Brain Oxygenation During Prehospital Anesthesia: an Observational Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Critically Ill, Major Trauma, Anesthesia, Emergencies

Intervention / Treatment
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* Diagnostic Test: Cerebral near-infrared spectroscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cerebral desaturation group<br>absolute drop of forehead cerebral oxygen saturation ≥ 10% from baseline for ≥ 5 minutes during prehospital anesthesia | Diagnostic Test: Cerebral near-infrared spectroscopy<br>* Nonin H500 one-channel near-infrared spectroscopy monitor on forehead of the patient from before induction of anesthesia to arrival to hospital<br>|
| Control group<br>no absolute drop of forehead cerebral oxygen saturation ≥ 10% from baseline for ≥ 5 minutes during prehospital anesthesia | Diagnostic Test: Cerebral near-infrared spectroscopy<br>* Nonin H500 one-channel near-infrared spectroscopy monitor on forehead of the patient from before induction of anesthesia to arrival to hospital<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Favorable neurological outcome | modified Rankin scale ≤2 (scale 0-6, 0 asymptomatic, 6 expired) | 30 days | 
| Cerebral desaturation event | an absolute drop of forehead cerebral saturation ≥ 10% from baseline for ≥ 5 minutes | through prehospital care, approximately 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Survival | 30 days | 
| Survival | Survival | 365 days | 
| Favorable neurological outcome | modified Rankin scale ≤2 (scale 0-6, 0 asymptomatic, 6 expired) | 1 year | 
| 15D score | Heal-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) | 1 year |