Effectiveness of a Novel Tablet Application in Reducing Guideline Deviations During Pediatric Cardiac Arrest: A Randomized Clinical Trial.

Importance: Deviations from international resuscitation guidelines during the management of pediatric cardiac arrest are frequent and affect clinical outcomes. An interactive tablet application (app), PediAppRREST, was developed to reduce guideline deviations during pediatric cardiac arrest. Objective: To assess the effectiveness of PediAppRREST in improving the management of simulated in-hospital pediatric cardiac arrest. Design, Setting, and Participants: This multicenter 3-group simulation-based randomized clinical trial was conducted from September 2020 to December 2021 at 4 Italian university hospitals (Padua, Florence, Rome, Novara). Participants included residents in pediatrics, emergency medicine, and anesthesiology. Analyses were conducted as intention-to-treat. Data were analyzed from January to June 2022. Interventions: Teams were randomized to 1 of 3 study groups: an intervention group that used the PediAppRREST app; a control group that used a paper-based cognitive aid, the Pediatric Advanced Life Support (PALS) pocket card; and a control group that used no cognitive aids. All the teams managed the same standardized simulated scenario of nonshockable pediatric cardiac arrest. Main Outcomes and Measures: The primary outcome was the number of deviations from guidelines, measured by a 15-item checklist based on guideline recommendations. The main secondary outcomes were quality of chest compressions, team clinical performance (measured by the Clinical Performance Tool), and perceived team leader's workload. Study outcomes were assessed via video reviews of the scenarios. Results: Overall 100 teams of 300 participants (mean [SD] age, 29.0 [2.2] years; 195 [65%] female) were analyzed by intention-to-treat, including 32 teams randomized to the PediAppRREST group, 35 teams randomized to the PALS control group, and 33 teams randomized to the null control group. Participant characteristics (210 pediatric residents [70%]; 48 anesthesiology residents [16%]; 42 emergency medicine residents [14%]) were not statistically different among the study groups. The number of deviations from guidelines was significantly lower in the PediAppRREST group than in the control groups (mean difference vs PALS control, -3.0; 95% CI, -4.0 to -1.9; P < .001; mean difference vs null control, -2.6; 95% CI, -3.6 to -1.5; P < .001). Clinical Performance Tool scores were significantly higher in the PediAppRREST group than control groups (mean difference vs PALS control, 1.4; 95% CI, 0.4 to 2.3; P = .002; mean difference vs null control, 1.1; 95% CI, 0.2 to 2.1; P = .01). The other secondary outcomes did not significantly differ among the study groups. Conclusions and Relevance: In this randomized clinical trial, the use of the PediAppRREST app resulted in fewer deviations from guidelines and a better team clinical performance during the management of pediatric cardiac arrest. Trial Registration: ClinicalTrials.gov Identifier: NCT04619498.

Adherence to guideline recommendations in the management of pediatric cardiac arrest: a multicentre observational simulation-based study.

BACKGROUND AND IMPORTANCE: Pediatric cardiac arrest is a rare emergency with associated high mortality. Its management is challenging and deviations from guidelines can affect clinical outcomes. OBJECTIVES: To evaluate the adherence to guideline recommendations in the management of a pediatric cardiac arrest scenario by teams of pediatric residents. Secondarily, the association between the use of the Pediatric Advanced Life Support-2015 (PALS-2015) pocket card, and the teams' adherence to international guidelines, were explored. DESIGN, SETTINGS AND PARTICIPANTS: Multicentre observational simulation-based study at three Italian University Hospitals in 2018, including PALS-2015 certified pediatric residents in their 3rd-5th year of residency program, divided in teams of three. INTERVENTION OR EXPOSURE: Each team conducted a standard nonshockable pediatric cardiac arrest scenario and independently decided whether to use the PALS-2015 pocket card. OUTCOME MEASURE AND ANALYSIS: The primary outcome was the overall number and frequency of individual deviations from the PALS-2015 guidelines, measured by the novel c-DEV15plus score (range 0-15). Secondarily, the performance on the validated Clinical Performance Tool for asystole scenarios, the time to perform resuscitation tasks and cardiopulmonary resuscitation (CPR) quality metrics were compared between the teams that used and did not use the PALS-2015 pocket card. MAIN RESULTS: Twenty-seven teams (81 residents) were included. Overall, the median number of deviations per scenario was 7 out of 15 [interquartile range (IQR), 6-8]. The most frequent deviations were delays in positioning of a CPR board (92.6%), calling for adrenaline (92.6%), calling for help (88.9%) and incorrect/delayed administration of adrenaline (88.9%). The median Clinical Performance Tool score was 9 out of 13 (IQR, 7-10). The comparison between teams that used ( n = 13) and did not use ( n = 14) the PALS-2015 pocket card showed only significantly higher Clinical Performance Tool scores in the former group [9 (IQR 9-10) vs. 7 (IQR 6-8); P = 0.002]. CONCLUSIONS: Deviations from guidelines, although measured by means of a nonvalidated tool, were frequent in the management of a pediatric cardiac arrest scenario by pediatric residents. The use of the PALS-2015 pocket card was associated with better Clinical Performance Tool scores but was not associated with less deviations or shorter times to resuscitation tasks.

