CClinicalTrials.gg
Status unknownNCT04144803BOPRAUpdated Oct 28, 2022

Brain Oxygenation During Prehospital Anesthesia: an Observational Study

An observational study in Critically Ill, Major Trauma and Anesthesia, sponsored by Helsinki University Central Hospital. Status unknown at 6 sites in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-28.

Sponsored by Helsinki University Central Hospital · Observational

The sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,300
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Critically Ill
  • Major Trauma
  • Anesthesia
  • Emergencies
03

In context

Emergencies

1,692 studies on the registry are indexed under Emergencies; 333 are open to participants now.

This study's planned enrollment of 1,300 is above the median of 353 across 714 observational studies indexed under Emergencies.

Browse Emergencies studies →

Lead sponsor

Helsinki University Central Hospital is the lead sponsor of 299 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients undergoing prehospital anesthesia and endotracheal intubation regardless of indication

Inclusion criteria

  • sedation or anesthesia provided to facilitate endotracheal intubation, performed by Helicopter Emergency Medical Services (HEMS) team regardless of the reason

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,300 participants (estimated)
Patient registry
No

Groups and cohorts

  • Cerebral desaturation group

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

    Diagnostic Test: Cerebral near-infrared spectroscopy

  • Control group

    no absolute drop of forehead cerebral oxygen saturation ≥ 10% from baseline for ≥ 5 minutes during prehospital anesthesia

    Diagnostic Test: Cerebral near-infrared spectroscopy

Interventions

  • Diagnostic testCerebral 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

06

What researchers measure

Primary outcomes

  1. Favorable neurological outcome

    modified Rankin scale ≤2 (scale 0-6, 0 asymptomatic, 6 expired)

    Time frame: 30 days

  2. Cerebral desaturation event

    an absolute drop of forehead cerebral saturation ≥ 10% from baseline for ≥ 5 minutes

    Time frame: through prehospital care, approximately 60 minutes

Secondary outcomes

  1. Survival

    Survival

    Time frame: 30 days

  2. Survival

    Survival

    Time frame: 365 days

  3. Favorable neurological outcome

    modified Rankin scale ≤2 (scale 0-6, 0 asymptomatic, 6 expired)

    Time frame: 1 year

  4. 15D score

    Heal-Related Quality of Life measured using 15-D instrument, scale 0-1 (0 = being dead, 0.0162 = being unconscious or comatose, 1 = no problems on any dimension = 'full' HRQOL)

    Time frame: 1 year

07

Study locations

6 sites
  • FinnHEMS 60 / Kuopio University Hospital
    Kuopio, Finland
  • FinnHEMS 50 / Oulu University Hospital
    Oulu, Finland
  • FinnHEMS 51 / Lapland hospital district
    Rovaniemi, Finland
  • FinnHEMS 30 / Tampere University Hospital
    Tampere, Finland
  • FinnHEMS 20 / Turku University Hospital
    Turku, Finland
  • FinnHEMS 10 / Helsinki University Hospital
    Vantaa, Finland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04144803
Lead sponsor
Helsinki University Central Hospital
Collaborators
FinnHEMS Ltd, Turku University Hospital, Tampere University Hospital, Oulu University Hospital, Lapland Hospital District, Kuopio University Hospital, Metropolia University of Applied Sciences, Turku University of Applied Sciences, Tampere University, Oulu University of Applied Sciences, Savonia University of Applied Sciences
Responsible party
Jouni Nurmi, MD (associate professor, Helsinki University Central Hospital) — Principal investigator
First posted
Oct 30, 2019
Start date
Nov 18, 2019
Primary completion
Sep 25, 2022
Completion
Dec 31, 2023 (estimated)
Last update
Oct 28, 2022

Study contacts

Jouni Nurmi, MD, PhD
principal investigator · Helsinki University Central Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion