Monidrop® clinical tests in the Kuopio University Hospital
The clinical device trial of the Monidrop device was carried out in the Kuopio University Hospital between September and December 2017. The title of this trial was “The benefits and performance of the Monidrop device in the monitoring of intravenous infusion in the hospital wards: A comparative study between the Monidrop device and conventional clinical practices.”
The aim of the trial was to ascertain the usability and performance of the device in a standard clinical environment. Another aim was to find out whether using the device could improve the accuracy of fluid therapy compared to the fluid therapy administered by visual assessment.
For the trial, a total of 31 patients, who had been prescribed intravenous fluid therapy or drug infusion, were recruited from the medical ward and the emergency department. 15 patients were randomised to receive intravenous therapy using the Monidrop device, and 16 patients were randomised to the control group. The patients were informed of the content of the trial, and they signed a consent form before the trial. The trial permit was applied for from the Research Ethical Committee of the Northern Savo Hospital District.
The patients’ fluid and drug therapy prescriptions were gathered from the electronic medical record system for research. The momentary infusion rate was measured from all the patients by the Monidrop device at 30 minutes and 6 hours from the beginning of the treatment. In addition, the patient’s total fluid intake and drugs administered to the patient were recorded. The alarms raised by the Monidrop device were recorded, and the nurses were asked to assess the appropriateness of those alarms.
The main results: No any adverse events or safety issues occurred during the trial. The Monidrop device was used in the research group for a total of 230 hours. A total of 53 alarms were recorded by the device. Most of the alarms (23) resulted from a variation in the flow rate. Three (3) of these were evaluated as inappropriate, but no security-related concerns or observations were raised. The primary endpoint of the trial was reached so that the device was found to be safe and usable in a clinical environment. 92.9% of the respondents did not find anything of concern, and only one respondent had paid attention to a seemingly great variation in the readings of the device during the treatment. The final analysis of the differences between Monidrop and the control groups is ongoing and will be published later on.