Trials
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Intraoperative driving pressure (ΔP) is associated with development of postoperative pulmonary complications (PPC). When tidal volume (VT) is kept constant, ΔP may change according to positive end-expiratory pressure (PEEP)-induced changes in lung aeration. ΔP may decrease if PEEP leads to a recruitment of collapsed lung tissue but will increase if PEEP mainly causes pulmonary overdistension. This study tests the hypothesis that individualized high PEEP, when compared to fixed low PEEP, protects against PPC in patients undergoing open abdominal surgery. ⋯ DESIGNATION will be the first randomized clinical trial that is adequately powered to compare the effects of individualized high PEEP with RM versus fixed low PEEP without RM on the occurrence of PPC after open abdominal surgery. The results of DESIGNATION will support anesthesiologists in their decisions regarding PEEP settings during open abdominal surgery.
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Dementia is a neurological condition that affects the cognitive and functional ability of the brain and is the leading cause of disability among those aged 65 years and above. More effective ways to manage dementia symptoms are needed because current treatment options (antidepressants and antipsychotics) can be ineffective and are associated with substantial side effects, including increased rate of mortality. Cannabinoid-based medicine (CBM) has shown an ability to inhibit some symptoms associated with dementia, and the adverse effects are often minimal; yet, little research has explored the use of CBM among this population. ⋯ The study design has been informed by medical professionals and key stakeholders, including those working in the residential aged-care industry to ensure patient safety, collection of non-invasive measures, and methodological rigor and study feasibility.
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Urgency is a complaint of sudden, compelling desire to pass urine, which is difficult to defer, caused by involuntary contraction of the detrusor muscle during the bladder-filling stage. To enable detrusor inhibition, electrotherapy resources such as transcutaneous tibial nerve stimulation (TTNS) and parasacral transcutaneous electrical stimulation (PTES) have been used. The objective this study is to publish the study protocol that aims to investigate whether urgency decreases after treatment with both of the techniques. ⋯ The present study aims to contribute evidence for a more in-depth discussion on electrode positioning for electrostimulation used in urgency treatment. It should be emphasized that, based on the possibility of confirming the hypothesis that urgency will decrease in a similar way after both treatments (TTNS and PTES), the PTES will be used as an option for positioning the electrodes alternatively to the tibial nerve region in special populations, such as amputees or people with severe lower limb sensory impairment.
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The objective of this trial is to investigate the effects of protective lung ventilation on regional cerebral oxygen saturation (rSO2) during dura opening, that is from Ta (after dura opening) to Tb (before dura closing), in patients undergoing intracranial tumor surgery. ⋯ This study aims to determine whether protective lung ventilation during dura opening can improve rSO2 and the state of pulmonary ventilation in patients undergoing intracranial tumor surgery, and to investigate whether this strategy affects the degree of brain tissue swelling and the reoperation rate after operation. If our results are positive, this study will show that protective lung ventilation during dura opening can be used effectively and safely in neurosurgical patients undergoing craniotomy for tumor resection.
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Comparative Study
Handling an uncertain control group event risk in non-inferiority trials: non-inferiority frontiers and the power-stabilising transformation.
Non-inferiority trials are increasingly used to evaluate new treatments that are expected to have secondary advantages over standard of care, but similar efficacy on the primary outcome. When designing a non-inferiority trial with a binary primary outcome, the choice of effect measure for the non-inferiority margin (e.g. risk ratio or risk difference) has an important effect on sample size calculations; furthermore, if the control event risk observed is markedly different from that assumed, the trial can quickly lose power or the results become difficult to interpret. ⋯ Our proposed methods of designing non-inferiority trials using power-stabilising non-inferiority frontiers make trial design more resilient to unexpected values of the control event risk, at the only cost of requiring somewhat larger sample sizes when the goal is to report results on the risk difference scale.