Trials
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Randomized Controlled Trial
A novel integrated dressing to secure peripheral intravenous catheters in an adult acute hospital: a pilot randomised controlled trial.
The reported incidence of peripheral intravenous catheter (PIV) failure has been as high as 69%. This is in part due to inadequate stabilisation or securement to the skin, which allows micro-motion of the catheter within the vein. ⋯ ISDs were significantly associated with decreased failure in the multivariable modelling. Feasibility outcomes were supportive of the need to undertake a larger trial to confirm these results.
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Trauma is the leading cause of morbidity and mortality in children in the United States. The antifibrinolytic drug tranexamic acid (TXA) improves survival in adults with traumatic hemorrhage, however, the drug has not been evaluated in a clinical trial in severely injured children. We designed the Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children (TIC-TOC) trial to evaluate the feasibility of conducting a confirmatory clinical trial that evaluates the effects of TXA in children with severe trauma and hemorrhagic injuries. ⋯ This multicenter trial will provide important preliminary data and assess the feasibility of conducting a confirmatory clinical trial that evaluates the benefits of TXA in children with severe trauma and hemorrhagic injuries to the torso and/or brain.
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The aim of this study was to assess adherence to the Consolidated Standards of Reporting Trials (CONSORT) extension for Abstracts (CONSORT-A) in the highest-impact anesthesiology journals. ⋯ RCT abstracts published in top anesthesiology journals are poorly reported, providing insufficient information to readers. Interventions are needed to increase adherence to relevant reporting checklists for writing RCT abstracts.
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Perioperative complications occur in 30-40% of non-cardiac surgical patients and are the leading cause of early postoperative morbidity and mortality. Regular visits by trained health professionals may decrease the incidence of complications and mortality through earlier detection and adequate treatment of complications. Until now, no studies have been performed on the impact of routine postsurgical anesthesia visits on the incidence of postoperative complications and mortality. ⋯ TRACE is the first to study the effects of a routine postoperative visit by an anesthesia healthcare professional on mortality and cost-effectiveness of surgical patients. If the intervention proves to be beneficial for the patient and cost-effective, the stepped-wedge design ensures direct implementation in the participating hospitals.
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The number of people with diabetes is growing rapidly. Diabetes can cause nerve damage leading to severe pain in the feet, legs and hands, which is known as diabetic peripheral neuropathic pain (DPNP). In the UK, the National Institute for Health and Care Excellence (NICE) recommends amitriptyline, duloxetine, pregabalin or gabapentin as initial treatment for DPNP. If this is not effective, adding one of the other drugs in combination with the first is recommended. NICE points out that these recommendations are not based on robust evidence. The OPTION-DM randomised controlled trial has been designed to address this evidence deficit, with the aims of determining the most clinically beneficial, cost-effective and tolerated treatment pathway for patients with DPNP. ⋯ The study includes direct comparisons of the mainstay treatment for DPNP. This novel study is designed to examine treatment pathways and capture clinically relevant outcomes which will make the results generalisable to current clinical practice. The study will also provide information on health economic outcomes and will include a subgroup study to provide information on whether patient phenotypes predict response to treatment.