Peer-reviewed article
Fasting-induced hypoglycaemia in anaesthetised paediatric patients (FIGS): protocol of an opt-out approach to consent for a multicentre cohort study measuring glycaemia and ketonaemia.
Hannah F Lewis, Hugh Lemonde, Chris Gale, Gemma Jones, Kirsty Logan et al. ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This is a protocol for a medical research study measuring blood glucose and ketone levels in children undergoing general anaesthesia in UK hospitals. The study aims to recruit over 2000 children to understand how fasting before surgery affects their metabolic health and to identify risk factors for hypoglycaemia. The research will use an opt-out consent approach and is scheduled to run from May 2025 to May 2026. This is a study protocol describing the planned methodology rather than results from implemented research.
Key points
- The study will measure blood glucose and ketone levels in fasted children undergoing general anaesthesia using point-of-care testing
- Over 2000 children will be recruited across all four nations of the United Kingdom
- The primary aim is to assess different thresholds anaesthetists use to define hypoglycaemia and identify risk factors
- An opt-out consent approach will be used to maximise recruitment
- Results are expected to be shared in 2027
Limitations
This is a protocol document describing a study that has not yet been completed, so it contains no outcome data or evidence of intervention effectiveness. The document provides no information about what the study will ultimately find or whether any interventions tested will be beneficial to children.
Abstract
BACKGROUND: Hypoglycaemia is a potentially a serious complication of the iatrogenic fasting required to deliver safe anaesthesia. Children may be at a higher risk because of their metabolic immaturity. METHODS: This is a prospective multi-centre cohort study recruiting children fasting before a procedure under general anaesthesia. Children will have their blood glucose and ketones measured using point-of-care testing on venous blood drawn from a cannula inserted during i.v. or inhalation induction of general anaesthesia. The primary aim is to recruit as many children as possible across the four nations of the United Kingdom, using an opt-out approach to consent, to assess different thresholds used by anaesthetists to define hypoglycaemia and identify risk factors of this metabolic complication. The primary endpoint is the decision by anaesthetists to manage a hypoglycaemia at induction in a large paediatric population. Secondary endpoints are the actual values of glycaemia and ketonaemia and to evaluate the distributions of these parameters in a large paediatric population together with assessing potential risk factors of adverse metabolic responses to fasting (mainly hypoglycaemia, hypoketosis, and hyperketosis). The fasting-induced hypoglycaemia in anaesthetised paediatric patients (FIGS) study aims to recruit over 2000 children across the 4 nations of the United Kingdom. Trial recruitment is in progress starting May 2025 and expected to end May 2026, with analysis and results shared in 2027. DISSEMINTATION PLANS: This study, using an opt-out approach to consent, will provide a large data set of glycaemia and ketonaemia values in a paediatric population, assessing current practice, identifying risk factors, and building new recommendations for the management of the metabolic risk in fasting children. CLINICAL TRIAL REGISTRATIONS: IRAS 329701 and NCT07259629. PROTOCOL VERSION NUMBER AND DATE: 1.8, 14 April 2026.