APRICOT & SPAN

1. APRICOT & SPAN Dunblane, 25 April 2014

2. APRICOT - SPAN Overview What is APRICOT? Why SPAN? How to participate Results & follow-up

3. APRICOT Anaesthesia Practice In Children Observational Trial European prospective multicenter observational study: Epidemiology of severe critical events research@esahq.org esa.apricot@gmail.com

4. APRICOT Aims Incidence of severe critical events in children undergoing anesthesia in Europe Differences in paediatric anaesthesia practice Impact of this variability on the occurrence of severe critical events Improve the quality and safety of anaesthesia in children

5. APRICOT Design Prospective, observational, multi–centre cohort study Inclusion All children (0-16 years) admitted for any elective/non-elective inpatient or outpatient procedure (general anaesthesia, sedation with or without regional analgesia) Exclusion Children admitted to theatres from PICU or procedures in PICU/NICU (include if spontaneous ventilation or non-intubated on CPAP)

6. APRICOT Primary Endpoint Incidence of severe critical events during and up to 60 minutes after anaesthesia

7. Severe critical events Laryngospasm Bronchospasm Stridor Pulmonary aspiration Drug error Anaphylaxis Cardiovascular instability Cardiac arrest Neurological damage

8. DefinitionsSevere critical events (CRF 1.4)

9. APRICOT Primary Endpoint Incidence of severe critical events during and up to 60 minutes after anaesthesia Secondary Endpoints Risk factors Consequences/ outcomes Sample Size 25,000 children Europe wide

10. Sponsor & CI ESA Clinical Trials Network Chief Investigator: Prof Walid Habre UK National Coordinator: Dr Neil Morton

11. Endorsements - ESPA - Association of Paediatric Anaesthetists of Great Britain and Ireland (APAGBI) - Association of French speaking Paediatric Anaesthetists and Intensivists (Association des Anesthésiste-Réanimateurs Pédiatriques d’expression française (ADARPEF-), - Swiss Society for Paediatric Anaesthesiology (Schweizerische Gesellschaft für Kinderanästhesie / Société Suisse d’Anesthésiologie Pédiatrique (SGKA/SSAP)), - Italian Society for Paediatric and Neonatal Anaesthesia and Intensive Care (La Società di Anestesia e Rianimazione Neonatale e Pediatrica Italiana (S.A.R.N.eP.I.)), - German Society of Anesthesiology and Intensive Care Medicine (Deutsche Gesellschaft für Anästhesiologie und lntensivmedizin e.V." (DGAI)), - The Belgian Association for Paediatric Anaesthesiology (BAPA), - Society of Anesthesia and Resuscitation of Belgium (SARB), - Austrian Society of Anesthesiology (Österreichische Gesellschaft für Anaesthesiologie, Reanimation und Intensivmedizin) (ÖGARI), - Hellenic Society of Anaesthesiology - Greece (EAE) - Ukrainian Society of Anesthesiologists - Ассоциация анестезиологов Украины – Ukraine (AAY)

12. Centres >300 centres 72 UK centres All Scottish centres in SPAN signed up

13. UK Study conditions Observational non-research study Data anonymised and protected Ethics waiver Waiver of individual patient consent Caldicott guardian and R&D approvals Family information leaflets and posters

14. WHY SPAN ? Unique national picture to inform and educate for the future Opportunity to measure against the whole European dataset Plan & model future studies SPAN/ UK / Europe

15. WHO has signed up?

16. HOW to participate Initial steps – registration (ESA/AAGBI membership) Date setting 01 April 2014 - 31 December 2014 Ethics not required – Audit (WOSRES) Caldicott Paper work and logistical issues

17. Everyone needs to be involved! (but only for 2 weeks)

18. Paperwork Email from ESA confirming registration Your contact details including ESA/AAGBI membership Site questionnaire (www.surveymonkey.com/s/APRICOTSTUDY ) Cover sheet, WOSRES notification, Information leaflet

19. Cover sheet, WOSRES, Information

20. Paperwork Email from ESA confirming registration Site questionnaire (www.surveymonkey.com/s/APRICOTSTUDY ) Cover sheet, WOSRES notification, Information leaflet ESA /UK notification of start date (8 days minimum) Case Report Form (CRF 1.4.1) – print one per patient

21. Cover per patient Case Report Form - v 1.4.1 only

22. Case Report Form - v 1.4.1 only Cover Preoperative data Intraoperative data Perioperative complications Postanaesthetic data

23. Cover Preoperative data Demographics Medical history Indication Anaesthesia Plan Case Report Form - v 1.4.1 only

24. Cover Preoperative data Intraoperative data Type of anaesthesia (sedation, GA, RA) Airway management Ventilation Fluids Timing Case Report Form - v 1.4.1 only

25. Cover Preoperative data Intraoperative data Perioperative complications Case Report Form - v 1.4.1 only

26. Cover Preoperative data Intraoperative data Perioperative complications Postanaesthetic data Case Report Form - v 1.4.1 only

27. Paperwork Email from ESA confirming registration Cover sheet, WOSRES notification Site questionnaire (www.surveymonkey.com/s/APRICOTSTUDY ) ESA /UK notification of start date (8 days minimum) Case Report Form (CRF 1.4) – print one per patient eCRF upload (Open Clinica electronic CRF) FAQ – in email response from ESA

28. FAQ

29. Results & Follow-up Overall results to paper for Lancet Benchmarking against overall results • by country • by centre • opportunity for complete national picture for Scotland QI projects (pain management and others)

30. Contacts & copies of talk Dr Lesley McKee: lesley.mckee@nhs.net Dr Neil Morton: neilmorton@mac.com Dr Thomas Engelhardt: t.engelhardt@nhs.net

31. APA - SPA joint meetingAberdeen, Scotland 14-15th May 2015 CCAN - CCAS joint meeting Aberdeen, Scotland 13th May 2015