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Brain Oxygenation During Prehospital Anesthesia (BOPRA-P)

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ClinicalTrials.gov Identifier: NCT03948711
Recruitment Status : Active, not recruiting
First Posted : May 14, 2019
Last Update Posted : September 18, 2019
Sponsor:
Collaborators:
Oulu University Hospital
FinnHEMS
Information provided by (Responsible Party):
Jouni Nurmi, MD, Helsinki University Central Hospital

Brief 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. 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.

Condition or disease Intervention/treatment
Critical Illness Device: Near-infrared spectroscopy (NIRS) monitoring of cerebral oxygenation

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Brain Oxygenation During Prehospital Anesthesia: an Observational Pilot Study
Actual Study Start Date : May 20, 2019
Actual Primary Completion Date : September 2, 2019
Estimated Study Completion Date : September 2020

Intervention Details:
  • Device: Near-infrared spectroscopy (NIRS) monitoring of cerebral oxygenation
    Monitoring before anesthesia to hospital admission. No treatment decisions made based on monitoring.


Primary Outcome Measures :
  1. 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

  2. Cerebral desaturation events [ Time Frame: During prehospital phase after induction of anesthesia ]
    Number of patients with forehead regional oxygen saturation ≤50% for ≥5 minutes


Secondary Outcome Measures :
  1. On-scene time [ Time Frame: Prehospital phase ]
    Time from arrival of helicopter emergency medical services unit on the patient to beginning of transportation

  2. Qualitative feedback from HEMS crews [ Time Frame: Prehospital phase ]
    Comments on the usability of the study device

  3. Survival [ Time Frame: 30 days, 12 months ]
    Data from population registry center

  4. Neurologic disability [ Time Frame: 30 days, 12 months ]
    3-6 on modified Rankin scale (range from 0 [no symptoms at all] to 6 [dead], evaluated by trained research nurse

  5. Health related quality of life [ Time Frame: 12 months ]
    total score of 15-D questionnaire including 15 dimensions each ranked from 1 (good quality of life) to 5 (poor quality of life)



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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
Critically ill or trauma patients undergoing prehospital anesthesia and endotracheal intubation for any reason by helicopter emergency medical team providing critical care.
Criteria

Inclusion Criteria:

  • sedation or anesthesia provided to facilitate endotracheal intubation, performed by HEMS team regardless of the reason

Exclusion Criteria:

  • 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

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): NCT03948711


Locations
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Finland
FinnHEMS 50 / Oulu University Hospital
Oulu, Finland, 90029
FinnHEMS 10 / Helsinki Univeristy Hospital
Vantaa, Finland, 01530
Sponsors and Collaborators
Helsinki University Central Hospital
Oulu University Hospital
FinnHEMS

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Responsible Party: Jouni Nurmi, MD, senior HEMS physician, associate professor, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT03948711     History of Changes
Other Study ID Numbers: BOPRA-P
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 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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Critical Illness
Disease Attributes
Pathologic Processes
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs