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NCT Number: NCT03948711

Brain Oxygenation During Prehospital Anesthesia

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.

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Key information

Conditions

Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

FinnHEMS 50 / Oulu University Hospital, Oulu, Finland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Near-infrared spectroscopy (NIRS) monitoring of cerebral oxygenation

Device

Monitoring before anesthesia to hospital admission. No treatment decisions made based on monitoring.

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • FinnHEMS
  • Oulu University Hospital

Registry information

Official study title

Brain Oxygenation During Prehospital Anesthesia: an Observational Pilot Study

Acronym: BOPRA-P

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
May 14, 2019
Registry last updated
Feb 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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