Study protocol training for life: a stepped wedge cluster randomized trial about emergency obstetric simulation-based training in a low-income country.

BACKGROUND: Globally perinatal and maternal mortality rates remain unacceptably high. There is increasing evidence that simulation-based training in obstetric emergencies is associated with improvement in clinical outcomes. However, the results are not entirely consistent. The need for continued research in a wide variety of clinical settings to establish what works, where and why was recommended. The aim of this study is to investigate the effectiveness of an emergency obstetric simulation-based training program with medical technical and teamwork skills on maternal and perinatal mortality in a low-income country. METHODS: A stepped wedge cluster randomized trial will be conducted at the medium to high-risk labour ward at Mulago Hospital, Kampala, Uganda, with an annual delivery rate of over 23,000. The training will be performed using a train-the-trainers model in which training is cascaded down from master trainers to local facilitators (gynaecologists) to learners (senior house officers). Local facilitators will be trained during a four-day train-the-trainers course with an annual repetition. The senior house officers will be naturally divided in seven clusters and randomized for the moment of training. The training consists of a one-day, monodisciplinary, simulation-based training followed by repetition training sessions. Scenarios are based on the main local causes of maternal and neonatal mortality and focus on both medical technical and crew resource management skills. Kirkpatrick's classification will be used to evaluate the training program. Primary outcome will be the composite of maternal and neonatal mortality ratios. Secondary outcome will comprise course perception, evaluation of the instructional design of the training, knowledge, technical skills, team performance, percentage of ventouse deliveries, percentage of caesarean sections, and a Weighted Adverse Outcome Score. DISCUSSION: This stepped wedge cluster randomized trial will investigate the effect of a monodisciplinary simulation-based obstetric training in a low-income country, focusing on both medical technical skills and crew resource management skills, on patient outcome at one of the largest labour wards worldwide. We will use a robust study design which will allow us to better understand the training effects, and difficulties in evaluating training programs in low-income countries. TRIAL REGISTRATION: ISRCTN98617255 , retrospectively registered July 23, 2018.

Retinal microcirculation imaging in sickle cell disease patients.

OBJECTIVES: To explore the feasibility of a new quantitative method for microvascular function: non-invasive retinal function imaging (RFI). in sickle cell disease (SCD) patients and healthy controls and have it benchmarked against Laser Speckle Contrast Imaging (LSCI) measurements. METHODS: The variability of Microvascular measurements was assessed in 8 SCD patients and 8 healthy matched controls. Measurements were conducted twice on two different study days. RFI was performed for assessment of arterial and venous retinal blood flow. LSCI measurements included post occlusive reactive hyperemia and IBH challenges. Measured variables included basal flow, flow upon occlusion-reperfusion and flow during an IBH. RESULTS: RFI arterial flow and venous flow and LSCI basal flow and peak flow showed excellent intra subject repeatability between days (CVC of 8.5% 9.5%, 7.6% and 7.7% respectively) and between measurements on one day (CVC of 7.0%, 7.7%, 7.6% and 4.7% respectively). RFI arterial flow (p<0.002), and RFI venous flow (p=0.007) differed significantly between SCD patients and controls in as did LSCI basal flow, maximal flow and delta flow during IBH (p<0.0001). CONCLUSIONS: RFI showed low variability for all readout measures, comparable with most microvascular measures from LSCI. The discriminating power of the RFI between SCD patients and controls demonstrate the feasibility of this device for quantitative assessment of the microcirculation in clinical research.

Near-field airborne particle concentrations in young children undergoing high-flow nasal cannula therapy: a pilot study.

