ANZCTR search results

It has been reported that both the occurrence of primary postpartum haemorrhage (PPH) (birth to 24 hours postpartum) and rates of maternal overweight and obesity are increasing. For the ‘routine’ management of the third stage of labour and primary post partum haemorrhage prophylaxis, mothers are usually given the same dose of oxytocin without consideration of their weight or body mass index (BMI), which many other pharmaceutical products require. We propose that for those whose body mass index (BMI) would classify them as being either overweight/pre-obese (BMI 25.00-29.99 Kg/m2) or obese (BMI equal to, or more than, 30Kg/m2), that this ‘standard dose’ for all maybe insufficient to attain the therapeutic levels of oxytocin necessary to invoke uterine contractility, thereby predisposing this cohort of mothers to atonic PPH. The research study is an investigator initiated, single centre (Monash Health), phase 4, open label, prospective, randomized controlled trial, to evaluate the relationship between participant (maternal) BMI and the pharmacokinetics (PK) of a single dose of oxytocin administered either as: a 'slow' bolus (1-2 minutes) intravenous (IV) injection or an intramuscular (IM) injection, given for primary postpartum haemorrhage prophylaxis following birth. The trial seeks to collect blood samples from n=120 participants: Those who are having an elective (no labour) caesarean section (n=100) under regional anaesthesia, and are representative of BMIs: normal range, (BMI 18.5-24.99 Kg/m2), overweight/pre-obese (BMI 25.00-29.99 Kg/m2), obese class I (BMI 30- 34.99 Kg/m2) obese class II (BMI 35-39 Kg/m2) or obese class III (equal to, or more than, 40.00 Kg/m2). Those who are having a vaginal birth (n=20) and composed of only of those who have a BMI that is within the normal range (18.5-24.9 Kg/m2). Ultimately, there will be n=20 participants in each of the six study groups. Of these, following randomisation, each study group, will be composed of n=10 participants who have received 5 IU of oxytocin via a ‘slow bolus’ (1-2 minutes) intravenous (IV) injection, and n=10 who have been given 10 IU oxytocin through an intramuscular (IM) injection. Blood samples will be collected from participants for pharmacokinetic (PK) analysis: before birth (1 hour, or less) and then following birth, and timed from the commencement of oxytocin administration, at a 'desired' nine further targeted time points of: 3 (+/-0) minutes, 5 (+/-1) minutes, 10 (+/-2) minutes, 15 (+/-2) minutes, 20 (+/-2) minutes, 30 (+/-3) minutes, 60 (+/-5) minutes, 120 (+/-5) minutes and 180 (+/-5) minutes. Pharmacokinetic parameters include: Absolute bioavailability (F), absorption rate constant, (Ka), clearance (Cl) and volume of distribution (Vd). Bioanalysis and modelling will be used to determine maximum plasma concentration (Cmax), time to Cmax (Tmax), area under the plasma concentration-time curve (AUC) and terminal phase half-life (t1/2).

Contact lens dissatisfaction is a major problem for contact lens wearers. Most research efforts have concentrated on contact lens discomfort as a source of contact lens dissatisfaction, but binocular vision disorders among contact lens wearers has not been researched as a potential source of contact lens dissatisfaction. This study aims to identify a questionnaire which measures dissatisfaction due to symptoms from binocular-vision disorders and discomfort in myopic non-presbyopic adult contact lens wearers and to determine the extent to which binocular-vision disorders contribute to contact lens dissatisfaction.

The Movember Foundation and Beyondblue have established the TrueNTH program to develop and implement an integrated multi-component care model to improve the lives of men with prostate cancer and their partner/carer in a variety of health care settings in Australia. The primary aim of this study is to implement and evaluate the impact of the program on men's health outcomes and quality of life. Who is it for? You may be eligible to participate in this study if you are over 18 years and have been diagnosed with prostate cancer and are receiving services from any of the participating sites. You may also nominate one partner/carer or support person, who will also be invited to participate if they are over 18 years and competent to give informed consent and complete questionnaires. Study details The study involves implementation of the following components of care to men with prostate cancer according to their stage of disease and individual needs: (1) care coordination, including screening, assessment, information provision and education, ongoing monitoring, navigation and referral, and practical and social support; (2) decision support; (3) lifestyle management, including individual exercise program and nutritional advice; (4) specialised clinical support services, including psycho-social support and management, sexual health support, continence management and other specialised clinical support; (5) prostate cancer comorbidities management; and (6) partner/carer support. While each component of the intervention is available for all participants, the intervention and each of its components are tailored to men’s stage of disease and their health related needs. Delivery of specialized support services will depend on resource availability, access, treating specialist /team preference and preference of the man. Men in this study will be asked to complete up to 5 surveys over a 12 month period in order to assess their prostate health symptoms, quality of life and mental health. Health service and carer-related outcomes will also be measured. At 6 months after the participation, men and/or their partner/carer may be asked to participate in individual interviews. Findings of the study will enhance our understanding of outcomes and areas for improvement, which in turn will benefit men with prostate cancer and their partner/carer.

