An observational study in Anaesthesia and Children, sponsored by European Society of Anaesthesiology. Completed at 38 sites in 33 countries. Open to participants aged Up to 15 Years. Per ClinicalTrials.gov, last updated 2015-10-14.
Sponsored by European Society of Anaesthesiology · Observational
The aims of the APRICOT study are:
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.
European Society of Anaesthesiology is the lead sponsor of 17 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Time frame: Children will be followed for the duration of their anaesthesia procedure and up to 60 minutes afterwards
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.
Time frame: Children will be followed for the duration of their anaesthesia procedure and up to 60 minutes afterwards
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).
Time frame: in-hospital and up to 30 days
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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European Society of Anaesthesiology