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SIAARTI-SARNePI Clinical-Organizational Standards

for paediatric anaesthesia

Edoardo Calderini *, Nicola Disma **, Laura Lorenzini *, Maria Cristina Mondardini **,

Sergio Picardo *, Ida Salvo *, Maria Sammartino **, Simonetta Tesoro **

* SIAARTI member

** SARNePI member

1. Aim and field of application

This document was drawn up by a Joint Committee of two Italian scientific societies: SIAARTI (Società

Italiana di Anestesia, Rianimazione e Terapia Intensiva) and SARNePI (Società Italiana di Anestesia,

Rianimazione Neonatale e Pediatrica). It sets out the clinical standards aimed at limiting the risk of major

complications during general or regional anaesthesia, or deep sedation, in children. These standards are

based on analysis of the literature and the expertise of the Committee members. The document will be

regularly updated in the light of future scientific evidence and the recommended process of centralization of

children’s care.

2. To whom the document is addressed

The document is intended for anaesthetists who have a regular commitment to paediatric anaesthesia or those

with occasional paediatric practice. The standards proposed should also be helpful for hospital managers in

scheduling paediatric surgery for the different specialities.

3. Content

3.1 Background

3.1.1 Incidents in anaesthesia and risk factors

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The incidence of major critical events, with risk of death, cardiac arrest, or serious long lasting neurologic

damage is significantly higher in children undergoing anaesthesia than in adults (1-3). The following risk

factors for major critical events have been identified (4-6):

i. The child’s age, particularly under the age of one year, and even grater risk under one month;

ii. The co-morbidity and severity of the acute pathology (ASA ≥ III);

iii. The operator(s)’ experience;

iv. The level of emergency/urgency.

Premature babies requiring anaesthesia are the paediatric population at greatest risk, and their mortality is

approximately double that of term infants (7-11).

3.1.2 Competencies in paediatric anaesthesia

The literature illustrates the correlation between the number of anaesthetics performed by each individual

anaesthetist and the complications, in adults (12) and children (13). Auroy et al. reported that fewer than 200

anaesthetics/year doubled the rate of critical events in children (14), and Zgleszewsky et al. (6) found an

inverse correlation between the number of days spent on paediatric anaesthesia and the risk of peri-operative

cardiac arrest. These figures have served to propose a minimum number of anaesthetics administered per

year by each anaesthetist in order to maintain his/her paediatric anaesthesiology skills (15). Some European

countries recommend solutions such as having two anaesthetists in attendance at induction and awakening,

for the smallest children. In France, children under the age of three years are treated only in centralized

specialized hospitals (16). In the USA, the specific features of paediatric anaesthesiology have led to the

recognition of a sub-speciality in this area, and some Northern European countries run ad hoc university and

post-graduate training courses.

3.1.3 Paediatric surgical admissions in Italy

To enable us to draw up a picture of paediatric anaesthesia in Italy, the Ministry of Health was asked to

provide a database of hospital discharges after in-patient or day-case surgery, for the population under the

age of 18 years, in 2014. The data were then statistically analysed by the Istituto Superiore di Sanità

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(National Institute of Health). The figures do not include sedation or anaesthesia for diagnostic or therapeutic

procedures that did not lead to a surgical diagnosis-related group (DRG): endoscopy, radiological

investigations, etc. Analysis of this data indicated that 68% of patients aged less than 18 years were

inappropriately admitted to adult wards. The figure was lower (41%) for children aged three years or less,

and 30% for those younger than one year, but these inappropriate admissions are still unacceptably high

(Appendix 1). The Code for the Rights of Minors to Health and healthcare services, issued by the Italian

Ministry of Health in 2012, specifies that children should always be cared for in paediatric departments (17).

These figures also highlighted the extreme fragmentation of paediatric care in Italy, which is dealt with in no

fewer than 875 centres, though with significant differences from one Region to another. This exposes

children to the potential of additional risks resulting from the limited experience of the healthcare teams in

hospitals with small paediatric caseload. In terms of risk management this splintered organization is

considered a ‘latent or system error’ and can raise the likelihood of adverse events.

