Cardiac Arrest, Out-Of-HospitalNCT03464123
Brain Oxygenation During Cardiopulmonary Resuscitation
An observational study of Cardiac Arrest, Out-Of-Hospital, run by Helsinki University Central Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Out-Of-Hospital
- What is being tested?
- Standard cardiopulmonary resuscitation
- How many people
- 80 participants
- Where
- 1 siteFinland
- Study dates
- 24 Feb 2017to 30 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Finland1 site
FinnHEMS 10, Emergency Medicine and Services, Helsinki University Hospital
Vantaa
About this study
Official title: 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.
- Conditions
- Cardiac Arrest, Out-Of-Hospital
- Being tested
- Standard cardiopulmonary resuscitation
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard cardiopulmonary resuscitationOther
Standard Advanced Life Support based on guidelines 2015, including mechanical chest compression device
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial oxygen partial pressure
Arterial oxygen partial pressure at the time of return of spontaneous circulation (ROSC)
Measured: 5-60 minutes
Secondary outcomes (1)
Forehead regional oxygen saturation during resuscitation
Oxygen saturation measured using near-infrared spectroscopy
Measured: 0-60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start24 Feb 2017
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Arrest, Out-Of-HospitalStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jouni Nurmi, MD, Helsinki University Central Hospital
- Investigators
- Jouni Nurmi, MD, PhD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03464123
- Sponsor's protocol ID
- 54/13/03/02/16
- Status last verified
- May 2019
- First submitted
- 9 Feb 2018
- Last updated
- 9 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Oxygenation During Cardiopulmonary Resuscitation - Observational Pilot Study
- ClinicalTrials.gov ID
- NCT03464123
- Acronym / sponsor ID
- 54/13/03/02/16
- Conditions
- Cardiac Arrest, Out-Of-Hospital
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 24 Feb 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 13 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard cardiopulmonary resuscitationStandard Advanced Life Support based on guidelines 2015, including mechanical chest compression device | Other | – |
Primary outcome
Arterial oxygen partial pressure
Time frame: 5-60 minutes
Arterial oxygen partial pressure at the time of return of spontaneous circulation (ROSC)
1 secondary outcome
Forehead regional oxygen saturation during resuscitation
Time frame: 0-60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2019.
- Individual participant dataSharing planned: No
Related trials for Cardiac Arrest, Out-Of-Hospital
Not yet recruiting
Execution of Prehospital Transesophageal Echocardiography During Cardiopulmonary Resuscitation in Patients With Out-of-hospital Cardiac Arrest
Out-of-hospital Cardiac Arrest (OHCA)
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
Active, not recruiting
RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
Cardiac Arrest
RecruitingObservational study
Cardiac Arrest - Ultrasound Detection of Occult Perfusion
Cardiac Arrest, Out-Of-Hospital, Hypotension
Not yet recruiting
The OXY-VENT Study
Cardiac Arrest (CA), Cardiopulmonary Resuscitation (CPR)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jouni Nurmi, MD, PhD principal investigator
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest, Out-Of-Hospital, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial oxygen partial pressure (time frame: 5-60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2019.