ANZCTR search results

The purpose of the study is to improve how we teach doctors, nurses and midwives how to breath for babies not breathing at birth. The primary objective is to compare the leak from mask ventilation performed on a mannequin, after learning using a respiratory function monitor and after learning without using a respiratory function monitor. The design is a single centre, randomised controlled trial. The participants will be randomised to either the intervention group (neonatal mask ventilation taught with a respiratory function monitor) or control (standard teaching of neonatal mask ventilation). Adult health care professionals attending the Victorian Neonatal Resuscitation training program (a structured simulation training program, NeoResus) in the Royal Children’s Hospital during the study period will be eligible to participate. 382 (191 in each arm) participants are expected, over 2 years 3 months. The primary outcome is the difference in leak measured after neonatal mask ventilation training between the control and intervention groups. Secondary outcomes are difference in the volume of breaths, the stability of breaths and the number of obstructed breaths.

Introduction Degenerate intervertebral disc can cause back pain or neck pain and /or arm or leg pain (if compressing on the nerve root). Correlation between MRI scan findings of degenerate disc and back pain is poor. It is not uncommon to find poor correlation between arm or leg pain symptoms and degree of compression of the nerve root (on MRI scan). Inflammatory mediators have been implicated as the cause for this discrepancy. A few investigators have found infection of disc by low virulent organisms in these degenerate discs and in sciatica in a surprising 45% of cases. The organisms found are skin commensals and there is a high likelihood that these are contaminants. Treating all back pain or sciatica patients with long-term antibiotics is unreasonable and harmful without a strong proof of infection. Unfortunately these studies are underpowered and do not have a stringent contaminant control arm. Aims Primary: To find the rate of true infection in degenerate discs Secondary: To find the risk factors for true infection Proposal research design This is a case control study comparing incidence of true infection of intervertebral disc in degenerate disc disease patients undergoing spine surgery to patients undergoing spine surgery without degenerate disc (trauma/scoliosis/tumour). Methods All patients undergoing discectomy for various indications will be eligible to participate. At the time of surgery, disc removed as a part of the intended procedure (discectomy or fusion) will be sent for culture. A small amount of tissue generally removed as a part of the procedure (fat/muscle/ligamentum) will serve as contamination control and will also be sent for culture. Prolonged cultures will be performed to identify low virulent organisms. Data collected will include demographic data (age, sex, pre-existing health problems, diabetes, smoking, medications, immunocompromised status, smoking, family history etc), radiological data and type of surgery. If the disc culture is positive and other tissue culture is negative it will be assumed to be infected. But if the other tissue is also positive then it is presumed to be contamination. Two other arms were added to the original study: . 1. Contamination (Sham) arm: paraspinal cultures were also undertaken in patients undergoing spinal surgery without discectomy. We aim to obtain contamination rate from this cohort. 2. Histopathological arm: A subset of patients also underwent histopatholgical evaluation to review inflammatory changes in the disc samples. this was planned to augment the notion of disc infection in degenerated discs

This study aims to evaluate if patients undergoing pancreaticoduodenectomy (Whipple’s procedure) managed by intraoperative goal directed therapy with the Flotrac/Vigileo deviceTM will have a shorter length of hospital stay with fewer post-operative complications compared to patients managed by standard care. Who is it for? You may be eligible to join this study if you are aged 18 years or more and are scheduled to undergo pancreaticoduodenectomy (Whipple procedure). Study details: Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will have their haemodynamic variables (fluid dynamic and blood flow) managed by intraoperative goal directed therapy (GDT) using the Flotrac/Vigileo deviceTM (FloTrac/Vigileo Version 3.02, Edwards Lifesciences, Irvine, CA, USA). This minimally invasive device automatically calculates key flow parameters every 20 seconds and recognizes and allows for adjustments in haemodynamic variables in patients undergoing major surgery. Importantly, it enables the anaesthetist to make a differential diagnosis leading to either a volume or cardiovascular intervention (preload, afterload and contractility), by providing continuous information on the patients cardiac output, stroke volume, and systemic vascular resistance. Participants allocated to the control group will have fluid management and inotropic use guided by the routine cardiovascular monitoring in place i.e. arterial line, and central venous catheter, which will be at the discretion of the anaesthetist, who will be blinded to Flotrac data. The Control group anaesthetist will be allowed to have the Flotrac haemodynamic data unblinded if needed for clinical decision making but patients will be removed from analysis if this occurs. There is now compelling evidence that fluid optimization and GDT in patients undergoing colorectal surgery leads to better outcomes, particularly in high risk patients. This study will contribute to understanding if similar benefit of GDT is also observed in patients undergoing major pancreatic surgery - pancreaticoduodenectomy (Whipples Procedure).

