ANZCTR search results

There are multiple small observational studies suggesting that treatment of sleep apnoea has beneficial anti-arrhythmic effects on arrhythmia recurrence in patients with atrial fibrillation. In this study we want to evaluate the impact of obstructive sleep apnoea treatment with continuous positive airway pressure on AF ablation outcomes. We hypothesise that treatment of OSA will improve ablation outcomes.

Psychological factors are important in medication adherence. Interventions geared towards education may help facilitate adherence. Two questionnaires were administered to screen IBD patients. The Medication Adherence Rating Scale (MARS) questionnaire screened for non-adherence and consisted of four questions on a Likert-type scale he Beliefs about Medications Questionnaire (BMQ) addressed necessity and concerns. The BMQ consisted of ten questions on a 5-point Likert scale The first five questions addressed patient necessity towards medications and the last five questions addressed patient concerns regarding medications totalling a maximum of 25 points per domain. High necessity and concerns was determined with a score of >15/25 in each corresponding domain. Patients with MARS scores below 17 were classified as non-adherers and were offered a structured personalised counselling session with an IBD pharmacist addressing misperceptions, concerns, risk and other queries. Adherers were recruited as controls. All patients were followed up with the MARS and BMQ questionnaire at 6 months after baseline questionnaires. The primary outcome was adherence measured by the MARS score. Secondary outcomes were medication necessity and concerns

Dexmedetomidine is increasingly used for procedural and intensive care unit sedation. This growing popularity is based on the belief that it has relatively little impact on both ventilatory drive and upper airway collapsibility, in contrast to benzodiazepines and propofol, which are known to depress ventilation and predispose to upper airway obstruction. However, we have preliminary data demonstrating that, at similar levels of sedation, the degree of upper airway collapsibility observed with dexmedetomidine is similar to that with propofol. Formal evaluation is now required. This study will compare the effects of dexmedetomidine and propofol on upper airway function in healthy people. Information gained from this study will improve our understanding of the effects of dexmedetomidine and its safe use for procedural and intensive care unit sedation Aim: To compare the degree of upper airway collapsibility and mechanisms underlying it during light and deep levels of dexmedetomidine and propofol sedation in healthy individuals Hypothesis: Upper airway collapsibility will increase with increasing depth of sedation but will be similar at comparable depths of dexmedetomidine and propofol sedation.

The primary purpose of this study is to compare two formulations of trastuzumab to determine whether a new formulation produces similar blood levels to the current product. Who is it for? You may be eligible to participate in this study if you are a healthy male, aged 18 to 55, with a BMI of 18-30 and body weight of 50-100kg. Study details Participants enrolled in this trial will be randomly allocated (by chance) to receive a single dose of either the existing formulation of trastuzumab (known as Herceptin), or the new formulation of trastuzumab. After the single dose has been administered, blood samples will be taken [at the end of infusion and at 0.5, 1 6, 24, 48, 72, 96 and 168 hours and at Days 15, 22, 29, 36, 50, 64 and 78], to check the concentration of the drug in the blood over time. Researchers will also monitor participants for side effects e.g. by physical examination etc, until Day 78. It is hoped that the findings of this study will provide information on whether the new formulation of trastuzumab is equivalent to the existing formulation in the manner in which it is moved through and absorbed by the body.

The survival of an organism in the face of internal and external events requires a measured and appropriate stress response. Recent strands of evidence suggest that an abnormal stress response is linked to the likelihood of the development and severity of critical illness and multi-organ failure. The stress response is coordinated by primitive brain structures in response to sensory inputs and comprises a broad range of effects. We hypothesise that the use of sedating medications confuses the normal generation of a stress response. If this is confirmed, this may be a fundamental underlying cause for the abnormal physiology, metabolic disturbances and organ dysfunction observed in critical illness. The current large multi-centre randomised-controlled Sedation Practices in Intensive Care Evaluation III (SPICE-III) study, in offers the opportunity to study two similar groups of patients who may have differing levels of physiological stress as a result of an Early Goal-Directed Sedation (EGDS) strategy as compared to standard care. The proposed observational study, to be conducted at Nambour Hospital, aims to provide the investigators with pilot data to determine the optimum timing of sampling for a stress panel and to conduct a statistical plan for a randomised–controlled sub-study of the larger SPICE-III study.

This study aims to determine, using a discrete choice experiment survey, the willingness of cancer patients to participate in a clinical trial, including travel, change in provider and type of clinical trial. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have a diagnosis of cancer for which you are attending a cancer clinic. Study details All participants in this study will be asked to complete a brief survey either online or using paper and pen, at the oncology clinic or at home at a later time. It will take approximately 10 minutes to complete. It asks questions about demographics, cancer diagnosis, treatment, and about preferences when considering a clinical trial. This will take the form of a discrete choice experiment, with ten scenarios per questionnaire. Participants will be asked to state whether they would join a clinical trial or continue with standard care, given the scenario presented. This study will provide useful information on how willing cancer patients are to travel, or to be referred to a different centre to participate in a clinical trial.

In this study we aim to enhance adolescent prevention programs through a theoretically-driven application of mindfulness meditation (MM) that will reduce alcohol use and behaviour problems by directly targeting impulse control. This study will be a cluster randomised controlled trial comparing a MM enhanced cognitive behavioural therapy (CBT) condition with a CBT with progressive muscle relation condition and a non-intervention control condition. These interventions will be delivered at 3 time-points and participants will be followed up at several time points during their schooling years. We hypothesise that the both the MM enhanced CBT and the standard CBT conditions will produce superior outcomes to the assessment-only control and that the MM enhanced CBT condition will result in superior outcomes to the standard CBT condition.

