Critical IllnessBOPRA-PNCT03948711
Brain Oxygenation During Prehospital Anesthesia
An observational study of Critical Illness, run by Helsinki University Central Hospital at 2 sites in Finland.
Trial summary
The study will evaluate the feasibility of Nonin SenSmart H500 device to measuring brain oxygenation during prehospital anesthesia of adult patient. The study also estimates the incidence of cerebral hypoxic events of anesthetized patients during prehospital care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Near-infrared spectroscopy (NIRS) monitoring of cerebral oxygenation
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 2 sitesFinland
- Study dates
- 20 May 2019to 30 Sep 2020
- 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: Critically ill or trauma patients undergoing prehospital anesthesia and endotracheal intubation for any reason by helicopter emergency medical team providing critical care.
Who may be able to join
- sedation or anesthesia provided to facilitate endotracheal intubation, performed by HEMS team regardless of the reason
Who cannot join
- Cardiac arrest at the time of intubation
- Physical barrier for NIRS measuring (e.g. forehead laceration)
- HEMS physician does not escort patient to the hospital (and patient is not dead on the scene after inclusion)
- Workload too high to ensure standard level of clinical care during the study
- Known special vulnerability including known mental disability (permanent, not related to acute condition), patients in nursing homes, prisoners and forensic psychiatric patients.
- Known or evident pregnancy
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
FinnHEMS 50 / Oulu University Hospital
Oulu, 90029
FinnHEMS 10 / Helsinki Univeristy Hospital
Vantaa, 01530
About this study
Official title: Brain Oxygenation During Prehospital Anesthesia: an Observational Pilot Study
The study will evaluate the feasibility of Nonin SenSmart H500 device to measuring brain oxygenation during prehospital anesthesia of adult patient. The study also estimates the incidence of cerebral hypoxic events of anesthetized patients during prehospital care. The study does not affect the treatment of the patient. The study is pilot study and will be followed with a main study to assess the association between cerebral oxygenation during prehospital care and outcome of the patient.
- Conditions
- Critical Illness
- Being tested
- Near-infrared spectroscopy (NIRS) monitoring of cerebral oxygenation
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near-infrared spectroscopy (NIRS) monitoring of cerebral oxygenationDevice
Monitoring before anesthesia to hospital admission. No treatment decisions made based on monitoring.
What is being measured
The primary outcome is the main question the study is designed to answer.
Disturbance-free time of the total monitoring time
Proportion of time with readable monitor signal of the total time monitor connected to the patient
Measured: Prehospital phase
Cerebral desaturation events
Number of patients with forehead regional oxygen saturation ≤50% for ≥5 minutes
Measured: During prehospital phase after induction of anesthesia
Secondary outcomes (5)
On-scene time
Time from arrival of helicopter emergency medical services unit on the patient to beginning of transportation
Measured: Prehospital phase
Qualitative feedback from HEMS crews
Comments on the usability of the study device
Measured: Prehospital phase
Survival
Data from population registry center
Measured: 30 days, 12 months
Neurologic disability
3-6 on modified Rankin scale (range from 0 [no symptoms at all] to 6 [dead], evaluated by trained research nurse
Measured: 30 days, 12 months
Health related quality of life
total score of 15-D questionnaire including 15 dimensions each ranked from 1 (good quality of life) to 5 (poor quality of life)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start20 May 2019
- Primary completion2 Sep 2019
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Oulu University Hospital, FinnHEMS
- Responsible party
- Principal investigator, Jouni Nurmi, MD, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948711
- Sponsor's protocol ID
- BOPRA-P
- Acronym
- BOPRA-P
- Status last verified
- Feb 2021
- First submitted
- 10 May 2019
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Oxygenation During Prehospital Anesthesia: an Observational Pilot Study
- ClinicalTrials.gov ID
- NCT03948711
- Acronym / sponsor ID
- BOPRA-P / BOPRA-P
- Conditions
- Critical Illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- Oulu University Hospital, FinnHEMS
- Study start
- 20 May 2019 (actual)
- Primary completion
- 2 Sep 2019 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 14 May 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.
The study will evaluate the feasibility of Nonin SenSmart H500 device to measuring brain oxygenation during prehospital anesthesia of adult patient. The study also estimates the incidence of cerebral hypoxic events of anesthetized patients during prehospital care. The study does not affect the treatment of the patient. The study is pilot study and will be followed with a main study to assess the association between cerebral oxygenation during prehospital care and outcome of the patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill or trauma patients undergoing prehospital anesthesia and endotracheal intubation for any reason by helicopter emergency medical team providing critical care.
Key inclusion criteria (1 listed)
- sedation or anesthesia provided to facilitate endotracheal intubation, performed by HEMS team regardless of the reason
Key exclusion criteria (6 listed)
- Cardiac arrest at the time of intubation
- Physical barrier for NIRS measuring (e.g. forehead laceration)
- HEMS physician does not escort patient to the hospital (and patient is not dead on the scene after inclusion)
- Workload too high to ensure standard level of clinical care during the study
- Known special vulnerability including known mental disability (permanent, not related to acute condition), patients in nursing homes, prisoners and forensic psychiatric patients.
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 |
|---|---|---|
| Near-infrared spectroscopy (NIRS) monitoring of cerebral oxygenationMonitoring before anesthesia to hospital admission. No treatment decisions made based on monitoring. | Device | – |
Primary outcome
Disturbance-free time of the total monitoring time
Time frame: Prehospital phase
Proportion of time with readable monitor signal of the total time monitor connected to the patient
Cerebral desaturation events
Time frame: During prehospital phase after induction of anesthesia
Number of patients with forehead regional oxygen saturation ≤50% for ≥5 minutes
5 secondary outcomes
On-scene time
Time frame: Prehospital phase
Qualitative feedback from HEMS crews
Time frame: Prehospital phase
Survival
Time frame: 30 days, 12 months
Neurologic disability
Time frame: 30 days, 12 months
Health related quality of life
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by Helsinki University Central Hospital at 2 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 6 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: finished, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Disturbance-free time of the total monitoring time (time frame: Prehospital phase). 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?
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 16 Feb 2021.