Trials
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A fiberoptic bronchoscope (FOB) is commonly used to identify the proper placement of a double-lumen endotracheal tube (DLT) for good lung isolation during thoracic surgery. We hypothesized that the FOB-guided method for DLT placement composed of tracheal intubation under initial guidance by a FOB via the bronchial lumen and subsequent selective left-bronchial intubation could be used to reduce the incidence of DLT malposition and reduce the time required for completion of DLT placement and confirmation of proper DLT position during intubation using a left-sided DLT, in comparison to the conventional method under direct laryngoscopy using a Macintosh laryngoscope. ⋯ This pilot study was designed as the first randomized controlled trial to confirm our hypothesis. This should provide information for a further full-scale trial, and the outcomes of the study should provide clinical evidence on the usefulness of the FOB-guided method for DLT placement, in comparison to the conventional method.
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Gabapentin has shown efficacy in the treatment of chronic neuropathic or mixed pain in adults. Although pediatric pain specialists have extensive experience with gabapentin for the treatment of neuropathic pain, its use is off-label. Its efficacy and safety in this context have never been shown. The aim of this trial is to compare gabapentin with placebo as add-on to morphine for the treatment of severe chronic mixed or neuropathic pain in children. This trial is part of the European Union Seventh Framework Programme project Gabapentin in Paediatric Pain (GAPP) to develop a pediatric use marketing authorization for a new gabapentin suspension. ⋯ We hope to provide evidence that the combination of morphine and gabapentin will provide better analgesia than morphine alone and will be safe. We also aim to obtain confirmation of the recommended pediatric dose.
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Randomized Controlled Trial
Process evaluation of the context, reach and recruitment of participants and delivery of dementia-specific case conferences (WELCOME-IdA) in nursing homes (FallDem): a mixed-methods study.
A system of dementia-specific case conferences (WELCOME-IdA) was evaluated using a stepped-wedge design in six nursing homes (NHs) to enable nursing staff to analyse properly the behavioural and psychological symptoms (BPSD) of residents with dementia. A process evaluation of the context, the recruitment and target populations reached (residents and nursing staff) and the delivery of the intervention and implementation strategy was carried out to explore the lack of effectiveness of WELCOME-IdA on the residents' prevalence of BPSD. ⋯ An analysis of the process evaluation data indicated that there were inaccuracies in the implementation of WELCOME-IdA and there were methodological limitations within the design of the effectiveness trial, both of which could explain the lack of effectiveness of WELCOME-IdA. To optimise the process structure of WELCOME-IdA, an assessment of BPSD and a pre-selection of possible domains for the behavioural analysis could be conducted prior to a dementia-specific case conference.
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The objective of the Dutch Sildenafil therapy in dismal prognosis early onset fetal growth restriction (STRIDER) randomised clinical trial is to assess the beneficial and harmful effects of sildenafil versus placebo on fetal and neonatal mortality in pregnant women with severe early-onset fetal growth restriction. The objective of this detailed statistical analysis plan is to minimize the risks of selective reporting and data-driven analysis. ⋯ This pre-specified statistical analysis plan was written and submitted without knowledge of the unblinded data and updated after stopping of the trial at interim analysis.
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Cardiac surgical procedures are associated with postoperative neurological complications such as cognitive decline and delirium, which can complicate recovery and impair quality of life. Perioperative depression and anxiety may be associated with increased mortality after cardiac surgeries. Surgical prehabilitation is an emerging concept that includes preoperative interventions to potentially reduce postoperative complications. While most current prehabilitation interventions focus on optimizing physical health, mind-body interventions are an area of growing interest. Preoperative mind-body interventions such as Isha Kriya meditation, may hold significant potential to improve postsurgical outcomes. ⋯ This study serves as the first step towards understanding the feasibility of implementing a mind-body intervention as a prehabilitative intervention to improve postoperative surgical outcomes after cardiac surgery.