Up to 55% of patients who see a GP have problems with stress, worries or depression, however it’s not always clear which patients will naturally recover and which ones would benefit from treatment. Researchers from the University of Melbourne have developed the Target-D Toolkit which identifies patients that might benefit from treatment and helps GPs to more effectively manage their patients’ emotional well-being. This study will improve people’s health and well-being and make better use of GPs time at less cost to the healthcare budget. It is funded by the National Health and Medical Research Council (NHMRC No: 1059863).

The aim of this study is to provide a model of sustainable and effective professional development for the early childhood education and care sector to improve staff understanding and competencies, as well as child outcomes. The overall design is a cluster randomized controlled trial with an intervention group (45 early childhood education centres) receiving a professional development intervention in 2016 and a control group (45 early childhood education centres) receiving this intervention on completion of the research evaluation in 2017. Pre- and post-intervention measures of centre quality (involving observation of typical centre operations) and child outcomes (involving direct and indirect assessment of participating children’s academic/cognitive, self-regulatory and social development) will permit estimation of effects of the intervention on both staff behaviour and child outcomes.

This multicentre, double-blind, placebo-controlled clinical trial is designed to determine whether prolonged reduction in blood cholesterol with pravastatin, one of the class of 3-hydroxy-3-methylglutaryl-coenzyme-A reductase (HMG-CoA reductase) inhibitors, will reduce mortality from coronary heart disease in patients with a history of myocardial infarction or unstable angina pectoris. To qualify for entry, a patient must have a blood cholesterol level in the range 4.0 to 7.0 mmol/L, and must have suffered a myocardial infarction or have been admitted to hospital with unstable angina, within three months to three years prior to screening. The primary study outcome will be death due to coronary heart disease. Secondary analyses will be of death from all causes, combined incidence of non fatal myocardial infarction and fatal coronary heart disease, stroke (total and non-haemorrhagic), cardiovascular mortality, coronary revascularisation (CABG and coronary angioplasty), and number of days in hospital during the follow-up period. The goal of intervention is to reduce total blood cholesterol by an average of 25% in patients allocated pravastatin compared with those allocated placebo. To detect reliably the expected effect of such a cholesterol difference on the primary endpoint requires about 9,000 patients be randomised in equal numbers to pravastatin or placebo, and that follow-up of these patients continues for a minimum 5 years for each surviving patient.

This study will evaluate the role of magnetic resonance imaging (MRI) in the treatment of Mucosal Primary Head and Neck Cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with histologically-proven invasive primary squamous cell carcinoma of mucosal primary head and neck region or suspect tumours for mucosal primary head and neck cancer. Study details: Imaging studies are not routinely performed during radiotherapy for head and neck cancer. In this study, all participants will receive multiple additional MRI sequences before, during and after radiotherapy treatment (with or without chemotherapy). MRI sequences used include DWI, R2*, and DCE. The results from all scans will be evaluated with respect to tumour response, local control, disease free survival and overall survival. The main purpose of this study is to see whether new MRI techniques during and after radiotherapy treatment provides the doctors with accurate information which predicts the later response of mucosal primary head and neck cancer to the treatment and also evaluates tumour recurrence following treatment.

