IntroductionEmergency intubation of children with abnormal respiratory or cardiac physiology is a high-risk procedure and associated with a high incidence of adverse events including hypoxemia. Successful emergency intubation is dependent on inter-related patient and operator factors. Preoxygenation has been used to maximise oxygen reserves in the patient and to prolong the safe apnoeic time during the intubation phase. Transnasal Humidified Rapid Insufflation Ventilatory Exchange (THRIVE) prolongs the safe apnoeic window for a safe intubation during elective intubation. We designed a clinical trial to test the hypothesis that THRIVE reduces the frequency of adverse and hypoxemic events during emergency intubation in children and to test the hypothesis that this treatment is cost-effective compared with standard care.Methods and analysisThe Kids THRIVE trial is a multicentre randomised controlled trial performed in participating emergency departments and paediatric intensive care units. 960 infants and children aged 0–16 years requiring emergency intubation for all reasons will be enrolled and allocated to THRIVE or control in a 1:1 allocation with stratification by site, age (<1, 1–7 and >7 years) and operator (junior and senior). Children allocated to THRIVE will receive weight appropriate transnasal flow rates with 100% oxygen, whereas children in the control arm will not receive any transnasal oxygen insufflation. The primary outcomes are defined as follows: (1) hypoxemic event during the intubation phase defined as SpO2<90% (patient-dependent variable) and (2) first intubation attempt success without hypoxemia (operator-dependent variable). Analyses will be conducted on an intention-to-treat basis.Ethics and disseminationEthics approval for the protocol and consent process has been obtained (HREC/16/QRCH/81). The trial has been actively recruiting since May 2017. The study findings will be submitted for publication in a peer-reviewed journal.Trial registration numberACTRN12617000147381.
During the winter of 1971/72, eleven dermatologists in private practice and the dermatological departments of the Finsen Institute and Marselisborg Hospital conducted a controlled clinical trial to investigate the effect of topically applied tretinoin in patients with acne vulgaris using a 0.02-percent cream, a 0.05-percent cream, and the cream base alone. The effect of the treatment was evaluated by counting the acne lesions, the number being arranged according to a score system. As regards the effect on comedones and papules, the tretinoin cream was significantly better than the cream base alone. A concentration of 0.05% showed a quicker onset of action and a more pronounced effect than a concentration of 0.02%. The effect of the treatment was less pronounced and not statistically significant as far as pustules and cysts were concerned. The investigation confirmed previous good experience with this form of treatment. The effect upon the placebo group was considerable. This calls for caution when the effect of new acne agents is to be evaluated. Attention is drawn to the special form of cooperation used in the investigation; in this way, it was possible to include a great number of out-patients.
BackgroundClinical decision rules (CDRs) are commonly used to guide imaging decisions in cervical spine injury (CSI) assessment despite limited evidence for their use in paediatric populations. We set out to determine CSI incidence, imaging rates and the frequency of previously identified CSI risk factors, and thus assess the projected impact on imaging rates if CDRs were strictly applied as a rule in our population.MethodsA single-centre prospective observational study on all aged under 16 years presenting for assessment of possible CSI to a tertiary paediatric emergency department over a year, commencing September 2015. CDR variables from the National Emergency X-Radiography Utilization Study (NEXUS) rule, Canadian C-Spine rule (CCR) and proposed Paediatric Emergency Care Applied Research Network (PECARN) rule were collected prospectively and applied post hoc.Results1010 children were enrolled; 973 had not received prior imaging. Of these, 40.7% received cervical spine imaging; 32.4% X-rays, 13.4% CT scan and 3% MRI. All three CDRs identified the five children (0.5%) with CSI who had not received prior imaging. If CDRs were strictly applied as a rule for imaging, projected imaging rates in our setting would be as follows: NEXUS-44% (95% CI 41% to 47.4%), CCR-at least 48.4% (95% CI 45.3% to 51.7%) and PECARN-68% (95% CI 65.1% to 71.1%).ConclusionCSIs were rare (0.5% of our cohort), however, 40% of children received imaging. CDRs have been designed to guide imaging decisions; if strictly applied as a rule for imaging, the CDRs assessed in this study would increase imaging rates. Projected rates differ considerably depending on the CDR applied. These findings highlight the need for a validated paediatric-specific cervical spine imaging CDR.
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