Brain Oxygenation During Prehospital Anesthesia

NCT ID: NCT03948711

Last Updated: 2021-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-20

Study Completion Date

2020-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Critical Illness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Near-infrared spectroscopy (NIRS) monitoring of cerebral oxygenation

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oulu University Hospital

OTHER

Sponsor Role collaborator

FinnHEMS

UNKNOWN

Sponsor Role collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jouni Nurmi, MD

senior HEMS physician, associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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FinnHEMS 50 / Oulu University Hospital

Oulu, , Finland

Site Status

FinnHEMS 10 / Helsinki Univeristy Hospital

Vantaa, , Finland

Site Status

Countries

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Finland

Other Identifiers

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BOPRA-P

Identifier Type: -

Identifier Source: org_study_id

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