3.1.4 Regional paediatric network

As part of the overall design for the hospital network, Law no. 135 dated 7 August 2012 specifies the

division into pathology networks, and makes reference to a specific paediatric network, to be organized by

the Regions. Appendix 2 illustrates a proposal for the organization of a network of paediatric hospitals, on

the basis of the Hub&Spoke model, in accordance with the details of the law (18), which specify

concentrating the most complex cases in a limited number of “hubs” – hospitals which will work closely

with the peripheral “spokes”.

3.2. Clinical-organizational standards for paediatric anaesthesia

Based on the above discussed points, the SIAARTI-SARNePI Committee proposes the following clinical

standards for paediatric anaesthesia, which takes into account of the complexity of the situation in Italy and

which will have to be updated in the future in the light of the most recent knowledge and the changes of the

organizational patterns.

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1. All children should always be assigned to paediatric departments where they will receive care in

dedicated areas, in the pre-admission zone and in the surgical block. Paediatric operating lists must

be separate from those for adults, and children must be managed by dedicated staff with specific

paediatric experience.

2. Paediatric anaesthesia should be part of a paediatric care network organized in three levels of

hospitals (Base Spoke, Levels I Spoke and Level II Spoke or Hub) (Appendix 2). The main points in

the network are:

a. centralization towards higher level of Paediatric Care: the decisive points are the patient’s

age, ASA classification, the availability of specialized paediatric anaesthetists (discussed in

section 3), and the complexity of the operation (see flow charts in Figs 1 and 2).

b. An efficient transport system able to ensure prompt, safe transfer to the most appropriate

centre.

c. Adequate training for the management of paediatric emergencies and urgencies,

especially in spoke hospitals where there is no specialist in paediatric anaesthesia or

paediatric intensivist, following a dedicated protocol, agreed with the strategic management.

As required by a law dated 30 December 2004, a paediatric care network should be set up, on a

regional or supra-regional basis, on the Hub&Spoke model, where there is not yet one active.

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(*) Individual anesthetist’s minimum experience:

• 150 anesthetics/year for children < 10 years, of which:

-40 anesthetics/year forchildren < 3 years-10 anesthetics/year forchildren < 6 months

Figure 1 – Organizational flow chart for paediatric anaesthesia for elective surgery.

SURGERYSURGERY

YESYES

LEVEL II SPOKE (HUB)LEVEL II SPOKE (HUB)

LEVEL I SPOKELEVEL I SPOKE

NONO

SURGERYSURGERYAge < 3 yrs or

ASA score > II orHighly complex surgery ?

Paediatric competence ? (*)YESYESNONO

ElectiveElectivepaediatricpaediatric

surgerysurgery

BASEBASE SPOKESPOKE

Figure 1 – Organizational flow chart for paediatric anaesthesia for elective surgery.

Figure 2 – Organizational flow chart for emergency

SURGERYSURGERY

YESYES

NONOSURGERYSURGERY

Age < 3 yrs orASA score > II orHighly complex

surgery?

Paediatriccompetence ? (*)

YESYES

Stabilization of vital signs

Age < 3 yrs orASA score > II or Highly complexsurgery ?

YESYES

NONO

Stabilization of vital signs

Stabilization of vital signs

NONO

UrgentUrgentpaediatricpaediatric

surgerysurgery

LEVEL II SPOKE (HUB)LEVEL II SPOKE (HUB)

LEVEL I SPOKELEVEL I SPOKE

BASEBASE SPOKESPOKE

Figure 2 - Organizational flow chart for centralising pediatric anesthesiology in emergency/urgency situations

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3. The hospitals where paediatric surgery is performed should prepare an operating procedure,

agreed by the head of the Anaesthesia and Intensive Care Department and the Hospital Management,

mentioning the minimum number of anaesthetics administered that are considered necessary to

maintain the skills of the paediatric care team. If these are not indicated, the Committee suggests the

following numbers per individual anaesthetist, to minimize the risk of peri-operative critical events:

150 deep sedations/anaesthetics in children under the age of 10 years, of which

i. 40 deep sedations/anaesthetics in children under the age of 3 years,

ii. 10 deep sedations/anaesthetics in children under the age of 6 months.

The Committee recommends that nursing staff assisting the anaesthetist should have the same level

of experience.

4. A nurse dedicated to anaesthesia, with all the necessary skills, should always be present when an

anaesthetic is being used.

