ANZCTR search results

The general purpose of this study is to compare Chitosan-dextran (Chitodex) gel versus current standard of care, Gelfoam, as a middle ear (ME) and external auditory canal (EAC) packing agent as part of tympanoplasty and mastoidectomy procedures to close tympanic membrane perforations (TMP). Packing of the middle ear has become a routine aspect of these procedures to provide structural support to graft material. Whilst no consensus exists regarding the best packing agents, Gelfoam has become the standard of care since its creation in 1945. Whilst it contains many desirable properties, it can be difficult to manipulate when wet and has been shown to illicit inflammatory responses and adhesions within the ME cavity. Chitodex is a chitin-based hydrogel that exhibits anti-inflammatory, anti-microbial and wound-healing properties. When set it remains in a semi-solid form and can provide similar structural support to Gelfoam. We aim to compare the success rates of tympanoplasty and mastoidectomy surgery between the two products. The ultimate goal is to identify the ME packing agent-of-choice to ensure TMP closure as well as minimal inflammation of the middle ear mucosa.

Biochemical validation is the gold standard of measuring smoking abstinence in smoking cessation clinical trials. It increases scientific rigor, however, feasibility of sample collection and stability of samples before testing can be a drawback in clinical trials. This study has the potential to establish acceptability of a novel urine collection method, and to test the feasibility of remote sample collection and stability of urine samples using the UriSWAB™ over time. If effective, this method will allow remote biochemical validation of smoking abstinence, which will be useful in larger scale smoking cessation clinical trials in the future.

The present study will evaluate whether a brief acceptance-facilitated intervention can improve participants acceptance of digital mental health interventions for recurrent binge eating. We will also assess whether this AFI can boost motivation, positive attitudes, intervention uptake and engagement, study retention, and symptom improvement. While AFIs have been shown to lead to these outcomes in other clinical conditions (e.g., depression, chronic pain etc.), it is as yet unclear whether this pattern of results generalize to people with recurrent binge eating. If demonstrated, improvements in receptiveness to cheap and scalable mental health interventions may be realized. The following hypothesis was derived. Participants randomized to the AFI will experience significantly greater improvements in all primary and secondary outcomes than participants randomized to an assessment only condition.

This research study will evaluate and update the efficiency of an old and new form of test to detect hCG in blood for an antidoping setting.

Delirium is a temporary state of confusion and inattention that occurs in patients who are unwell or have undergone a major injury. Delirium is common and can worsen outcomes. This is an observational study of delirium and the factors associated with delirium in trauma patients admitted to the intensive care unit. We hypothesize that the rate of delirium and the severity in this group of patients will be higher than in other populations. There are certain factors that make the occurrence of delirium more likely and this study aims to quantify the occurrence of these factors . Among them is the quality of sleep, as poor quality sleep has been associated with delirium. To do this we will perform nightly assessments of duration of sleep, ask patients who have been discharged from ICU to answer a questionnaire about their sleep in ICU, and a small group of patients will undergo polysomnography, which is a specific sleep test that provides with in depth information about sleep.

Anxiety and depression after stroke are associated with poor rehabilitation outcomes. High quality evidence on psychological treatments for these conditions in this population is lacking. Relaxation training is a proven treatment for anxiety in the non-stroke population and has shown promise in those with stroke. The aim of the proposed investigation is to investigate the effectiveness of this treatment for those with communication problems via a case series study. In this study 10 stroke survivors will complete relaxation training five times a week for five weeks and their depression and anxiety symptoms will be measured before and after treatment. Following this participants will be given the opportunity to provide feedback on the intervention. It is hypothesised that this relaxation video will reduce both anxiety and depressive symptoms in stroke survivors.

This study aims to externally validate existing international adult and paediatric clinical decision rules (CDRs) designed to guide emergency clinician imaging decisions in a large cohort of Australian and New Zealand children presenting with suspected cervical spine injury. It aims to assess (i) their accuracy in detecting cervical spine injury (CSI) (ii) their ability to accurately identify children who do not need cervical spine imaging and (iii) their cost-effectiveness. An exploratory analysis of the data will also be conducted to determine whether a new paediatric CDR can be derived and validated to improve accurate detection of CSI and/or risk stratification of children with suspected CSI into those who do and do not require imaging. This study is expected to identify the most child appropriate CDR. The epidemiology and outcomes of CSI in this cohort of children will also be described.

In newborns requiring resuscitation in the delivery room, we will investigate if an application (app)-based electronic documentation using an iPad (Tablet) is more accurate than conventional paper-based documentation for recording neonatal resuscitation interventions, compared with video recording as the gold standard. We hypothesise that app-based documentation will be a more accurate method for recording events during neonatal resuscitation when compared to paper-based recording, regarding time error, numerical error, omission error and commission error. Three types of documentation records will be available after each resuscitation: Video recording, Tablet report, and paper report. The Tablet and paper report will be recorded simultaneously and independently by two researchers. Data recorded on the tablet and paper form will be compared with the timing of events noted from the video recording. Primary outcomes will be to analyse errors regarding precision and accuracy of events and intervention times (time discrepancy): time to face-mask application, time to start and stop positive pressure ventilation (PPV), time to start and stop chest compressions, time of endotracheal intubation attempts and when the concentration of supplemental oxygen altered. Secondary outcomes are to describe types of documentation errors in the following parameters: SpO2 (oxygen saturation,(%)); concentration of supplemental oxygen (%) and heart rate (beats per minute) at 3, 5 and 10 minutes after birth .

Stroke is commonly caused by blockage of arteries which carry blood and oxygen to the brain. Thrombolysis, a process of unblocking or recanalizing blood vessels with an injection of tissue plasminogen activator (tPA), has become a standard of care in acute stroke treatment however, only ~40% patients will respond to treatment. This study looks at the variation in blood protein biomarkers involved in thrombolysis including plasmin levels and its relation to the recanalization effect. Adult patients arriving at The Alfred with acute ischemic stroke will be recruited for the study. Informed consent will be obtained from the patient or from the patient’s Medical Treatment Decision Maker (MTDM). Consent will be gained for gaining research blood samples and to use clinical information contained in the hospital electronic patient record for comparative analysis. We aim to recruit at least 40 patients in total. One blood sample, ~10 mL (or 2 teaspoons), will be collected from patients, prior to thrombolysis treatment or on arrival, another one at 1 or 2 hours from the time of thrombolysis or from the time of arrival, then again at 24 hours and 72 hours. Plasmin levels and other immunological parameters will be analysed in these samples, and also in patient’s routine clinical bloods, at the Australian Centre of Blood Diseases on the Alfred campus. The results of this study are expected to expand our understanding on the mechanisms of thrombolysis and potentially improve future stroke therapeutics.

The primary objective of this study is to train an algorithm to accurately classify abnormal paediatric heart sounds using a digital stethoscope. Our hypothesis is that once trained, a digital stethoscope can identify abnormal paediatric heart sounds with similar accuracy to an experienced paediatric cardiologist using a standard stethoscope.