Quality in)Pediatric Anesthesia:) The)APRICOT)Study Walid Habre, MD, PhD Anesthesiological Investigations Unit & Pediatric Anesthesia Unit Geneva University Children’s Hospital Lancet Respir Med. 2017 May;5(5):412-425. www.walidhabre.org Anaesthesia Practice In Children Observational Trial European prospective multicenter observational study: Epidemiology of severe critical events • Primary endpoint - Incidence of severe critical events during & immediately following anaesthesia (PACU) (laryngospasm, bronchospasm, aspiration, anaphylaxis, cardiovascular instability, neurological damage, drug errors and cardiac arrest) • Secondary endpoints - Risk factors for the occurrence of severe critical events - Consequences of the critical events: Irreversible damage, in-hospital mortality within 30 days Enrollment Criteria • ALL Consecutive patients from birth to 15 years old • Inpatient or outpatient procedures • Under sedation or general anaesthesia with or without regional analgesia or under regional anaesthesia alone • All diagnostic and surgical procedures • In the OR or outside the OR • Including an urgent or emergency procedure performed in- or out-of-hours. Exclusion Criteria • Children admitted directly from the intensive care units to the operating rooms • Anaesthesia procedures in the intensive care unit settings 3 EC/IRB Approval: a real challenge • Variability regarding ethical requirements for each EC/IRB • Variable duration in obtaining EC approval • Variability within one given country Reporting Severe Critical0events 5 Definition of perioperative complications: A consequence of a critical event ? Or a severe critical event ? Laryngospasm • Predictable and preventable ? Bronchospasm • Predictable but Unpreventable ? Haemorrhage • Unpredictable and Unpreventable ? Arrhythmia Cardiac arrest Speaking the+same language… Variability in+the+Definition of+the+Complications Influence Outcomes Statistics 7 Laryngospasm “,complete(airway(obstruction(associated,with, rigidity,of,the,abdominal,and,chest,walls,and, leading,to,unsuccessful,child’s,ventilation,,or, glottic closure,associated,with,chest,movement, but,silent,unsuccessful,child’s,respiratory,efforts, and,assisted,ventilation,,unrelieved(in(both( situations(with(simple(jaw(thrust(and(CPAP( manoeuvres(and(requiring(the(administration( of(medication((propofol,(suxamethonium etc.)( and/or(tracheal(intubation. 8 Agreement between CRF and definition CPAP$ Oxygen Important number Jaw$thrust of requests for laryngospasm Manual$ventilation CALL FOR CENTRES between 1stJune 2013 and 28 February 2014 372 centres from 36 countries 109 centres excluded !Staff shortage for research and consent !Difficulties dealing with Ethics Boards RECRUITMENT during 2 consecutive weeks between 17 March 2014 and 31 January 2015 263 centres from 33 countries !3791 screening failure !200 patients excluded: !2 centres not eligible (150 patients) !29 Informed consent not obtained !7 Data Lost !14 Patients not filling inclusion criteria TOTAL RECRUITED 261 centres from 33 countries n=30’878 subjects 29’145 queries sent to centres • 28’253 queries resolved • 62 subjects with repeated events by mistake • 4 patients excluded as age missing • 74 patients listed erroneously as having complications DATA AVAILABLE FOR ANALYSIS 261 centres from 33 countries n=30’874 subjects n=31’127 procedures