ANZCTR search results

This study will use patient-specific, electromyogram-informed neuromusculoskeletal modelling to determine the immediate effects of an Ossur Unloader One knee brace on medial knee joint contact force during walking in 30 people with established medial knee osteoarthritis and who have outward (varus) knee alignment. A secondary aim is to determine the short-term (8 week) effects of the valgus brace on symptoms and joint forces. This study will test the hypotheses that medial knee joint force during walking will reduce immediately wearing an Unloader One knee brace compared to not wearing the knee brace; and 2) braced walking following daily use of an Unloader One knee brace over 8 weeks, compared to braced walking at baseline.

Heart surgery is known to cause damage to the inner lining of blood vessels called the "endothelial glycocalyx". This damage can affect bleeding, swelling and inflammation which can harm organs and delay recovery after surgery. Damage to this layer can be measured using special blood tests. Currently there are no drugs used to protect this layer during surgery. Some experiments have shown the commonly used local anaesthetic "lidocaine" and the antibiotic "doxycycline" may be of benefit to protect this layer. We propose a project in which patients undergoing heart surgery are randomly allocated to receive one or other of the medicines or neither (a "control" group). Blood tests will indicate if these medicines have an effect on this layer. We hypothesise that lidocaine and or doxycycline may protect the endothelial glycocalyx during heart surgery.

Background High flow humidified nasal oxygen (HFNO) is an emerging technology with perioperative and critical care applications. We proposed a role for HFNO in obstetric anaesthesia for preoxygenation and apnoeic oxygenation in the context of general anaesthesia for pregnant women. The potential benefit is a prolongation of safe apnoea time after induction and prevention of hypoxia in a population with an elevated risk of failed airway management. Our previous observational study investigated HFNO as a single entity and found that only 60% of our participants (term pregnant women) reached the target etO2 concentration of 90%. The median [IQR] first etO2 concentration was 91 [83-93] %. A comparison study of HFNO versus usual care (face mask oxygen) is required to inform anaesthetists about whether HFNO is a suitable alternative to current clinical practice for preoxygenation of pregnant women. Aims To examine the comparative efficacy of HFNO versus face mask oxygen for preoxygenation we aim to determine the etO2 concentration in 100 women in late pregnancy at the end of protocolised preoxygenation with both systems. •Our primary aim is to assess whether HFNO is non-inferior to face mask oxygen for preoxygenation in pregnant women. We have set a clinically significant difference of 5% in etO2 concentration after three minutes of preoxygenation. •Our secondary aim is to determine if there is a difference in the proportion of pregnant women who reach the adequate etO2 concentration target of 90% with HFNO versus face mask oxygen. •Thirdly, we aim to establish an indicative reference range for etO2 concentration in term pregnant women after preoxygenation with both modalities. This will help guide future airway management recommendations specific to pregnant women. •The post-partum follow-up component of the study aims to determine the effect size (if present) of the physiological changes of pregnancy on adequacy of preoxygenation. Experimental Method We aim to recruit women in late pregnancy who will undergo two simulated preoxygenation protocols in an order based on their randomisation group. The HFNO group will undergo HFNO preoxygenation followed by face mask preoxygenation. The face mask group will undergo face mask preoxygenation followed by HFNO preoxygenation. There will be a washout period in between protocols. The participants will also be re-randomised and undergo postpartum testing according to the same two simulated preoxygenation protocols at 6 months post-delivery.

This randomised controlled trial (RCT) seeks to assess the efficacy of psychological group intervention for children with type-1 diabetes and anxiety, including their primary caregiver. The intervention is an adaption of an existing manualised cognitive behavioural therapy program combined with self-compassion content and exercises. Qualified clinicians (including a clinical psychologist and either a paediatric diabetes nurse educator or a paediatric social worker) will run these group interventions (with 5-8 families at a time) at the Children’s Hospital at Westmead, Sydney. Primary Aims: Reduction in anxiety symptoms in the child (as reported by child, primary and parent/ care giver). Secondary Aims: Improvement in metabolic outcomes (HbA1c) and other psychosocial outcomes (self-compassion, diabetes self-care behaviours, parental wellbeing) We hypothesise that both parents and children will report significant improvement in the following primary outcomes compared to the waitlist control group: 1. Decreased anxiety symptoms in the child (as reported by child, and parent/caregiver) 2. Decreased anxiety symptoms in the parent/caregiver (as reported by parent/caregiver) We anticipate these changes will occur from baseline to post assessment, and be maintained at the follow-up time point (at least 3 months later). 3.2 Secondary Objectives We also hypothesise that results will show significant improvement in the following secondary outcomes compared to the waitlist control group: 1. Improved metabolic outcomes (HbA1c reading) 2. Increased self-compassion in the child (as reported by child) 3. Increased health-related diabetes self-care behaviours in the child (as reported by child) 4. Improved parental outcomes (parent’s own anxiety symptoms and self-compassion) 5. Improved child behaviour as measured by the strengths and difficulties questionnaire completed by the parent The secondary outcome of this study is to assess the practicality and feasibility of the SCAN intervention. This will be assessed by attendance records and open-ended qualitative questions about what the participants found helpful (or not helpful) about the intervention.

