ANZCTR search results

This research will explore the immediate, medium and long-term impacts of COVID-19 on rural and regional health care workers and the communities in which they live. A cohort of Loddon Mallee healthcare workers (COVID-19+/COVID-19-) will be recruited and followed over three years to examine the effects of the COVID-19 pandemic on the health and wellbeing of these workers. The main aims of the study are to: • Use a longitudinal study design to explore and describe the health and wellbeing impacts of the COVID-19 pandemic among the rural/regional healthcare worker cohort and sub-cohorts. • Identify protective/resilience factors, at the individual, organisation and community level that predict better physical and mental health outcomes for health workers. Evidence-based resilience interventions may then be implemented in the future to improve the workforce response to major disruptions such as the COVID-19 pandemic. • Inform policy options to support our rural/regional health care workers in responding to major disruptions such as the COVID-19 pandemic.

Trans-nasal humidified rapid insufflation ventilatory exchange (THRIVE) has been widely taken up by anaesthetic and ear, nose and throat (ENT) departments worldwide for airway management. THRIVE is a technique that uses rapidly insufflated, heated and humidified oxygen administered via nasal cannula to maintain oxygenation during periods of apnoea. It is regularly used for ENT procedures, in particular microlaryngoscopy. It allows for maintenance of oxygenation and unobscured surgical field by anaesthetic endotracheal tubes. The mechanism by which THRIVE and other apnoeic techniques (such as low flow intra-tracheal oxygen insufflation) maintain oxygenation is well understood, i.e. bulk flow of oxygen from the upper airway to replace the volume of oxygen taken up from the alveoli. However, a concern with all apnoeic techniques is the rise of blood and tissue carbon dioxide (CO2) levels in the absence of ventilation. Much of the support for THRIVE has centred on claims that unlike other apnoeic techniques, it is effective at eliminating CO2.. Recently, however, a study (1) of THRIVE in ENT microlaryngoscopy patients has suggested that when arterial CO2 levels are measured, the rate of rise of CO2 is actually as much as would be expected with other apnoeic techniques. In our anaesthetic department, we have considerable experience of apneoic oxygenation by low flow intra-tracheal oxygen insufflation (Lo-Flo). An oxygen catheter is directly passed under vision using a laryngoscope through the glottic opening to sit at mid tracheal level. This is then attached to oxygen supply at 0.5-1L/min. Transcutaenous carbon dioxide (TcCO2) can be easily measured with a transcutaneous probe that attaches to the patient’s skin in a non painful, non invasive manner. It is applied a few minutes prior to the start of the procedure. This study would build on the previous departmental experience with apnoeic oxygenation research. We plan to compare the two techniques of apnoeic oxygenation for ENT microlaryngoscopy, focusing particularly on the rate of rise of TcCO2. We believe it is likely that we will disprove the now widely held belief that CO2 rises less quickly with THRIVE than with other apnoeic techniques. (1) Gustafsson IM, Lodenius A, Tunelli J, Ullman J, Jonsson-Fagerlund M. Apnoeic oxygenation in adults under general anaesthesia using transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) – a physiological study. British Journal of Anaesthesia 2017; 118: 610–7

Total hip replacement is a common operation performed in Australia. A proportion of patients will transiently feel unable to get out of bed following this surgery due to dizziness, lightheadedness, blurred vision, nausea or low blood pressure. The medical term for this is orthostatic intolerance or orthostatic hypotension. The aim of this study is to administer a medication to investigate its effect on mobilisation after this operation.

Bleeding is among the most common complications following endoscopic sinus and turbinate surgery and has historically been managed through the use of nasal packing. Haemostatic gels are seeing as use as an alternative method that is more comfortable for patients and reduces complications due to excessive tamponade by packs. This study evaluates the effect of RADA16, a nanopeptide based haemostatic hydrogel with a proposed role in reducing post-operative bleeding as well as reducing the incidence of other common complications including crusting/adhesion formation and chronic nasal infection, in the setting of endoscopic nasal surgery.

Malignant pleural mesothelioma (MPM) is a rare cancer of the lung lining caused by exposure to asbestos. MPM is regarded as one of the most aggressive solid tumours, with limited treatment options and poor prognosis. Emerging MPM treatment options are of particular interest in Australia where the incidence of MPM is among the highest in the world. One such emerging treatment involves the injection of chemotherapeutic agents into the aorta, where they perfuse directly into the vessels which supply the pleural lining. This approach, termed transarterial chemoperfusion, allows a high concentration of chemotherapy to be delivered directly to the cancer. This study is investigating the safety and effectiveness of transarterial chemoperfusion for the treatment of patients with MPM. We will evaluate tumour response, symptoms, quality of life, progression free survival and overall survival. Who is it for? You may be eligible to participate in this study if you are aged 18 years or older, have been diagnosed with malignant pleural mesothelioma that is not being treated with surgery and you have not had recent chemotherapy (within the last 4 weeks). Study details Participants enrolled in this study will undergo an angiogram (imaging of the heart and blood vessels), which involves having a catheter inserted into a vein. The chemotherapy agents will then be directly infused into the aorta and surrounding blood vessels over a period of 60 minutes. All participants will be receive this treatment for at least 2 sessions scheduled every 3-6 weeks, before undergoing a CT scan to assess treatment response. Participants who show a reduction in their tumour burden will continue to receive therapy every 3-6 weeks until they no longer respond to treatment. Participants who do not show a response to treatment after the first 2 procedures will not undergo further infusion therapy. It is hoped this research will determine whether this specific method of chemotherapy infusion is a safe and effective treatment for patients with malignant pleural mesothelioma, and can improve outcomes for future patients.

