Search

Background: Published reports of complex interventions in randomized controlled trials often lack sufficient detail to allow trial replication and adoption into practice. Aim: The aim of this paper is to describe our experience of using the Template for Intervention Description and Replication (TIDieR) checklist in reporting a recent trial of sedation and ventilation weaning in critically ill children (the Sedation and Weaning in Children [SANDWICH] trial). Methods: The TIDieR 12‐point checklist has been used to detail and describe the specific SANDWICH trial intervention and methods of implementation. Results/Discussion: Overall, we found the checklist a useful tool to direct and ensure consistency of reporting of our complex intervention used in a multi‐centre clinical trial. We experienced some minor limitations in classifying training materials and delivery mode into one item because of the overlapping nature of this component. Conclusion: Using the TIDieR checklist to report complex interventions tested in trials provides a structured, systematic way of describing necessary detail. This allows clinicians to understand the theory behind the intervention, how it should be delivered, and the resources required. Relevance to Clinical Practice: The SANDWICH intervention had a significant beneficial effect on reducing time on ventilation for children. The detailed description of the team‐based intervention will aid replication, implementation and monitoring of fidelity in other paediatric intensive care units. [ABSTRACT FROM AUTHOR]

Introduction: Detection of neurological complications during extracorporeal membrane oxygenation (ECMO) may be enhanced with non-invasive neuro-monitoring. We investigated the feasibility of non-invasive neuro-monitoring in a paediatric intensive care (PIC) setting. Methods: In a single centre, prospective cohort study we assessed feasibility of recruitment, and neuro-monitoring via somatosensory evoked potentials (SSEP), electroencephalography (EEG) and near infrared spectroscopy (NIRS) during venoarterial (VA) ECMO in paediatric patients (0–15 years). Measures were obtained within 24h of cannulation, during an intermediate period, and finally at decannulation or echo stress testing. SSEP/EEG/NIRS measures were correlated with neuro-radiology findings, and clinical outcome assessed via the Pediatric cerebral performance category (PCPC) scale 30 days post ECMO cannulation. Results: We recruited 14/20 (70%) eligible patients (median age: 9 months; IQR:4–54, 57% male) over an 18-month period, resulting in a total of 42 possible SSEP/EEG/NIRS measurements. Of these, 32/42 (76%) were completed. Missed recordings were due to lack of access/consent within 24 h of cannulation (5/42, 12%) or PIC death/discharge (5/42, 12%). In each patient, the majority of SSEP (8/14, 57%), EEG (8/14, 57%) and NIRS (11/14, 79%) test results were within normal limits. All patients with abnormal neuroradiology (4/10, 40%), and 6/7 (86%) with poor outcome (PCPC ≥4) developed indirect SSEP, EEG or NIRS measures of neurological complications prior to decannulation. No study-related adverse events or neuro-monitoring data interpreting issues were experienced. Conclusion: Non-invasive neuro-monitoring (SSEP/EEG/NIRS) during ECMO is feasible and may provide early indication of neurological complications in this high-risk population. [ABSTRACT FROM AUTHOR]

Importance: The optimal first-line mode of noninvasive respiratory support for acutely ill children is not known.Objective: To evaluate the noninferiority of high-flow nasal cannula therapy (HFNC) as the first-line mode of noninvasive respiratory support for acute illness, compared with continuous positive airway pressure (CPAP), for time to liberation from all forms of respiratory support.Design, Setting, and Participants: Pragmatic, multicenter, randomized noninferiority clinical trial conducted in 24 pediatric critical care units in the United Kingdom among 600 acutely ill children aged 0 to 15 years who were clinically assessed to require noninvasive respiratory support, recruited between August 2019 and November 2021, with last follow-up completed in March 2022.Interventions: Patients were randomized 1:1 to commence either HFNC at a flow rate based on patient weight (n = 301) or CPAP of 7 to 8 cm H2O (n = 299).Main Outcomes and Measures: The primary outcome was time from randomization to liberation from respiratory support, defined as the start of a 48-hour period during which a participant was free from all forms of respiratory support (invasive or noninvasive), assessed against a noninferiority margin of an adjusted hazard ratio of 0.75. Seven secondary outcomes were assessed, including mortality at critical care unit discharge, intubation within 48 hours, and use of sedation.Results: Of the 600 randomized children, consent was not obtained for 5 (HFNC: 1; CPAP: 4) and respiratory support was not started in 22 (HFNC: 5; CPAP: 17); 573 children (HFNC: 295; CPAP: 278) were included in the primary analysis (median age, 9 months; 226 girls [39%]). The median time to liberation in the HFNC group was 52.9 hours (95% CI, 46.0-60.9 hours) vs 47.9 hours (95% CI, 40.5-55.7 hours) in the CPAP group (absolute difference, 5.0 hours [95% CI -10.1 to 17.4 hours]; adjusted hazard ratio 1.03 [1-sided 97.5% CI, 0.86-∞]). This met the criterion for noninferiority. Of the 7 prespecified secondary outcomes, 3 were significantly lower in the HFNC group: use of sedation (27.7% vs 37%; adjusted odds ratio, 0.59 [95% CI, 0.39-0.88]); mean duration of critical care stay (5 days vs 7.4 days; adjusted mean difference, -3 days [95% CI, -5.1 to -1 days]); and mean duration of acute hospital stay (13.8 days vs 19.5 days; adjusted mean difference, -7.6 days [95% CI, -13.2 to -1.9 days]). The most common adverse event was nasal trauma (HFNC: 6/295 [2.0%]; CPAP: 18/278 [6.5%]).Conclusions and Relevance: Among acutely ill children clinically assessed to require noninvasive respiratory support in a pediatric critical care unit, HFNC compared with CPAP met the criterion for noninferiority for time to liberation from respiratory support.Trial Registration: ISRCTN.org Identifier: ISRCTN60048867. [ABSTRACT FROM AUTHOR]

Importance: There is limited evidence on the optimal strategy for liberating infants and children from invasive mechanical ventilation in the pediatric intensive care unit.Objective: To determine if a sedation and ventilator liberation protocol intervention reduces the duration of invasive mechanical ventilation in infants and children anticipated to require prolonged mechanical ventilation.Design, Setting, and Participants: A pragmatic multicenter, stepped-wedge, cluster randomized clinical trial was conducted that included 17 hospital sites (18 pediatric intensive care units) in the UK sequentially randomized from usual care to the protocol intervention. From February 2018 to October 2019, 8843 critically ill infants and children anticipated to require prolonged mechanical ventilation were recruited. The last date of follow-up was November 11, 2019.Interventions: Pediatric intensive care units provided usual care (n = 4155 infants and children) or a sedation and ventilator liberation protocol intervention (n = 4688 infants and children) that consisted of assessment of sedation level, daily screening for readiness to undertake a spontaneous breathing trial, a spontaneous breathing trial to test ventilator liberation potential, and daily rounds to review sedation and readiness screening and set patient-relevant targets.Main Outcomes and Measures: The primary outcome was the duration of invasive mechanical ventilation from initiation of ventilation until the first successful extubation. The primary estimate of the treatment effect was a hazard ratio (with a 95% CI) adjusted for calendar time and cluster (hospital site) for infants and children anticipated to require prolonged mechanical ventilation.Results: There were a total of 8843 infants and children (median age, 8 months [interquartile range, 1 to 46 months]; 42% were female) who completed the trial. There was a significantly shorter median time to successful extubation for the protocol intervention compared with usual care (64.8 hours vs 66.2 hours, respectively; adjusted median difference, -6.1 hours [interquartile range, -8.2 to -5.3 hours]; adjusted hazard ratio, 1.11 [95% CI, 1.02 to 1.20], P = .02). The serious adverse event of hypoxia occurred in 9 (0.2%) infants and children for the protocol intervention vs 11 (0.3%) for usual care; nonvascular device dislodgement occurred in 2 (0.04%) vs 7 (0.1%), respectively.Conclusions and Relevance: Among infants and children anticipated to require prolonged mechanical ventilation, a sedation and ventilator liberation protocol intervention compared with usual care resulted in a statistically significant reduction in time to first successful extubation. However, the clinical importance of the effect size is uncertain.Trial Registration: isrctn.org Identifier: ISRCTN16998143. [ABSTRACT FROM AUTHOR]

Abstract Background There is increasing evidence that tight blood glucose (BG) control improves outcomes in critically ill adults. Children show similar hyperglycaemic responses to surgery or critical illness. However it is not known whether tight control will benefit children given maturational differences and different disease spectrum. Methods/Design The study is an randomised open trial with two parallel groups to assess whether, for children undergoing intensive care in the UK aged ≤ 16 years who are ventilated, have an arterial line in-situ and are receiving vasoactive support following injury, major surgery or in association with critical illness in whom it is anticipated such treatment will be required to continue for at least 12 hours, tight control will increase the numbers of days alive and free of mechanical ventilation at 30 days, and lead to improvement in a range of complications associated with intensive care treatment and be cost effective. Children in the tight control group will receive insulin by intravenous infusion titrated to maintain BG between 4 and 7.0 mmol/l. Children in the control group will be treated according to a standard current approach to BG management. Children will be followed up to determine vital status and healthcare resources usage between discharge and 12 months post-randomisation. Information regarding overall health status, global neurological outcome, attention and behavioural status will be sought from a subgroup with traumatic brain injury (TBI). A difference of 2 days in the number of ventilator-free days within the first 30 days post-randomisation is considered clinically important. Conservatively assuming a standard deviation of a week across both trial arms, a type I error of 1% (2-sided test), and allowing for non-compliance, a total sample size of 1000 patients would have 90% power to detect this difference. To detect effect differences between cardiac and non-cardiac patients, a target sample size of 1500 is required. An economic evaluation will assess whether the costs of achieving tight BG control are justified by subsequent reductions in hospitalisation costs. Discussion The relevance of tight glycaemic control in this population needs to be assessed formally before being accepted into standard practice. Trial Registration Current Controlled Trials ISRCTN61735247

The role played by fever in the outcome of critical illness in children is unclear. This survey of medical and nursing staff in 35 paediatric intensive care units and transport teams in the United Kingdom and Ireland established attitudes towards the management of children with fever. Four hundred sixty-two medical and nursing staff responded to a web-based survey request. Respondents answered eight questions regarding thresholds for temperature control in usual clinical practice, indications for paracetamol use, and readiness to participate in a clinical trial of permissive temperature control. The median reported threshold for treating fever in clinical practice was 38 °C (IQR 38-38.5 °C). Paracetamol was reported to be used as an analgesic and antipyretic but also for non-specific comfort indications. There was a widespread support for a clinical trial of a permissive versus a conservative approach to fever in paediatric intensive care units. Within a trial, 58% of the respondents considered a temperature of 39 °C acceptable without treatment.Conclusions: Staff on paediatric intensive care units in the United Kingdom and Ireland tends to treat temperatures within the febrile range. There was a willingness to conduct a randomized controlled trial of treatment of fever. What is known: • The effect of fever on the outcome in paediatric critical illness is unknown. • Paediatricians have traditionally been reluctant to allow fever in sick children. What is new: • Paediatric intensive care staff report a tendency towards treating fever, with a median reported treatment threshold of 38 °C. • There is widespread support amongst PICU staff in the UK for a randomized controlled trial of temperature in critically ill children. • Within a trial setting, PICU staff attitudes to fever are more permissive than in clinical practice. [ABSTRACT FROM AUTHOR]

Objectives Internationally there is no consensus on defining and funding of paediatric high dependency care (HDC). This study tested whether a new UK Healthcare Resource Group (HRG) classification for HDC, with two categories of basic and advanced HDC, can identify children who consume greater staff resource. It also explored the impact of a change in basic HDC HRG criteria introduced in April 2011. Design Observational study of medical and nursing staff resource use. Setting 16 paediatric wards across 6 regional hospitals; 1 tertiary children's hospital (November 2010 to March 2011). Participants 1098 infants and children admitted to paediatric wards. Main outcome measures Number of children meeting criteria for basic and advanced HDC HRGs; care in a cubicle; medical and nursing staff costs, extrapolated from time spent at patient bedside. Results 223 (20.3%) children met original HDC criteria (15.9% basic, 4.4% advanced). This fell to 88 (8.0%) with the change in basic HDC definition (3.6% basic, 4.4% advanced). Children who met original HDC criteria consumed greater bedside staff resource than those not meeting criteria (cost ratio 1.0:1.75:2.96 (non-HDC:basic HDC:advanced HDC)), with revised criteria identifying a (smaller) basic group with greater staff resource use (cost ratio 1.0:2.35:2.76). Being cared for in a cubicle was not associated with greater staff costs. Conclusions HDC HRG criteria identify children who consume significantly greater staff resources. Revision of the definition has resulted in a large reduction of cases meeting the criteria but identifies a group consuming greater staff resources. [ABSTRACT FROM AUTHOR]

