ANZCTR search results

Induction of labour is a common obstetric intervention that 1 in 4 women will experience. The ultimate goal of induction of labour is to achieve a vaginal birth, however in almost 40% of first time mothers it fails. The outcome of a failed induction, a caesarean delivery is associated with vast range of adverse effects, both short and long term for the mother and her baby. In this application we propose that a simple and inexpensive intervention will increase the success of induction of labour. Lessons from successful spontaneous births tell us that labour occurs more frequently, and is shorter with less intervention when it occurs at night. The driver of this is thought to be the endogenous hormone, melatonin. Melatonin is synthesised by the placenta. Healthy pregnant women have higher concentrations of melatonin compared to non-pregnant women. Melatonin levels also increase with gestation, peaking during labour and then falling rapidly after delivery. The biological reason for an altered melatonin cycle in pregnancy is unclear. However, the myometrium of the pregnant uterus expresses melatonin receptors and these receptors have been shown to be up-regulated in labouring compared to non-labouring women. Intriguingly, both melatonin and oxytocin activate the same signalling pathway that results in uterine contractions. Specifically, melatonin treatment of myometrium increases it’s sensitivity, enhances oxytocin-induced contractions and improves myometrium cell communication and synchronization. Taken together this suggests an important role of melatonin in the onset and progress of labour. We therefore hypothesise that supplementing women undergoing induction of labour with melatonin will improve the success rate of induction of labour. We will undertake a double-blinded randomised controlled trial of melatonin supplementation to improve the success of induction of labour in healthy first time mothers.

In a crossover study, we aim to determine whether a Mediterranean diet with adequate dairy foods, consumed over 8 weeks, will improve measures of blood pressure, cardiometablic health, wellbeing and cognitive performance, more than a low fat diet in an high risk population of men and women with for cardiovascular disease (CVD). We believe that volunteers consuming a Mediterranean diet enriched with dairy foods (MedDairy diet), to meet the nutrient reference values for calcium in Australia, will have greater improvements in blood pressure than a low fat diet, based on Heart Foundation recommendations. Low fat diets are recommended for treatment of many chronic diseases such as type 2 diabetes mellitus, heart health and secondary prevention of stroke etc. together with regular physical activity. We know that the MedDiet, rich in bioactive foods and nutrients, has significant effects on longevity as well as reduced total death and death from CVD. Furthermore, given the independent reported health benefits of dairy foods on CVD risk factors including blood pressure, blood lipids etc. a diet combing both a Mediterranean diet and dairy foods (MedDairy diet) may in fact improve indices of cardiovascular health more than a low fat diet.

This study is a pilot observational study, conducting a cross-sectional survey on patient attitudes and satisfaction with medical consultations whilst a medical scribe is present during an Emergency Medicine consultation. It will use a convenience sample of all patients attending Cabrini ED between the dates of April 2016 to September 2016 (the period of time there is a study being undertaken on the economics of using medical scribes at Cabrini Emergency Department). It will commence once ethics approval is obtained from Cabrini HREC. It will use a survey developed specifically for the purpose. Items will relate to patient satisfaction with the consultation and patient satisfaction with various components of the consultation. It will also include a net promoter score for the Emergency Department. It will compare consultations with scribes to consultations without scribes during the same time period using the same group of physicians and the same investigation site. Medical scribes are an emerging role in health. Their numbers are rapidly expanding. Research to date has focused on the economics of their use. There is a need for health administrators and emergency doctors to understand their potential impact on the patient during consultations and this exploratory work should assist with directing future work and guiding administrators and doctors on whether and how to utilise scribes in the future.

The aims of this research project are to determine how hamstring muscle function and structure change over time during rehabilitation for hamstring strain injury and whether exercising completely pain-free or to a pain-threshold effects the time course of these changes. The research project is split into two parts, part A is a cohort study to determine presence of acute hamstring strain injury and part B is a randomised control trial. We will recruit recreationally active males and females who suspect they have suffered an acute hamstring strain injury for part A of the study until we have recruited forty participants with clinically confirmed acute hamstring strain injury within seven days of initial suspected injury for part B of the study. Part A of the study involves a one off initial clinical assessment including a subjective interview, inspection of the injury site, assessments of muscle structure, strength and flexibility to determine presence of acute hamstring strain injury. If acute hamstring strain injury is confirmed within seven days of initial suspected injury, participants will be eligible to participate in part B of the study and randomised to either a pain-free or pain-threshold exercise group. Both groups in part B of the study will complete identical follow-up clinical assessments and rehabilitation including progressive running and resistance exercise twice per week until pre-determined return to play criteria is met. Participants in the pain-free group must complete all exercises and running within the rehabilitation protocol completely pain-free and if any level of pain in caused during rehabilitation, exercises will be altered appropriately. Participants in the pain-threshold group will be allowed to exercise and run to a pain-threshold of 4/10 on a visual analogue scale (VAS) and if any level of pain greater than this is experienced during rehabilitation, exercises will be adjusted accordingly. Once these criteria have been met, participants will be free to resume their previous level of activity and invited to attend ACU on a weekly basis for follow-up clinical assessment as above for a period of 3 months. During this period and the subsequent 24 months following return to play clearance, participants will be contacted on a weekly basis to enquire whether any suspected re-injury has occurred. In this event participants will be required to attend a follow-up clinical assessment to confirm presence of re-injury and if confirmed they may be eligible for additional rehabilitation services.