Aims and Justification The induction of anaesthesia can be associated with a drop in oxygen saturation particularly when there is difficulty in intubation (the placement of a flexible plastic tube into the trachea (windpipe) to maintain an open airway). We have recently published a study which showed that buccal (attached to the inside of the cheek) oxygen administration was highly effective at prolonging the time to oxygen desaturation in obese patients, at induction of anaesthesia. Nevertheless, a third of patients desaturated earlier than expected. This may have been due to the development of pulmonary shunt (collapse of the small airways) or a failure of the device to maintain a high oxygen concentration at the open glottis (start of the windpipe). The device may also be limited by accumulation of carbon dioxide during breaks in breathing (apnoea), and the degree of positive pressure generation at the glottis. This follow up study will repeat the methodology of the original project, whilst assessing glottic oxygen concentration and pressure, as well as carbon dioxide accumulation. The objective is to ascertain the reliability of this technique at maintaining glottic oxygen concentration >0.7 over 10 min apnoea. This will help us to further evaluate and refine this technique for oxygenation during apnoea. Project Design and Participant Groups This will be an open label, randomised, controlled trial in healthy, non-obese patients due for elective surgery. Methods The protocol is based on our previous study with two study groups: (a) 10 l/min oxygen via a buccal RAE tube attached to the inside of the cheek as the intervention group, compared to: (b) Standard care. Measurements of glottic oxygen concentration (FO2), glottic airway pressure and transcutaneous carbon dioxide (CO2) concentration will be taken during 10 min of apnoea from induction of anaesthesia. The primary outcome will be the maintenance of glottic oxygen concentration >0.7 after 10 min apnoea. We hypothesise that >80% patients will maintain a glottic FO2> 0.7 at 10 min apnoea using buccal oxygen in comparison to the <10% of control patients. Our secondary aim is to find out the pressure at the glottis and rate of rise of CO2 during this technique. This secondary information will delineate the possible length of its clinical use and further evaluate this technique.

Insulin pump therapy is a potential long-term treatment options in patients with type 1 diabetes not achieving optimal glycemic control. Compared to standard care insulin pump therapy is expensive and requires high levels of medical and patient input, and its use in Australia is rapidly increasing. Despite this the potential long-term effects of insulin pump therapy in patients with type 1 diabetes in comparison with standard of care is poorly documented, with no studies published with more than 5 years of follow-up. The aim of this study is to review long term (5 to 16 years) follow-up clinic data relating to clinical outcomes (glycemic control, hypoglycaemia, weight, clinical service utilisation) between 2000 and 2016 of people commenced on insulin pump therapy compared to standard care which is people who have undergone formalised training in insulin dose adjustment (FlexIt Program) between 2000 and 2011.. We intend to provide “real life” long term data to examine the efficacy and costs of on insulin pump therapy compared to modern standard care.

The currently accepted paradigm holds that systemic autoimmunity and inflammation have a directly causal relationship with rheumatoid arthritis (RA) and psoriatic arthritis (PsA) and with the associated cardiovascular (CV) disease. However, the evidence supporting this paradigm is inconclusive and possibly contradicted but clinical studies. The T-BIRD study inverts the existing paradigm to explore the hypothesis that while autoimmunity sets the stage for the development of arthritis, it is the connective tissue biomechanical properties (stiffness) that: 1. Determine the risk of developing RA and PsA 2. Influence the severity of the RA and PsA and; 3. Determine the severity of the CV disease seen in association with RA and PsA . If this hypothesis is confirmed then a considerable part of the inheritance of RA and PsA (much of which remains unaccounted for) might be explained. There would also be important clinical implications as it would change the way clinicians undertake risk assessment and therapeutic decisions in managing inflammatory arthritis and its associated cardiovascular disease. This preliminary study will begin exploring this hypothesis by evaluating the relationship between articular biomechanical characteristics in the joints, skin and arteries and exploring the relationships between tissue biomechanical properties upon rheumatoid and psoriatic arthritis and vascular and cutaneous disease.

