Brain Oxygenation During Prehospital Anesthesia

Study Overview
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Brief Summary
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The study will evaluate the feasibility of Nonin SenSmart H500 device to measuring brain oxygenation during prehospital anesthesia of adult patient. The study also estimates the incidence of cerebral hypoxic events of anesthetized patients during prehospital care. The study does not affect the treatment of the patient. The study is pilot study and will be followed with a main study to assess the association between cerebral oxygenation during prehospital care and outcome of the patient.

Official Title
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Brain Oxygenation During Prehospital Anesthesia: an Observational Pilot Study

Conditions
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Critical Illness

Intervention / Treatment
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* Device: Near-infrared spectroscopy (NIRS) monitoring of cerebral oxygenation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: sedation or anesthesia provided to facilitate endotracheal intubation, performed by HEMS team regardless of the reason Exclusion Criteria: Cardiac arrest at the time of intubation Physical barrier for NIRS measuring (e.g. forehead laceration) HEMS physician does not escort patient to the hospital (and patient is not dead on the scene after inclusion) Workload too high to ensure standard level of clinical care during the study Known special vulnerability including known mental disability (permanent, not related to acute condition), patients in nursing homes, prisoners and forensic psychiatric patients. Known or evident pregnancy

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

| Intervention/Treatment |
| --- |
|Device: Near-infrared spectroscopy (NIRS) monitoring of cerebral oxygenation|Monitoring before anesthesia to hospital admission. No treatment decisions made based on monitoring.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disturbance-free time of the total monitoring time | Proportion of time with readable monitor signal of the total time monitor connected to the patient | Prehospital phase | 
| Cerebral desaturation events | Number of patients with forehead regional oxygen saturation ≤50% for ≥5 minutes | During prehospital phase after induction of anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| On-scene time | Time from arrival of helicopter emergency medical services unit on the patient to beginning of transportation | Prehospital phase | 
| Qualitative feedback from HEMS crews | Comments on the usability of the study device | Prehospital phase | 
| Survival | Data from population registry center | 30 days, 12 months | 
| Neurologic disability | 3-6 on modified Rankin scale (range from 0 [no symptoms at all] to 6 [dead], evaluated by trained research nurse | 30 days, 12 months | 
| Health related quality of life | total score of 15-D questionnaire including 15 dimensions each ranked from 1 (good quality of life) to 5 (poor quality of life) | 12 months |