Cerebral Oxygenation in Cardiac Arrest and Hypothermia (CoCaHYp)
Data indicate that neurological prognostication is difficult after cardiac arrest if mild therapeutic hypothermia is part of the post resuscitation care. Cerebral oxygenation detected by near-infrared spectroscopy, could be a new, non-invasive index marker for outcome assessment after cardiac arrest. The investigators hypothesize that cardiac arrest survivors with a continuously low cerebral oxygenation index have a poor prognosis.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Cerebral Oxygen Saturation as Outcome Predictor in Cardiac Arrest Patients Undergoing Mild Therapeutic Hypothermia|
- neurological outcome (death; CPC: 5) [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3-6 weeks ] [ Designated as safety issue: No ]Cerebral Performance Category 5: death
- neurological outcome CPC 1-5 [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3-6 weeks and a 12 month follow up will be performed ] [ Designated as safety issue: No ]CPC 1: Conscious and alert with normal function or only slight disability CPC 2: Conscious and alert with moderate disability CPC 3: Conscious with severe disability CPC 4: Comatose or persistent vegetative state CPC 5: death
|Study Start Date:||January 2012|
|Study Completion Date:||January 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
|NIRS continuous monitoring||
Device: near infrared spectroscopy (INVOS®, Covidien)
Measurement of regional cerebral oxygen saturation with non-invasive near-infrared INVOS® (In-Vivo Optical Spectroscopy) monitor by Covidien.
The measurement of cerebral oxygen saturation by a non-invasive near-infrared monitor, INVOS® (In-Vivo Optical Spectroscopy; Covidien) can detect changes in oxygen levels reflecting regional blood oxygen saturation of the brain tissue beneath the sensor. If this monitoring can add further information towards reliable prognostication after cardiac arrest is unknown so far.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01531426
|Berlin, Germany, 13353|
|Principal Investigator:||Christian Storm, MD||Charité-Universitätsmedizin Berlin, Germany|