ANZCTR search results

In Australia 33,000 open-heart surgery operations are performed annually via an incision at the breast bone. Chest pain and non-union of the breast bone have been reported as complications following cardiac surgery. This is significant as if patients have pain that persists beyond 6 weeks it is more likely to continue as chronic sternal pain thus highlighting the importance of optimal pain management in the initial post-operative period. Following surgery patients are encouraged to observe sternal precautions that restrict the use of their arms and trunk to prevent these complications. These precautions are applied across Australia and worldwide practice without evidence to support them. Sternal precautions may be overly restrictive and not necessary for all patients as they may delay recovery by impacting on function. Upper limb movements have been shown to reduce post-operative pain and improve function. The aim of this project is to examine whether modified precautions that allow the use of the upper limbs and trunk within safe limits will facilitate recovery and function following cardiac surgery via a median sternotomy.

Atrial fibrillation (AF) is the most common heart rhythm disorder and develops in 20-25% of people over their lifetime. The initial treatment has been medication therapy, however in the past decade, a catheter ablation procedure called pulmonary vein isolation has become increasingly widely practiced and is more effective than medical therapy at treating AF. This is performed by introducing catheters via the groin veins to the heart. There are two methods available in Australia for performing this procedure which aims to electrically isolate the pulmonary veins from the rest of the left atrium to which they connect in the heart as these usually contain abnormal foci that trigger the initiation of AF. The first of the two methods utilises radiofrequency ablation to create burns to the inside of the left atrium to encircle the pulmonary veins and the back wall of the left atrium. From a recent randomised clinical trial, we have found that the use of a large single ring was better than the conventional two separate rings in preventing the recurrence of AF. The second method uses more recent technology and involves a cryoballoon catheter that freezes the tissues around the pulmonary veins to achieve the same effect. Recent studies of this technique has shown it to be a safe and effective means of performing pulmonary vein isolation. It is not known which of the two procedures is more effective. We aim in the present randomised controlled clinical trial to investigate the relative efficacy and safety of the two procedures.

The aim of this study is to examine whether patients who are waiting on a surgical waitlist for Total Knee Replacement, can decrease pain by participating in regular supervised exercise, together with targeted manual therapy. HYPOTHESIS: Patients with severe OA of the knee who participate in a Physiotherapy intervention programme will experience a reduction in knee pain.

This international multicentre prospective observational study, performed at the Royal Women’s Hospital, Melbourne, Australia, and Chelsea & Westminster Hospital, London, UK, and Mowbray Maternity Hospital, Cape Town, South Africa aims to determine the reference range for an exercise test, the six minute walk test, in healthy pregnant women and non-pregnant women of childbearing age. This test is commonly used in non-pregnant adults to determine cardiovascular fitness and as a prognostic test in adults with chronic medical conditions. Its utility has not been investigated in pregnant women. It is hoped that this study will provide the baseline data for further studies investigating the usefulness of this test in pregnant women and non-pregnant women of childbearing age. Specifically, the use of this test to predict women who will develop new onset hypertension in pregnancy, the use of this test as part of a pre-pregnancy exercise intervention program to reduce the likelihood of developing new onset hypertension in pregnancy, and the use of the test to quantify symptoms of fatigue and breathlessness in pregnancy. As part of this study 30 pregnant women in second trimester will undergoing three additional test - the incremental shuttle walk test, cardiopulmonary exercise testing and transthoracic echocardiography. The reason to do this is to determine the relationship between submaximal exercise testing with exercise tests (The Six Minute Walk Test - an unpaced test, and the Incremental Shuttle Walk Test - a paced test) and cardiac function with echocardiography and direct measurement of maximal oxygen utilisation capacity with the cardiopulmonary exercise testing.

