APRICOT SPAN Dunblane 25 April 2014 APRICOT SPAN

APRICOT & SPAN Dunblane, 25 April 2014

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

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

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

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)

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

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

Definitions Severe critical events (CRF 1. 4)

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

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

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. e. P. 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)

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

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

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

WHO has signed up?

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

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

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

Cover sheet, WOSRES, Information

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

Case Report Form - v 1. 4. 1 only • Cover patient

Case Report Form - v 1. 4. 1 only • • • Cover Preoperative data Intraoperative data Perioperative complications Postanaesthetic data

Case Report Form - v 1. 4. 1 only • Cover • Preoperative data – Demographics – Medical history – Indication – Anaesthesia Plan

Case Report Form - v 1. 4. 1 only • Cover • Preoperative data • Intraoperative data – Type of anaesthesia (sedation, GA, RA) – Airway management – Ventilation – Fluids – Timing

Case Report Form - v 1. 4. 1 only • • Cover Preoperative data Intraoperative data Perioperative complications

Case Report Form - v 1. 4. 1 only • • • Cover Preoperative data Intraoperative data Perioperative complications Postanaesthetic data

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 e. CRF upload (Open Clinica electronic CRF) FAQ – in email response from ESA

FAQ

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)