Brain Oxygenation During Prehospital Anesthesia: an Observational Study (BOPRA)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04144803 |
Recruitment Status :
Recruiting
First Posted : October 30, 2019
Last Update Posted : February 16, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Critically Ill Major Trauma Anesthesia Emergencies | Diagnostic Test: Cerebral near-infrared spectroscopy |
Study Type : | Observational |
Estimated 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 : | November 18, 2019 |
Estimated Primary Completion Date : | December 31, 2021 |
Estimated Study Completion Date : | December 31, 2022 |
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 |
- Favorable neurological outcome [ Time Frame: 30 days ]modified Rankin scale ≤2 (scale 0-6, 0 asymptomatic, 6 expired)
- Cerebral desaturation event [ Time Frame: through prehospital care, approximately 60 minutes ]an absolute drop of forehead cerebral saturation ≥ 10% from baseline for ≥ 5 minutes
- Survival [ Time Frame: 30 days ]Survival
- Survival [ Time Frame: 365 days ]Survival
- Favorable neurological outcome [ Time Frame: 1 year ]modified Rankin scale ≤2 (scale 0-6, 0 asymptomatic, 6 expired)
- 15D score [ Time Frame: 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)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04144803
Contact: Jouni Nurmi, MD, PhD | +358 50 595 1576 | jouni.nurmi@hus.fi | |
Contact: Anna Olkinuora, PhD | +358 400 237 211 | anna.olkinuora@finnhems.fi |
Finland | |
FinnHEMS 60 / Kuopio University Hospital | Recruiting |
Kuopio, Finland | |
Contact: Pamela Hiltunen, MD, PhD +358 50 050 1023 pamela.hiltunen@kuh.fi | |
FinnHEMS 50 / Oulu University Hospital | Recruiting |
Oulu, Finland | |
Contact: Lasse Raatiniemi, MD, PhD +358 50 300 5575 lasse.raatiniemi@ppshp.fi | |
FinnHEMS 51 / Lapland hospital district | Recruiting |
Rovaniemi, Finland | |
Contact: Simo Tukia, RN +358 44 028 8841 simo.tukia@lshp.fi | |
FinnHEMS 30 / Tampere University Hospital | Recruiting |
Tampere, Finland | |
Contact: Heini Piiroinen, MD +358 44 522 1869 heini.piiroinen@pshp.fi | |
FinnHEMS 20 / Turku University Hospital | Recruiting |
Turku, Finland | |
Contact: Miretta Tommila, MD, PhD +358 50 590 6183 miretta.tommila@tyks.fi | |
FinnHEMS 10 / Helsinki University Hospital | Recruiting |
Vantaa, Finland | |
Contact: Hetti Kirves, MD, PhD +358 50 427 1790 hetti.kirves@hus.fi |
Principal Investigator: | Jouni Nurmi, MD, PhD | Helsinki University Central Hospital |
Responsible Party: | Jouni Nurmi, MD, associate professor, Helsinki University Central Hospital |
ClinicalTrials.gov Identifier: | NCT04144803 |
Other Study ID Numbers: |
BOPRA |
First Posted: | October 30, 2019 Key Record Dates |
Last Update Posted: | February 16, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Emergencies Critical Illness Disease Attributes Pathologic Processes |