Cardiac Arrest, Cardiopulmonary Arrest With Successful Resuscitation, Cerebral Oxygenation
Conditions
Keywords
near-infrared spectroscopy, cardiopulmonary resuscitation, cardiac arrest, cerebral oximetry
Brief summary
Sudden cardiac death is one of the main causes of morbidity and mortality worldwide. Cardiac arrest requires prompt intervention by cardiopulmonary resuscitation (CPR). The resuscitation guidelines are the current recommendations for CPR and are revised by expert panels such as the European Resuscitation Council (ERC). Up to now, a parameter for assessing the quality of CPR is missing and further monitoring methods are urgently needed. Near-infrared spectroscopy (NIRS) is a portable method for measuring regional oxygen levels in the brain. Recent clinical trials suggest that cerebral oxygenation measured by NIRS may correlate with survival and outcome after cardiac arrest. The investigators propose that NIRS technology may not only be suitable to determine or predict the outcome of the patients, but could also be a useful tool to guide the CPR providers to optimize the CPR techniques and guide the individual treatments/interventions. The present study was therefore designed to determine if NIRS guided CPR with the aim to optimize NIRS values is superior compared to the current standard practice according to published CPR guidelines (return of spontaneous circulation \[ROSC\] rate, short and long-term cerebral performance).
Interventions
COMBINATION_PRODUCTCerebral oximetry (near infrared) based CPR-Algorithm
If NIRS values do not increase over time until ROSC (target: \>40 % after 10 min), interventions are suggested in a modified CPR/NIRS algorithm.
Sponsors
Dr. Serge Thal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
On group will have NIRS reading available to adjust CPR interventions, whereas the control group will not be able use NIRS readings (masked by cover)
Intervention model description
Does near-infrared spectroscopy (NIRS) technology based advanced cardiac life support improve cardiopulmonary resuscitation (CPR) quality in patients (in-house \[IHCA\] and out-of-hospital cardiac arrest \[OHCA\], randomized enrollment immediately with CPR) and thereby improve return of spontaneous circulation (ROSC) rate (primary outcome) and patient outcome compared to European Resuscitation Council (ERC)-based CPR (concealed NIRS recording).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with a cardiac arrest from the age of 18 years (in and out-of-hospital cardiac arrest)
Exclusion criteria
* post-traumatic cardiac arrest * non-fitting NIRS sensor (size)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| successful cardiopulmonary resuscitation (CPR) | DAY 1 | Influence of the intervention on the number of patients with successful return of spontaneous circulation (ROSC) during cardiopulmonary resuscitation (CPR) \[ROSC: yes/no\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time-to-ROSC | DAY 1 | Time from start of cardiopulmonary resuscitation (CPR) until successful return of spontaneous circulation (ROSC) \[min\] |
| Cerebral Performance Category (CPC) after successful return of spontaneous circulation (ROSC) | DAY 30, DAY 180, DAY 360 | Neurofunctional recovery, total score, range: 1-5 |
| Glasgow Outcome Scale Extended (GOS-E) after successful return of spontaneous circulation (ROSC) | DAY 30, DAY 180, DAY 360 after successful return of spontaneous circulation (ROSC) | Neurofunctional recovery, total score, range: 1-8 |
| The Bathel-Index (Barthel) after successful return of spontaneous circulation (ROSC) | Discharge from intensive care unit (variable time point, depending on condition of patient) | Neurofunctional recovery, total score, range: 0-100 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Neuron Specific Enolase (NSE) blood level after successful return of spontaneous circulation (ROSC) | DAY 1, DAY 2, DAY 3, DAY 4 | NSE as marker for brain damage after cardiac arrest |
| S100B blood level after successful return of spontaneous circulation (ROSC) | DAY 1, DAY 2, DAY 3, DAY 4 | S100B as marker for brain damage after cardiac arrest |
| plasminogen activator inhibitor 1/2 (PAI1/2) blood level after successful return of spontaneous circulation (ROSC) after successful return of spontaneous circulation (ROSC) after successful return of spontaneous circulation (ROSC) | DAY 1, DAY 2, DAY 3, DAY 4 | PAI1/2 as marker for brain damage after cardiac arrest |
| proBNDF/BDNF blood level after successful return of spontaneous circulation (ROSC) | DAY 1, DAY 2, DAY 3, DAY 4 | proBNDF/BDNF as marker for brain damage after cardiac arrest |
| Neurofilament blood level after successful return of spontaneous circulation (ROSC) | DAY 1, DAY 2, DAY 3, DAY 4 | Neurofilament as marker for brain damage after cardiac arrest |
Countries
Germany
Outcome results
None listed