Brain Oxygenation During Prehospital Anesthesia

Helsinki University Central Hospital100 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Critical Illness

Interventions

Near-infrared spectroscopy (NIRS) monitoring of cerebral oxygenationDEVICE

Monitoring before anesthesia to hospital admission. No treatment decisions made based on monitoring.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

FinnHEMS 50 / Oulu University Hospital

Oulu, Finland

FinnHEMS 10 / Helsinki Univeristy Hospital

Vantaa, Finland

Outcomes

Primary Outcomes

Disturbance-free time of the total monitoring time

Proportion of time with readable monitor signal of the total time monitor connected to the patient

Time frame: Prehospital phase

Cerebral desaturation events

Number of patients with forehead regional oxygen saturation ≤50% for ≥5 minutes

Time frame: During prehospital phase after induction of anesthesia

Secondary Outcomes

On-scene time

Time from arrival of helicopter emergency medical services unit on the patient to beginning of transportation

Time frame: Prehospital phase

Qualitative feedback from HEMS crews

Comments on the usability of the study device

Time frame: Prehospital phase

Survival

Data from population registry center

Time frame: 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

Time frame: 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)

Time frame: 12 months

Data from ClinicalTrials.gov

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