Children Clinical Trial
— APRICOTOfficial title:
APRICOT: Anaesthesia PRactice In Children Observational Trial - European Prospective Multicenter Observational Study: Epidemiology of Severe Critical Events in Paediatric Anaesthesia
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).
Status | Completed |
Enrollment | 30000 |
Est. completion date | April 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 15 Years |
Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Austria | Medical University Graz | Graz | |
Belgium | Cliniques Universitaires St Luc | Bruxelles | |
Croatia | General Hospital Pula | Pula | |
Czech Republic | University Children´s Hospital | Brno | |
Denmark | Odense University Hospital | Odense | |
Estonia | Tartu University Hospital | Tartu | |
Finland | Oulu University Hospital | Oulu | |
Finland | Turku University Hospital | Turku | |
France | CHU Lille | Lille | |
France | Lapeyronie University Hospital | Montpellier | |
Germany | Universitaetsklinikum Leipzig | Leipzig | |
Germany | Cnopf'sche Kinderklinik/Klinik Hallerwiese | Nürnberg | |
Germany | Asklepios Klinik Sankt Augustin GmbH - Department of Paediatric Anaesthesia | Sankt Augustin | |
Gibraltar | Gibraltar Health Authority, St. Bernard´s Hospital | Gibraltar | |
Greece | Children Hospital P&A Kyriakoy | Athens | |
Ireland | Our Ladys Children's Hospital | Dublin | |
Israel | Schneider Children's Medical center of Israel | Petah Tiqwa | |
Italy | Instituto Giannina Gaslini | Genoa | |
Kosovo | University Clinical Center of Kosovo | Prishtina | |
Latvia | Children University Hospital | Riga | |
Lithuania | Vilnius Children Hospital | Vilnius | |
Malta | Mater Dei Hospital MSD | Msida | |
Netherlands | Maastricht University Medical Center MUMC | Maastricht | |
Norway | Oslo University Hospital, Rikshospitalet | Oslo | |
Poland | Clinical University Hospital Department of Anaesthesiology and Intensive Care | Wroclaw | |
Portugal | Centro Hospitalar Lisboa Norte - Hospital de Santa Maria | Lisbon | |
Romania | Spitalul de Copiin Maria Curie | Bucharest | |
Russian Federation | Pirogov Russian National Research Medical University | Moscow | |
Serbia | University Childrens hospital | Belgrade | |
Slovakia | Paediatric District Hospital | Banska Bystrica | |
Slovenia | University Klinical Centre Ljubljana | Ljubljana | |
Spain | Hospital Sant Joan Déu | Esplugues de Llobregat | |
Sweden | Queen Silvis Childrens Hospital Sahlgrens University Hospital | Gothenburg | |
Switzerland | Geneva University Hospitals | Geneva | |
Switzerland | Anästhesie Kinderspital Klinik für Anästhesie, Intensivmedizin, Rettungsmedizin und Schmerztherapie (KLIFAIRS) Luzerner Kantonsspital Spitalstrasse | Luzern | |
Turkey | Cukurova University Faculty Of Medicine | Adana | |
Ukraine | P.L.Shupyk National Medical Academy of Postgraduate Education, Municipal Children's Hospital #1 | Kyiv | |
United Kingdom | Royal Hospital For Sick Children | Glasgow | Scotland |
Lead Sponsor | Collaborator |
---|---|
European Society of Anaesthesiology |
Austria, Belgium, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Gibraltar, Greece, Ireland, Israel, Italy, Kosovo, Latvia, Lithuania, Malta, Netherlands, Norway, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of severe critical events | Incidence of the following severe critical events defined as any incident occurring during and up to 60 minutes after anaesthesia or sedation (PACU), requiring immediate intervention and that may lead to major disability and/or death: Laryngospasm Bronchospasm Pulmonary aspiration Drug error Anaphylaxis Cardiovascular instability Neurological damage Perianaesthetic Cardiac arrest Postanaesthetic Stridor (in the PACU) |
Children will be followed for the duration of their anaesthesia procedure and up to 60 minutes afterwards | No |
Secondary | Risk factors for the occurrence of severe critical events | Assessment of risk factors will be achieved by collecting data on social and demographic data of the patients, family and child's medical history, presence of co-morbidities, details on anesthesia procedure, elective or emergency cases, level of experience of the anesthesiologist, postoperative prescriptions. | Children will be followed for the duration of their anaesthesia procedure and up to 60 minutes afterwards | No |
Secondary | Consequences of the critical events: irreversible damage, in-hospital mortality | Consequences of critical events: no harm, minor sequelae, irreversible damage, in-hospital mortality (up to 30 days or discharge). | in-hospital and up to 30 days | No |
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