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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03464123
Other study ID # 54/13/03/02/16
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 24, 2017
Est. completion date April 30, 2019

Study information

Verified date May 2019
Source Helsinki University Central Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date April 30, 2019
Est. primary completion date April 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Finland FinnHEMS 10, Emergency Medicine and Services, Helsinki University Hospital Vantaa

Sponsors (1)

Lead Sponsor Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Arterial oxygen partial pressure Arterial oxygen partial pressure at the time of return of spontaneous circulation (ROSC) 5-60 minutes
Secondary Forehead regional oxygen saturation during resuscitation Oxygen saturation measured using near-infrared spectroscopy 0-60 minutes
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