5. All children requiring anaesthesia should be assessed in advance by an anaesthetist.

6. A paediatric anaesthesia unit requires certain basic equipment and features, as follows (19-20):

a. The premises used for paediatric care should always have room for parents, or caregivers,

who should be separated from the children for as short a time as possible. The pre-operative

and recovery areas in this surgical block should therefore be separate from zones for adults.

All hospitals without paediatric intensive care facilities should maintain an area equipped for

children in critical conditions.

b. Hospitals where paediatric anaesthesia is employed should be fully equipped for the care of

children, with all devices of the appropriate sizes for children of different ages. This will

have to include:

Emergency trolley(s) with all the necessary monitoring equipment, defibrillator with

paediatric plates, vasoactive drugs and dantrolene (according to the hospital procedure).

The trolley should have a check-list naming the drugs for use in an emergency, their

concentrations and dosages.

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A trolley equipped for dealing with difficult paediatric airways, including a

laryngoscope and video-laryngoscope, with blades of different sizes, face and laryngeal

masks, endotracheal tubes, stylets, fibreoptic scope with adequate sizes for all ages, and

instruments for rapid tracheal access, as recommended by SIAARTI for the

management of difficult airways in children (21).

Anaesthesia equipment, with a ventilator adequate for paediatric use, EKG and heart

rate monitor, pulse oximeter, capnometer, oxygen, and halogenated agents, and pressure

monitor, as specified in the SIAARTI standards for minimal monitoring equipment

(22).

Temperature control equipment: heat lamps, body and fluid warming systems,

medical gas humidifiers, room temperature control systems, body temperature monitors.

Systems for infusion of fluids including volumetric pumps. Syringe-pump for drugs.

Peripheral and central venous catheters; intra-osseous needles and arterial catheters in

all sizes.

Ultrasound with paediatric probes for central venous cannulation.

Trolley for moving all paediatric monitoring equipment and ventilator.

All hospitals should have internally approved protocols for treating emergencies: anaphylactic

shock, airway obstruction, local anaesthetics toxicity, malignant hyperthermia.

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4. Regulatory references and bibliography

1. Gonzalez LP, Pignaton W, Kusano PS, Mo´dolo NSP, Braz JRC, Braz LG. Anesthesia-related mortality in

pediatric patients: a systematic review. Clinics 2012; 67:381-7.

2. Morray J, Geiduschek J, Ramamoorthy C, Haberkern CM, Hackel A, Caplan RA, et al. Anesthesia-related

cardiac arrest in children. Anesthesiology 2000; 93: 6–14.

3. Arbous MS, Meursing AE, van Kleef JW, de Lange JJ, Spoormans HH, Touw P, et al. Impact of anesthesia

management characteristics on severe morbidity and mortality. Anesthesiology 2005;102:257-68.

4. Fiadjoe JE, Nishisaki A, Jagannathan N, Hunyady AI, Greenberg RS, Reynolds PI, et al. Airway management

complications in children with difficult tracheal intubation from the Pediatric Difficult Intubation (PeDI)

registry: a prospective cohort analysis. Lancet Respir Med 2016; 4:37-48.

5. Paterson N, Waterhouse P. Risk in pediatric anesthesia. Paediatr Anaesth 2011;21:848-57.

6. Zgleszewski SE, Graham DA, Hickey PR, Brustowicz RM, Odegard KC, Koka R, et al. Anesthesiologist- and

System-Related Risk Factors for Risk-Adjusted Pediatric Anesthesia-Related Cardiac Arrest. Anesth Analg

2016; 122:482-9.

7. Havidich JE, Beach M, Dierdorf SF, Onega T, Suresh G, Cravero JP. Preterm Versus Term Children: Analysis

of Sedation/Anesthesia Adverse Events and Longitudinal Risk. Pediatrics 2016; 137:1-9.

8. Jevtovic-Todorovic V, Absalom AR, Blomgren K et al. Anaesthetic neurotoxicity and neuroplasticity: an

expert group report and statement based on the BJA Salzburg Seminar. Br J Anaesth 2013 Aug;111(2):143-

51.

9. Davidson AJ, Disma N, de Graaff JC, and GAS consortium. Neurodevelopmental outcome at 2 years of age

after general anaesthesia and awake-regional anaesthesia in infancy (GAS): an international multicentre,

randomised controlled trial. Lancet. 2016 Jan 16;387(10015):239-50.