This study will compare the effect of two different indwelling pleural catheter (IPC) drainage strategies on breathlessness and quality of life in patients with a malignant pleural effusion (MPE). Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with a symptomatic malignant pleural effusion (MPE) for which drainage is considered appropriate by the managing clinician. Study details All participants in this study will be eligible if they need to have an indwelling Pleural Catheter (IPC) inserted for the management of their malignant pleural effusion. IPC allow fewer invasive procedures and reduced hospitalizations than conventional talc pleurodesis. Participants will then be randomly allocated (by chance) to one of two groups. Participants in one group will be asked to drain their effusions every day for the first 60 days (unless certain criteria are met). For participants in the other group, drainage will only be performed if the patient feels that the effusion-related symptoms (usually breathlessness, cough and/or tightness) have recurred. All participants will be asked to complete regular questionnaires for up to 1 year in order to rate their level of breathlessness and quality of life. Other clinical outcomes, any adverse events, and health care utilisation will also be monitored throughout the study. We hope to determine which regime is superior in improving clinical outcomes so that management of cancer patients with an MPE can be optimised.

This research will evaluate a new parenting program, Tuning in to Toddlers (TOTS), an intervention with goals to prevent the onset of social, emotional and behavioural difficulties in young children. TOTS aims to improve parents’ emotional responsiveness and emotion regulation in order to assist their child to begin to understand and regulate their emotional reactions and to reduce stress for parent and child. There are few available evidence based programs for parents of toddlers and none have taken an emotion-focused approach despite early childhood being a time of intense emotions for parents and a critical time in toddler’s emotional development. TOTS will focus on and promote emotional competencies, strengthening the parent-child relationship that will reduce the likelihood of child emotional or behavioural problems during these early years. The study will recruit 290 parents of a 2-3 year old child through maternal and child health centres, Playgroups Victoria and childcare services in Melbourne. Participants will be randomised to either TOTS or a wait-list control group. TOTS participants will attend a 6-session parenting program while wait-list participants will be offered the program after a 15-month waiting period (unless they require clinical intervention). Participants will complete measures at baseline, immediately post- intervention (intervention participants only) and at 15-month follow-up. To assess the efficacy of TOTS we will use well validated measures including questionnaires about parenting and children’s functioning; a parent-toddler observation task measuring parental emotion coaching, parental emotional responsiveness and toddler emotion regulation; and hair samples to assess parent and toddler stress levels. TOTS is a manualised intervention and measures will be used to determine program acceptability and fidelity. Statistical analyses will compare participants in the two groups at follow-up. Outcomes will be reported in peer-reviewed journals, at conferences and in a facilitator manual of TOTS that will enable program dissemination.

The present study will implement a treatment of gambling problems through use of an online cognitive behavioural therapy (CBT) program. Participants will have access to this internet-based self-directed intervention for a duration of six weeks. The online intervention will allow participants to explore their gambling behaviour and develop ways to change or stop it completely. The current study aims to evaluate the clinical outcomes for problem gamblers completing a self-directed online CBT-based program, one with and one without the addition of a one-off telephone call with a clinician using a motivational interviewing. intervention.

Negative sensitivity is one of the most significant source of error in regards to the tetrapolar method used most commonly in bio-impedance (Grimnes & Martinsem 2006). The tetrapolar method consists of a pair of current carrying electrodes which sends tiny electrical current into a localised area. This current is then detected via another pair of electrodes, which help map out the resistance levels in the area. Numerous studies have been conducted making use of this method to help understand the underlying material composition of the area, without the need for time consuming imagery and surgeries (Oh & Sadleir 2005 and Moretti et al. 2011). Unfortunately a common error which occurs in this method, is the occurrence of negative sensitivity, which acts an opposing force and distorts measurements made with the tetrapolar method. In particular, impedance measurements made around the fingers and wrist area, which has the highest concentration of resistivity in the body (Foster & Lukaski 1996 and Gislason et al. 2010). Moreover, the use of FEM modelling and experimental data to help examine impedance readings have been well documented as a feasible method with good results for understanding the effects of errors in the execution of the tetrapolar method (Jafarppor et. al. 2011). While there are many causes where this error has affected measurements, there has yet to be any definitive research into negative sensitivity itself. Thus we hope to fill in the gaps left in the literature and conduct a pilot study into the origins and circumstances of negative sensitivity, rather than leaving it as an excuse for future error.

