BOPRA: Brain Oxygenation During Prehospital Anesthesia: an Observational Study

• Sponsor: Helsinki University Central Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04144803
• Collaborator: FinnHEMS Ltd (Other), Turku University Hospital (Other), Tampere University Hospital (Other), Oulu University Hospital (Other), Lapland Hospital District (Other), Kuopio University Hospital (Other), Metropolia University of Applied Sciences (Other), Turku University of Applied Sciences (Other), Tampere University (Other), Oulu University of Applied Sciences (Other), Savonia University of Applied Sciences (Other)
• Enrollment: 1,300
• Locations: 6
• Anticipated Duration (Months): 49.4
• Patients Per Site: 216.7
• Patients Per Site Per Month: 4.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Critically Ill; Major Trauma; Anesthesia; Emergencies	Diagnostic Test: Cerebral near-infrared spectroscopy

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1300 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Brain Oxygenation During Prehospital Anesthesia: an Observational Study (The BOPRA Study)
• Actual Study Start Date: Nov 18, 2019
• Anticipated Primary Completion Date: Sep 30, 2022
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Favorable neurological outcome [30 days]

   modified Rankin scale ≤2 (scale 0-6, 0 asymptomatic, 6 expired)

2. Cerebral desaturation event [through prehospital care, approximately 60 minutes]

   an absolute drop of forehead cerebral saturation ≥ 10% from baseline for ≥ 5 minutes

Secondary Outcome Measures

1. Survival [30 days]

   Survival

2. Survival [365 days]

   Survival

3. Favorable neurological outcome [1 year]

   modified Rankin scale ≤2 (scale 0-6, 0 asymptomatic, 6 expired)

4. 15D score [1 year]

   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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	FinnHEMS 60 / Kuopio University Hospital	Kuopio		Finland
2	FinnHEMS 50 / Oulu University Hospital	Oulu		Finland
3	FinnHEMS 51 / Lapland hospital district	Rovaniemi		Finland
4	FinnHEMS 30 / Tampere University Hospital	Tampere		Finland
5	FinnHEMS 20 / Turku University Hospital	Turku		Finland
6	FinnHEMS 10 / Helsinki University Hospital	Vantaa		Finland

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Jouni Nurmi, MD, PhD, Helsinki University Central Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jouni Nurmi, MD, associate professor, Helsinki University Central Hospital
• ClinicalTrials.gov Identifier: NCT04144803
• Other Study ID Numbers: BOPRA
• First Posted: Oct 30, 2019
• Last Update Posted: May 24, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Emergencies; Critical Illness

Study Results

No Results Posted as of May 24, 2022