Critically IllBOPRANCT04144803
Brain Oxygenation During Prehospital Anesthesia: an Observational Study
An observational study of Critically Ill and Major Trauma, run by Helsinki University Central Hospital at 6 sites in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill, Major Trauma, Anesthesia
- What is being tested?
- Cerebral near-infrared spectroscopy
- How many people
- 1,300 participants
- Where
- 6 sitesFinland
- Study dates
- 18 Nov 2019to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing prehospital anesthesia and endotracheal intubation regardless of indication
Who may be able to join
- sedation or anesthesia provided to facilitate endotracheal intubation, performed by Helicopter Emergency Medical Services (HEMS) team regardless of the reason
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Finland6 sites
FinnHEMS 60 / Kuopio University Hospital
Kuopio
FinnHEMS 50 / Oulu University Hospital
Oulu
FinnHEMS 51 / Lapland hospital district
Rovaniemi
FinnHEMS 30 / Tampere University Hospital
Tampere
FinnHEMS 20 / Turku University Hospital
Turku
FinnHEMS 10 / Helsinki University Hospital
Vantaa
About this study
Official title: 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.
- Conditions
- Critically Ill, Major Trauma, Anesthesia, Emergencies
- Being tested
- Cerebral near-infrared spectroscopy
- Medical subject headings
- Critical Illness, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebral near-infrared spectroscopyDiagnostic test
Nonin H500 one-channel near-infrared spectroscopy monitor on forehead of the patient from before induction of anesthesia to arrival to hospital
| Study group | Role | What they receive |
|---|---|---|
| Cerebral desaturation group | absolute drop of forehead cerebral oxygen saturation ≥ 10% from baseline for ≥ 5 minutes during prehospital anesthesia Receives: Diagnostic Test: Cerebral near-infrared spectroscopy | |
| Control group | no absolute drop of forehead cerebral oxygen saturation ≥ 10% from baseline for ≥ 5 minutes during prehospital anesthesia Receives: Diagnostic Test: Cerebral near-infrared spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Favorable neurological outcome
modified Rankin scale ≤2 (scale 0-6, 0 asymptomatic, 6 expired)
Measured: 30 days
Cerebral desaturation event
an absolute drop of forehead cerebral saturation ≥ 10% from baseline for ≥ 5 minutes
Measured: through prehospital care, approximately 60 minutes
Secondary outcomes (4)
Survival
Survival
Measured: 30 days
Survival
Survival
Measured: 365 days
Favorable neurological outcome
modified Rankin scale ≤2 (scale 0-6, 0 asymptomatic, 6 expired)
Measured: 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)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start18 Nov 2019
- Primary completion25 Sep 2022
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critically IllStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- FinnHEMS Ltd, Turku University Hospital, Tampere University Hospital, Oulu University Hospital, Lapland Central Hospital, 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
- Responsible party
- Principal investigator, Jouni Nurmi, MD, Helsinki University Central Hospital
- Investigators
- Jouni Nurmi, MD, PhD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04144803
- Sponsor's protocol ID
- BOPRA
- Acronym
- BOPRA
- Status last verified
- Oct 2022
- First submitted
- 7 Oct 2019
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saviluoto A, Raatiniemi L, Makela S, Toivonen T, Setala P, Kirves H, Tommila M, Toivonen P, Tukia S, Nurmi J. Association of Cerebral Oxygenation During Prehospital Anaesthesia and Functional Outcome: A Prospective, Observational Multi-Centre Cohort Study of 1014 Patients. Acta Anaesthesiol Scand. 2026 Jan;70(1):e70161. doi: 10.1111/aas.70161.
PubMed 41359999
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Oxygenation During Prehospital Anesthesia: an Observational Study (The BOPRA Study)
- ClinicalTrials.gov ID
- NCT04144803
- Acronym / sponsor ID
- BOPRA / BOPRA
- Conditions
- Critically Ill, Major Trauma, Anesthesia, Emergencies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- FinnHEMS Ltd, Turku University Hospital, Tampere University Hospital, Oulu University Hospital, Lapland Central Hospital, 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
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 25 Sep 2022 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 30 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cerebral desaturation group | – | Diagnostic Test: Cerebral near-infrared spectroscopyabsolute drop of forehead cerebral oxygen saturation ≥ 10% from baseline for ≥ 5 minutes during prehospital anesthesia |
| Control group | – | Diagnostic Test: Cerebral near-infrared spectroscopyno absolute drop of forehead cerebral oxygen saturation ≥ 10% from baseline for ≥ 5 minutes during prehospital anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing prehospital anesthesia and endotracheal intubation regardless of indication
Key inclusion criteria (1 listed)
- sedation or anesthesia provided to facilitate endotracheal intubation, performed by Helicopter Emergency Medical Services (HEMS) team regardless of the reason
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerebral near-infrared spectroscopyNonin H500 one-channel near-infrared spectroscopy monitor on forehead of the patient from before induction of anesthesia to arrival to hospital | Diagnostic test | Cerebral desaturation group, Control group |
Primary outcome
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
4 secondary outcomes
Survival
Time frame: 30 days
Survival
Time frame: 365 days
Favorable neurological outcome
Time frame: 1 year
15D score
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Derived from this study: PubMed 41359999Saviluoto A, Raatiniemi L, Makela S, Toivonen T, Setala P, Kirves H, Tommila M, Toivonen P, Tukia S, Nurmi J. Association of Cerebral Oxygenation During Prehospital Anaesthesia and Functional Outcome: A Prospective, Observational Multi-Centre Cohort Study of 1014 Patients. Acta Anaesthesiol Scand. 2026 Jan;70(1):e70161. doi: 10.1111/aas.70161.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jouni Nurmi, MD, PhD principal investigator
Helsinki University Central Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critically Ill and Major Trauma, run by Helsinki University Central Hospital at 6 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Favorable neurological outcome (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04144803, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2022.