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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04144803
Other study ID # BOPRA
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date November 18, 2019
Est. completion date December 31, 2023

Study information

Verified date October 2022
Source Helsinki University Central Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1300
Est. completion date December 31, 2023
Est. primary completion date September 25, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Diagnostic Test:
Cerebral near-infrared spectroscopy
Nonin H500 one-channel near-infrared spectroscopy monitor on forehead of the patient from before induction of anesthesia to arrival to hospital

Locations

Country Name City State
Finland FinnHEMS 60 / Kuopio University Hospital Kuopio
Finland FinnHEMS 50 / Oulu University Hospital Oulu
Finland FinnHEMS 51 / Lapland hospital district Rovaniemi
Finland FinnHEMS 30 / Tampere University Hospital Tampere
Finland FinnHEMS 20 / Turku University Hospital Turku
Finland FinnHEMS 10 / Helsinki University Hospital Vantaa

Sponsors (12)

Lead Sponsor Collaborator
Helsinki University Central Hospital FinnHEMS Ltd, Kuopio University Hospital, Lapland Hospital District, Metropolia University of Applied Sciences, Oulu University Hospital, Oulu University of Applied Sciences, Savonia University of Applied Sciences, Tampere University, Tampere University Hospital, Turku University Hospital, Turku University of Applied Sciences

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Favorable neurological outcome modified Rankin scale =2 (scale 0-6, 0 asymptomatic, 6 expired) 30 days
Primary Cerebral desaturation event an absolute drop of forehead cerebral saturation = 10% from baseline for = 5 minutes through prehospital care, approximately 60 minutes
Secondary Survival Survival 30 days
Secondary Survival Survival 365 days
Secondary Favorable neurological outcome modified Rankin scale =2 (scale 0-6, 0 asymptomatic, 6 expired) 1 year
Secondary 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
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