Download - APRICOT & SPAN
APRICOT & SPAN
Dunblane, 25 April 2014
APRICOT - SPAN
Overview• What is APRICOT?• Why SPAN?• How to participate• Results & follow-up
APRICOT
[email protected]@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: [email protected] Neil Morton: [email protected] Dr Thomas Engelhardt: [email protected]
APA - SPA joint meetingAberdeen, Scotland 14-15th May 2015
CCAN - CCAS joint meeting Aberdeen, Scotland 13th May 2015