The Cambridge medical device that could help NHS discover quickly which Covid-19 patients need a ventilator
A Cambridge company is accelerating production of a medical device that could help doctors identify early which Covid-19 patients are deteriorating and need ventilation.
Cambridge Respiratory Innovations is hopeful that its N-Tidal device will go live in an NHS hospital within two or three weeks, which could prompt a major order – and open the door to its use globally.
N-Tidal is a simple-to-use, fully automated, connected and highly sensitive capnography machine, measuring exhaled carbon dioxide.
Amid a shortage of ventilators, the device could enable clinicians to prioritise their use based on firm data.
Dr James Whitticase told the Cambridge Independent: “All the evidence suggests that if you need ventilating, you need it quickly, because the sooner you get on a ventilator, the better your outcome.
“Any delay, and the chances of survival drop off dramatically.
“The reason we’re working with hospital trusts now is that by having this on a ward, with patients breathing into it, they will be able to spot quickly which patients need ventilating. That’s how we will save lives.”
Currently, clinicians must rely on observations, blood pressure and oxygen statistics – which involve getting close to the patient – to make such judgment calls.
“If a single doctor is looking after a ward of 30 people, how can they spot who is deteriorating fast? It’s so hard. They don’t have the technology to monitor that – a lot of it is clinical judgment and very subjective. We’re bringing in objective measures via a clinical ward base dashboard, which makes it simple to make the clinical decision remotely,” explained James.
Built originally for patients with asthma or chronic obstructive pulmonary disease (COPD), N-Tidal is a CE-marked class one device that can be used by anyone.
“It collects all the data from normal breathing – it is not technique-dependent. The frail and elderly, or the very young can use it, unsupervised,” explained James. “From that data, we can look at the physiology and functionality of a patient’s lungs.
“We have a patient view, so clinicians can look at an individual, or they could look at a whole ward, to see who is deteriorating, stable and how many are improving.
“There is also a hospital-wide view, and we are just building a national view, so the NHS can look at the whole hospital network and see where the greatest demand is.”
Later this year the company, which has moved from Swavesey to the WeWork site in Station Road, Cambridge, will seek regulatory approval for the use of machine learning and artificial intelligence models with N-Tidal. It is planned that these will forecast a patient’s trajectory, indicating whether he or she may need a ventilator within the next 12 hours or the next two weeks, for example.
“Phase one is about getting this into hospitals to support the doctors to make decisions rapidly,” said James.
“In phase two, we see patients being discharged home with it, because ultimately it’s a home device. When they get home, we can keep monitoring them and spot who is deteriorating and plan early interventions to hopefully avoid a readmission.”
Cambridge Respiratory Innovations is putting all its efforts into the fight against the coronavirus.
“In the UK we can make 400-500 a month at the moment. Soon, we’ll be able to make 4,000 a month. We’ve ramped that right up,” said James, who explained that its manufacturing partners are working around the clock.
The company could, however, move much faster with further investment.
“Our challenge is that we are an early-stage company. If we were well-funded today we would stockpile all the components and get on with building. That would cost a few hundred thousand pounds and we can’t afford it.
“Once we get the orders in from the NHS and ultimately the US and European markets, we think we’ll be able to get up to tens of thousands manufactured a month,” said James, who confirmed that he is in the middle of an investment round.
For now, the company has repurposed grants it has received, and has 200 devices that it can deploy.
“We’ve got several hospitals, in and around London, putting it through their ethics committees. This usually takes three months, but they are trying to do it in two weeks,” James revealed. “In two or three weeks time we hope to have the first devices on wards monitoring Covid-19 patients.”
It is these proactive hospital trusts, prepared to introduce new devices, who are likely to get the device first.
But the company is liaising with NHS England, the Cabinet Office and Innovate UK, along with various clinical commissioning groups, to discuss a wider roll-out, and has links into major hospitals, including Addenbrooke’s.
“We just need the first site to go live so the clinicians can say they can’t function without it,” said James. “We are very confident that will happen.”