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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1231-2797 | Registry Identifier | UTN |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ERC guided CPR (intervention/NIRS group) | Active Comparator | CPR protocol according to current ERC guidelines (2015) |
|
| ERC-based CPR (control group) | No Intervention | modified CPR protocol based on current ERC guidelines (2015), extended by evaluation of NIRS readings and interventions to optimize CPR quality |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cerebral oximetry (near infrared) based CPR-Algorithm | Combination Product | If NIRS values do not increase over time until ROSC (target: >40 % after 10 min), interventions are suggested in a modified CPR/NIRS algorithm. |
| Measure | Description | Time Frame |
|---|---|---|
| successful cardiopulmonary resuscitation (CPR) | Influence of the intervention on the number of patients with successful return of spontaneous circulation (ROSC) during cardiopulmonary resuscitation (CPR) [ROSC: yes/no] | DAY 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Time-to-ROSC | Time from start of cardiopulmonary resuscitation (CPR) until successful return of spontaneous circulation (ROSC) [min] | DAY 1 |
| Cerebral Performance Category (CPC) after successful return of spontaneous circulation (ROSC) |
| Measure | Description | Time Frame |
|---|---|---|
| Neuron Specific Enolase (NSE) blood level after successful return of spontaneous circulation (ROSC) | NSE as marker for brain damage after cardiac arrest | DAY 1, DAY 2, DAY 3, DAY 4 |
| S100B blood level after successful return of spontaneous circulation (ROSC) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Serge C Thal, MD | Department of Anesthesiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Center of the Johannes Gutenberg-University Mainz | Mainz | Rhineland-Palatinate | 55131 | Germany |
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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).
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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)
Neurofunctional recovery, total score, range: 1-5
| DAY 30, DAY 180, DAY 360 |
| Glasgow Outcome Scale Extended (GOS-E) after successful return of spontaneous circulation (ROSC) | Neurofunctional recovery, total score, range: 1-8 | DAY 30, DAY 180, DAY 360 after successful return of spontaneous circulation (ROSC) |
| The Bathel-Index (Barthel) after successful return of spontaneous circulation (ROSC) | Neurofunctional recovery, total score, range: 0-100 | Discharge from intensive care unit (variable time point, depending on condition of patient) |
S100B as marker for brain damage after cardiac arrest
| DAY 1, DAY 2, DAY 3, DAY 4 |
| 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) | PAI1/2 as marker for brain damage after cardiac arrest | DAY 1, DAY 2, DAY 3, DAY 4 |
| proBNDF/BDNF blood level after successful return of spontaneous circulation (ROSC) | proBNDF/BDNF as marker for brain damage after cardiac arrest | DAY 1, DAY 2, DAY 3, DAY 4 |
| Neurofilament blood level after successful return of spontaneous circulation (ROSC) | Neurofilament as marker for brain damage after cardiac arrest | DAY 1, DAY 2, DAY 3, DAY 4 |