APRICOT: Anaesthesia PRactice In Children Observational Trial
- Conditions
- ChildrenAnaesthesia
- Registration Number
- NCT01878760
- Lead Sponsor
- European Society of Anaesthesiology
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30000
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of severe critical events Children will be followed for the duration of their anaesthesia procedure and up to 60 minutes afterwards 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)
- Secondary Outcome Measures
Name Time Method Risk factors for the occurrence of severe critical events Children will be followed for the duration of their anaesthesia procedure and up to 60 minutes afterwards 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.
Consequences of the critical events: irreversible damage, in-hospital mortality in-hospital and up to 30 days Consequences of critical events: no harm, minor sequelae, irreversible damage, in-hospital mortality (up to 30 days or discharge).
Trial Locations
- Locations (38)
Cliniques Universitaires St Luc
🇧🇪Bruxelles, Belgium
General Hospital Pula
ðŸ‡ðŸ‡·Pula, Croatia
Medical University Graz
🇦🇹Graz, Austria
University Children´s Hospital
🇨🇿Brno, Czech Republic
Tartu University Hospital
🇪🇪Tartu, Estonia
Odense University Hospital
🇩🇰Odense, Denmark
Turku University Hospital
🇫🇮Turku, Finland
Oulu University Hospital
🇫🇮Oulu, Finland
CHU Lille
🇫🇷Lille, France
Lapeyronie University Hospital
🇫🇷Montpellier, France
Universitaetsklinikum Leipzig
🇩🇪Leipzig, Germany
Cnopf'sche Kinderklinik/Klinik Hallerwiese
🇩🇪Nürnberg, Germany
Gibraltar Health Authority, St. Bernard´s Hospital
🇬🇮Gibraltar, Gibraltar
Asklepios Klinik Sankt Augustin GmbH - Department of Paediatric Anaesthesia
🇩🇪Sankt Augustin, Germany
Children Hospital P&A Kyriakoy
🇬🇷Athens, Greece
Schneider Children's Medical center of Israel
🇮🇱Petah Tiqwa, Israel
Instituto Giannina Gaslini
🇮🇹Genoa, Italy
University Clinical Center of Kosovo
Prishtina, Kosovo
Children University Hospital
🇱🇻Riga, Latvia
Vilnius Children Hospital
🇱🇹Vilnius, Lithuania
Maastricht University Medical Center MUMC
🇳🇱Maastricht, Netherlands
Mater Dei Hospital MSD
🇲🇹Msida, Malta
Oslo University Hospital, Rikshospitalet
🇳🇴Oslo, Norway
Spitalul de Copiin Maria Curie
🇷🇴Bucharest, Romania
Clinical University Hospital Department of Anaesthesiology and Intensive Care
🇵🇱Wroclaw, Poland
Pirogov Russian National Research Medical University
🇷🇺Moscow, Russian Federation
University Childrens hospital
🇷🇸Belgrade, Serbia
University Klinical Centre Ljubljana
🇸🇮Ljubljana, Slovenia
Hospital Sant Joan Déu
🇪🇸Esplugues de Llobregat, Spain
Geneva University Hospitals
🇨ðŸ‡Geneva, Switzerland
Anästhesie Kinderspital Klinik für Anästhesie, Intensivmedizin, Rettungsmedizin und Schmerztherapie (KLIFAIRS) Luzerner Kantonsspital Spitalstrasse
🇨ðŸ‡Luzern, Switzerland
Cukurova University Faculty Of Medicine
🇹🇷Adana, Turkey
P.L.Shupyk National Medical Academy of Postgraduate Education, Municipal Children's Hospital #1
🇺🇦Kyiv, Ukraine
Queen Silvis Childrens Hospital Sahlgrens University Hospital
🇸🇪Gothenburg, Sweden
Royal Hospital For Sick Children
🇬🇧Glasgow, Scotland, United Kingdom
Our Ladys Children's Hospital
🇮🇪Dublin, Ireland
Centro Hospitalar Lisboa Norte - Hospital de Santa Maria
🇵🇹Lisbon, Portugal
Paediatric District Hospital
🇸🇰Banska Bystrica, Slovakia