BACKGROUND: High-flow nasal cannula therapy (HFNC) may increase aerosol generation, putting healthcare workers at risk, including from SARS-CoV-2. AIM: To examine whether use of HFNC increases near-field aerosols and whether there is an association with flow rate. METHODS: Subjects aged four weeks to 24 months were recruited. Each child received HFNC therapy at different flow rates. Three stations with particle counters were deployed to measure particle concentrations and dispersion in the room: station 1 within 0.5 m, station 2 at 2 m, and station 3 on the other side of the room. Carbon dioxide (CO2) and relative humidity were measured. Far-field measurements were used to adjust the near-field measurements. FINDINGS: Ten children were enrolled, aged from 6 to 24 months (median: 9). Elevated CO2 indicated that the near-field measurements were in the breathing plane. Near-field breathing plane concentrations of aerosols with diameter 0.3-10 µm were elevated by the presence of the patient with no HFNC flow, relative to the room far-field, by 0.45 particles/cm3. Whereas variability between subjects in their emission and dispersion of particles was observed, no association was found between HFNC use, at any flow rate, and near-field particle counts. CONCLUSION: This method of particle sampling is feasible in hospital settings; correcting the near-patient aerosol and CO2 levels for the room far-field may provide proxies of exposure risk to pathogens generated. In this pilot, near-patient levels of particles with a diameter between 0.3 and 10 µm and CO2 were not affected by the use of HFNC.

Repeatability of the Manchester Triage System for children.

OBJECTIVE: The authors aimed to assess the repeatability of the Manchester Triage System (MTS) in children. METHODS: All emergency department nurses (n=43) from a general teaching hospital and a university children's hospital in The Netherlands triaged 20 written case scenarios using the Manchester Triage system. Second, at two emergency departments (EDs), real-life simultaneous triage of patients (<16 years) was performed by ED nurses and two research nurses. The written case scenarios and the patients included in the real-life simultaneous triage study were representative of children attending the ED, in age, problem and urgency level. The authors assessed inter-rater agreement using quadratic weighted kappa values. RESULTS: The weighted kappa between the nurses, triaging the case scenarios, was 0.83 (95% CI 0.74 to 0.91). In total, 88% (N=198) of the eligible ED patients were triaged simultaneously, with a weighted kappa of 0.65 (95% CI 0.56 to 0.72). CONCLUSIONS: The MTS showed good to very good repeatability in paediatric emergency care.

[Diagnostic image (346). A child with prominent cranial fissures]. / Diagnose in beeld (346). Een kind met geprononceerde schedelnaden.

A 2-week-old boy was presented with prominent cranial fissures. He was diagnosed with malleability post partum.

Validity of the Manchester Triage System in paediatric emergency care.

OBJECTIVE: To assess the validity of the Manchester Triage System (MTS) in paediatric emergency care, using information on vital signs, resource utilisation and hospitalisation. METHODS: Patients were eligible if they had attended the emergency department of a large inner-city hospital in The Netherlands from August 2003 to November 2004 and were <16 years of age. A representative sample of 1065 patients was drawn from 18,469 eligible patients. The originally assigned MTS urgency levels were compared with resource utilisation, hospitalisation and a predefined reference classification for true urgency, based on vital signs, resource utilisation and follow-up. Sensitivity, specificity and percentage of overtriage and undertriage of the MTS were calculated. RESULTS: The number of patients who used more than two resources increased with a higher level of MTS urgency. The percentage of hospital admissions increased with the increase in level of urgency, from 1% in the non-urgent patients to 54% in emergent patients. According to the reference classification, the sensitivity of the MTS to detect emergent/very urgent cases was 63%, and the specificity was 78%. Undertriage occurred in 15% of patients, of which 96% were by one urgency category lower than the reference classification. Overtriage occurred in 40%, mostly in lower MTS categories. In 36% of these cases, the MTS classified two or more urgency categories higher than the reference classification. CONCLUSIONS: The MTS has moderate sensitivity and specificity in paediatric emergency care. Specific modifications of the MTS should be considered in paediatric emergency care to reduce overtriage, while maintaining sensitivity in the highest urgency categories.

[Clinical drug research in children: current international guidelines. Committee for Proprietary Medicinal Products]. / Klinisch geneesmiddelenonderzoek bij kinderen: nieuwe internationale richtlijnen. Committee for Proprietary Medicinal Products.