Regular aerobic exercise has now been established as an effective therapy for reducing liver fat in patients with non-alcoholic fatty liver disease (NAFLD), even in the absence of weight loss. However the efficacy of regular exercise in progressive liver disease such as non-alcoholic steatohepatitis (NASH) is yet to be established. Recent evidence has suggested that high intensity exercise may be required for benefit and, as such, high intensity interval training (HIIT) may be an effective modality for improving cardiovascular, metabolic and liver health in patients with NASH. A key feature to the success of any exercise intervention is the ability to adhere to the intervention in the long-term. The ability to perform HIIT on a regular basis, in an unsupervised environment has yet to be determined. The aims are to i) examine the efficacy of a 12 week supervised exercise intervention involving high-intensity interval training (HIIT) in patients with biopsy-proven non-alcoholic steatohepatitis (NASH) for improving cardiorespiratory fitness (CRF), and ii) examine the safety and feasibility of regular HIIT in patients with NASH both when performed under supervision and when performed unsupervised (home-based, for 12 weeks). We hypothesise that, compared with control: i) the HIIT intervention will significantly improve CRF, and ii) the HIIT intervention will be safe and feasible for sustaining both supervised and unsupervised exercise adherence in people with NASH. Eligible participants (n=22) will be randomised into 12 weeks of HIIT (n=11) or a control (n=11). The primary analysis will examine the efficacy of 12 weeks of HIIT on changes in cardiorespiratory fitness, body composition, liver fat, liver stiffness, abdominal visceral fat, vascular function, and other cardio-metabolic risk factors, compared with control. The supervised HIIT training will begin with a warm-up for 5 min and at 60% of maximal heart rate (HRmax) followed by 4 x 4 min intervals at 85-95% HRmax interspersed with 3 min ‘recovery’ periods at 60% HRmax, then a 5 min cool down. Participants randomised to the control group will perform 12 weeks of stretching and then be invited to complete the HIIT protocol. On completion of the HIIT intervention, all participants (n=22) will be prescribed an on-going exercise program based on an equivalent type and intensity of exercise, modified for an unsupervised home/gym environment. Feasibility and adherence will be assessed via self-administered questionnaires and focus group after 12 weeks of home based exercise.

Borderline Personality Disorder (BPD) is a severe mental disorder that arises during adolescence and young adulthood. This study investigates the most effective form of psychoeducation for families and friends of young people (15-25 years old) presenting for treatment of BPD for the first time. It is a randomised controlled trial comparing two interventions: the MS-BPD group with online BPD program compared with the individual, self-directed online BPD program alone. The primary outcome is reduction in burden of care. It is expected that post-intervention, participants who receive the MS-BPD group in addition to the online BPD program will have better outcomes than those who receive the online BPD program without the MS-BPD group. The measures to be used assess level of coping, burden, and personality disorders knowledge of participants, along with mood and anxiety symptoms, expressed emotion, and quality of life.

In older persons in the community postprandial hypotension (PPH) is an important clinical problem, being a potent predictor of falls, syncope, coronary events and stroke. Furthermore, the presence of PPH is strongly associated with dying independent of other risk factors. Older patients that have survived critical illness and been discharged from hospital have a greater mortality rate compared to younger populations. Older survivors of critical illness also experience a greater reduction in physical function post–ICU when compared to younger survivors. Given the prevalence and impact of PPH in older persons living in the community it is intuitively likely that PPH will occur frequently in survivors of critical illness aged 65 years and older and be associated with adverse outcomes. It is essential to obtain these epidemiological data prior to embarking on a program of work to evaluate potential treatments.

