Condition category
Circulatory System
Date applied
25/07/2013
Date assigned
08/08/2013
Last edited
08/08/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

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

http://www.ukc-mb.si/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes