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Brain Oxygenation During Cardiopulmonary Resuscitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03464123
Recruitment Status : Recruiting
First Posted : March 13, 2018
Last Update Posted : March 13, 2018
Information provided by (Responsible Party):
Jouni Nurmi, MD, Helsinki University Central Hospital

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.

Condition or disease Intervention/treatment
Cardiac Arrest, Out-Of-Hospital Other: Standard cardiopulmonary resuscitation

Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Brain Oxygenation During Cardiopulmonary Resuscitation - Observational Pilot Study
Actual Study Start Date : February 24, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Other: Standard cardiopulmonary resuscitation
    Standard Advanced Life Support based on guidelines 2015, including mechanical chest compression device

Primary Outcome Measures :
  1. Arterial oxygen partial pressure [ Time Frame: 5-60 minutes ]
    Arterial oxygen partial pressure at the time of return of spontaneous circulation (ROSC)

Secondary Outcome Measures :
  1. Forehead regional oxygen saturation during resuscitation [ Time Frame: 0-60 minutes ]
    Oxygen saturation measured using near-infrared spectroscopy

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03464123

Contact: Jouni Nurmi, MD, PhD 358505951576

FinnHEMS 10, Emergency Medicine and Services, Helsinki University Hospital Recruiting
Vantaa, Finland
Contact: Jouni Nurmi, MD, PhD    358505951576   
Contact: Susanne Ångerman, MD    ‭+358505818015‬   
Sponsors and Collaborators
Helsinki University Central Hospital
Principal Investigator: Jouni Nurmi, MD, PhD Helsinki University Central Hospital

Responsible Party: Jouni Nurmi, MD, Consultant in Anaesthesia and Intensive Care Medicine, Helsinki University Central Hospital Identifier: NCT03464123     History of Changes
Other Study ID Numbers: 54/13/03/02/16
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases