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Brain Oxygenation During Prehospital Anesthesia: an Observational Study

Brain Oxygenation During Prehospital Anesthesia: an Observational Study (The BOPRA Study)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04144803
Acronym
BOPRA
Enrollment
1300
Registered
2019-10-30
Start date
2019-11-18
Completion date
2023-12-31
Last updated
2022-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critically Ill, Major Trauma, Anesthesia, Emergencies

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.

Interventions

Nonin H500 one-channel near-infrared spectroscopy monitor on forehead of the patient from before induction of anesthesia to arrival to hospital

Sponsors

FinnHEMS Ltd
CollaboratorUNKNOWN
Turku University Hospital
CollaboratorOTHER_GOV
Tampere University Hospital
CollaboratorOTHER
Oulu University Hospital
CollaboratorOTHER
Lapland Hospital District
CollaboratorUNKNOWN
Kuopio University Hospital
CollaboratorOTHER
Metropolia University of Applied Sciences
CollaboratorOTHER
Turku University of Applied Sciences
CollaboratorUNKNOWN
Tampere University
CollaboratorOTHER
Oulu University of Applied Sciences
CollaboratorUNKNOWN
Savonia University of Applied Sciences
CollaboratorOTHER
Helsinki University Central Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Favorable neurological outcome30 daysmodified Rankin scale ≤2 (scale 0-6, 0 asymptomatic, 6 expired)
Cerebral desaturation eventthrough prehospital care, approximately 60 minutesan absolute drop of forehead cerebral saturation ≥ 10% from baseline for ≥ 5 minutes

Secondary

MeasureTime frameDescription
Survival30 daysSurvival
Favorable neurological outcome1 yearmodified Rankin scale ≤2 (scale 0-6, 0 asymptomatic, 6 expired)
15D score1 yearHeal-Related Quality of Life measured using 15-D instrument, scale 0-1 (0 = being dead, 0.0162 = being unconscious or comatose, 1 = no problems on any dimension = 'full' HRQOL)

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026