Obesity is one of the most significant health issues of our time. Regardless of pre-pregnancy BMI, the amount of weight gained during pregnancy [gestational weight gain (GWG)] has the potential to impact the health and wellbeing of the childbearing woman and her baby in the short, medium and long term. Women who gain excessive weight in pregnancy are more likely to retain weight in the short, medium and long term, progressing from normal weight to obese over their childbearing years. The Institute of Medicine (IOM) offers the most robust guidance, recommending specific GWG target ranges for women who are underweight, normal, overweight and obese according to defined Body Mass Index (BMI) categories. Only 36% of Australian women have optimal GWG. Interventions targeting GWG have focused on overweight and obese women, been resource intensive and have had limited success. Behavioural change interventions have also been criticised for increasing the socio-economic gradient of obesity. There is a critical need to reduce the burden of maternal obesity and excessive GWG with programs that are effective, accessible and scalable for delivery at a population level and to understand how socio-economic factors impact on GWG and uptake of interventions. This project addresses these two key issues by examining the efficacy of the “Eating4Two” Smartphone application in a population of pregnant women of all BMI categories. We hypothesise that use of the Eating4Two smartphone App will reduce rates of excessive gestational weight gain.

In Australia there are currently >425,000 people living with a stroke related disability and this number is only set to rise with the aging population and burgeoning epidemics of diabetes and obesity. In the chronic post-stroke period the only way to improve function and independence is through rehabilitation. Constraint-Induced Movement Therapy (CIMT) is the current best practice for upper-limb rehabilitation. Recent evidence suggests that CIMT's success may be due to one component, the transfer package which encourages patients to be more responsible for their own recovery. The package includes daily revision of a behavioural contract, Motor Activity Log (an index of how well the patient can complete everyday activities with their more-affected hand), daily activity diary, daily schedule (including home practice), and patient-centred goal setting and problem solving. Preliminary research also suggests that this package can be transferred to other intensive therapies with equal benefits. However, such intensive programs are rarely used in routine clinical practice due to lack of staff and resources. This study aims to investigate the use of the transfer package delivered via telehealth in current hospital outpatient rehabiltation programs. I hypothesise that patients receiving the transfer package will have greater improvements in function and will not require recurrent outpatient programs thus reducing costs and improving the capacity of the outpatient hospital system.

Stress incontinence (SUI) is defined as urinary leakage with activities that increase intra-abdominal pressure (e.g. cough, sneeze, laugh and exercise). SUI is a prevalent condition with high burden of suffering. Midurethral slings (MUS) have become the operation of choice for treatment of female stress urinary incontinence. MUS are synthetic tapes that are implanted transvaginally to support the urethra. The urethra is a tube that connects the bladder to the outside of the body and removes urine from the body. Midurethral slings can be deployed in a retropubic or transobturator fashion. A retropubic approach involves tunneling the sling from the suburethral region, in close contact to the bladder in the retropubic space (behind the pubic bone), to the lower abdominal wall. In contrast, the transobturator approach involves the passage of a sling through the obturator membrane which is further away from the bladder. This approach has been shown to have a reduced rate of intra-operative bladder perforation. Recent systematic reviews of retropubic or transobturator midurethral tapes suggest equivalent efficacy, at least in the medium term. Long term success rates of the retropubic approach are up to 91%. Both midurethral systems continue to have clinically significant complications such as bladder injuries, vagina mesh exposures, voiding difficulty, denovo (new onset) urgency and groin/thigh pain reported. Retropubic slings have more hematoma, bladder perforations, whereas transobturator slings have less over active bladder symptoms and less voiding difficulties. The minisling is a single incision sling system with small integrated self-fixating tips that anchor into the obturator internus muscle. This potentially avoids complications associated with trocar passage through retropubic or transobturator route. Randomised trials of minislings against transobturator slings have shown similar results, with the added advantage of less overactive bladder symptoms and voiding difficulties. The self-fixating tips of the minislings allow them to be placed under more tension, whilst retaining the advantages of the transobturator sling. There have been no studies comparing the efficacy of the retropubic sling with the minisling. Minislings may provide equivalent results as the retropubic sling with lower complication rates. We seek to examine if the minisling is as efficacious as the retropubic sling for women with urodynamic stress incontinence (USI) and compare their clinical outcomes.

The primary purpose of this trial is to evaluate whether early referral for palliative care can improve quality of life, cost effectiveness and quality of end of life care for adults who are newly diagnosed with advanced lung cancer. Who is it for? You may be eligible to enroll in this trial if you are aged 18 or over and have been diagnosed with advanced non-small cell lung cancer, extensive small cell lung cancer or advanced malignant pleural mesothelioma within the last 60 days. Study details All participants enrolled in this trial will be randomly allocated (by chance) to receive either standard care referral to palliative care at the discretion of the treating oncologist, or to receive early referral to palliative care within 7 days of enrolling in this trial. With the exception of the timing of the referral, the palliative care received by each group will be as per standard care, with information and care provided by the palliative care team as required for each participant. Participants will be asked to complete a number of questionnaires relating to quality of life and cancer symptoms at regular time points until their death. Carers will be asked to complete quality of life and death questionnaires and an interview at regular intervals up to six months following participant death. It is anticipated that the findings from this trial will provide information on whether early referral to palliative care following diagnosis of advanced lung cancer is beneficial for patient quality of life and end of life, and cost-effectiveness of care.