Medical problem

Results of the recent prospective multi-centre observational study “APRICOT” will provide an insight into the incidence of severe perioperative critical events in children. More than 260 centres across Europe successfully contributed data for “APRICOT”. The new Clinical Trial Network “NECTARINE” represents a natural extension of the APRICOT study and will specifically focus on the neonatal population.

The primary aim of NECTARINE is to provide information on morbidity and mortality related to neonatal anaesthesia. Currently, the lack of validated ‘normal’ ranges for physiological parameters in neonates of different post-menstrual ages limits our ability to develop standardised policies and procedures for interventions based on predetermined values. NECTARINE will provide valuable information on the incidence of potential out-of-range physiological parameters, whether these are associated with altered postoperative outcome, and whether specific parameters or degrees of change are potential predictors of poor outcome. Finally, NECTARINE will identify variations in clinical practice across Europe. Centres providing anaesthesia care for neonates, including those that participated in the APRICOT study, will be invited to take part in this new CTN.

Design

Prospective, observational, multi–centre audit of clinical practice.

Criteria

Inclusion Criteria

The audit population will include all neonates and infants from birth to 60 weeks of post-menstrual age  admitted to participating centres during a pre-determined 12-week recruitment period:

  • all elective in-patient or out-patient surgical procedures performed under general anaesthesia with or without regional analgesia, or under sole regional anaesthesia;
  • all diagnostic procedures performed under general anaesthesia;
  • all urgent or emergency procedures performed in- or out-of-hours;
  • all procedures performed in NICU/PICU or directly admitted from the Intensive Care to the Operating Room.

Exclusion Criteria

  • Infants aged over 60 weeks of postmenstrual age on the day of anaesthesia

Primary objective

The incidence of interventions performed by the anaesthesia team in response to (i) a critical event or (ii) a major change of physiological parameters during anaesthesia management.

List of physiological parameters that will be observed for (i) and (ii):

  1. Airway management
  2. Peripheral oxygen saturation (SpO2) and/or arterial oxygen saturation (SaO2) ;
  3. End-tidal carbon dioxide (CO2) (and/or arterial or venous CO2);
  4. Glycaemia, and Na+;
  5. Cardiovascular instability: blood pressure, heart rate;
  6. Body temperature;
  7. Brain oxygenation by NIRS (if available);
  8. Haemoglobin level.

Secondary objectives

The incidence of adverse events up to the first 120 minutes after anaesthesia.

Post-anaesthesia events to be reported are:

– Unplanned PICU/NICU admission.

– Unplanned delayed extubation.

– Need for ECMO.

– Need for chest left open (for cardiac surgery only).

– Unplanned hospital admission (originally scheduled as outpatient).

  • In-hospital mortality up to 30 days after anaesthesia as determined from medical records.
  • Morbidity at 30 days after anaesthesia as determined from medical records: until discharge or at 30 days if still in hospital
  • In-and out-hospital mortality and morbidity at 90 days after anaesthesia

The NECTARINE study has been endorsed by:

Асоціація Анестезіологів України (ААУ-AAU) -Association of Anesthesiologists of Ukraine

Association of French speaking Paediatric Anaesthetists and Intensivists

Association of Paediatric Anaesthetists of Great Britain and Ireland (APAGBI)

Česká společnost anesteziologie, resuscitace a intenzívní medicíny (ČSARIM): - Czech Society of Anaesthesiology and Intensive Care Medicine

Danish Society of Anaesthesiology and Intensive Care Medicine (DASAIM)

Deutsche Gesellschaft für Anästhesiologie & Intensivmedizin (DGAI) German Society for Anaesthesiology and Intensive Care Medicine

Eesti Anestesioloogide Selts (EAS) Estonian National Society of Anaesthesiology