Brain Oxygenation During Prehospital Anesthesia: an Observational Study

NCT ID: NCT04144803

Last Updated: 2022-10-28

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

UNKNOWN

Total Enrollment

1300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-18

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Critically Ill Major Trauma Anesthesia Emergencies

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cerebral desaturation group

absolute drop of forehead cerebral oxygen saturation ≥ 10% from baseline for ≥ 5 minutes during prehospital anesthesia

Cerebral near-infrared spectroscopy

Intervention Type DIAGNOSTIC_TEST

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

Cerebral near-infrared spectroscopy

Intervention Type DIAGNOSTIC_TEST

Nonin H500 one-channel near-infrared spectroscopy monitor on forehead of the patient from before induction of anesthesia to arrival to hospital

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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FinnHEMS Ltd

UNKNOWN

Sponsor Role collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role collaborator

Tampere University Hospital

OTHER

Sponsor Role collaborator

Oulu University Hospital

OTHER

Sponsor Role collaborator

Lapland Hospital District

UNKNOWN

Sponsor Role collaborator

Kuopio University Hospital

OTHER

Sponsor Role collaborator

Metropolia University of Applied Sciences

OTHER

Sponsor Role collaborator

Turku University of Applied Sciences

UNKNOWN

Sponsor Role collaborator

Tampere University

OTHER

Sponsor Role collaborator

Oulu University of Applied Sciences

UNKNOWN

Sponsor Role collaborator

Savonia University of Applied Sciences

OTHER

Sponsor Role collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jouni Nurmi, MD

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jouni Nurmi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Locations

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FinnHEMS 60 / Kuopio University Hospital

Kuopio, , Finland

Site Status

FinnHEMS 50 / Oulu University Hospital

Oulu, , Finland

Site Status

FinnHEMS 51 / Lapland hospital district

Rovaniemi, , Finland

Site Status

FinnHEMS 30 / Tampere University Hospital

Tampere, , Finland

Site Status

FinnHEMS 20 / Turku University Hospital

Turku, , Finland

Site Status

FinnHEMS 10 / Helsinki University Hospital

Vantaa, , Finland

Site Status

Countries

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Finland

Other Identifiers

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BOPRA

Identifier Type: -

Identifier Source: org_study_id

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