Brain Oxygenation During Cardiopulmonary Resuscitation

Brain Oxygenation During Cardiopulmonary Resuscitation - Observational Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Arrest, Out-Of-Hospital
• Intervention / Treatment: Other: Standard cardiopulmonary resuscitation

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Finland
  • Vantaa, Finland
    • FinnHEMS 10, Emergency Medicine and Services, Helsinki University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial oxygen partial pressure	Arterial oxygen partial pressure at the time of return of spontaneous circulation (ROSC)	5-60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forehead regional oxygen saturation during resuscitation	Oxygen saturation measured using near-infrared spectroscopy	0-60 minutes

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2017
• Primary Completion (Actual): April 30, 2019
• Study Completion (Actual): April 30, 2019

Study Registration Dates

• First Submitted: February 9, 2018
• First Submitted That Met QC Criteria: March 12, 2018
• First Posted (Actual): March 13, 2018

Study Record Updates

• Last Update Posted (Actual): May 9, 2019
• Last Update Submitted That Met QC Criteria: May 8, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: 54/13/03/02/16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No