Tobacco remains a major cause of death in Australia & NZ, with 20,000 annual deaths. Approximately 300,000 smokers have elective surgery each year in Australia & NZ. Smoking increases anaesthetic and surgical risks; particularly respiratory complications and wound infections. Stopping smoking for >4 weeks before surgery significantly reduces these risks, but there is little data on the best ways to help patients quit before surgery. Many smokers make unassisted quit attempts prior to surgery but relapse is common so most arrive in hospital having smoked that day. The use of nicotine patches and engagement with telephone Quitlines significantly increase quitting success in community settings, but have been little studied in surgical populations. Despite strong evidence in their favour, few smokers having surgery use patches and fewer have Quitline contact. There are no studies looking at using these measures at the time patients go onto the surgical wait-list. More research is important because: (1)Stopping before surgery, especially >4-weeks reduces surgical & anaesthetic complications. (2)There is often a significant period of time on the surgical waiting list to allow such quit times to be achieved (3)Surgery is recognised as a teachable moment for behaviour change; a period in one’s life when there is reflection upon health behaviours and increased motivation for positive change. (4) A significant proportion of patients quitting before surgery remain a lifelong non-smoker. Given the large numbers of smokers having surgery each year, efforts to increase abstinence may be a significant public health benefit. This is health services research to evaluate if an offer of a stop-smoking program will increase quitting before surgery. Smokers of 10 or more cigarettes per day (nicotine dependent) will be offered a free 5-week course of free nicotine patches shortly after they go onto the waiting list. The 5-week nicotine patch supply will be mailed to patients in order to make their use as easy and convenient as possible; eliminating many of the barriers to use. Patients who were smokers at time of waiting list placement will be approached on their day of surgery by a data collector and asked for verbal consent for a short interview (<4-minutes). This will ask if they have quit smoking, or made quit attempts before surgery. For those that claim to have quit (>24 hours), we will ask for written permission to confirm this by exhaled carbon monoxide testing plus to make brief telephone contact at 3 and 6 months after surgery to see if they are still quit. A comparison group of patients who smoke will not have this quit package promoted or offered to them.

The aim of this study is to examine the efficacy of an infant and family health and wellbeing short-term message service (SMS) intervention in supporting expectant and new parents both birthing at partnered Queensland Hospitals. The intervention period will be for 48 weeks from recruitment date and involves the provision of relevant and timely information on positive parenting strategies, attachment and health behaviours and support networks via an SMS program. Participants will be recruited in the antenatal period via antenatal clinics in partnered hospitals in late 2015 (600 intervention; 600 control). This study will follow a mixed methods design involving qualitative and quantitative methodologies. The researchers aim to measure the effectiveness of the project by following a mixed methods design. Study procedures will involve face-to-face and web-based surveys pre-intervention and web based and telephone surveys for the last three data collection points in the evaluation, including post-intervention. Focus group interviews with a selection of participants post project intervention. This trial follows on from the Connecting2u (C2u) pilot project conducted with families delivering at Logan Hospital between March and October 2014 which indicated the effectiveness of text messages in supporting parental confidence. Phase Two includes the dissemination of text messages in the antenatal period as research has indicated the importance of early intervention before birth in regards to health and wellbeing of the parents and child.

Background: The KneeAlign 'Registered Trademark' is an accelerometer-based, electronic, portable device which was designed for use in navigational total knee arthroplasty. There is literature which supports its efficacy and safety in achieving satisfactory knee alignment following total knee arthroplasty. However, most studies on the device has come from the designer unit and further information gathered from independent operators will be important. Its potential benefit is in the area of navigated arthroplasty as it is less-bulky than current navigation equipment and may prove important in complex surgeries where navigation is most useful. The risks are minimal and may even protect the medullary canal (as this is invaded using conventional alignment guides). The patient receives the same implant by the same surgeon and this device is to be used solely as an aid in achieving accurate bony cuts during surgery. This study will compare conventional guides and the navigation device in question. The trial will be conducted in compliance with the protocol laid out, GCP and the ethics regulations. The study will look at patients who are undergoing routine total knee replacement for osteoarthritis (the most common reason for prosthetic replacement). Trial Objectives: To prospectively compare patient-reported outcome measures and radiological results between conventionally guided and accelerometer-based navigation in patients undergoing total knee replacement surgery. Specifically, we will compare pain and functional scores together with mechanical axes correction in both sagittal and coronal planes. trial will be a prospective, patient-blinded, randomised comparative study with the end-points being patient-reported outcome measures, radiological results and duration of surgery. Patient consent and ethical approval will be obtained prior to trial commencement. Clinical outcome measures would be assessed via the Knee Society Score (KSS) and the Knee Injury and Osteoarthritis Outcome score (KOOS) questionnaires which are both validated patient reported outcome measures following knee arthroplasty. These questionnaires will be taken at the time of standard appointments (pre-surgery & 6 months). Radiological outcomes will be assessed via CT imaging studies pre and post op using the CT Perth Protocol (To assess for mechanical & anatomical alignment). Patients will be recruited at the time when a decision to proceed with a knee arthroplasty is made during consultation.