COVID-19 CPAP VENTILATOR: CTEX-WG5 v01 (Current Device: CTEX WG7) [COVID-19]
Research type
Research Study
Full title
The ‘COVID-19 CPAP CTEX-WG5 Ventilator’ Multi-site device investigation
IRAS ID
282487
Contact name
Keir Lewis
Contact email
Sponsor organisation
Hywel Dda University Health Board
ISRCTN Number
ISRCTN12345678
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 0 months, 8 days
Research summary
Summary of Research
This study seeks to trial the use of a new continuous positive airway pressure (CPAP) device, known as the CTEX-WG5, on COVID-19 patients in hospitals in Wales. CPAP is a standard treatment already in use for COVID-19 patients in the early stages of this disease. The CTEX-WG5 CPAP device is a new device but is based on the same principles as standard CPAP devices. \n\nThe RT-MK8 will be used on patients already assessed as suitable for and already receiving standard CPAP. Patients will be started on standard CPCP before being switched RT-MK8 CPAP for up to 12 hours and then switched back to standard CPAP. Patients will be closely monitored at all times and if clinically indicated will be taken off RT-MK8 CPAP. \n\nThe study will provide some initial indications of the effectiveness of RT-MK8 CPAP in maintaining oxygenating saturation. It will also gather information on patient acceptibility and staff experience along with any adverse incidents should they occur.\n\nThe information gained from this study will enable the design of more comprehensive assessments of the performance of RT-MK8, or subsequent models.
Summary of Results
It is important to acknowledge the small sample size and limited time on trial CPAP (Continuous Positive Airway Pressure) when considering the following conclusions. A much larger study would be required to fully investigate the utility of the trial CPAP device, the CTEX WG7.
1. Within the confines of this very small trial, the CTEX WG7 provided a sufficiently similar degree of oxygen saturation as the standard CPAP machines is was compared against.
2. The CTEX WG7 is designed to be rapidly manufactured and is cheaper, so is not as refined, in terms of noise, controllability and alarm systems, as the fully marketed CPAP devices in use in the NHS.
3. Although CTEX WG7 was less favoured by participants and drew some criticism from staff, there is no evidence from this study to suggest the noise or ergonomics issues caused harm.
4. There is no evidence from this study to suggest the lack of a leak alarm caused any harm. However, it does appear to be a potential weakness that may wish to be addressed in any further development of this product and/or in any future rapid manufacturing challenge.REC name
South Central - Oxford A Research Ethics Committee
REC reference
20/SC/0177
Date of REC Opinion
3 Apr 2020
REC opinion
Favourable Opinion