The NECTARINE project
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The APRICOT project
Walid Habre and Francis Veyckemans proposed a research project entitled “Anaesthesia Practice In Children an Observational Trial (APRICOT)” to the Clinical Trial Network of the European Society for Anaesthesiologists (ESA) and the Scientific Committee of the European Society for Paediatric Anaesthesiology (ESPA). Both Committees accepted to support this project and a common steering committee has been appointed.
The aims of the APRICOT study are:
- to describe the differences in pediatric anesthesia practice throughout Europe
- to establish the incidence of severe critical events in children undergoing anesthesia in Europe
- to study the potential impact of this variability on the occurrence of some severe critical events : e.g., laryngospasm, bronchospasm, aspiration, anaphylaxis, cardiovascular instability, neurological damage and cardiac arrest
It will thus be a prospective observational multi–center cohort study.
The patients’ inclusion criteria are:
- age: from birth to 15 years included
- all children admitted for an inpatient or outpatient procedure under general anaesthesia with or without regional analgesia
- children admitted for a diagnostic procedure under general anesthesia (such as endoscopy, radiology…)
- children admitted out-of-hours for emergency procedures
This study will recruit as many participating institutions as possible among the 30 European countries represented at the ESA Council. It is planned to recruit at least 24,000 children over a period of two consecutive weeks including weekends and after-hours. The 2-weeks recruitment period will be chosen by each site to occur between 1st April 2014 and 31st December 2014. The study designers anticipate that a total number of at least 200 centres will be needed to include between 20 and 200 children over the 2 weeks period.
In order to obtain the largest view possible on pediatric anesthesia in each countries, every hospital is invited to participate whether it is academic, specialized in pediatric care, a district general hospital, a private hospital or a small hospital. The participation of all the BAPA members but also of colleagues whose anesthetic practice is occasional is strongly encouraged.
Each centre will have a local coordinator. Each country will have one or two national coordinators who will ensure that all participating centres in her/his country are in accordance with the study protocol. The study CRF protocol is currently being written and will be tested on the field in a few centers before being distributed among participating centers. In short, epidemiologic and anesthetic data of every anesthetic will be summarized on an anonymized CRF protocol. The latter will have to be completed on a secured website by the local coordinator.
The study will be launched as soon as possible but will not start before April 1st 2014 to allow each center to obtain its Ethical Committee advice (parental consent needed or waived, depending on the national and local regulations) in time.