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Research question: Does an 8-week home-based high intensity inspiratory muscle training (H-IMT) program affect inspiratory muscle strength in healthy adults? Hypothesis (feasibility objectives): To test the feasibility of an 8-week home-based H-IMT program in healthy adults in regards to compliance and satisfaction Aims - feasibility This study aims to explore the feasibility of an 8-week home-based H-IMT program with regard to participant compliance and satisfaction levels. Compliance will be measured by the number of completed training sessions and satisfaction will be measured using a 5 point-scale in reference to the participant’s sense of well-being. Good compliance is defined as completing 80% of the total number of training sessions over the 8-week period. This equates to completing a minimum of 45 of the total 56 sessions. The satisfaction 5 point-scale will include the following options: very satisfied, satisfied, neutral, dissatisfied and very dissatisfied. The intervention will be deemed to be satisfactory from the participant’s point of view if they circle 4 (satisfied) or 5 (very satisfied) for at least 80% all training sessions. Feasibility consideration will extend to investigating the time commitment required by participants for completing assessments and intervention, along with the financial cost of delivering the intervention. Time per training session will be recorded and cost estimates will be calculated for the duration of the intervention period.

Tubal ectopic pregnancies (EPs) are diagnosed earlier in their natural history due to transvaginal ultrasound (TVS) technology. There is no evidence that methotrexate (MTX) is necessary for all these early EPs, as many may resolve spontaneously in the absence of any treatment. Two recent randomised controlled trials demonstrate the safety of expectant management for patients with early EPs. In these studies, patients were randomised and treated with MTX or placebo on the day of diagnosis. By monitoring them expectantly without therapy for 48 hours following diagnosis, it is possible to identify patients with declining hCG levels, representing a subset of patients with spontaneous resolution of the EP. As such, the aim of this study is to verify if MTX is more effective than the placebo in patients with tubal EP and rising/plateauing serum hCG (< 1500 IU/L) levels at a 48-hour mark following definitive diagnosis. Our goal is to study treatment with systemic MTX in a single dose intramuscular regimen in patients with EP and increasing/plateauing serum hCG concentrations, with regards to treatment success, complications and length of follow-up. The primary hypothesis is that single-dose MTX is more effective than a placebo in patients with an early tubal EPs and rising or plateauing hCG.

Title Microcirculatory DySfunction and Skin Failure in Critically Ill patients: An exploratory study. (SoFIa Study) Aim To explore skin microvascular and macrovascular changes in critically ill patients. Study Design Quantitative, prospective, observational, exploratory design. Planned Sample Size 30 ICU patients meeting the selection criteria. Selection Criteria Inclusion Criteria • Intubated and mechanically ventilated. • 18 years old and over. • Expected length of ICU stay greater than 6 days. • SEM scanner score greater than or equal to 0.5 Exclusion Criteria • Pregnant Women • Imminent Death • Physiological condition prohibiting side positioning e.g. spinal injuries. • Skin conditions at perfusion measurement sites e.g. burns • Community acquired skin breakdown • Droplet precautions Outcome Measures Primary outcome measure Changes in perfusion at a cellular, microvascular and macrovascular levels measured by: • High levels of Syndecan-1 and soluble thrombomodulin in blood analysis, indicative widespread endothelial glycocalyx shedding and endothelial cell compromise. • Global microcirculatory blood flow changes via Incidental Dark Field imaging. • Local cutaneous blood flow changes at the sacrum and heels via Laser Speckle Contrast Imaging. • Macrovascular changes though the assessment of bedside haemodynamic measures. Statistical Analysis Plan Descriptive data will be analysed using frequencies, means as percentages as appropriate for continuous and categorical variables. Relationships between variables will be examined using a mixed effects model. Kaplan-Meier survival analysis will be used to compare time to new skin breakdown events. Duration of the study Commencement date – 21 August 2019; Completion date – 07 November 2019.

Dementia is a disorder with huge, growing, global economic burden. There are no effective treatments as yet, to combat or alter the course of dementia- the development of such treatments is an inter-governmentally agreed global public health priority. Clinicians have long delineated a prodromal condition with cognitive symptoms prior to the onset of dementia and Alzheimer’s disease (AD). This condition is known as Mild Cognitive Impairment (MCI). Individuals in this clinical staging present with subjective cognitive impairments and/or objective evidence of impaired cognitive testing whilst still being able to function. Whilst not all rigorously defined MCI patients progress into dementia, the rate of progression to AD is most probably, while the rate of reversion is least. Cognitive inactivity is estimated to be the most prevalent modifiable dementia risk factor worldwide. Our meta-analysis of 18 prospective longitudinal studies found high levels of complex mental activity was associated with a 46% decreased risk of incident dementia. Similarly, a systematic review based on aggregated data of 47,000 individuals followed for an average of 5 years revealed that lifespan complex mental activity slows the rate of cognitive decline in otherwise healthy older individuals. MCI has been associated with other neuropsychiatric conditions (as have dementia and AD). There is increasing evidence to suggest that sleep quality also plays an important role in cognitive health in ageing. Recently it was revealed that people with MCI are almost twice as likely to have sleep disturbance than those with normal cognition. This study also provides evidence to suggest that sleep disturbance is predictive of cognitive decline in older adults and those with neurodegenerative disorders. It has been identified that changes in sleeping patterns occur in MCI in the form of poor sleep efficiency, fragmented sleep, increased frequency of daytime napping, propensity to fall asleep and wake up earlier, and decreased levels of slow wave sleep. In AD, there are the same alterations in sleeping patterns, but to a higher intensity. One positive aspect of these knowledge combined, is that these are modifiable and manageable risk factors that contribute to hastened cognitive decline. Therefore, by treating these modifiable risk factors, we hypothesise that this may help prevent against the development of dementia and AD. One such intervention that is able to target these risk factors is Computerised Cognitive training (CCT). We hypothesis that by carrying out CCT we will reduce the cognitive deficits associated with MCI and sleep disturbance in individuals with this condition

Aim: To determine if outpatient management (via Hospital in the Home [HITH]) of uncomplicated acute diverticular disease is as safe and effective. Research Design: Patients who present to University Hospital Geelong Emergency Department diagnosed with acute uncomplicated diverticulitis with be randomised into either an intravenous antibiotics group or oral antibiotic group. Both groups will be treated as outpatients with the Hospital in the Home team. Primary Endpoint: Time to resumption of normal activities of daily living. Secondary Endpoints: Pain, Diet, Bowel habit, Patient satisfaction, Biochemical markers, Cost comparison.

Many babies born with a congenital heart condition resulting in only one working heart pumping chamber instead of two undergo a heart operation known as the Fontan procedure. This heart operation enables their heart to function normally however can leave them susceptible to many complications as time goes on, one in particular being kidney damage. There is evidence to suggest (from The ANZ Fontan Registry) that approximately one third of Fontan patients have some degree of kidney damage in the current Australian and New Zealand population. ACEI medications are a class of drugs that have been shown to be effective in improving kidney function and preventing progression of kidney damage, however their effect in Fontan patients is uncertain. This study will evaluate the efficacy of the drug lisinopril, an angiotensin receptor inhibitor (ACEI), on established kidney damage in patients with a Fontan circulation. The main aim of this project is to find out whether initiation of lisinopril is superior to placebo in reducing the degree of kidney damage and preserving kidney function in children and adults with a Fontan circulation. We hypothesise that: 1. Lisinopril initiation will significantly reduce the degree of kidney damage and preserve kidney function after a treatment duration of 6 months. If the hypothesis holds true than it will provide evidence to support the use of ACEI in a subset of Fontan patients with established kidney damage. This would represent a unique group of patients with a clear, testable indication for ACEI therapy after the Fontan procedure. Future implications of this trial would include establishing a model of care for these patients both in terms of screening and treatment of kidney damage and disease hence reducing the burden of this disease for this population group.

Around 30% of deaths at the Royal Adelaide Hospital (300 per annum) occur in the ICU or shortly after leaving ICU. The importance of reviewing end-of-life care in the ICU is well recognised. Benefits include assisting family members to process their grief and the opportunity to improve the care delivered to dying patients. Primary aim of this study is to establish the feasibility of delivering a bereavement service by the intensive care unit. Secondary aims are to assess the value of feedback received about the end-of-life care and how the service is viewed by family members. This is a prospective, observational study. All family representatives of patients who die in ICU are included in the study. They are excluded if a family representative is not contactable or declines participation.. Patients are referred to the bereavement follow-up service at medical consensus of end-of-life. After the patient's death, the appropriate family representative will be given a brochure providing bereavement information and a letter outlining the follow-up service. The 30 minute interview is based on the validated CAESAR tool, focused on care around the end-of-life. The responses will be recorded as Likert scores with the option to provide qualitative feedback. The bereavement calls will be made at 4 weeks, by clinicians who are experienced intensive care clinicians. The telephone interview questionnaire consists of 16 questions in 4 sections. The first section of the questionnaire relates to the care of the patient and support for the family. The second section relates to the communication between ICU and the family. The care of the patient and the discussion around organ donation are covered in the next two sections. The last section consists of open-ended question relating to how the family member feel the end-of-life care can be improved.

Patients who present for elective/non-emergent electrical cardioversion for atrial arrhythmias require sedation for the procedure. A combination of drugs, often including midazolam, a sedative that causes respiratory depression, is typically used. We hypothesise that removing midazolam from the combination of drugs used will result in a lower need for airway and breathing rescue techniques, without increasing patient's memory for the cardioversion procedure.

This study is designed to test the potential activity/benefit, safety and feasibility of adding a drug commonly used for bone protection (denosumab) to an immunotherapy drug (nivolumab) before surgery in patients with non-small cell lung cancer (NSCLC) for whom surgery has been recommended. Who is it for? You may be eligible for this study if you are aged 18 years or above and have a confirmed non-small cell lung cancer (NSCLC) for which surgery has been recommended to remove the cancer. Study details Participants will be randomly allocated (by chance) into one of two groups: in group 1, participants will receive two doses of nivolumab in the month prior to surgery, and in group 2, participants will receive two doses of denosumab in addition to the two doses of nivolumab in the month prior to surgery. Nivolumab is administered intravenously (i.e. directly into the vein) and denosumab is administered subcutaneously (i.e. as in injection under the skin). All participants will then proceed to surgery as planned. After surgery, no further trial medications are offered, but participants may be offered standard therapies according to the opinion of their treating clinicians. Those patients who receive denosumab will also be asked to take vitamin D and calcium supplementation during the course of their denosumab treatment. It is hoped this study will confirm that two doses of nivolumab prior to lung cancer surgery results in significant rates of tumour shrinkage similar to a previous USA study, and that denosumab added to nivolumab may show evidence of better effectiveness.

The study is a randomised, placebo-controlled, double-blind trial. Participants aged 40-70 with pre-diabetes (as per HbA1c) will be invited to participate through GP Practices involved in the diabetes alliance. Participants will be randomly allocated on a ratio1:1, to receive zinc or control treatment options, and followed up at one month, three months, six months and twelve months. Both treatment arms will have Get Healthy Information and Coaching Service, type 2 diabetes Prevention Program involved in their care for the first six months of the trial.