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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
360
If NIRS values do not increase over time until ROSC (target: \>40 % after 10 min), interventions are suggested in a modified CPR/NIRS algorithm.
Medical Center of the Johannes Gutenberg-University Mainz
Mainz, Rhineland-Palatinate, Germany
successful cardiopulmonary resuscitation (CPR)
Influence of the intervention on the number of patients with successful return of spontaneous circulation (ROSC) during cardiopulmonary resuscitation (CPR) \[ROSC: yes/no\]
Time frame: DAY 1
Time-to-ROSC
Time from start of cardiopulmonary resuscitation (CPR) until successful return of spontaneous circulation (ROSC) \[min\]
Time frame: DAY 1
Cerebral Performance Category (CPC) after successful return of spontaneous circulation (ROSC)
Neurofunctional recovery, total score, range: 1-5
Time frame: 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
Time frame: 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
Time frame: Discharge from intensive care unit (variable time point, depending on condition of patient)
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