Critical Illness
Conditions
Brief summary
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.
Interventions
DEVICENear-infrared spectroscopy (NIRS) monitoring of cerebral oxygenation
Monitoring before anesthesia to hospital admission. No treatment decisions made based on monitoring.
Sponsors
Oulu University Hospital
FinnHEMS
Helsinki University Central Hospital
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disturbance-free time of the total monitoring time | Prehospital phase | Proportion of time with readable monitor signal of the total time monitor connected to the patient |
| Cerebral desaturation events | During prehospital phase after induction of anesthesia | Number of patients with forehead regional oxygen saturation ≤50% for ≥5 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival | 30 days, 12 months | Data from population registry center |
| On-scene time | Prehospital phase | Time from arrival of helicopter emergency medical services unit on the patient to beginning of transportation |
| Health related quality of life | 12 months | total score of 15-D questionnaire including 15 dimensions each ranked from 1 (good quality of life) to 5 (poor quality of life) |
| Neurologic disability | 30 days, 12 months | 3-6 on modified Rankin scale (range from 0 \[no symptoms at all\] to 6 \[dead\], evaluated by trained research nurse |
| Qualitative feedback from HEMS crews | Prehospital phase | Comments on the usability of the study device |
Countries
Finland
Outcome results
None listed