10. McCann ME, Schouten AN, Dobija N, Munoz C, Stephenson L, Poussaint TY, et al. Infantile postoperative

encephalopathy: perioperative factors as a cause for concern. Pediatrics 2014; 133:e751-7.

11. Weiss M, Vutskits L, Hansen TG, Engelhardt T. Safe Anesthesia For Every Tot - The SAFETOTS initiative.

Curr Opin Anaesthesiol 2015; 28:302-7.

12. Silber JH, Kennedy SK, Even-Shoshan O, Chen W, Mosher RE, Showan AM, et al. Anesthesiologist board

certification and patient outcomes. Anesthesiology 2002; 96:1044-52.

13. Lunn JN. Implications of the National Confidential Enquiry into Perioperative Deaths for paediatric

anaesthesia. Paediatr Anaesth 1992; 2:69–72.

14. Auroy Y, Benhamou D. Anesthetic risk. Rev Prat 2010; 60:1256-7.

15. Tufano R, Ivani G, Messeri A. Recommendations and guidelines in paediatric anesthesia . Minerva Anestesiol

2004; 70: 27-28.

16. Courrèges P, Ecoffey C, Galloux Y, Godard J, Goumard D, Orliaguet G, et al. Maintaining competence in

pediatric anesthesia. Ann Fr Anesth Reanim 2006; 25:353-5.

17. Codice al diritto del minore alla salute e ai servizi sanitari, 2012. Disponibile in:

http://www.garanteinfanzia.org/news/codice-del-diritto-del-minore-alla-salute-e-ai-servizi-sanitari

18. Legge 7 agosto 2015 n. 135. Disponibile in: http://www.gazzettaufficiale.it/eli/id/2012/08/14/12A09068/sg

19. Aknin P, Bazin G, Bing J, Courrèges P, Dalens B, Devos AM, et al. Sfar. Recommendations for hospital units

and instrumentation in pediatric anesthesia. Ann Fr Anesth Reanim 2000; 19:168-72.

20. American Academy of Pediatrics. Critical elements for the pediatric perioperative anesthesia environment.

Pediatrics 2015; 136,1200-5.

21. Gruppo di Studio SIAARTI “Vie Aeree Difficili”. Raccomandazioni per l’intubazione difficile e la difficoltà di

controllo delle vie aeree in età pediatrica. Minerva Anestesiol. 67(10):683-92,2001. Disponibile in:

http://www.siaarti.it/gestione-vie-aeree/Pages/Gruppo-di-Studio.aspx

22. Gruppo di Studio SIAARTI per la Sicurezza in anestesia. Standard per il monitoraggio in anestesia, 2012.

Disponibile in: http://www.siaarti.it/SiteAssets/Ricerca/Standard-per-il-monitoraggio-in-

Anestesia/linee_guida_file_43.pdf

23. Orr RA, Felmet KA, Han Y, McCloskey KA, Dragotta MA, Bills DM, et al. Pediatric specialized transport

teams are associated with improved outcomes. Pediatrics 2009; 124:40-54.

24. Stroud MH, Trautman MS, Meyer K, Moss MM, Schwartz HP, Bigham MT et al. Pediatric and neonatal

interfacility transport: results from a national consensus conference. Pediatrics 2013; 132:359-66.

25. Barry PW, Ralston C. Adverse events occurring during interhospital transfer of the critically ill. Arch Dis

Child 1994; 71: 8-11.

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Appendix 1: Paediatric surgery admissions in Italy, 2014

Table 1 lists the figures for paediatric surgery admissions in Italy in 2014.

Table 2 divides the surgery according to specialty. Of the total of 228,000 admissions, 30% were for

urology-digestive tract surgery, 24% for orthopedic operations, 23% for ENT cases (70% of them

tonsillectomy), and 4% eye surgery. Only 4% were admitted for cardiac or neuro-surgery.

Analysis also focused on the distribution of paediatric surgery in the different categories of hospital, and

brought to light the extreme fragmentation of surgery in Italy, where there are no fewer than 875 centres,

though with appreciable differences between regions. Tuscany provides a good example of centralization:

61% of admissions for surgery in 2014 took place in only four centres. Liguria concentrated 71% of

admissions in the Gaslini Paediatric Institute. In Lombardy, however, only 24% of admissions were to the

four hospitals most specialized in paediatrics, while 131 others hospitals recorded some paediatric surgery.

