Clinical trial NCT01878760: APRICOT: Anaesthesia PRactice In Children Observational Trial
Official title: APRICOT: Anaesthesia PRactice In Children Observational Trial - European Prospective Multicenter Observational Study: Epidemiology of Severe Critical Events in Paediatric Anaesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anaesthesia
Children
Keywords: APRICOT
Anaesthesia
Children
kids
Paediatric Anaesthesia
Observational Trial
epidemiology
severe critical events in
European Society of Anaesthesiology
Europe
Lead sponsor: European Society of Anaesthesiology
Sponsor class: OTHER
First posted: 2013-06-17
Enrollment: 30000
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children from birth to 15 years included admitted for an inpatient or outpatient procedure under general anaesthesia with or without regional analgesia or admitted for a diagnostic procedure under general anaesthesia (such as endoscopy, radiology...) or admitted out-of-hours for emergency procedures

Brief summary: The aims of the APRICOT study are:

* To establish the incidence of severe critical events in children undergoing anesthesia in Europe.
* To describe the differences in paediatric anaesthesia practice throughout Europe.
* To study the potential impact of this variability on the occurrence of severe critical events (Laryngospasm, Bronchospasm, Pulmonary aspiration, Drug error, Anaphylaxis, Cardiovascular instability, Neurological damage, Perianaesthetic cardiac arrest and postanaesthetic Stridor).

Detailed description: Despite the introduction of better-structured programmes for paediatric anaesthesia training and the development of some recommendations for paediatric anaesthesia services, the incidence of severe critical events in children is still unknown in Europe. Considering that the major life-threatening complications following general or regional anaesthesia are uncommon, it is therefore crucial to consider a large multinational, multicentre trial in order to establish a realistic statistical estimation and identify the risk factors for severe critical events. Thus, this prospective observational multicentre cohort study is designed to identify the incidence and potential risk factors of severe critical events in children undergoing anaesthesia in Europe.

The study aims to include all children from birth to 15 years old scheduled for an elective or urgent diagnostic or surgical procedure under sedation or general anaesthesia with or without regional analgesia or under regional anaesthesia. This represents the denominator dataset for calculation of the incidence of severe critical events, which is the primary aim of the study. The anaesthesiologist in charge will record the occurrence of selected severe critical events during and up to 60 minutes after anaesthesia or sedation AND requiring immediate intervention. These severe critical incidents include: Laryngospasm, Bronchospasm, Pulmonary aspiration, Drug error, Anaphylaxis, Cardiovascular instability, Neurological damage, Perianaesthetic cardiac arrest and postanaesthetic Stridor. The secondary endpoint is represented by the risk factors and the consequences for the occurrence of these severe critical events including in-hospital mortality established up to 30 days or at discharge. Relevant aspects of the child's medical and family history will be recorded.

Following sample size estimation, we plan to recruit at least 25 000 children over a period of two consecutive weeks including weekends and after-hours across the 30 European countries represented at the European Society of Anaesthesiology Council or part of geographical Europe. The 2-week recruitment period will be chosen by each site commencing on 15 March 2014.The last possible inclusion date will be decided by the Study Steering Committee depending on the recruitment rate. Participating hospitals will be provided with data acquisition sheets that enable anonymous standardized recording of all patients' parameters, which will be used by the local institution to fill in the electronic case report form (eCRF).

Descriptive statistical analysis will be performed for the primary endpoint (occurrence of severe critical events and 95% confidence interval). Univariate and multivariate analysis will be performed to test factors associated with the endpoint. Results of logistic regression will be reported as adjusted odds ratio (OR) with 95 % confidence intervals.

Eligibility criteria: Inclusion Criteria:

* Age: from birth to 15 years included
* All children admitted for an inpatient or outpatient procedure under general anaesthesia with or without regional analgesia or under regional anaesthesia alone. This includes all kind of surgeries and procedures requiring anaesthesia and analgesia to be performed such as central venous access, burn care, cast, etc.,
* Children admitted for a diagnostic procedure under sedation (performed by an Anaesthetist) or general anaesthesia (such as endoscopy, radiology (CT-scan, MRI), cardiac catheterisation and electrophysiology, PET-scan, radiotherapy, lumbar and bone marrow puncture, biopsies), diagnostic procedure under general anaesthesia (such as endoscopy, radiology...)
* Children admitted for 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 neonatal or paediatric intensive care units.
* Age: All children aged ≥ 16 years.