PediAppRREST: effectiveness of an interactive cognitive support tablet app in reducing deviations from guidelines in the management of paediatric cardiac arrest: protocol for a simulation-based randomised controlled trial.

INTRODUCTION: Paediatric cardiac arrest (PCA), despite its low incidence, has a high mortality. Its management is complex and deviations from guideline recommendations occur frequently. We developed a new interactive tablet app, named PediAppRREST, to support the management of PCA. The app received a good usability evaluation in a previous pilot trial. The aim of the study is to evaluate the effectiveness of the PediAppRREST app in reducing deviations from guideline recommendations in PCA management. METHODS AND ANALYSIS: This is a multicentre, simulation-based, randomised controlled, three-parallel-arm study. Participants are residents in Paediatric, Emergency Medicine, and Anaesthesiology programmes in Italy. All 105 teams (315 participants) manage the same scenario of in-hospital PCA. Teams are randomised by the study statistician into one of three study arms for the management of the PCA scenario: (1) an intervention group using the PediAppRREST app or (2) a control group Paediatric Advanced Life Support (CtrlPALS+) using the PALS pocket reference card; or (3) a control group (CtrlPALS-) not allowed to use any PALS-related cognitive aid. The primary outcome of the study is the number of deviations (delays and errors) in PCA management from PALS guideline recommendations, according to a novel checklist, named c-DEV15plus. The c-DEV15plus scores will be compared between groups with a one-way analysis of variance model, followed by the Tukey-Kramer multiple comparisons adjustment procedure in case of statistical significance. ETHICS AND DISSEMINATION: The Ethics Committee of the University Hospital of Padova, coordinating centre of the trial, deemed the project to be a negligible risk study and approved it through an expedited review process. The results of the study will be disseminated in peer-reviewed journals, and at national and international scientific conferences. Based on the study results, the PediAppRREST app will be further refined and will be available for download by institutions/healthcare professionals. TRIAL REGISTRATION NUMBER: NCT04619498; Pre-results.

Efficacy and safety of exogenous surfactant therapy in patients under 12 months of age invasively ventilated for severe bronchiolitis (SURFABRON): protocol for a multicentre, randomised, double-blind, controlled, non-profit trial.

INTRODUCTION: Some evidence indicates that exogenous surfactant therapy may be effective in infants with acute viral bronchiolitis, even though more confirmatory data are needed. To date, no large multicentre trials have evaluated the effectiveness and safety of exogenous surfactant in severe cases of bronchiolitis requiring invasive mechanical ventilation (IMV). METHODS AND ANALYSIS: This is a multicentre randomised, placebo-controlled, double-blind study, performed in 19 Italian paediatric intensive care units (PICUs). Eligible participants are infants under the age of 12 months hospitalised in a PICU, suffering from severe acute hypoxaemic bronchiolitis, requiring IMV. We adopted a more restrictive definition of bronchiolitis, including only infants below 12 months of age, to maintain the population as much homogeneous as possible. The primary outcome is to evaluate whether exogenous surfactant therapy (Curosurf, Chiesi Pharmaceuticals, Italy) is effective compared with placebo (air) in reducing the duration of IMV in the first 14 days of hospitalisation, in infants suffering from acute hypoxaemic viral bronchiolitis. Secondary outcomes are duration of non-invasive mechanical ventilation in the post-extubation phase, number of cases requiring new intubation after previous extubation within 14 days from randomisation, PICU and hospital length of stay (LOS), duration of oxygen dependency, effects on oxygenation and ventilatory parameters during invasive mechanical respiratory support, need for repeating treatment within 24 hours of first treatment, use of other interventions (eg, high-frequency oscillatory ventilation, nitric oxide, extracorporeal membrane oxygenation), mortality within the first 14 days of PICU stay and before hospital discharge, side effects and serious adverse events. ETHICS AND DISSEMINATION: The trial design and protocol have received approval by the Italian National Agency for Drugs (AIFA) and by the Regional Ethical Committee of Verona University Hospital (1494CESC). Findings will be disseminated through publication in peer-reviewed journals, conference/meeting presentations and media. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov, issue date 22 May 2019. NCT03959384.

Development and Usability of a Novel Interactive Tablet App (PediAppRREST) to Support the Management of Pediatric Cardiac Arrest: Pilot High-Fidelity Simulation-Based Study.