The primary purpose of this trial is to investigate the feasibility and efficacy of performing contrast enhanced spectral mammography (CESM) in comparison with the standard of care tests (which are breast tomosynthesis and ultrasound) for the detection of breast cancer in women with dense breast tissue. Who is it for? You may be eligible to participate in this study if you are aged 18 to 65, have dense breast tissue and have been recalled for further investigation of least one non-calcified finding on a screening mammogram. Study details: As part of standard care investigations, all participants enrolled in this trial will undergo tomosynthesis of the breast in which a possible abnormality has been found and an ultrasound scan of both breasts. The tomosynthesis study is a type of mammogram that is able to show the breast tissue slices, As part of this trial, a contrast enhanced spectral mammogram is being tested. This involves the injection of a dye into a vein, followed by two mammogram pictures of each breast taken 2-4 minutes later. The specialised equipment used for the CESM study is able to take mammograms at two different energy levels as well as performing the normal tomosynthesis study. This CESM study is taken at the same time as the tomosynthesis scan and the combined tomosynthesis and CESM study will take about 12 minutes from the start of the injection to completion of the pictures. During this study, the injection will be given first with the participant seated. Two to four minutes later the participant is asked to stand and mammograms of both breasts will be taken with the breasts gently compressed. The tomosynthesis mammograms are taken first, immediately followed by the contrast enhanced mammogram. The tomosynthesis and CESM scans are both taken during the same episode of breast compression ie each breast is only compressed once for each of the views that is taken. Having the CESM scan will mean the breast is compressed for approximately one extra minute longer per view than for a tomosythesis only scan. Researchers will compare the results of the CESM scans to the results from the tomosynthesis and ultrasound scans. Based on all results available, the physician will then make a decision as to whether any further tests, such as a needle biopsy are needed. The treating doctor will be asked to rate their level of confidence in the diagnosis made, and researchers will follow-up to assess whether performing the CESM scan was able to reduce the need for further tests such as needle biopsy and ultrasound. It is hoped that the findings from this trial will provide information on whether CESM may be a useful and feasible tool to aid in the diagnosis of breast cancer in women with dense breasts and help prevent unnecessary extra tests.

The overall aim of this study is to examine whether oxytocin has a mechanistic effects on pain perception, physical functioning, central sensitisation, and physiological and psychological arousal in individuals with musculoskeletal pain associated with chronic neck and shoulder pain. This study involves receiving a one-off administration of oxytocin, relative to placebo, to investigate the role of this peptide in pain experience. Oxytocin is a hormone that is produced naturally within the human body. Although it is traditionally known for its role in initiating childbirth and breastfeeding, oxytocin has also been shown to have pain- and anxiety-reducing effects. We expect that oxytocin will help you to modulate your responses to painful experiences.

One of the most serious complications of general anaesthesia in pregnant women is hypoxic brain injury and fetal and/or maternal death related to difficulty oxygenating a pregnant woman. This is due to inability of the anaesthetist to intubate the trachea and ventilate a pregnant woman because of the changed anatomy and physiology of pregnant women leading to the known problem of the difficult obstetric airway. The latest obstetric airway management guidelines by the Obstetric Anaesthetists’ Association (OAA) & Difficult Airway Society (DAS) discuss the importance of pre-oxygenation in managing pregnant women undergoing general anaesthesia as it increases oxygen reserve in the lungs during apnoea. The guidelines recommend that the end-tidal oxygen fraction (FetO2) of equal to or greater than 90%, indicating effective lung denitrogentation, should be achieved prior to induction of anaesthesia. The current way anaesthetists pre-oxygenate pregnant women undergoing general anaesthesia is to use a tight fitting face mask to deliver 100% inspired oxygen. The new guideline also states an alternative method. The guidelines states that nasal oxygenation, to facilitate bulk flow of oxygen to the alveoli could be considered as part of 1. Pre-oxygenation - A pre-oxygenation method and 2. Apnoeic oxygenation - A technique to increase apnoeic time. The guideline suggests that the anaesthetist should consider attaching nasal cannulae with 5 l.min-1 oxygen flow before starting pre-oxygenation, to maintain bulk flow of oxygen (O2) during intubation attempts, or attach nasal oxygenation after pre-oxygenation during the apnoeic period. There is also mention of humidified high flow nasal oxygenation however no data exists in pregnant women as to its safety or efficacy or acceptability by pregnant women. It is possible that a new pre-oxygenation technique, using high flow humidified nasal oxygen, may have an application in pregnant women however before this new pre-oxygenation technique is considered, it should be equivalent (at least) to the current available technique in terms of safety and efficacy i.e. be able to obtain FetO2 of at least 90% after three minutes of pre-oxygenation. Currently there are no studies reporting FetO2 values in pregnant women with high-flow humidified nasal oxygen delivery systems and no studies reporting the use of nasal high flow oxygen to increase apnoea times therefore it is unclear whether humidified high flow nasal oxygenation, is safe and beneficial in pregnant women. In this prospective study we aim to recruit two groups of women. The first group of women will be those who will electively undertake high flow humidified nasal oxygenation in order to examine this technique in the setting of pre-oxygenation (Pre-oxygenation group). The second group of women will be those who are undergoing general anaesthesia for caesarean section and will have high flow humidified nasal oxygenation after induction of anaesthesia.