We report a case series of four children who developed fixed dilated pupils associated with high tacrolimus levels (>30 nanograms/ millilitre [ng/mL]) in the immediate post-operative period following isolated liver or liver and small bowel transplantation. [ABSTRACT FROM AUTHOR]

Objective: To identify factors associated with the use of intracranial pressure (ICP) monitoring and to establish which ICP-targetted therapies are being used in children with severe traumatic brain injury (TBI) in the United Kingdom. To evaluate current practice against recently published guidelines.Design and Setting: Prospective data collection of clinical and demographic information from paediatric and adult intensive care units in the UK and Ireland admitting children (< 16 years) with TBI between February 2001 and August 2003.Results: Detailed clinical information was obtained for 501 children, with information on the use of ICP monitoring available in 445. ICP monitoring was used in only 59% (75/127) of children presenting with an emergency room Glasgow Coma Scale of 8 or below. Large between centre variation was seen in the use of ICP monitoring, independent of severity of injury. There were 86 children who received ICP-targetted therapies without ICP monitoring. Wide between centre variation was found in the use of ICP-targetted therapies and in general aspects of management, such as fluid restriction, the use of muscle relaxants and prophylactic anticonvulsants. Intra-ventricular catheters are rarely placed (6% of cases); therefore cerebrospinal fluid drainage is seldom used as a first-line therapy for raised ICP. Jugular venous bulb oximetry (4%), brain microdialysis (< 1%) and brain tissue oxygen monitoring (< 1%) are rarely used in current practice. Contrary to published guidelines, moderate to severe hyperventilation is being used without monitoring for cerebral ischaemia.Conclusions: There is an urgent need for greater standardisation of practice across UK centres admitting children with severe TBI. [ABSTRACT FROM AUTHOR]

• There is substantial agreement amongst professionals who interpret and perform prognostic SSEPs. • Agreement is lower in patients below 2 years of age, in those with poor outcome and when interpreting SSEPs as absent. • Clinicians using SSEPs to prognosticate poor outcome should be aware of the inter-rater variability amongst professionals. To measure inter- and intra-rater agreement in the interpretation of cortical somatosensory evoked potential (SSEP) components following paediatric cardiac arrest (CA) in multi-professional neurophysiology teams. Thirteen professionals blinded to patient outcome interpreted 96 SSEPs in paediatric patients 24-/48-/72-hours following CA. Of these, 34 were duplicates used to assess intra-rater agreement. Consistent interpretations (absent/present/indeterminate) between scientists (who record/identify SSEP components) and neurophysiologists (who provide prognostic SSEP interpretation) were expressed as percentages. Rates of agreement were calculated using Fleiss' kappa coefficient (K). Unanimous agreement between professionals was present in 40% (95%CI: 28–54%) of the interpreted SSEPs, with a K value of 0.62 (95%CI: 0.55–0.70) based on average agreement. Agreement was similar between neurophysiologists (K = 0.67; 95%CI: 0.57–0.77) and scientists (K = 0.62; 95%CI: 0.54–0.70) but lower in patients < 2 years old (K = 0.23; 95%CI: 0.14–0.33) and in those with poor outcome (K = 0.21; 95%CI: 0.07–0.35). No SSEP was unanimously interpreted as absent and 92% (95%CI: 89–95%) of duplicate SSEPs were interpreted consistently. Despite substantial agreement when interpreting prognostic SSEPs, this was significantly lower in children with poor outcome and of younger age. Clinicians using SSEPs in the intensive care unit should be aware of the inter-rater variability when interpreting SSEPs as absent. [ABSTRACT FROM AUTHOR]