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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 : December 23, 2019
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Jouni Nurmi, MD, Helsinki University Central Hospital

Study Description
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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
Critically Ill Major Trauma Anesthesia Emergencies Diagnostic Test: Cerebral near-infrared spectroscopy

Study Design
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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
Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Favorable neurological outcome [ Time Frame: 30 days ]
    modified Rankin scale ≤2 (scale 0-6, 0 asymptomatic, 6 expired)

  2. Cerebral desaturation event [ Time Frame: through prehospital care, approximately 60 minutes ]
    an absolute drop of forehead cerebral saturation ≥ 10% from baseline for ≥ 5 minutes


Secondary Outcome Measures :
  1. Survival [ Time Frame: 30 days ]
    Survival

  2. Survival [ Time Frame: 365 days ]
    Survival

  3. Favorable neurological outcome [ Time Frame: 1 year ]
    modified Rankin scale ≤2 (scale 0-6, 0 asymptomatic, 6 expired)

  4. 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)


Eligibility Criteria
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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
Study Population
Adult patients undergoing prehospital anesthesia and endotracheal intubation regardless of indication
Criteria

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
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Information from the National Library of Medicine

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


Contacts
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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

Locations
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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   
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
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Principal Investigator: Jouni Nurmi, MD, PhD Helsinki University Central Hospital
More Information
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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: December 23, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Emergencies
Critical Illness
Disease Attributes
Pathologic Processes
 Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs