APRICOT: Anaesthesia PRactice In Children Observational Trial

NCT01878760 | Completed

• 1 other identifier: APRICOT
• Study Type: observational
• Target: 30,000
• Locations: 30 countries
• Sites: 35

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).

Conditions

Anaesthesia; Children

Keywords

APRICOT; Anaesthesia; Children; kids; Paediatric Anaesthesia; Observational Trial; epidemiology; severe critical events in; European Society of Anaesthesiology; Europe

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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

• Consequences of the critical events: irreversible damage, in-hospital mortality

  in-hospital and up to 30 days

Eligibility Criteria

• Age: Up to 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• European Society of Anaesthesiology: lead

Study Sites (38)

Medical University Graz

Graz, A-8034, Austria

Location

Cliniques Universitaires St Luc

Brussels, 1200, Belgium

Location

General Hospital Pula

Pula, 52100, Croatia

Location

University Children´s Hospital

Brno, 61300, Czechia

Location

Odense University Hospital

Odense, Denmark

Location

Tartu University Hospital

Tartu, 51014, Estonia

Location

Oulu University Hospital

Oulu, 90220, Finland

Location

Turku University Hospital

Turku, 20521, Finland

Location

CHU Lille

Lille, France

Location

Lapeyronie University Hospital

Montpellier, 34000, France

Location

Universitaetsklinikum Leipzig

Leipzig, 04103, Germany

Location

Cnopf'sche Kinderklinik/Klinik Hallerwiese

Nuremberg, 90419, Germany

Location

Asklepios Klinik Sankt Augustin GmbH - Department of Paediatric Anaesthesia

Sankt Augustin, 53757, Germany

Location

Gibraltar Health Authority, St. Bernard´s Hospital

Gibraltar, 11111, Gibraltar

Location

Children Hospital P&A Kyriakoy

Athens, 11527, Greece

Location

Our Ladys Children's Hospital

Dublin, 12, Ireland

Location

Schneider Children's Medical center of Israel

Petah Tikva, 49202, Israel

Location

Instituto Giannina Gaslini

Genoa, 6100, Italy

Location

University Clinical Center of Kosovo

Pristina, 10000, Kosovo

Location

Children University Hospital

Riga, 1004, Latvia

Location

Vilnius Children Hospital

Vilnius, 8406, Lithuania

Location

Mater Dei Hospital MSD

Msida, 2090, Malta

Location

Maastricht University Medical Center MUMC

Maastricht, Netherlands

Location

Oslo University Hospital, Rikshospitalet

Oslo, 421, Norway

Location

Clinical University Hospital Department of Anaesthesiology and Intensive Care

Wroclaw, 50-556, Poland

Location

Centro Hospitalar Lisboa Norte - Hospital de Santa Maria

Lisbon, 1649-035, Portugal

Location

Spitalul de Copiin Maria Curie

Bucharest, 41451, Romania

Location

Pirogov Russian National Research Medical University

Moscow, 117997, Russia

Location

University Childrens hospital

Belgrade, 11000, Serbia

Location

Paediatric District Hospital

Banská Bystrica, 97409, Slovakia

Location

University Klinical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

Hospital Sant Joan Déu

Esplugues de Llobregat, 8950, Spain

Location

Queen Silvis Childrens Hospital Sahlgrens University Hospital

Gothenburg, SE 41685, Sweden

Location

Geneva University Hospitals

Geneva, Switzerland

Location

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

Lucerne, 6000, Switzerland

Location

Cukurova University Faculty Of Medicine

Adana, 01330, Turkey (Türkiye)

Location

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

Kyiv, 4209, Ukraine

Location

Royal Hospital For Sick Children

Glasgow, Scotland, G3 8SJ, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 38447107 DERIVED

• 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.

  PMID: 31200009 DERIVED

• 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.

  PMID: 30640246 DERIVED

• 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.

  PMID: 29935596 DERIVED

• 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.

  PMID: 28363725 DERIVED

Study Officials

• Walid Habre, M.D.

  University Hospital, Geneva

  STUDY CHAIR

• Francis Veyckemans, M.D.

  Cliniques Universitaires St Luc asbl Brussels

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2013
• First Posted: June 17, 2013
• Study Start: March 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: April 1, 2015
• Last Updated: October 14, 2015

Record last verified: 2015-10

Locations

AU (1); GR (1); LI (1); BE (1); GI (1); PL (1); IE (1); SE (1); ES (1); UA (1); DE (3); IT (1); NO (1); SL (1); FR (2); RO (1); GB (1); DK (1); IL (1); LA (1); RU (1); CR (1); KO (1); PT (1); NL (1); FI (2); MA (1); CH (2); CZ (1); TU (1)