BACKGROUND: Pediatric cardiac arrest (PCA), although rare, is associated with high mortality. Deviations from international management guidelines are frequent and associated with poorer outcomes. Different strategies/devices have been developed to improve the management of cardiac arrest, including cognitive aids. However, there is very limited experience on the usefulness of interactive cognitive aids in the format of an app in PCA. No app has so far been tested for its usability and effectiveness in guiding the management of PCA. OBJECTIVE: To develop a new audiovisual interactive app for tablets, named PediAppRREST, to support the management of PCA and to test its usability in a high-fidelity simulation-based setting. METHODS: A research team at the University of Padova (Italy) and human-machine interface designers, as well as app developers, from an Italian company (RE:Lab S.r.l.) developed the app between March and October 2019, by applying an iterative design approach (ie, design-prototyping-evaluation iterative loops). In October-November 2019, a single-center nonrandomized controlled simulation-based pilot study was conducted including 48 pediatric residents divided into teams of 3. The same nonshockable PCA scenario was managed by 11 teams with and 5 without the app. The app user's experience and interaction patterns were documented through video recording of scenarios, debriefing sessions, and questionnaires. App usability was evaluated with the User Experience Questionnaire (UEQ) (scores range from -3 to +3 for each scale) and open-ended questions, whereas participants' workload was measured using the NASA Raw-Task Load Index (NASA RTLX). RESULTS: Users' difficulties in interacting with the app during the simulations were identified using a structured framework. The app usability, in terms of mean UEQ scores, was as follows: attractiveness 1.71 (SD 1.43), perspicuity 1.75 (SD 0.88), efficiency 1.93 (SD 0.93), dependability 1.57 (SD 1.10), stimulation 1.60 (SD 1.33), and novelty 2.21 (SD 0.74). Team leaders' perceived workload was comparable (P=.57) between the 2 groups; median NASA RTLX score was 67.5 (interquartile range [IQR] 65.0-81.7) for the control group and 66.7 (IQR 54.2-76.7) for the intervention group. A preliminary evaluation of the effectiveness of the app in reducing deviations from guidelines showed that median time to epinephrine administration was significantly longer in the group that used the app compared with the control group (254 seconds versus 165 seconds; P=.015). CONCLUSIONS: The PediAppRREST app received a good usability evaluation and did not appear to increase team leaders' workload. Based on the feedback collected from the participants and the preliminary results of the evaluation of its effects on the management of the simulated scenario, the app has been further refined. The effectiveness of the new version of the app in reducing deviations from guidelines recommendations in the management of PCA and its impact on time to critical actions will be evaluated in an upcoming multicenter simulation-based randomized controlled trial.

Salivary glands abnormalities in oculo-auriculo-vertebral spectrum.

BACKGROUND: Feeding and swallowing impairment are present in up to 80% of oculo-auriculo-vertebral spectrum (OAVS) patients. Salivary gland abnormalities have been reported in OAVS patients but their rate, features, and relationship with phenotype severity have yet to be defined. MATERIAL AND METHODS: Parotid and submandibular salivary gland hypo/aplasia was evaluated on head MRI of 25 OAVS patients (16 with severe phenotype, Goldenhar syndrome) and 11 controls. RESULTS: All controls disclosed normal salivary glands. Abnormal parotid glands were found exclusively ipsilateral to facial microsomia in 21/25 OAVS patients (84%, aplasia in six patients) and showed no association with phenotype severity (14/16 patients with Goldenhar phenotype vs 7/9 patients with milder phenotype, p = 0.6). Submandibular salivary gland hypoplasia was detected in six OAVS patients, all with concomitant ipsilateral severe involvement of the parotid gland (p < 0.001). Submandibular salivary gland hypoplasia was associated to Goldenhar phenotype (p < 0.05). Parotid gland abnormalities were associated with ipsilateral fifth (p < 0.001) and seventh cranial nerve (p = 0.001) abnormalities. No association was found between parotid gland anomaly and ipsilateral internal carotid artery, inner ear, brain, eye, or spine abnormalities (p > 0.6). CONCLUSIONS: Salivary gland abnormalities are strikingly common in OAVS. Their detection might help the management of OAVS-associated swallowing and feeding impairment.

Surfactants in Acute Respiratory Distress Syndrome in Infants and Children: Past, Present and Future.

There is a lack of definitive data on the effective management of acute respiratory distress syndrome (ARDS) in infants and children. The development and validation of the Berlin definition (BD) for ARDS and the Pediatric Acute Lung Injury Consensus Conference (PALICC) recommendations in children represented a major advance in optimizing research and treatment, mainly due to the introduction of a severe ARDS category. Proposed reasons for the lack of consistent results with surfactants in children and infants compared with neonates include different causes, type of lung damage (direct or indirect), timing and mode of administration as well as the type of surfactant used. Secretory phospholipase A2 plays an important role in inflammation and possible dysfunction of surfactants in ARDS. Bronchoalveolar lavage (BAL) with normal saline and surfactant allows the removal of inhaled material, the recruitment of non-ventilating areas and the maintenance of the surfactant pool size. BAL with diluted surfactant allows rapid absorption of the surfactant at the air/liquid interface, which blocks the progression of pathological lung disease and in turn disrupts the inflammatory cycle. Importantly, it is now recognized that the type of surfactant, the time of administration and the method of administration could all play an important role in the management of ARDS, and there is evidence that surfactant is effective and well tolerated in children and infants with ARDS.