APRICOT: Anaesthesia PRactice In Children Observational Trial

Children Clinical Trial

— APRICOT  

Official title:

APRICOT: Anaesthesia PRactice In Children Observational Trial - European Prospective Multicenter Observational Study: Epidemiology of Severe Critical Events in Paediatric Anaesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01878760
• Other study ID #: APRICOT
• Status: Completed
• Phase: N/A
• First received: May 28, 2013
• Last updated: October 12, 2015
• Start date: March 2014
• Est. completion date: April 2015

Study information

• Verified date: October 2015
• Source: European Society of Anaesthesiology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics CommitteeSwitzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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).

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 information / eligibility

• 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anaesthesia
• Children

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
European Society of Anaesthesiology

Countries where clinical trial is conducted

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, 

Outcome

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

External Links

•   European Society of Anaesthesiology Clinical Trial Network website