Direct electrical cardioversion (DCR) is an important aspect of atrial fibrillation and/or atrial flutter (AF) management, and is routinely performed to restore normal sinus rhythm. Success rates range from 50 – 93% , depending on left atrial size, AF duration and transthoracic impedance. Total body weight is a key factor in determining transthoracic impedance and therefore cardioversion failure is more frequent in obese patients . In a randomised trial of 201 patients, hand-held paddle electrodes successfully cardioverted 98% patients,compared to 86% with self-adhesive patches (p = 0.001) . This is likely related to the fact that handheld paddles convey a lower transthoracic impedence and hence enable more efficient delivery of energy to the left atrium . The mean body mass index (BMI) in this trial was 28. It is likely that an even greater difference would be observed with paddles in patients with higher BMIs. While a recent large meta-analysis did not demonstrate a difference in cardioversion success rates for different electrode positions / shock vectors (anterior-posterior vs antero-apical, this may not be the case for obese patients. Currently, self-adhesive patches remain more widely utilized in Australian hospitals, due to their ease of use. However with the emerging obesity epidemic, we believe this practice is contributing to an increasing failure of DCR in this patient group. Our study is a multi-centre randomised controlled trial comparing hand-held paddle electrodes and self-adhesive patch electrodes in obese patients (BMI at least 30). We hope to determine whether rates of successful cardioversion for AF are higher in obese patients using hand-held paddle electrodes compared with self-adhesive patch electrodes. We hypothesise that handheld paddle electrodes have a significantly higher efficacy at restoring sinus rhythm in obese patients. Our 2 x 2 design will comprehensively evaluate the best way to cardiovert obese patients (patch vs paddle AND anteroapical vs anteroposterior). Patients will be randomised to one of four arms (2 paddle arms - 1 antero-posterior, 1 antero-apical shock vector & 2 patch arms - 1 antero-posterior, 1 antero-apical shock vector). Cardioversion will proceed until sinus rhythm is restored. Patients in each group will receive up to 2 shocks with the modality they are assigned to (patch or paddle), with the 3rd (final) shock being a cross-over to the alternative modality (patch or paddle). Additional shocks up to 360J may be delivered at the discretion of the clinician, and all patients with failed cardioversions will be offered a referral for an attempted shock up to 360J on a different date. Patients with successful cardioversions will also be contacted at 3 months to determine if they have had a recurrence of AF, and if not, will be asked to have an ECG performed.

This research proposal seeks funding to conduct a vanguard randomised controlled trial (RCT) of automated control of oxygen therapy in preterm infants <28 weeks gestation in Australian neonatal Units. Our hypothesis is that automated oxygen control using a control device developed by our research team can produce a sustained improvement in time in the desired oxygen saturation (SpO2) target range over many weeks of hospitalisation, reduce blood markers of oxygen toxicity and oxygen debt, and thus have the potential to improve outcome. Background Almost all extremely preterm infants <28 weeks gestation receive supplemental oxygen during their first hospitalisation, with fraction of inspired oxygen (FiO2) titrated to target a preferred SpO2 range. Both hypoxia and hyperoxia are known to be associated with adverse outcomes, including mortality, chronic lung disease, retinopathy and necrotizing enterocolitis. SpO2 targeting is, however, fraught with difficulty, with manual oxygen control targeting the desired SpO2 range less than 50% of the time. Automated oxygen control may offer a solution, and existing control algorithms increase time in target range by around 10% in short term studies. Whether automated control can produce sustained improvements in SpO2 targeting, and do so in all individuals, are unknown. Research Proposal Preterm infants 23+0 to 27+6 weeks gestation (N=180) will be randomly allocated to automated oxygen control, or standard manual control, from early life until 36 weeks post-menstrual age (PMA). Automated control will be applied for as much of the time as possible, and with all manner of respiratory support modalities. FiO2 and SpO2 will be logged continuously, and blood markers of oxygen toxicity and debt examined at days 1, 7, 28 and at 36 weeks PMA. Time in the SpO2 target range (primary outcome), blood markers of oxidation and hypoxia, survival and complications of prematurity will be compared between groups.

Many preterm infants receive supplemental oxygen during their first hospitalisation, with fraction of inspired oxygen (FiO2) titrated to target a preferred oxygen saturation (SpO2) range. Both hypoxia and hyperoxia are known to be associated with adverse outcomes, including mortality, chronic lung disease, retinopathy and necrotizing enterocolitis. SpO2 targeting is, however, fraught with difficulty, with manual oxygen control targeting the desired SpO2 range less than 50% of the time. Automated oxygen control may offer a solution, with existing control algorithms increase time in target range by around 10% in short term studies. We have developed an adaptive and intuitive algorithm (VDL1.1) for automated control of inspired oxygen in the preterm infant, which is to be used in the study outlined in this proposal. A forerunner version of the algorithm (VDL1.0), has been found to be very effective in SpO2 targeting, both in pre-clinical studies using a simulation of oxygenation, and in a 4 hour crossover study in preterm infants. We propose to evaluate the effectiveness of the VDL1.1 algorithm in a 24 hour crossover study under standard clinical conditions. Preterm infants <32 weeks gestation at birth will be eligible if less than 4 months of age, receiving non-invasive respiratory support and showing the need or potential need for supplemental oxygen. In a non-randomised crossover study, a 24 hour period of automated oxygen control will be compared with two flanking 12 hour periods of standard manual control of inspired oxygen (total 24 hours). Additionally, within the 24 hour automated control period the function of the VDL1.1 algorithm with an apnoea-responsive element active or inactive (12 hours each in random order) will be evaluated. Primary outcome for the main study is eupoxia - the proportion of time with oxygen saturation in the desired target range, or above the desired target range when no supplemental oxygen is being administered. Secondary outcomes include i) proportion of time, and episodes of, hypoxia (SpO2 <80%, 80-84%, 85-88%) and hyperoxia (SpO2 >96% and >98%) when in supplemental oxygen; and ii) number of manual FiO2 adjustments per 24 hours. A total of 60 crossover periods will be studied.