Drugs research in children entails a number of problems: medical-ethical, pharmacological (owing to the immaturity of the organs and the growth and development of the child) and financial (because children do not use many drugs). Consequently, children are exposed to insufficiently tested drugs and new therapeutic possibilities are withheld from them. Currently, little clinical drugs research in children is being carried out, but this is about to change. By now, European guidelines have been drawn up for the performance of clinical drugs trials according the 'good clinical practice' standards in children. In the Netherlands, a cooperative body has been set up (the Pediatric Pharmacology Network), which is to promote and coordinate paediatric pharmacological research in according with these guidelines.

Undertriage in the Manchester triage system: an assessment of severity and options for improvement.

BACKGROUND: The Manchester Triage System (MTS) determines an inappropriately low level of urgency (undertriage) to a minority of children. The aim of the study was to assess the clinical severity of undertriaged patients in the MTS and to define the determinants of undertriage. METHODS: Patients who had attended the emergency department (ED) were triaged according to the MTS. Undertriage was defined as a 'low urgent' classification (levels 3, 4 and 5) under the MTS; as a 'high urgent' classification (levels 1 and 2) under an independent reference standard based on abnormal vital signs (level 1), potentially life-threatening conditions (level 2), and a combination of resource use, hospitalisation, and follow-up for the three lowest urgency levels. In an expert meeting, three experienced paediatricians used a standardised format to determine the clinical severity. The clinical severity had been expressed by possible consequences of treatment delay caused by undertriage, such as the use of more interventions and diagnostics, longer hospitalisation, complications, morbidity, and mortality. In a prospective observational study we used logistic regression analysis to assess predictors for undertriage. RESULTS: In total, 0.9% (119/13,408) of the patients were undertriaged. In 53% (63/119) of these patients, experts considered undertriage as clinically severe. In 89% (56/63) of these patients the high reference urgency was determined on the basis of abnormal vital signs. The prospective observational study showed undertriage was more likely in infants (especially those younger than three months), and in children assigned to the MTS 'unwell child' flowchart (adjusted OR<3 months 4.2, 95% CI 2.3 to 7.7 and adjusted ORunwell child 11.1, 95% CI 5.5 to 22.3). CONCLUSION: Undertriage is infrequent, but can have serious clinical consequences. To reduce significant undertriage, the authors recommend a systematic assessment of vital signs in all children.

Primary chondrosarcoma of the ovary.

A case of a large, completely excised left-sided primary ovarian chondrosarcoma occurring in a 61-year-old woman is described. There was no evidence of metastases. Histologically the tumour was a pure chondrosarcoma, which was mainly well differentiated. The patient is well and disease free at 4 years. Review of the literature revealed no other reported cases of pure chondrosarcoma of the ovary. The possible histogenetic origin of this neoplasm is discussed.

Pharmacokinetics of rectal tramadol in postoperative paediatric patients.

BACKGROUND: Postoperative analgesia in children may be improved by using tramadol. The pharmacokinetics of rectal tramadol in young children were therefore investigated. METHODS: The pharmacokinetics of rectal tramadol and its active metabolite were studied in 12 young children (age: 1-6 yr) postoperatively. On the basis of these data, a population model was constructed. Using this model, the pharmacokinetics of different doses of tramadol were calculated. RESULTS: The pharmacokinetics of rectal tramadol could be adequately described by a one-compartment model. The pharmacokinetic parameters derived from the model indicate that a low variability was present. Elimination half-life was 4.3 (0.2) h (sem) and the apparent clearance was 16.4 (1.5) litre h(-1) (sem). CONCLUSIONS: The study showed that after rectal administration, tramadol is absorbed at a reasonable rate and with a low inter-individual variability in small children. The data also suggested that a rectal dose of tramadol 1.5-2.0 mg kg(-1) is therapeutic.