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Table 1. Hospital admissions for paediatric surgery

Table 2: Types of surgery

Surgical admissions Total %

Total 1425000 100

Paediatric 228000 16

Paediatric surgical admissions

Elective 186960 82

Urgent 41040 18

In-patient 141000 62

Day-case 87000 38

Department at discharge Paediatric Adult

Age less than 1 year 70% 30%

Age 1-3 years 59% 41%

Age more than 3 years 32% 68%

No. %

Urology/digestive tract 68400 30

Orthopedic 54720 24

ENT (tonsillectomy) 52440 23 (70)

Oculistic 9120 4

Neuro- and cardiac surgery 9120 4

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Appendix 2: Paediatric hospital network

Italian law no. 135 dated 7 August 2012 specifies that hospitals are to be classified on three levels (basic,

levels I and II care) depending on their catchment area and the complexity of the care provided (18). Within

the overall hospital system, pathology networks are to be set up, and reference is made to a specific

paediatric network to be established by regional authorities, divided as follows:

- centres acting as Basic Paediatric Spoke. These hospitals have no paediatric departments, and

consequently should not do elective paediatric cases;

- centres acting as Level I Paediatric Spoke. These hospitals have paediatric departments but no

paediatric intensive care units, and provide minor elective interventions not requiring post-operative

intensive care. They work according to a program shared with the hubs for managing children lower

than 3 years, with ASA score > 2, undergoing highly complex surgery or in critical conditions;

- centres acting as Level II Paediatric Spoke or Hubs. These hospitals have multi-specialist paediatric

competencies, including paediatric intensive care. They may be paediatric hospitals, regional

paediatric care centres, and level II paediatric emergency admission facilities (Italian Paediatrics

DEA) in hospitals with high level of paediatric specialization. They should coordinate the network’s

activities, organizing training for spoke hospitals, and promote research.

The network’s function is therefore based on three main points:

a) Centralized admission in referral paediatric centres for the most complex paediatric cases by age,

severity (concomitant acute and/or chronic pathology), type of surgery and level of urgency.

b) An efficient transport system for rapid transfer to the most appropriate hospital, with well-equipped

vehicles and specialized staff, in order to minimize the risk of adverse events and improve survival (23-

25). Some Italian regions have a neonatal transport system (STEN) which is a valid reference model.

c) Specific training for managing paediatric emergencies and urgencies in all the hospitals equipped to care

for children.

An important point, particularly in today’s conditions, is that children from ‘developing countries’ must

be assured full access to social and health care (including surgery) on an ad hoc basis; protocols should

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be drawn up that take account of the institutions and associations working in this field, as set down in

Article 21 of the Code for the Rights of Minors to Health.

Rome, 31 January 2017

The SIAARTI-SARNePI Committee on paediatric anaesthesia:

Calderini Edoardo*, UOC di Anestesia e Terapia Intensiva Donna-Bambino, Dipartimento di Anestesia, Rianimazione

ed Emergenza, Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico, Milano

Disma Nicola**, Department of Anaesthesia, Great Ormond Street Hospital, and University College London-Institute

of Child Health, London, UK

Lorenzini Laura*, UOC Anestesia e Terapia intensiva Ospedale Maggiore, AUSL di Bologna

Mondardini Maria Cristina**, UOC Anestesia e Rianimazione Pediatrica, Dipartimento della donna, del bambino e

delle malattie urologiche, Azienda Ospedaliero Universitaria di Bologna, Policlinico S.Orsola Malpighi, Bologna

Picardo Sergio*, DEA ARCO,Ospedale Bambino Gesù, Roma

Salvo Ida*, UOC Anestesia e Rianimazione, ASST Sacco-FBF, Ospedale V. Buzzi, Milano

Sammartino Maria**, UOC Anestesia delle Chirurgie Specialistiche e Terapia del dolore 1, Fondazione Policlinico

Universitario A. Gemelli, Università Cattolica del Sacro Cuore, Roma

Tesoro Simonetta**, UOC Anestesia per il Dipartimento Materno Infantile, Dipartimento di Scienze Chirurgiche e

Biomediche, Azienda Ospedaliera di Perugia, Universita' degli Studi di Perugia