NCT04144803

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2019

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 30, 2019

Completed
19 days until next milestone

Study Start

First participant enrolled

November 18, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2022

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

October 28, 2022

Status Verified

October 1, 2022

Enrollment Period

2.9 years

First QC Date

October 7, 2019

Last Update Submit

October 27, 2022

Conditions

Critically IllMajor TraumaAnesthesiaEmergencies

Outcome Measures

Primary Outcomes (2)

  • Favorable neurological outcome

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

    30 days

  • Cerebral desaturation event

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

    through prehospital care, approximately 60 minutes

Secondary Outcomes (4)

  • Survival

    30 days

  • Survival

    365 days

  • Favorable neurological outcome

    1 year

  • 15D score

    1 year

Study Arms (2)

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

Cerebral near-infrared spectroscopyDIAGNOSTIC_TEST

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

Cerebral desaturation groupControl group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients undergoing prehospital anesthesia and endotracheal intubation regardless of indication

You may qualify if:

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

You may not qualify if:

  • Ongoing cardiopulmonary resuscitation at the time of intubation
  • Physical barrier for near-infrared spectroscopy measuring (e.g. forehead laceration)
  • Workload too high to ensure standard level of clinical care during the study
  • For interviews: no competence in Finnish, Swedish or English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

FinnHEMS 60 / Kuopio University Hospital

Kuopio, Finland

Location

FinnHEMS 50 / Oulu University Hospital

Oulu, Finland

Location

FinnHEMS 51 / Lapland hospital district

Rovaniemi, Finland

Location

FinnHEMS 30 / Tampere University Hospital

Tampere, Finland

Location

FinnHEMS 20 / Turku University Hospital

Turku, Finland

Location

FinnHEMS 10 / Helsinki University Hospital

Vantaa, Finland

Location

Related Publications (1)

  • Saviluoto A, Raatiniemi L, Makela S, Toivonen T, Setala P, Kirves H, Tommila M, Toivonen P, Tukia S, Nurmi J. Association of Cerebral Oxygenation During Prehospital Anaesthesia and Functional Outcome: A Prospective, Observational Multi-Centre Cohort Study of 1014 Patients. Acta Anaesthesiol Scand. 2026 Jan;70(1):e70161. doi: 10.1111/aas.70161.

    PMID: 41359999DERIVED

MeSH Terms

Conditions

Critical IllnessEmergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jouni Nurmi, MD, PhD

    Helsinki University Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

October 7, 2019

First Posted

October 30, 2019

Study Start

November 18, 2019

Primary Completion

September 25, 2022

Study Completion

December 31, 2023

Last Updated

October 28, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

FI(6)