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BOPRA-P: Brain Oxygenation During Prehospital Anesthesia

Sponsor
Helsinki University Central Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03948711
Collaborator
Oulu University Hospital (Other), FinnHEMS (Other)
100
Enrollment
2
Locations
16.4
Actual Duration (Months)
50
Patients Per Site
3
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Device: Near-infrared spectroscopy (NIRS) monitoring of cerebral oxygenation

Study Design

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 :
Sep 2, 2019
Actual Study Completion Date :
Sep 30, 2020

Outcome Measures

Primary Outcome Measures

  1. Disturbance-free time of the total monitoring time [Prehospital phase]

    Proportion of time with readable monitor signal of the total time monitor connected to the patient

  2. Cerebral desaturation events [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 [Prehospital phase]

    Time from arrival of helicopter emergency medical services unit on the patient to beginning of transportation

  2. Qualitative feedback from HEMS crews [Prehospital phase]

    Comments on the usability of the study device

  3. Survival [30 days, 12 months]

    Data from population registry center

  4. Neurologic disability [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 [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 FinnHEMS 50 / Oulu University Hospital Oulu Finland 90029
2 FinnHEMS 10 / Helsinki Univeristy Hospital Vantaa Finland 01530

Sponsors and Collaborators

  • Helsinki University Central Hospital
  • Oulu University Hospital
  • FinnHEMS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jouni Nurmi, MD, senior HEMS physician, associate professor, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT03948711
Other Study ID Numbers:
  • BOPRA-P
First Posted:
May 14, 2019
Last Update Posted:
Feb 16, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Critical Illness

Study Results

No Results Posted as of Feb 16, 2021