The BOPRA pilot study was successfully completed in September and we are almost ready to move on to the main study.
The pilot study was carried out in two Finnish HEMS units, Vantaa and Oulu, between 20.5.–2.9.2019. The aim was to ensure the feasibility of the study protocol and to collect data necessary for sample size calculations for the main study.
All patients above 18 years old, sedated/anesthetized and intubated by the HEMS unit were eligible for the study. During the study period, the units treated 128 patients who met the inclusion criteria, of which 100 were included. Inclusion rate should be even higher in the main study, as eligible patients were mostly excluded due to device-related issues; the new hand-held device was still under development during the pilot study but the issues were solved during the pilot. The main study will be carried out with a new version of the device.
The pilot study was very successful and fulfilled all the aims that were set. The results also seem very promising considering the aims of the main study, which are to reveal the risk factors of prehospital anesthesia related cerebral desaturation events (CDE) and to define the association between CDE and neurological outcome, quality of life and survival. The findings of the main study will be useful for clinical practice and also enable the planning of intervention studies assessing the benefit of cerebral oxygen saturation guided therapy.
The main study will be carried out in all Finnish HEMS units. Data collection will begin in November 2019 and optimally approximately 1300 patients will be recruited. However, after one year of data collection the study group will evaluate if it is necessary and reasonable to continue patient recruitment.
More information:
Study leader, principal investigator Jouni Nurmi
FinnHEMS Research and Development Unit / Helsinki University Hospital
jouni.nurmi@hus.fi
p. 050 595 1576
Project Manager Anna Olkinuora
FinnHEMS Research and Development Unit
anna.olkinuora@finnhems.fi
p. 0400 237 211