APRICOT & SPAN

Dunblane, 25 April 2014

APRICOT - SPAN

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

APRICOT

research@esahq.orgesa.apricot@gmail.com

Anaesthesia Practice In Children Observational Trial

European prospective multicenter observational study: Epidemiology of severe critical events

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

DesignProspective, 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)

ExclusionChildren 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 critical events during and up to 60 minutes after anaesthesia

Severe critical events

Laryngospasm Bronchospasm

Stridor Pulmonary aspiration

Drug error Anaphylaxis

Cardiovascular instability Cardiac arrest

Neurological damage

DefinitionsSevere critical events (CRF 1.4)

APRICOT

Primary EndpointIncidence of severe critical events during and up to 60 minutes after anaesthesia

Secondary EndpointsRisk factorsConsequences/ outcomes

Sample Size25,000 children Europe wide

Sponsor & CI

ESA Clinical Trials NetworkChief Investigator: Prof Walid HabreUK 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.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)

Centres

>300 centres72 UK centresAll Scottish centres in SPAN signed up

UK Study conditions

Observational non-research studyData anonymised and protectedEthics waiverWaiver of individual patient consentCaldicott guardian and R&D approvalsFamily 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 setting01 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

• Cover per patient

Case Report Form - v 1.4.1 only

Case Report Form - v 1.4.1 only

• Cover• Preoperative data• Intraoperative data• Perioperative complications• Postanaesthetic data

• 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

Case Report Form - v 1.4.1 only

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

FAQ

Results & Follow-up

Overall results to paper for LancetBenchmarking against overall results– by country– by centre– opportunity for complete national picture for Scotland

QI projects (pain management and others)

Contacts & copies of talk

Dr Lesley McKee: lesley.mckee@nhs.netDr Neil Morton: neilmorton@mac.com Dr Thomas Engelhardt: t.engelhardt@nhs.net

APA - SPA joint meetingAberdeen, Scotland 14-15th May 2015

CCAN - CCAS joint meeting Aberdeen, Scotland 13th May 2015