NCT03464123

Brief Summary

The study is aimed to assess (a) the incidence of hyperoxia at the point of return of spontaneous circulation (ROSC) and (b) the role of arterial blood oxygen partial pressure to brain oxygenation during out-of-hospital cardiac arrest. 80 adult patients will be recruited in a physician staffed helicopter emergency medical services. Brain regional oxygen saturation and invasive blood pressure are monitored until hospital admission and arterial blood gases are analyzed immediately when the unit arrives to the patient and again at the time of ROSC.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 24, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 13, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

May 9, 2019

Status Verified

May 1, 2019

Enrollment Period

2.2 years

First QC Date

February 9, 2018

Last Update Submit

May 8, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Arterial oxygen partial pressure

    Arterial oxygen partial pressure at the time of return of spontaneous circulation (ROSC)

    5-60 minutes

Secondary Outcomes (1)

  • Forehead regional oxygen saturation during resuscitation

    0-60 minutes

Interventions

Standard Advanced Life Support based on guidelines 2015, including mechanical chest compression device

Eligibility Criteria

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

All adult patients met in cardiac arrest by the physician-led prehospital critical care team are to be screened and recruited based the eligibility criteria. The patients include patients in all primary rhythms.

You may qualify if:

  • out-of-hospital cardiac arrest of presumed cardiac origin
  • resuscitation will be continued at least 5 minutes (if return of spontaneous circulation not achieved earlier) after arrival of physician team

You may not qualify if:

  • do-not-attempt-resuscitation (DNAR) order or withdrawal of treatment by prehospital critical care physician
  • return of spontaneous circulation achieved before physician-led critical team arrives
  • external cause for cardiac arrest (e.g. trauma, suffocation)
  • workload too high or environment too dangerous to perform study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FinnHEMS 10, Emergency Medicine and Services, Helsinki University Hospital

Vantaa, Finland

Location

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular Diseases

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
Consultant in Anaesthesia and Intensive Care Medicine

Study Record Dates

First Submitted

February 9, 2018

First Posted

March 13, 2018

Study Start

February 24, 2017

Primary Completion

April 30, 2019

Study Completion

April 30, 2019

Last Updated

May 9, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations