20
Participants
Start Date
July 15, 2021
Primary Completion Date
January 11, 2023
Study Completion Date
January 14, 2023
Oxygen saturation probe Mindray 520 N and Mindray 521 N
"Two oxygen saturation probes will be used in this study:~Mindray 520 N is a disposable oxygen saturation sensor for neonates and adults. It is a disposable, single-use sensor that is wrapped around the infant's arm or foot. Its ends stick together giving a firm, close contact with the skin.~Mindray 521 N is another disposable oxygen saturation sensor for neonates and adults that is used on the neonatal unit in routine practice. As Mindray 520 N and 521 N are CE marked and used within their intended purposes we do not require a letter of no objection from the MHRA for that usage. The Mindray probes will be used without modification and there are no safety issues to the patient. Therefore, a letter of no objection from the MHRA is not required and this is not a medical device study under the Medical Devices Directive."
University Hospitals of Derby and Burton, Derby
University Hospitals of Derby and Burton NHS Foundation Trust
OTHER
University of Nottingham
OTHER