Brain Oxygenation During Prehospital Anesthesia: an Observational Study

Anesthesia Clinical Trial

— BOPRA  

Official title:

Brain Oxygenation During Prehospital Anesthesia: an Observational Study (The BOPRA Study)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04144803
• Other study ID #: BOPRA
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Anesthesia
• Critical Illness
• Critically Ill
• Emergencies
• Major Trauma

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