Monitoring of tissue oxygen levels during out-of-hospital cardio-pulmonary resuscitation
| ISRCTN | ISRCTN80017232 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80017232 |
| Secondary identifying numbers | 18041979 |
- Submission date
- 25/07/2013
- Registration date
- 08/08/2013
- Last edited
- 14/08/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Scientific
Gregorciceva 48
Maribor
2000
Slovenia
| Phone | +386 41 311 695 |
|---|---|
| gregorprosen@gmail.com |
Study information
| Study design | Two-year observational longitudinal study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Other |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Monitoring of cerebral tissue oxygenation during out-of-hospital cardio-pulmonary resuscitation |
| Study objectives | 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(s) | The study was approved by Slovenian National Ethics Committee, on 22nd may 2012, No. 123/05/12 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/06/2012 |
| Completion date | 01/06/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 53 |
| Key inclusion criteria | All adult (male and female >18 years) in cardiac arrest, where treating physicians has decided to commence CPR |
| Key exclusion criteria | 1. Traumatic cardiac arrest 2. Intoxication 3. Drowning 4. Age <18 years |
| Date of first enrolment | 01/06/2012 |
| Date of final enrolment | 01/06/2014 |
Locations
Countries of recruitment
- Slovenia
Study participating centre
2000
Slovenia
Sponsor information
Hospital/treatment centre
Ulica proletarskih brigad 22
Maribor
2000
Slovenia
| Website | http://www.ukc-mb.si/ |
|---|---|
"ROR" |
https://ror.org/02rjj7s91 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2018 | 14/08/2019 | Yes | No |
Editorial Notes
14/08/2019: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
