Univeristy Children's Hospital
Tübingen, 72076, Germany
NCT Number: NCT04810013
Feasibility of non-invasive cerebral autoregulation measurement at the PICU and impact of changes in oxygen supply
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All sexes
Observational
Tübingen, 72076, Germany
Cerebral protection is a major issue in the treatment of neonates and infants with complex congenital heart disease, because most common long-term morbidities of newborn heart surgery are related not to the heart, but instead to the cognitive challenges experienced by this population. Disruption of cerebral autoregulation in the postoperative period may contribute to brain injury in these patients. Blood pressure management, respirator management and red blood cell transfusion management after cardiopulmonary bypass surgery using endpoints such cerebral autoregulation monitoring might provide a method to optimize organ perfusion and improve neurologic outcome from cardiac surgery in the vulnerable postoperative period.
Primary Objectives: Feasibility of non-invasive cerebral autoregulation measurement at the PICU: Identification of the range of mean arterial blood pressure (MAP) with optimal vasoreactivity (MAPOPT), indicating intact cerebral autoregulation.
Secondary Objectives: Impact of decreased oxygen delivery, increased cerebral oxygen extraction, decreased cardiac output, arterial hypotension, severe hypoxemia and/or severe anemia on cerebral autoregulation.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Non-invasive measurement of the cerebral autoregulation in the postoperative period in 80 neonates and infants with complex congenital heart disease undergoing cardiopulmonary bypass surgery. A continuous, moving Pearson's correlation coefficient will be calculated between the arterial pressure and near-infrared spectroscopy signals and displayed continuously during surgery using a laptop computer and the ICM+ software (Cambridge Enterprise).
Time frame: 4within 8 hours after cardiac surgery at the PICU
Measurement of the range of mean arterial blood pressure (MAP) with optimal vasoreactivity (MAPOPT)
Time frame: before surgery, 12 hours, 48 hours, 72 hours post surgery and before discharge
Detection of cerebral haemorrhage grade III or IV, cystic periventricular leukomalacia, cerebellar haemorrhage, post-haemorrhagic ventricular dilatation or cerebral atrophy) on routinely performed serial cranial ultrasound scans
Time frame: at age of 2 years
Landmarks of development score (Grenzsteine der Entwicklung Score) aus (Monatsschr Kinderheilkd_2013 · 161:898-910_· DOI 10.1007/s00112-012-2751-0 © Springer-Verlag Berlin Heidelberg 2013 R._Michaelis_· R._Berger_· U._Nennstiel-Ratzel_· I._Krägeloh-Mann Validierte und teilvalidierte Grenzsteine der Entwicklung).
The score uses dichotomous questions, that asks for a Yes/No response. The score consists of a total of 16 questions, the more questions answered yes, the better the outcome and vice versa. Minimum value is n=0 yes and n=16 no answers, maximum value is n=16 yes and n=0 no answers.
Time frame: within 8 hours after cardiac surgery at the PICU
Analysis of the influence of changed fractional cerebral oxygen extraction (cFTOE) on cerebral autoregulation.Association between cFTOE and cerebral autoregulation indices (COx and HVx).
Time frame: within 8 hours after cardiac surgery at the PICU
Analysis of the influence of changed arterial blood pressure on cerebral autoregulation. Association between arterial blood pressure (mmHg) and cerebral autoregulation indices (COx and HVx).
Time frame: within 8 hours after cardiac surgery at the PICU
Analysis of the influence of changed arterial oxygen saturation on cerebral autoregulation. Association between arterial SPO2 (%) and cerebral autoregulation indices (COx and HVx).
Time frame: within 8 hours after cardiac surgery at the PICU
University Hospital Tuebingen
Other
Noninvasive Measurement of the Cerebral Autoregulation in Neonates and Infants With Complex Congenital Heart Disease After Cardiac Surgery With Cardiopulmonary Bypass at the Pediatric Intensive Care Unit (PICU)
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