Skin-to-skin contact (SSC) is defined as placing a baby prone directly onto their mother’s or father’s chest. SSC has advantages for newborn babies. It increases weight gain, reduces mortality, severe infection, and length of hospital stay. There are, however, conflicting results from studies, which measured physiological parameters (heart rate, breathing frequency and oxygen saturation) of preterm babies. Some studies showed an increase in oxygen desaturations and a decrease in regular breathing, others however a decrease in oxygen desaturations during SSC. This uncertainty is a barrier to implementation of SSC especially in very immature preterm babies. Both too much and too little oxygen supply to the brain contributes to morbidity and mortality in very preterm babies. Regional brain oxygenation (rcO2) can now be measured by a technology called near-infrared spectroscopy (NIRS). There is a lack of knowledge about brain oxygenation during SSC and there are no data in very preterm babies during their first days of life. If stability in rcO2 during SSC could be demonstrated this would provide reassurance that SSC is “safe” and could be used in immature babies who are receiving breathing assistance. The primary objective of this study is to measure rcO2 during SCC compared with measurements when the baby is being cared for in their incubator or cot. We aim to include 68 very preterm babies with a gestational age at birth less than 33 weeks receiving breathing assistance. We hypothesise that rcO2 remains stable during SSC (non-inferiority trial). The brain oxygen levels will not be visible to the medical and nursing staff. The primary outcome will be changes (mean of the differences) in rcO2 between SSC (intervention) and incubator care (baseline) (1 hour period for each observation). Secondary outcome will be changes (mean of the differences) in physiological and ventilation parameters e.g. peripheral oxygen saturation (SpO2), fractional tissue oxygen extraction (FTOE) equal to (SpO2 – rcO2)/SpO2, inspired oxygen (FiO2), heart rate (HR), and respiratory rate (RR), axillary body temperature between SSC (intervention) and incubator care (baseline), the number of hypoxemic (SpO2 less than 80%) and bradycardic episodes (bradycardia: fall in instantaneous HR by one third of the infants’ baseline HR lasting for at least 5 seconds between SSC (intervention) and incubator care (baseline), changes (mean of the differences) in rcO2, SpO2, fractional tissue oxygen extraction (FTOE) equal to (SpO2 – rcO2)/SpO2, HR, RR, FiO2, number of hypoxemic and bradycardic episodes, axillary body temperature between post-intervention incubator care and pre-intervention incubator care (baseline) (1 hour period for each observation). Further sub group analysis will be changes (mean of the differences) in rcO2 obtained during washout period with those obtained during the main observation period for all three periods (baseline, intervention, post-intervention), changes in rcO2 (mean of the differences) obtained during feeding periods with the rest of the observation period for all three periods (baseline, intervention, post-intervention), changes in rcO2 (mean of the differences) between baseline and intervention period of ventilated infants with those from infants on CPAP and High-Flow nasal cannula.

Low back pain is a major public health problem in Australia, ranking 2nd only to cancer as the leading cause of disability. While its prevalence is high, with 80% of Australians experiencing low back pain during their lifetime, effective treatments are limited. In 2013 a study was published which showed that antibiotics were effective in treating a specific type of low back pain involving injury to the disc and oedema of the bone. The trial was based on the hypothesis that following a disc injury (experienced as acute back pain) a secondary infection develops in the disc which leads to a chronic, disabling condition. There has been both immense interest and controversy regarding this trial. While leading, international surgeons suggest that it should be nominated for a Nobel prize, others have called for further research. To date the results of the trial have not been translated into clinical practice, as there are unanswered questions regarding the approach. The specific group of patients who need to be targeted is unclear, the effectiveness of this treatment in conjunction with standard care is unknown, and the costs and associated resistance to the antibiotic therapy has not been investigated. We aim to perform a clinical trial to investigate the effectiveness of antibiotic treatment in a broader group of individuals with chronic low back pain and a disc injury, to determine whether specific Magnetic Resonance Imaging (MRI) changes predict response to this approach, and to examine the cost-effectiveness and antibiotic resistance of this therapy. If antibiotics are found to be a cost-effective and safe treatment for some patients with chronic low back pain, this will provide a novel approach for the prevention of long term pain and disability in these individuals.