Infection in preterm babies (babies born early) remains a common problem in neonatal units – up to 1 in 4 babies born at less than 29 weeks of pregnancy develops a serious infection at some time during their stay. Preterm babies are vulnerable to infection, and the impact of infection can be far-reaching: not only can infection make babies critically unwell, but can also contribute to poorer health and development when babies grow up into childhood. It is crucial that neonatal units try to reduce infection rates. One of the main sources of infection comes from bugs that are usually carried on babies’ or healthcare workers’ skin. These bugs are carried harmlessly on the skin, but if they get into the bloodstream they can cause infection. The ‘Gloves On’ study is looking at a simple intervention to try to prevent infection: using gloves when staff touch babies in addition to the handwashing that we would normally do before we touch any baby. Gloves are not used routinely at present. We think using gloves would reduce infection by lowering the rate of transmission of bugs from healthcare workers’ hands to babies and back again. We would like to assess the impact of using gloves on infection rates in preterm babies, as well as making sure it is safe for babies, and safe and acceptable to the families and everyone who uses them. This simple and cheap intervention would be easy to introduce into every neonatal unit if it is shown to be successful and cost-effective. This would mean reduced numbers of infections in fragile preterm babies, with improved survival rates. Lower infection rates means shorter times in hospital for the babies and reduced costs for hospitals. Lower infection rates would also improve health and development of these babies when they grow into young children, making life better for families around Australia.

This study will compare the level of protection afforded by two different influenza vaccination strategies in patients who have undergone autologous haematopoietic stem cell transplantation. Who is it for? You may be eligible to join this study if you are aged at least 18 years, have received an autologous haematopoietic stem cell transplantation (autoHSCT) within the last 12 months, and have not received an influenza vaccine for the 2019 season following your transplant. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will receive a new two dose strategy, which consists of the trivalent high dose influenza vaccine followed by a second dose of quadrivalent standard dose influenza vaccine one month later. Participants in the other group will receive the current standard two dose strategy of quadrivalent influenza vaccine one month apart. All vaccines will be administered by injection into the muscle. All participants will be required to provide blood samples at four time points: 1) before first influenza vaccination, 2) before second influenza vaccination; 3) 21-28 days post-second-vaccination; and 4) approximately 6 months post-vaccination. They will also be asked to provide information on vaccination history, side effects and occurrence of influenza-like illnesses (ILI). Participants who develop respiratory symptoms during the study period will be asked to provide a nasal swab. Findings may assist in improving vaccine responses and protection from influenza in a highly vulnerable patient group

This intervention study will assess the effect of prebiotic supplementation ßGOS on Quality of life, basal cortisol levels, social and mealtime behaviours, GI symptoms and sleep patterns in children aged 4 to 10 years with a clinical diagnosis of Autism Spectrum Disorder (ASD).

Procedural sedation in children is a commonly performed task in mixed emergency departments around Australia. Ketamine has gained significant acceptance as the drug of choice to conduct this sedation. The preferred route of ketamine administration is an ongoing debate. Historically intravenous ketamine sedation has been favoured, however the evidence is not strong and mostly based on anecdotes. Further, the initial intravenous cannulation required has the negative consequence of inducing significant pain and distress. Aim To demonstrate in a randomised control trial that intramuscular ketamine, given in one needle, can achieve successful procedural sedation in children. Research Design This is an open label multicentre randomised control trial investigating whether paediatric procedural sedation can be achieved with just one needle. Study sites include Gold Coast University Hospital and Logan Hospital - 537 participants will be enrolled. Patients 1-12 yrs of age presenting to emergency department and requiring procedural sedation with ketamine (as determined by the senior treating clinician) will be eligible for inclusion into the study. Exclusion criteria will include the lack of informed consent and intravenous cannulation being required for another aspect of their management. The study has two intervention arms, one arm will receive 3mg/kg and the other arm will receive 4mg/mg via intramuscular injection. Participants will be randomised in a 1:1:1 ratio between the two intervention arms and control. Intramuscular injections will be administered by the treating doctor or nurse. Where adequate sedation to undertake the required procedure is not achieved with the initial intramuscular dose, additional intramuscular or intravenous doses of ketamine will be administered at treating clinician discretion.. Patients in the control group will be intravenously cannulated and ketamine given initially at 1mg/kg and then dose titrated to effect at the treating clinician’s discretion. The primary outcome will be success of paediatric procedural sedation with only one needle. Secondary outcomes include length of stay in the emergency department, length of sedation and adverse effects in the intramuscular versus intravenous groups. Significance This multicentre randomised trial will allow definitive assessment of the efficacy of a one needle approach giving intramuscular ketamine to achieve paediatric procedural sedation in children, with the goal of minimising unnecessary distress.

Ulcerative colitis (UC) is a chronic, disabling immune mediated inflammatory condition affecting the large bowel, which is thought to be caused by an aberrant interaction between the immune system and a dysbiotic intestinal microbiome. There is emerging evidence that faecal microbiota transplantation (FMT) is effective in treating UC. This is a multi-centre double blind, randomised, placebo-controlled trial of orally administered FMT in patients with chronic active UC over an 8 week period.

This open-label, 16-week, 20-subject study is to assess if LM011 is safe and efficacious in treating subjects diagnosed with non-alcoholic steatohepatitis (NASH).