Sphere Medical's intravenous anaesthetic propofol measuring device has met the primary endpoint and demonstrated equivalent performance to a standard method for propofol analysis.
The point-of-care Pelorus 1500 diagnostic device is designed to provide real-time measurements of propofol administered during infusion in patients undergoing cardiopulmonary bypass surgery.
In the study, a total of 111 whole blood samples from 32 patients undergoing cardiopulmonary bypass surgery were analysed at the Papworth Hospital in Cambridge, UK.
All the samples were tested using both Pelorus 1500 and the standard High Performance Liquid Chromatography (HPLC) reference test.
The study demonstrated that Pelorus 1500 diagnosed propofol and provided results in the same way as the reference method.
Other clinical studies have also shown that a single measurement carried out during general anaesthesia can improve clinicians' understanding of propofol levels during an operation, according to the company.
Papworth Hospital study chief investigator Dr Alain Vuylsteke said Propofol is widely used as an anaesthetic for cardiac surgery patients, but the dose varies based on the nature of the procedures.
"Until now, we have had no clinical tool that will allow us to determine in real time the concentration of the drug in the individual patient in front of us," Vuylsteke said.
"The results from this study demonstrate that the Pelorus 1500 has the accuracy required for me to understand exactly what is happening to drug concentrations in this patient group It opens many clinical possibilities, including tailoring the infusion to the patient's specific and complex needs."
Sphere Medical CEO Dr Stuart Hendry said; "We are focused on driving this product to the market in the UK and through our Japanese distributor."