PORPOISE

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Globally, millions of children are exposed to general anesthesia every year during which deviations from normal physiological conditions could lead to negative effects on the brain. This neurocognitive damage may lead to negative post-operative behaviour changes in children.

Near-infrared spectroscopy (NIRS) is increasingly used in paediatric cardiac surgery and neonatal intensive care, and there is low-grade evidence suggesting that neurological complications may be reduced if values less than 20% below baseline were acted upon. While recent research has suggested an increased risk of negative postoperative changes in children with regional cerebral desaturation, the studies found differences in the incidence and depth of cerebral oxygenation changes. This feasibility study is designed to address this issue and to prepare for a later multi-centre randomized controlled trial. The large RCT will investigate the impact on negative post-operative changes of using an anaesthesia management protocol based on reacting to changes in near-infrared spectroscopy (NIRS) as well as hypotension and systemic desaturation episodes, we aim to perform a feasibility study.

The study will determine the anaesthesia team´s reactions to changes in cerebral oxygen saturation and systemic hypotension or hypoxaemia as well as the incidence of negative post-operative changes and the association with reduced cerebral oxygen saturation. The next step will be a randomised controlled trial in children undergoing anaesthesia in which the intervention is a protocol for acting on cerebral oxygen desaturation vs a control group without access to cerebral oxygen saturation monitoring.

This multi-centre observational study aims to investigate the feasibility of a protocol to optimize cerebral oxygenation during anaesthesia to reduce negative post-operative changes in children.

Contact

The study administration is based in Uppsala, Sweden. The principal investigator is Adjunct senior lecturer Peter Frykholm, and Clinical research coordinator is Ali-Reza Modiri, Department of Surgical Sciences, Uppsala University, 751 85 Uppsala, Sweden.

The study's email address: porpoise@uu.se

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