Trials
-
Randomized Controlled Trial
Tranexamic acid in bleeding trauma patients: an exploration of benefits and harms.
The CRASH-2 trial showed that tranexamic acid (TXA) administration reduces mortality in bleeding trauma patients. However, the effect appeared to depend on how soon after injury TXA treatment was started. Treatment within 3 h reduced bleeding deaths whereas treatment after 3 h increased the risk. We examine how patient characteristics vary by time to treatment and explore whether any such variations explain the time-dependent treatment effect. ⋯ The time-dependent effect of TXA in bleeding trauma patients is not explained by the type of injury, the presence or absence of head injury or systolic blood pressure. When given within 3 h of injury, TXA reduces death due to bleeding regardless of type of injury, GCS or blood pressure.
-
Randomized Controlled Trial Multicenter Study Pragmatic Clinical Trial
Smoking Cessation Intervention for Severe Mental Ill Health Trial (SCIMITAR+): study protocol for a randomised controlled trial.
Smoking is highly prevalent among people who have experience of severe mental ill health, contributing to their poor physical health. Despite the 'culture' of smoking in mental health services, people with severe mental ill health often express a desire to quit smoking; however, the services currently available to aid quitting are those which are widely available to the general population and may not be suitable or effective for people with severe mental ill health. The aim of this study is to explore the effectiveness and cost-effectiveness of a bespoke smoking-cessation intervention specifically targeted at people with severe mental ill health. ⋯ SCIMITAR+ trial is the largest trial to our knowledge to investigate the effectiveness of a bespoke smoking-cessation service for people with severe mental ill health.
-
Randomized Controlled Trial
Telemedical support for prehospital Emergency Medical Service (TEMS trial): study protocol for a randomized controlled trial.
Increasing numbers of emergency calls, shortages of Emergency Medical Service (EMS), physicians, prolonged emergency response times and regionally different quality of treatment by EMS physicians require improvement of this system. Telemedical solutions have been shown to be beneficial in different emergency projects, focused on specific disease patterns. Our previous pilot studies have shown that the implementation of a holistic prehospital EMS teleconsultation system, between paramedics and experienced tele-EMS physicians, is safe and feasible in different emergency situations. We aim to extend the clinical indications for this teleconsultation system. We hypothesize that the use of a tele-EMS physician is noninferior regarding the occurrence of system-induced patient adverse events and superior regarding secondary outcome parameters, such as the quality of guideline-conforming treatment and documentation, when compared to conventional EMS-physician treatment. ⋯ The evidence underlines the better quality of service using telemedicine networks between medical personnel and medical experts in prehospital emergency care, as well as in other medical areas. The worldwide unique EMS teleconsultation system in Aachen has been optimized and evaluated in pilot studies and subsequently integrated into routine use for a broad spectrum of indications. It has enabled prompt, safe and efficient patient treatment with optimized use of the "resource" EMS physician. There is, however, a lack of evidence as to whether the advantages of the teleconsultation system can be replicated in wider-ranging EMS-physician indications (excluding life-threatening emergency calls).
-
Randomized Controlled Trial
NIRS-based neurofeedback training in a virtual reality classroom for children with attention-deficit/hyperactivity disorder: study protocol for a randomized controlled trial.
Children with attention-deficit/hyperactivity disorder (ADHD) suffer from attention deficits, motor hyperactivity, and impulsive behaviour. These impairments are experienced at home, at school, and with friends. Functional imaging studies show that ADHD behaviour and impairments in executive functions (EFs) are mirrored by aberrant neurophysiological functioning. Moreover, several studies show that ADHD behaviour, impairments in EFs, and a lack of self-control contribute to poor school performance. Non-pharmacological interventions such as neurofeedback training (NFT), for instance, aim at improving neurophysiological and neuropsychological functioning as well as behaviour. Consequently, NFT is expected to improve school performance, EFs, and self-control in children with ADHD. Generalization of acquired self-regulation skills from laboratory to real life is crucial for a transfer to everyday situations and is hypothesized to be facilitated via training using virtual reality (VR) environments. Consequently, experiencing NFT in VR is expected to yield greater effects than training in two dimensions (2D). ⋯ This is, to our knowledge, the first study investigating the efficacy of NFT for children with ADHD in a VR compared to a 2D environment. Furthermore, this study will contribute to the discussion about the efficacy and specific and unspecific effects of NFTs in children with ADHD. In addition to commonly assessed variables such as ADHD symptoms, NIRS and behavioural data obtained in EF measures, health-related quality of life, and parents' expectations about the intervention's effects, this study will investigate the effects on self-control, school performance, and motor activity.
-
Randomized Controlled Trial Multicenter Study Comparative Study
Impact of the duration of antibiotics on clinical events in patients with Pseudomonas aeruginosa ventilator-associated pneumonia: study protocol for a randomized controlled study.
Ventilator-associated pneumonia (VAP) accounts for 25% of infections in intensive care units. Compared to a long duration (LD) of antibiotic therapy, a short duration (SD) has a comparable clinical efficacy with less antibiotic use and less multidrug-resistant (MDR) pathogen emergence, with the exception of documented VAP of non-fermenting Gram-negative bacilli (NF-GNB), including Pseudomonas aeruginosa (PA). These results have led the American Thoracic Society to recommend SD therapy for VAP, except for PA-VAP. Thus the beneficial effect of SD therapy in PA-VAP is still a matter of debate. We aimed to assess the non-inferiority of a short duration of antibiotics (8 days) versus prolonged antibiotic therapy (15 days) in PA-VAP. ⋯ Demonstrating that an SD (8 days) versus LD (15 days) therapy strategy in PA-VAP treatment is safe and not associated with an increased mortality or recurrence rate could lead to a change in practices and guidelines in the management of antibiotic therapy of this frequent ICU complication. This strategy could lead to decreased antibiotic exposure during hospitalization in the ICU and in turn reduce the acquisition and the spread of MDR pathogens.