Brain Oxygenation During Prehospital Anesthesia

Completed

• Conditions: Critical Illness

• Registration Number: NCT03948711
• Lead Sponsor: Helsinki University Central Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-10
• Study First Submitted QC: 2019-05-10
• Study First Posted: 2019-05-14
• Study Start: 2019-05-20
• Primary Completion: 2019-09-02
• Study Completion: 2020-09-30
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-14
• Last Update Posted: 2021-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
On-scene time	Prehospital phase	Time from arrival of helicopter emergency medical services unit on the patient to beginning of transportation
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
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)
Qualitative feedback from HEMS crews	Prehospital phase	Comments on the usability of the study device
Survival	30 days, 12 months	Data from population registry center

Trial Locations

Locations (2)

FinnHEMS 50 / Oulu University Hospital; 🇫🇮 Oulu, Finland

FinnHEMS 10 / Helsinki Univeristy Hospital; 🇫🇮 Vantaa, Finland