Trials
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Multicenter Study Clinical Trial
The PRECious trial PREdiction of Complications, a step-up approach, CRP first followed by CT-scan imaging to ensure quality control after major abdominal surgery: study protocol for a stepped-wedge trial.
After major abdominal surgery (MAS), 20% of patients endure major complications, which require invasive treatment and are associated with increased morbidity and mortality. A quality control algorithm after major abdominal surgery aimed at early identification of patients at risk of developing major complications can decrease associated morbidity and mortality. Literature studies show promising results for C-reactive protein (CRP) as an early marker for postoperative complications, however clinical significance has yet to be determined. ⋯ the PRECious trial is a stepped-wedge, multicenter, open label, prospective clinical trial to determine the effect of a standardized postoperative quality control algorithm on postoperative morbidity and mortality, and cost-effectiveness.
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Randomized Controlled Trial
Effectiveness of dual-task functional power training for preventing falls in older people: study protocol for a cluster randomised controlled trial.
Falls are a major public health concern with at least one third of people aged 65 years and over falling at least once per year, and half of these will fall repeatedly, which can lead to injury, pain, loss of function and independence, reduced quality of life and even death. Although the causes of falls are varied and complex, the age-related loss in muscle power has emerged as a useful predictor of disability and falls in older people. In this population, the requirements to produce explosive and rapid movements often occurs whilst simultaneously performing other attention-demanding cognitive or motor tasks, such as walking while talking or carrying an object. The primary aim of this study is to determine whether dual-task functional power training (DT-FPT) can reduce the rate of falls in community-dwelling older people. ⋯ The study offers a novel approach that may guide the development and implementation of future community-based falls prevention programmes that specifically focus on optimising muscle power and dual-task performance to reduce falls risk under 'real life' conditions in older adults. In addition, the 'step down' programme will provide new information about the efficacy of a less intensive maintenance programme for reducing the risk of falls over an extended period.
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Ventilator-associated pneumonia (VAP) is the most common infection in intubated critically ill patients. Microaspiration of the contaminated gastric and oropharyngeal secretions is the main mechanism involved in the pathophysiology of VAP. Tracheal cuff plays an important role in stopping the progression of contaminated secretions into the lower respiratory tract. Previous in vitro studies suggested that conical cuff shape might be helpful in improving tracheal sealing. However, clinical studies found conflicting results. The aim of this study is to determine the impact of conical tracheal cuff shape on the microaspiration of gastric contents in critically ill patients. ⋯ BEST Cuff is the first randomized controlled study evaluating the impact of PVC tracheal-cuff shape on gastric microaspirations in patients receiving invasive mechanical ventilation. Enrollment began in June 2014 and is expected to end in October 2015.
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Randomized Controlled Trial
Determination of the efficacy of EVICEL™ on blood loss in orthopaedic surgery after total knee replacement: study protocol for a randomised controlled trial.
After total knee replacement, overall blood loss is often underestimated, although it exceeds the visible blood loss caused by bleeding into the tissues or into the joint. The use of fibrin sealants during surgery has been suggested to reduce perioperative blood loss and transfusion rates and may be beneficial for patient recovery and the postoperative function of the joint. ⋯ So far, studies on the effect of fibrin sealants in total knee replacement have delivered inconsistent and ambivalent results, indicating that there is still a need for high-evidence studies as proposed in the presented study protocol.
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Randomized Controlled Trial
Three donor site dressings in pediatric split-thickness skin grafts: study protocol for a randomised controlled trial.
For children requiring split-thickness skin grafting for burn injury, the optimum donor site dressing is an ongoing subject of debate. The most common dressings in use, both regionally and worldwide, are calcium alginates. We will compare an alginate with two other dressings, all of which are in current use in the Pegg Leditschke Paediatric Burns Centre (PLPBC), to determine which dressing performs the best. ⋯ This study will provide comprehensive short- and long-term data on DSW dressings in pediatric split-thickness skin grafting. The best-performing dressing will become the preferred dressing for the PLPBC. We will provide rigorous data against which other dressings can be compared in future, recognising that alginates are the most common DSW dressing currently in use. Our study design replicates a real-world scenario in order to identify clinically significant differences between the three dressings.