Plain English Summary
Background and study aims
Cardiac arrest is a major cause of death in developed nations and the death rate after cardiac arrest has not improved significantly in recent years. Although almost half of patients being resuscitated with cardiopulmonary resuscitation (CPR) regain spontaneous circulation (ROSC), the majority of these patients do not achieve a good neurologic outcome, as brain is most at risk to even short periods of hypoxia (lack of oxygen) during cardiac arrest. The aim of this study is to better understand and help guide resuscitation efforts during CPR, mostly predicting success or ineffectiveness (futility) of ongoing CPR.
Who can participate?
The study will enrol all adult patients (of both genders) in cardiac arrest where CPR will be started and treated by our local Prehospital medical unit (EMS) in Maribor, Slovenia.
What does the study involve?
We will observe the dynamics of oxygen supply to the brain following cardiac arrest during standard CPR. The study does not involve or compare any treatment, it is an observation with new monitoring technology, namely near-infrared spectroscopy (NIRS).
What are the possible benefits and risks of participating?
All patients enrolled in the study will receive standard treatment as per international guidelines. Due to the observational nature of the study, patients themselves will not gain any direct benefit, but knowledge gained by our study will enhance our understanding in the field of cardiac arrest and CPR.
Where is the study run from?
The study is run from and will be conducted in a single centre in Maribor, Slovenia.
When is the study starting and how long is it expected to run for?
The study started in June 2012 and is expected to run until July 2014 or until we are able to enrol 60 patients. Patients will be recruited as cardiac arrest events happen.
Who is funding the study?
The study has no additional funding, it will be conducted as part of regular work at the Center for Emergency Medicine, Maribor, Slovenia
Who is the main contact?
Gregor Prosen, MD
gregorprosen@gmail.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Gregor Prosen
ORCID ID
Contact details
Gregorciceva 48
Maribor
2000
Slovenia
+386 41 311 695
gregorprosen@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
18041979
Study information
Scientific title
Monitoring of cerebral tissue oxygenation during out-of-hospital cardio-pulmonary resuscitation
Acronym
Study hypothesis
We hypothesise that continous cerebral tissue oxygenation (StO2) with Near-Infrared spectroscopy (NIRS) during cardio-pulmonary resuscitation (CPR) in pre-hospital setting can help us predict success of CPR and even final neurologic outcome of these patients. Our main hypotheses are, that continuously low or undetectable levels of cerebral StO2 predict unsuccessful CPR and that rapid restoration of normal or near-normal StO2 levels predicts good outcomes.
Ethics approval
The study was approved by Slovenian National Ethics Committee, on 22nd may 2012, No. 123/05/12
Study design
Two-year observational longitudinal study
Primary study design
Observational
Secondary study design
Other
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cardiac arrest, cardiopulmonary resuscitation
Intervention
The study does not involve/compare any interventions. It is observational study during standard CPR treatment.
We will be observing trending of values of cerebral tissue partial oxygen pressure (ScO2) during standard cardiopulmonary resuscitation (CPR). Initial values of ScO2 of patients found in cardiac arrest in field are expected to be very low/critical or mostly even unmeasurable and we hypothesize that dynamic changes during CPR will be able to predict outcome.
ScO2 will be observed for total duration of CPR, from commencing of chest compressions until successful return of spontaneous circulation (ROSC) or pronouncement of dead/stoping CPR efforts.
Parallel to ScO2 measurements, we will be also observing end-tidal CO2 (EtCO2) during CPR and basic vitals signs achieved after ROSC.
Patients that will achieve ROSC and will be successfully transported to Hospital, will be followed up until discharge from hospital (usually weeks).
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Return of spontaneous circulation (ROSC) will be assessed immediately during CPR, eg. the patient either achieves ROSC (successful CPR) or patient is pronounced dead in the field. ROSC assesment is made in standard manner, by palpating carotid pulse.
Secondary outcome measures
1. Neurologic outcome will be measured at the discharge from hospital by assesment with "Glasgow-Pittsburgh cerebral performance category scale" (CPC scale).
2. Discharge from hospital will measure total duration spent in ICU (intensive care unit), time patient needed mechanical support on ventilator and time until discharge from hospital
Overall trial start date
01/06/2012
Overall trial end date
01/06/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All adult (male and female >18 years) in cardiac arrest, where treating physicians has decided to commence CPR
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Total final enrolment
53
Participant exclusion criteria
1. Traumatic cardiac arrest
2. Intoxication
3. Drowning
4. Age <18 years
Recruitment start date
01/06/2012
Recruitment end date
01/06/2014
Locations
Countries of recruitment
Slovenia
Trial participating centre
Gregorciceva 48
Maribor
2000
Slovenia
Sponsor information
Organisation
Center for Emergency Medicine Maribor (Slovenia)
Sponsor details
Ulica proletarskih brigad 22
Maribor
2000
Slovenia
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Center for Emergency Medicine Maribor (Slovenia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2018 results in https://www.ncbi.nlm.nih.gov/pubmed/29763712 (added 14/08/2019)