APRICOT: Anaesthesia PRactice In Children Observational Trial

NCT ID: NCT01878760

Last Updated: 2015-10-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-04-30

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.

Conditions

Anaesthesia; Children

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Society of Anaesthesiology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Walid Habre, M.D.

Role: STUDY_CHAIR

University Hospital, Geneva

Francis Veyckemans, M.D.

Role: STUDY_DIRECTOR

Cliniques Universitaires St Luc asbl Brussels

Locations

Medical University Graz

Graz, , Austria

Cliniques Universitaires St Luc

Brussels, , Belgium

General Hospital Pula

Pula, , Croatia

University Children´s Hospital

Brno, , Czechia

Odense University Hospital

Odense, , Denmark

Tartu University Hospital

Tartu, , Estonia

Oulu University Hospital

Oulu, , Finland

Turku University Hospital

Turku, , Finland

CHU Lille

Lille, , France

Lapeyronie University Hospital

Montpellier, , France

Universitaetsklinikum Leipzig

Leipzig, , Germany

Cnopf'sche Kinderklinik/Klinik Hallerwiese

Nuremberg, , Germany

Asklepios Klinik Sankt Augustin GmbH - Department of Paediatric Anaesthesia

Sankt Augustin, , Germany

Gibraltar Health Authority, St. Bernard´s Hospital

Gibraltar, , Gibraltar

Children Hospital P&A Kyriakoy

Athens, , Greece

Our Ladys Children's Hospital

Dublin, , Ireland

Schneider Children's Medical center of Israel

Petah Tikva, , Israel

Instituto Giannina Gaslini

Genoa, , Italy

University Clinical Center of Kosovo

Pristina, , Kosovo

Children University Hospital

Riga, , Latvia

Vilnius Children Hospital

Vilnius, , Lithuania

Mater Dei Hospital MSD

Msida, , Malta

Maastricht University Medical Center MUMC

Maastricht, , Netherlands

Oslo University Hospital, Rikshospitalet

Oslo, , Norway

Clinical University Hospital Department of Anaesthesiology and Intensive Care

Wroclaw, , Poland

Centro Hospitalar Lisboa Norte - Hospital de Santa Maria

Lisbon, , Portugal

Spitalul de Copiin Maria Curie

Bucharest, , Romania

Pirogov Russian National Research Medical University

Moscow, , Russia

University Childrens hospital

Belgrade, , Serbia

Paediatric District Hospital

Banská Bystrica, , Slovakia

University Klinical Centre Ljubljana

Ljubljana, , Slovenia

Hospital Sant Joan Déu

Esplugues de Llobregat, , Spain

Queen Silvis Childrens Hospital Sahlgrens University Hospital

Gothenburg, , Sweden

Geneva University Hospitals

Geneva, , Switzerland

Anästhesie Kinderspital Klinik für Anästhesie, Intensivmedizin, Rettungsmedizin und Schmerztherapie (KLIFAIRS) Luzerner Kantonsspital Spitalstrasse

Lucerne, , Switzerland

Cukurova University Faculty Of Medicine

Adana, , Turkey (Türkiye)

P.L.Shupyk National Medical Academy of Postgraduate Education, Municipal Children's Hospital #1

Kyiv, , Ukraine

Royal Hospital For Sick Children

Glasgow, Scotland, United Kingdom

Countries

Austria; Belgium; Croatia; Czechia; Denmark; Estonia; Finland; France; Germany; Gibraltar; Greece; Ireland; Israel; Italy; Kosovo; Latvia; Lithuania; Malta; Netherlands; Norway; Poland; Portugal; Romania; Russia; Serbia; Slovakia; Slovenia; Spain; Sweden; Switzerland; Turkey (Türkiye); Ukraine; United Kingdom

References

Dagher K, Benvenuti C, Virag K, Habre W. The Incidence of Postoperative Complications Following Lumbar and Bone Marrow Punctures in Pediatric Anesthesia: Insights From APRICOT. J Pediatr Hematol Oncol. 2024 Apr 1;46(3):165-171. doi: 10.1097/MPH.0000000000002849. Epub 2024 Mar 4.

Reference Type: DERIVED

PMID: 38447107 (View on PubMed)

Dahmani S, Laffargue A, Dadure C, Veyckemans F; French APRICOT trial group. Description of practices and complications in the French centres that participated to APRICOT: A secondary analysis. Anaesth Crit Care Pain Med. 2019 Dec;38(6):637-645. doi: 10.1016/j.accpm.2019.06.001. Epub 2019 Jun 11.

Reference Type: DERIVED

PMID: 31200009 (View on PubMed)

Virag K, Sabourdin N, Thomas M, Veyckemans F, Habre W; APRICOT Group of the European Society of Anaesthesiology Clinical Trial Network. Epidemiology and incidence of severe respiratory critical events in ear, nose and throat surgery in children in Europe: A prospective multicentre observational study. Eur J Anaesthesiol. 2019 Mar;36(3):185-193. doi: 10.1097/EJA.0000000000000951.

Reference Type: DERIVED

PMID: 30640246 (View on PubMed)

Engelhardt T, Virag K, Veyckemans F, Habre W; APRICOT Group of the European Society of Anaesthesiology Clinical Trial Network. Airway management in paediatric anaesthesia in Europe-insights from APRICOT (Anaesthesia Practice In Children Observational Trial): a prospective multicentre observational study in 261 hospitals in Europe. Br J Anaesth. 2018 Jul;121(1):66-75. doi: 10.1016/j.bja.2018.04.013. Epub 2018 May 18.

Reference Type: DERIVED

PMID: 29935596 (View on PubMed)

Habre W, Disma N, Virag K, Becke K, Hansen TG, Johr M, Leva B, Morton NS, Vermeulen PM, Zielinska M, Boda K, Veyckemans F; APRICOT Group of the European Society of Anaesthesiology Clinical Trial Network. Incidence of severe critical events in paediatric anaesthesia (APRICOT): a prospective multicentre observational study in 261 hospitals in Europe. Lancet Respir Med. 2017 May;5(5):412-425. doi: 10.1016/S2213-2600(17)30116-9. Epub 2017 Mar 28.

Reference Type: DERIVED

PMID: 28363725 (View on PubMed)

Other Identifiers

APRICOT

Identifier Type: -

Identifier Source: org_study_id