Primary outcomes:
measure: Incidence of severe critical events
timeFrame: Children will be followed for the duration of their anaesthesia procedure and up to 60 minutes afterwards
Secondary outcomes:
measure: Risk factors for the occurrence of severe critical events
timeFrame: Children will be followed for the duration of their anaesthesia procedure and up to 60 minutes afterwards
measure: Consequences of the critical events: irreversible damage, in-hospital mortality
timeFrame: in-hospital and up to 30 days
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St Luc
city: Pula
country: Croatia
facility: General Hospital Pula
city: Brno
country: Czech Republic
facility: University Children´s Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
city: Lille
country: France
facility: CHU Lille
city: Montpellier
country: France
facility: Lapeyronie University Hospital
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig
city: Nürnberg
country: Germany
facility: Cnopf'sche Kinderklinik/Klinik Hallerwiese
city: Sankt Augustin
country: Germany
facility: Asklepios Klinik Sankt Augustin GmbH - Department of Paediatric Anaesthesia
city: Gibraltar
country: Gibraltar
facility: Gibraltar Health Authority, St. Bernard´s Hospital
city: Athens
country: Greece
facility: Children Hospital P&A Kyriakoy
city: Dublin
country: Ireland
facility: Our Ladys Children's Hospital
city: Petah Tiqwa
country: Israel
facility: Schneider Children's Medical center of Israel
city: Genoa
country: Italy
facility: Instituto Giannina Gaslini
city: Prishtina
country: Kosovo
facility: University Clinical Center of Kosovo
city: Riga
country: Latvia
facility: Children University Hospital
city: Vilnius
country: Lithuania
facility: Vilnius Children Hospital
city: Msida
country: Malta
facility: Mater Dei Hospital MSD
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center MUMC
city: Oslo
country: Norway
facility: Oslo University Hospital, Rikshospitalet
city: Wroclaw
country: Poland
facility: Clinical University Hospital Department of Anaesthesiology and Intensive Care
city: Lisbon
country: Portugal
facility: Centro Hospitalar Lisboa Norte - Hospital de Santa Maria
city: Bucharest
country: Romania
facility: Spitalul de Copiin Maria Curie
city: Moscow
country: Russian Federation
facility: Pirogov Russian National Research Medical University
city: Belgrade
country: Serbia
facility: University Childrens hospital
city: Banska Bystrica
country: Slovakia
facility: Paediatric District Hospital
city: Ljubljana
country: Slovenia
facility: University Klinical Centre Ljubljana
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan Déu
city: Gothenburg
country: Sweden
facility: Queen Silvis Childrens Hospital Sahlgrens University Hospital
city: Geneva
country: Switzerland
facility: Geneva University Hospitals
city: Luzern
country: Switzerland
facility: Anästhesie Kinderspital Klinik für Anästhesie, Intensivmedizin, Rettungsmedizin und Schmerztherapie (KLIFAIRS) Luzerner Kantonsspital Spitalstrasse
city: Adana
country: Turkey
facility: Cukurova University Faculty Of Medicine
city: Kyiv
country: Ukraine
facility: P.L.Shupyk National Medical Academy of Postgraduate Education, Municipal Children's Hospital #1
city: Glasgow
country: United Kingdom
facility: Royal Hospital For Sick Children
state: Scotland
Study officials:
affiliation: University Hospital, Geneva
name: Walid Habre, M.D.
role: STUDY_CHAIR
affiliation: Cliniques Universitaires St Luc asbl Brussels
name: Francis Veyckemans, M.D.
role: STUDY_DIRECTOR
References:
citation: Dahmani S, Laffargue A, Dadure C, Veyckemans F; French APRICOT trial group. Description of practices and complications in the French centres that participated to APRICOT: A secondary analysis. Anaesth Crit Care Pain Med. 2019 Dec;38(6):637-645. doi: 10.1016/j.accpm.2019.06.001. Epub 2019 Jun 11.
citation: Virag K, Sabourdin N, Thomas M, Veyckemans F, Habre W; APRICOT Group of the European Society of Anaesthesiology Clinical Trial Network. Epidemiology and incidence of severe respiratory critical events in ear, nose and throat surgery in children in Europe: A prospective multicentre observational study. Eur J Anaesthesiol. 2019 Mar;36(3):185-193. doi: 10.1097/EJA.0000000000000951.
citation: Engelhardt T, Virag K, Veyckemans F, Habre W; APRICOT Group of the European Society of Anaesthesiology Clinical Trial Network. Airway management in paediatric anaesthesia in Europe-insights from APRICOT (Anaesthesia Practice In Children Observational Trial): a prospective multicentre observational study in 261 hospitals in Europe. Br J Anaesth. 2018 Jul;121(1):66-75. doi: 10.1016/j.bja.2018.04.013. Epub 2018 May 18.
citation: Habre W, Disma N, Virag K, Becke K, Hansen TG, Johr M, Leva B, Morton NS, Vermeulen PM, Zielinska M, Boda K, Veyckemans F; APRICOT Group of the European Society of Anaesthesiology Clinical Trial Network. Incidence of severe critical events in paediatric anaesthesia (APRICOT): a prospective multicentre observational study in 261 hospitals in Europe. Lancet Respir Med. 2017 May;5(5):412-425. doi: 10.1016/S2213-2600(17)30116-9. Epub 2017 Mar 28.