Impact case study database

Rapid delivery of UCL-Ventura CPAP machines and UCL developed oxygen analysers to hospitals in the UK and worldwide

In response to the UK Government Ventilator Challenge, launched on 16 March 2020, the UCL-led consortium of critical care specialists and engineers from UCL and Mercedes AMG-HPP reverse engineered, tested, modified and manufactured the UCL Ventura CPAP device that safely and effectively treated respiratory distress in COVID-19 patients. Authorisation for use in COVID-19 patients was secured from the MHRA within 36 hours of application. The modified, more oxygen-efficient Mark II device was MHRA-approved six days later (2 April). In tandem, the UCL team worked alongside two UK companies (Oxford Optronix and Life Racing) to design, build from scratch, benchmark and clinically test in-line oxygen analysers to monitor the oxygen concentration being delivered to the patient by the CPAP circuit. The Department of Health and Social Care (DHSC) ordered 10,000 devices plus oxygen analysers, which were delivered to the NHS by 15 April, less than a month from inception of the idea.

CPAP (using available devices augmented by the UCL Ventura device) has enabled UK hospitals to “offer life-saving treatments to patients in a timely fashion”, “accommodate patients from local trusts” and “prevented many patients from being exposed to the risks of sedation and mechanical ventilation” ( S1). The MHRA interim Director of Devices, said in a press release on 31 March 2020: “This achievement is a brilliant example of cross-disciplinary and collaborative teamwork ahead of the anticipated London surge in coronavirus patients” ( S2).

To support the worldwide healthcare crisis that was unfolding, the UCL team released the design blueprints and manufacturing instructions of the UCL Ventura device at zero-cost to support in-country manufacture. The designs have been downloaded over 1884 times by 105 countries ( S3). The UCL-Ventura team are working with in-country teams to support local manufacture through technical and manufacturing support, local supply chains, regulatory support, and have provided clinical guidance through the dedicated UCL website, including educational videos, instructions for use and by email and webinars with local clinicians. Approximately 30 groups are now manufacturing devices in countries including Peru, Pakistan, the Philippines, Ukraine and South Africa ( S4). Charities, companies and governments have also purchased devices at cost for use in Uganda, Palestine, Tajikistan and South Africa.

In August 2020, the UCL-Ventura team (including Brealey, Lomas, Shipley and Singer) won a Royal Academy of Engineering award for exceptional services during a pandemic, and in recognition of the team’s impact. Lord Agnew, Minister of State said: "The UCL-Ventura team has been a remarkable collaboration of medicine, science and industry brought together through engineering innovation at pace with few examples in modern British Life. The availability of these devices has helped frame the debate for less invasive oxygen treatment, a result from which everyone benefits - the patient who is in hospital for a shorter period of time, and the hospital as it puts less strain on their infrastructure” ( S5).

Changing the patient care pathway for patients with severe COVID-19 symptoms

Initial NHS guidelines in early March 2020 did not recommend use of CPAP for COVID-19 patients due to a theoretical increased risk of virus transmission to healthcare staff. However, Singer’s data from China and Italy showing healthcare worker safety and clinical effectiveness, convinced UCLH clinicians and UCL administration that a CPAP care pathway commencing in the Emergency Department, should be instituted from the beginning of the pandemic. A respiratory unit outside the ICU was quickly established to provide CPAP support in a supervised environment. A care pathway algorithm was developed in collaboration with UCL Health Creatives and made freely available as the mobile App UCLH COVID 19 Clinical Guidance for use in clinical settings (downloaded 3,700 times) ( S6), This assessed the clinical response to CPAP in patients not improving with standard oxygen therapy and, depending on the response, the patient could be assigned to an Amber pathway and maintained on CPAP, or to a Red pathway where they would undergo mechanical ventilation. Patients were monitored closely thereafter for consideration of invasive ventilation, if failing.

Singer also presented his data from China and Italy to the Department of Health, NHS England and NHS Scotland. In combination with initial clinical experience of CPAP gained at UCLH and other London hospitals, and with input from Singer and other intensive care and respiratory clinicians, NHS England changed guidance on 25 March 2020 stating: “CPAP is the preferred form of non-invasive ventilatory support in the management of the hypoxaemic COVID-19 patient” ( S7).

The model of care, pioneered at UCLH, with establishment of respiratory units offering non-invasive respiratory support, has been copied by many hospitals around the UK ( S8).

Clinicians who adopted the pathway early in the pandemic said: “We adopted the use of the UCL-Ventura into our routine clinical treatment alongside our established cohort of CPAP machines. They were embraced by staff as they were simple and effective to use... Moreover, the UCL-Ventura was well tolerated by patients. All the patients treated with the Ventura survived to leave hospital. Without this equipment we could have not delivered this life saving therapy to many of our patients” ( S1).

Another specialist said: “I have looked through our clinical data and can confidently say that for patients with Covid19 they (Ventura CPAP) helped reduce rates of invasive mechanical ventilation by over 50%. This had a huge positive impact upon our staffing and resource utilisation in critical care, and I believe led to improved patient survival too (by reduction in secondary harm caused by mechanical ventilation and associated organ dysfunction)” ( S1).

Published reports from individual UK hospitals show an average 50% avoidance of mechanical ventilation in patients for full escalation of therapy. In such patients, hospital survival rates of more than 90% are reported in those managing on CPAP alone, with overall survival rates of ~75% when patients who failed CPAP and progressed to ventilation are included ( S9). CPAP has also been used to support patients not deemed suitable for escalation to mechanical ventilation because of their underlying comorbidities and/or frailty; published reports from UK hospitals show survival rates of 25-30% in these very frail patients ( S10).

National increase in the use of CPAP as an alternative treatment pathway

The Intensive Care National Audit and Research Centre (ICNARC) provides weekly reports on all COVID-19 patients admitted to critical care across England, Wales and Northern Ireland. The 12 Feb 2021 report ( S11) compares demographics, organ support and outcomes in patients admitted in the first wave (10,927 admissions between 1 Feb – 31 Aug 2020) and second wave (21,859 admissions from 1 Sept onwards) of the pandemic. The data show that for patients in the second wave, “despite a higher degree of illness severity”, only 49.9% received advanced respiratory support. Duration of stay for survivors reduced from 12 days to a median of 6 days, reflecting the faster turnover of patients who avoid invasive ventilation. As 17% of patients were still receiving critical care at the time of this report, survival rates cannot be compared at present.

The ICNARC group also reported changes in management during the first wave ( S12), identifying a fall in use of invasive ventilation from 85% in the pre-peak phase to 61.1% in the post-peak phase. Over the same period 28-day hospital mortality improved from 43.6% to 33.6% whereas ICU stay for survivors fell from a median 16.5 to 14.1 days.