard into the spirometer can disperse Coronavirus particles and create an aerosol of the virus the air. The N-Tidal device could be used to assess patients' lungs without generating dangerous aerosols.
It is hoped the CE marked N-Tidal device will start trials in NHS and US hospitals within two or three weeks, opening the door for a roll out across the UK and potentially globally.
Russell Overend, Wideblue's managing director, said: "Wideblue has made 200 devices already and has a purchase order for another 1,000 units which will be manufactured over the next few weeks. These devices were destined for clinical trials with COPD and Asthma patients, but these devices are now being reconfigured and reallocated to COVID-19 patients. We are very hopeful these N-Tidal devices can be deployed in hospitals within the next couple of weeks.
"Wideblue are gearing up to rapidly increase production of this new N-Tidal device, the replaceable breath tubes and the mouthpieces. Normally new medical devices like take a long time to gain approval and acceptance. We would also normally carry out a technology transfer to a volume manufacturer but given the immediate need and the inability to travel to support start up production at an external manufacturing company we are scaling up production in-house. Over the next few weeks we will purchase additional materials, reconfigure our product development labs to become production areas, train additional staff and assemble new N-Tidal devices, Breath tubes and mouthpieces. It is quite an exciting time in the development of this new product and one we are proud to be manufacturing and doing our bit in the fight against Coronavirus."
CRI is currently working alongside hospital trusts to generate protocols for use and is seeking ethics committee approval to start trials.
N-Tidal was originally developed to be used by patients with respiratory related diseases such as asthma, COPD and Congestive Heart Failure for hospital and home monitoring. This new application could see the device used in hospitals and the community to help in the fight against Coronavirus. Currently in normal hospital use, capnometers are a large bedside machine connected to a patient's face mask or a sensor located in life support equipment. N-Tidal is transformational as it has miniaturised the capnometer and puts it directly at the patient’s mouth give much greater resolution and more detailed clinical information. It is designed to be used as a personal respiratory monitor, allowing it to be easily used in hospitals or in the home.