This study is a new initiative to promote appropriate use of long-term macrolide antibiotics such as azithromycin, clarithromycin, roxithromycin and erythromycin in the management of respiratory diseases such as asthma, COPD and non-cystic fibrosis bronchiectasis. Although these drugs are effective, it is not clear for how long the treatment should be continued. Guidelines recommend a treatment duration of 6-12 months. They also recommend a drug break each year. In this study, we are investigating whether it is possible to stop these drugs permanently or at least temporarily after undergoing a certain period of treatment. We are looking for participants who are currently taking azithromycin, clarithromycin, roxithromycin or erythromycin for the treatment of asthma, COPD or bronchiectasis for at least 6 months. Participants will be randomised to one of the two study groups. Participants in both groups will stop the current macrolide during the Australian summer season as we anticipate that the summer season would be the best time to try medication withdrawal in respiratory diseases. After stopping the current macrolide, group 1 will start an equivalent macrolide which will be azithromycin, and group 2 will start an identical placebo. Participants will continue the study medication for a period of nine months with scheduled follow-ups at 3-, 6- and 9-months.

Post-operative ileus (POI) is characterized by impairment of bowel motility and is a common complication after major abdominal surgery in general, and after colorectal surgery in particular. The principal features of POI include nausea and vomiting, inability to tolerate diet, significant abdominal distension and delayed passage of flatus and stool. POI as a complication has the largest overall effect on length of postoperative hospitalization. The purpose of this phase II trial is to determine the safety and effectiveness of oral pyridostigmine after elective colorectal surgery. We hypothesise that, within an optimised Enhanced Recovery Protocols (ERPs) setting, giving oral pyridostigmine to patients post-operatively will result in a reduction in the duration of postoperative Ileus.

This study will determine the pharmacokinetics and safety of the controlled released formulation of Lanreotide acetate in healthy male volunteers Who is it for? You may be eligible to join this study if you are male, aged 18-50, and in good general health. Study details After a screening period beginning up to 28 days before admission to the Clinical Research Unit (CRU), 8 participants in this study will receive one injection of Lanreotide acetate at a dose of 60mg. In the absence of safety issues, the remaining 8 participants will receive one injection of Lanreotide acetate at a dose of 120mg. As part of the study, participants will undergo safety assessments, Plasma/serum pharmacokinetic and global local tolerance assessment. Participants will be admitted to the CRU until day 2. Compared to the product already available on the market, this new lanreotide formulation [Lanreotide CRF] allows for a more convenient administration for both the patients and caregivers. The Lanreotide CRF is provided in a shorter and standard pre-filled syringe and a smaller needle is used for the injection (21G needle). In terms of PK profile, an equivalent performance is expected for the new Lanreotide CRF formulation when compared to the marketed product. It is hoped this research will determine whether this new lanreotide formulation can be administered safely without causing severe reactions. Once the PK profiles and safety have been determined in healthy volunteers, additional trials investigating the efficacy of Lanreotide CRF as a treatment for patients with neuroendocrine cancer or acromegaly may proceed.

In this feasibility trial, we will create a version of Aussie-FIT, a men’s health program that uses the appeal of sport to engage men, adapted for cardiac patients’ needs. We aim to recruit 72 participants; 36 men will complete “Aussie-FIT” and 36 will receive “usual care”. The Aussie-FIT program will consist of workshops on healthy eating and building physical activity habits, and will offer a range of exercises, ball skills and circuit training. We will take pre- and post- assessments of weight, diet, physical activity, well-being and biomedical markers of cardiovascular risk. The project will provide pioneering evidence of the feasibility and acceptability of this program among cardiac populations and will set the stage for a future, fully powered trial to assess the potential role such programs to complement existing cardiac rehabilitation options.

This will be a first-in-human safety and tolerability trial of a novel ophthalmic solution for the treatment of the visual disorder myopia (short-sightedness). Myopia has been hypothesised to be driven by a reduction in dopamine levels within the eye. Over the past five decades, levodopa (the precursor to dopamine) has been the primary treatment for neurological disorders involving the dysregulation of the dopaminergic system, such as Parkinson’s disease. Before we can examine the efficacy of this compound at inhibiting myopia, this study will assess the safety and tolerability of levodopa as a reformulated eye drop solution.