AnaesthesiaAPRICOTNCT01878760
APRICOT: Anaesthesia PRactice In Children Observational Trial
An observational study of Anaesthesia and Children, run by European Society of Anaesthesiology at 38 sites in 33 countries.
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. Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Anaesthesia, Children
- How many people
- 30,000 participants
- Where
- 38 sitesin 33 countries
- Study dates
- Mar 2014to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 15 years
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
38 sites in 33 countries.
38 sites in 33 countries
Germany3 sites
Universitaetsklinikum Leipzig
Leipzig, 04103
Cnopf'sche Kinderklinik/Klinik Hallerwiese
Nuremberg, 90419
Asklepios Klinik Sankt Augustin GmbH - Department of Paediatric Anaesthesia
Sankt Augustin, 53757
Finland2 sites
Oulu University Hospital
Oulu, 90220
Turku University Hospital
Turku, 20521
Switzerland2 sites
Geneva University Hospitals
Geneva
Anästhesie Kinderspital Klinik für Anästhesie, Intensivmedizin, Rettungsmedizin und Schmerztherapie (KLIFAIRS) Luzerner Kantonsspital Spitalstrasse
Lucerne, 6000
Gibraltar1 site
Gibraltar Health Authority, St. Bernard´s Hospital
Gibraltar, 11111
Poland1 site
Clinical University Hospital Department of Anaesthesiology and Intensive Care
Wroclaw, 50-556
Portugal1 site
Centro Hospitalar Lisboa Norte - Hospital de Santa Maria
Lisbon, 1649-035
Russia1 site
Pirogov Russian National Research Medical University
Moscow, 117997
Sweden1 site
Queen Silvis Childrens Hospital Sahlgrens University Hospital
Gothenburg, SE 41685
Turkey (Türkiye)1 site
Cukurova University Faculty Of Medicine
Adana, 01330
Ukraine1 site
P.L.Shupyk National Medical Academy of Postgraduate Education, Municipal Children's Hospital #1
Kyiv, 4209
United Kingdom1 site
Royal Hospital For Sick Children
Glasgow, Scotland, G3 8SJ
About this study
Official title: APRICOT: Anaesthesia PRactice In Children Observational Trial - European Prospective Multicenter Observational Study: Epidemiology of Severe Critical Events in Paediatric Anaesthesia
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).
Read the 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
- Keywords
- APRICOT, Anaesthesia, Children, kids, Paediatric Anaesthesia, Observational Trial, epidemiology, severe critical events in, European Society of Anaesthesiology, Europe
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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.
Measured: 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).
Measured: in-hospital and up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2013 (estimated)
- Study startMar 2014
- Primary completionJan 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AnaesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Society of Anaesthesiology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Walid Habre, M.D., Study chair, University Hospital, GenevaFrancis Veyckemans, M.D., Study director, Cliniques Universitaires St Luc asbl Brussels
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01878760
- Sponsor's protocol ID
- APRICOT
- Acronym
- APRICOT
- Status last verified
- Oct 2015
- First submitted
- 28 May 2013
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 38447107Dahmani 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.
PubMed 31200009Virag 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.
PubMed 30640246Engelhardt 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.
PubMed 29935596Habre 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.
PubMed 28363725
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- APRICOT: Anaesthesia PRactice In Children Observational Trial - European Prospective Multicenter Observational Study: Epidemiology of Severe Critical Events in Paediatric Anaesthesia
- ClinicalTrials.gov ID
- NCT01878760
- Acronym / sponsor ID
- APRICOT / APRICOT
- Conditions
- Anaesthesia, Children
- Keywords
- APRICOT, Anaesthesia, Children, kids, Paediatric Anaesthesia, Observational Trial, epidemiology, severe critical events in
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30,000 participants (actual)
- Lead sponsor
- European Society of AnaesthesiologyUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 17 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of severe critical events
Time frame: Children will be followed for the duration of their anaesthesia procedure and up to 60 minutes afterwards
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)
2 secondary outcomes
Risk factors for the occurrence of severe critical events
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
Time frame: in-hospital and up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
- Derived from this study: PubMed 38447107Dagher 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.
- Derived from this study: PubMed 31200009Dahmani 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.
- Derived from this study: PubMed 30640246Virag 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.
- Derived from this study: PubMed 29935596Engelhardt 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.
- Derived from this study: PubMed 28363725Habre 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walid Habre, M.D. study chair
University Hospital, Geneva
Francis Veyckemans, M.D. study director
Cliniques Universitaires St Luc asbl Brussels
38 sites in 33 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anaesthesia and Children, run by European Society of Anaesthesiology at 38 sites in 33 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in Germany, Finland, France, Switzerland, Austria and 28 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of severe critical events (time frame: Children will be followed for the duration of their anaesthesia procedure and up to 60 minutes afterwards). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01878760, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2015.