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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Emergencies; Anesthesia; Critically Ill; Major Trauma
• Intervention / Treatment: Diagnostic test: Cerebral near-infrared spectroscopy

• Study Type: Observational
• Enrollment (Anticipated): 1300

Contacts and Locations

Study Locations

• Finland
  • Kuopio, Finland
    • FinnHEMS 60 / Kuopio University Hospital
  • Oulu, Finland
    • FinnHEMS 50 / Oulu University Hospital
  • Rovaniemi, Finland
    • FinnHEMS 51 / Lapland hospital district
  • Tampere, Finland
    • FinnHEMS 30 / Tampere University Hospital
  • Turku, Finland
    • FinnHEMS 20 / Turku University Hospital
  • Vantaa, Finland
    • FinnHEMS 10 / Helsinki University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing prehospital anesthesia and endotracheal intubation regardless of indication

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cerebral desaturation group; absolute drop of forehead cerebral oxygen saturation ≥ 10% from baseline for ≥ 5 minutes during prehospital anesthesia	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
Control group; no absolute drop of forehead cerebral oxygen saturation ≥ 10% from baseline for ≥ 5 minutes during prehospital anesthesia	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Favorable neurological outcome	modified Rankin scale ≤2 (scale 0-6, 0 asymptomatic, 6 expired)	30 days
Cerebral desaturation event	an absolute drop of forehead cerebral saturation ≥ 10% from baseline for ≥ 5 minutes	through prehospital care, approximately 60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	Survival	30 days
Survival	Survival	365 days
Favorable neurological outcome	modified Rankin scale ≤2 (scale 0-6, 0 asymptomatic, 6 expired)	1 year
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

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Collaborators: Turku University Hospital; Oulu University Hospital; Kuopio University Hospital; Tampere University; Tampere University Hospital; Turku University of Applied Sciences; Savonia University of Applied Sciences; FinnHEMS Ltd; Lapland Hospital District; Metropolia University of Applied Sciences; Oulu University of Applied Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 18, 2019
• Primary Completion (ACTUAL): September 25, 2022
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: October 7, 2019
• First Submitted That Met QC Criteria: October 29, 2019
• First Posted (ACTUAL): October 30, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 28, 2022
• Last Update Submitted That Met QC Criteria: October 27, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies; Critical Illness
• Other Study ID Numbers: BOPRA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No