Clinical trial NCT04144803: Brain Oxygenation During Prehospital Anesthesia: an Observational Study
Official title: Brain Oxygenation During Prehospital Anesthesia: an Observational Study (The BOPRA Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critically Ill
Major Trauma
Anesthesia
Emergencies
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: FinnHEMS Ltd
name: Turku University Hospital
name: Tampere University Hospital
name: Oulu University Hospital
name: Lapland Hospital District
name: Kuopio University Hospital
name: Metropolia University of Applied Sciences
name: Turku University of Applied Sciences
name: Tampere University
name: Oulu University of Applied Sciences
name: Savonia University of Applied Sciences
First posted: 2019-10-30
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergoing prehospital anesthesia and endotracheal intubation regardless of indication

Brief summary: Brain oxygenation of adult patients undergoing prehospital emergency anesthesia is monitored using noninvasive near-infrared spectroscopy. Patients are afterwards interviewed to define neurological outcome to measure quality of life. The purpose of this study is to reveal the risk factors of prehospital anesthesia related cerebral desaturation events (CDE) and to define the association between CDE and survival, neurological outcome or quality of life.


Eligibility criteria: Inclusion Criteria:

* sedation or anesthesia provided to facilitate endotracheal intubation, performed by Helicopter Emergency Medical Services (HEMS) team regardless of the reason

Exclusion Criteria:

* Ongoing cardiopulmonary resuscitation at the time of intubation
* Physical barrier for near-infrared spectroscopy measuring (e.g. forehead laceration)
* HEMS unit does not escort patient to the hospital (exception: in case of death on scene after inclusion, patient is included)
* Workload too high to ensure standard level of clinical care during the study
* For interviews: no competence in Finnish, Swedish or English

Primary outcomes:
measure: Favorable neurological outcome
timeFrame: 30 days
measure: Cerebral desaturation event
timeFrame: through prehospital care, approximately 60 minutes
Secondary outcomes:
measure: Survival
timeFrame: 30 days
measure: Survival
timeFrame: 365 days
measure: Favorable neurological outcome
timeFrame: 1 year
measure: 15D score
timeFrame: 1 year
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: FinnHEMS 60 / Kuopio University Hospital
city: Oulu
country: Finland
facility: FinnHEMS 50 / Oulu University Hospital
city: Rovaniemi
country: Finland
facility: FinnHEMS 51 / Lapland hospital district
city: Tampere
country: Finland
facility: FinnHEMS 30 / Tampere University Hospital
city: Turku
country: Finland
facility: FinnHEMS 20 / Turku University Hospital
city: Vantaa
country: Finland
facility: FinnHEMS 10 / Helsinki University Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Jouni Nurmi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: