Andrea Wolfler

Pediatric Index of Mortality 2 score in Italy: a multicenter, prospective, observational study.

ObjectivesTo assess the performance of the Pediatric Index of Mortality (PIM) 2 score in Italian pediatric intensive care units (PICUs).DesignProspective, observational, multicenter, 1-year study.SettingEighteen medical–surgical PICUs.PatientsConsecutive patients (3266) aged 0–16 years admitted between 1 March 2004 and 28 February 2005.InterventionsNone.Measurements and main resultsTo assess the performance of the PIM2 score, discrimination and calibration measures were applied to all children admitted to the 18 PICUs, in the entire population and in different groups divided for deciles of risk, age and admission diagnosis. There was good discrimination, with an area under the receiver operating characteristic (ROC) curve of 0.89 (95% CI 0.86–0.91) and good calibration of the scoring system [non-significant differences between observed and predicted deaths when the population was stratified according to deciles of risk (χ2 9.86; 8 df, p = 0.26) for the whole population].ConclusionsThe PIM2 score performed well in this sample of the Italian pediatric intensive care population. It may need to be reassessed in the injury and postoperative groups in larger studies.

A case of severe diazoxide toxicity

Hyperinsulism is a rare cause of persistent hypoglycemia in the neonatal period. Therapy can be accomplished either surgically or pharmacologically. Diazoxide treatment remains the mainstay of medical therapy. Tolerance of diazoxide is usually excellent, but several adverse effects of this drug have been described. A case of severe diazoxide intoxication with fluid retention, congestive heart failure, and respiratory failure is reported. The patient was a 43‐day‐old infant, affected by persistent and severe hypoglycemia. After the diagnosis, hyperinsulinism was established he was treated with diazoxide (17 mg·kg−1 daily) and octreotide (12 μg·kg−1 daily). A few days later he presented with hepatomegaly, severe fluid retention, diffuse edema, congestive heart failure, and respiratory failure requiring mechanical ventilation. After introduction of ACE inhibitors he developed acute renal failure. The clinical condition worsened and he developed pulmonary hypertension requiring high‐frequency oscillatory ventilation. Diazoxide was stopped on the 12th day in spite of poor control of blood sugar. During the next 5 days his hemodynamic status dramatically improved and he was weaned from catecholamines: he lost weight, had a negative fluid balance, and the edema disappeared, a normal diuresis resumed and renal function improved. Improvement of respiratory patterns and gas exchange made it possible to switch back to conventional ventilation and then to extubate the patient. Echocardiography demonstrated reduction of the PA pressure to normal and resolution of atrial enlargement. The patient was scheduled for elective subtotal pancreatectomy. Diagnosis and management of diazoxide intoxication are discussed.

Evolution of Noninvasive Mechanical Ventilation Use: A Cohort Study among Italian PICUs

Objective: To assess how clinical practice of noninvasive ventilation has evolved in the Italian PICUs. Design: National, multicentre, retrospective, observational cohort. Setting: Thirteen Italian medical/surgical PICUs that participated in the Italian PICU Network. Patients: Seven thousand one-hundred eleven admissions of children with 0–16 years old admitted from January 1, 2011, to December 31, 2012. Interventions: None. Measurements and Main Results: Cause of respiratory failure, length and mode of noninvasive ventilation, type of interfaces, incidence of treatment failure, and outcome were recorded. Data were compared with an historical cohort of children enrolled along 6 months from November 1, 2006, to April 30, 2007, over the viral respiratory season. Seven thousand one-hundred eleven PICU admissions were analyzed, and an overall noninvasive ventilation use of 8.8% (n = 630) was observed. Among children who were admitted in the PICU without mechanical ventilation (n = 3,819), noninvasive ventilation was used in 585 patients (15.3%) with a significant increment among the three study years (from 11.6% in 2006 to 18.2% in 2012). In the endotracheally intubated group, 17.2% children received noninvasive ventilation at the end of the weaning process to avoid reintubation: 11.9% in 2006, 15.3% in 2011, and 21.6% in 2012. Noninvasive ventilation failure rate raised from 10% in 2006 to 16.1% in 2012. Conclusions: Noninvasive ventilation is increasingly and successfully used as first respiratory approach in several, but not all, Italian PICUs. The current study shows that noninvasive ventilation represents a feasible and safe technique of ventilatory assistance for the treatment of mild acute respiratory failure. Noninvasive ventilation was used as primary mode of ventilation in children with low respiratory tract infection (mainly in bronchiolitis and pneumonia), in acute on chronic respiratory failure or to prevent reintubation.

Efficacy of ketamine in refractory convulsive status epilepticus in children: a protocol for a sequential design, multicentre, randomised, controlled, open-label, non-profit trial (KETASER01).

Introduction Status epilepticus (SE) is a life-threatening neurological emergency. SE lasting longer than 120 min and not responding to first-line and second-line antiepileptic drugs is defined as ‘refractory’ (RCSE) and requires intensive care unit treatment. There is currently neither evidence nor consensus to guide either the optimal choice of therapy or treatment goals for RCSE, which is generally treated with coma induction using conventional anaesthetics (high dose midazolam, thiopental and/or propofol). Increasing evidence indicates that ketamine (KE), a strong N-methyl-d-aspartate glutamate receptor antagonist, may be effective in treating RCSE. We hypothesised that intravenous KE is more efficacious and safer than conventional anaesthetics in treating RCSE. Methods and analysis A multicentre, randomised, controlled, open-label, non-profit, sequentially designed study will be conducted to assess the efficacy of KE compared with conventional anaesthetics in the treatment of RCSE in children. 10 Italian centres/hospitals are involved in enrolling 57 patients aged 1 month to 18 years with RCSE. Primary outcome is the resolution of SE up to 24 hours after withdrawal of therapy and is updated for each patient treated according to the sequential method. Ethics and dissemination The study received ethical approval from the Tuscan Paediatric Ethics Committee (12/2015). The results of this study will be published in peer-reviewed journals and presented at international conferences. Trial registration number NCT02431663; Pre-results.

Continuous Positive Airway Pressure With Helmet Versus Mask in Infants With Bronchiolitis: An RCT

BACKGROUND: Noninvasive continuous positive airway pressure (CPAP) is usually applied with a nasal or facial mask to treat mild acute respiratory failure (ARF) in infants. A pediatric helmet has now been introduced in clinical practice to deliver CPAP. This study compared treatment failure rates during CPAP delivered by helmet or facial mask in infants with respiratory syncytial virus-induced ARF. METHODS: In this multicenter randomized controlled trial, 30 infants with respiratory syncytial virus-induced ARF were randomized to receive CPAP by helmet (n = 17) or facial mask (n = 13). The primary endpoint was treatment failure rate (defined as due to intolerance or need for intubation). Secondary outcomes were CPAP application time, number of patients requiring sedation, and complications with each interface. RESULTS: Compared with the facial mask, CPAP by helmet had a lower treatment failure rate due to intolerance (3/17 [17%] vs 7/13 [54%], P = .009), and fewer infants required sedation (6/17 [35%] vs 13/13 [100%], P = .023); the intubation rates were similar. In successfully treated patients, CPAP resulted in better gas exchange and breathing pattern with both interfaces. No major complications due to the interfaces occurred, but CPAP by mask had higher rates of cutaneous sores and leaks. CONCLUSIONS: These findings confirm that CPAP delivered by helmet is better tolerated than CPAP delivered by facial mask and requires less sedation. In addition, it is safe to use and free from adverse events, even in a prolonged clinical setting.

EMpowerment of PArents in THe Intensive Care Questionnaire: Translation and Validation in Italian PICUs

Objectives: To translate and validate the EMpowerment of PArents in THe Intensive Care questionnaire to measure parent satisfaction and experiences in Italian PICUs. Design: Prospective, multicenter study. Setting: Four medical/surgical Italian PICUs in three tertiary hospitals. Patients: Families of children, 0–16 years old, admitted to the PICUs were invited to participate. Inclusion criteria were PICU length of stay greater than 24 hours and good comprehension of Italian language by parents/guardians. Exclusion criteria were readmission within 6 months and parents of a child who died in the PICU. Interventions: Distribution, at PICU discharge, of the EMpowerment of PArents in THe Intensive Care questionnaire with 65 items divided into five domains and a six-point rating scale: 1 “ certainly no” to 6 “certainly yes.” Measurements and Main Results: Back and forward translations of the EMpowerment of PArents in THe Intensive Care questionnaire between Dutch (original version) and Italian languages were deployed. Cultural adaptation of the instrument was confirmed by a consultation with a representative parent group (n = 10). Totally, 150 of 190 parents (79%) participated in the study. On item level, 12 statements scored a mean below 5.0. The Cronbach’s &agr;, measured for internal consistency, on domain level was between 0.67 and 0.96. Congruent validity was measured by correlating the five domains with four gold standard satisfaction measures and showed adequate correlations (rs, 0.41–0.71; p < 0.05). No significant differences occurred in the nondifferential validity testing between three children’s characteristics and the domains; excepting parents with a child for a surgical and planned admission were more satisfied on information and organization issues. Conclusions: The Italian version of the EMpowerment of PArents in THe Intensive Care questionnaire has satisfactory reliability and validity estimates and seems to be appropriate for Italian PICU setting. It is an important instrument providing benchmark data to be used in the process of quality improvement toward the development of a family-centered care philosophy within Italian PICUs.

Factors influencing the shape of the inspiratory flow

An index (IS), quantitating the departure of the inspiratory flow profile (IFP) from the rectangular one, i.e. the optimal profile (IS=0), was computed from pneumotachograms recorded in 26 normal, anesthetized subjects breathing spontaneously through the endotracheal tube (ETT) or face mask (FM) with or without added resistances (R) and in 27 awake subjects breathing through the mouth and FM in the supine and seated posture at rest and during exercise (40 W) on a cycloergometer, through the nose and FM, and through the mouthpiece (MP). During anesthesia, IS decreased with R both while breathing through the ETT (DeltaIS=-0.037+/-0.006 (SE); P<0.001) and FM (DeltaIS=-0.054+/-0.008; P<0.001). This indicates that (a) the change of IFP towards the optimal shape is reflex in nature and related to the dynamic inspiratory load, and (b) tracheobronchial mechanoreceptors and inspiratory muscles are involved in this response. The reflex is also operative in awake subjects, since IS decreased whenever the inspiratory dynamic load was increased, as on turning from seated to supine posture (DeltaIS=-0.024+/-0.003; P<0.001), shifting from mouth to nose breathing (DeltaIS=-0.034+/-0.003; P<0.05), from rest to mild exercise (DeltaIS=-0.066+/-0.005; P<0.001). The different IS value between FM and MP breathing (DeltaIS=0.036+/-0.004; P<0.001) indicates, however, that other factors, likely behavioral, also affect the IFP.

Non-invasive ventilation practices in children across Europe

To describe the diversity in practice in non‐invasive ventilation (NIV) in European pediatric intensive care units (PICUs).

Withdrawal Assessment Tool-1 Monitoring in PICU: A Multicenter Study on Iatrogenic Withdrawal Syndrome.

Objectives: Withdrawal syndrome is an adverse reaction of analgesic and sedative therapy, with a reported occurrence rate between 17% and 57% in critically ill children. Although some factors related to the development of withdrawal syndrome have been identified, there is weak evidence for the effectiveness of preventive and therapeutic strategies. The main aim of this study was to evaluate the frequency of withdrawal syndrome in Italian PICUs, using a validated instrument. We also analyzed differences in patient characteristics, analgesic and sedative treatment, and patients’ outcome between patients with and without withdrawal syndrome. Design: Observational multicenter prospective study. Setting: Eight Italian PICUs belonging to the national PICU network Italian PICU network. Patients: One hundred thirteen patients, less than 18 years old, mechanically ventilated and treated with analgesic and sedative therapy for five or more days. They were admitted in PICU from November 2012 to May 2014. Interventions: Symptoms of withdrawal syndrome were monitored with Withdrawal Assessment Tool-1 scale. Measurements and Main Results: The occurrence rate of withdrawal syndrome was 64.6%. The following variables were significantly different between the patients who developed withdrawal syndrome and those who did not: type, duration, and cumulative dose of analgesic therapy; duration and cumulative dose of sedative therapy; clinical team judgment about analgesia and sedation’s difficulty; and duration of analgesic weaning, mechanical ventilation, and PICU stay. Multivariate logistic regression analysis revealed that patients receiving morphine as their primary analgesic were 83% less likely to develop withdrawal syndrome than those receiving fentanyl or remifentanil. Conclusions: Withdrawal syndrome was frequent in PICU patients, and patients with withdrawal syndrome had prolonged hospital treatment. We suggest adopting the lowest effective dose of analgesic and sedative drugs and frequent reevaluation of the need for continued use. Further studies are necessary to define common preventive and therapeutic strategies.

Scoring Systems to Assess Severity of Illness in Pediatric Intensive Care Medicine

Critical care medicine (CCM) has been developed during the last 30 years with important improvements in both morbidity and mortality. Clinical and epidemiological research, an improved knowledge of the etiology and physiopathology of several diseases, the availability of powerful drugs with reduced toxicity, and improvements of technologies like ventilators and in techniques such as monitoring of vital signs, all contribute to an improved outcome [1]. For clinical research, the appropriate use of disease definitions, for example, sepsis-related diagnosis and acute respiratory distress syndrome, and the evaluation of patient characteristics and severity on intensive care unit (ICU) admission or during ICU stay were fundamental when comparing patients with similar conditions and severity. Mortality risk scoring systems are integral to the provision of modern intensive care, providing a measure of performance both between and within individual ICUs over time. A valid scoring system must predict mortality accurately while adjusting for case mix and disease severity, but it also requires data capture that is feasible in clinical practice. In adults, CCM severity scores were adopted a long time ago and, subsequently, their use was extended to children. The common pediatric intensive care scores identify physical ICU admission as a crucial event and may use data captured either prior or subsequent to ICU admission, or from a combination of both [2].