ANZCTR search results

Perioperative respiratory adverse events (PRAE) are one of the major causes of morbidity and mortality during paediatric anaesthesia. Three quarters of critical incidents and at least one third of peri-operative cardiac arrests are linked to adverse respiratory events. Fortunately most perioperative respiratory adverse events are easily managed with no postoperative sequelae but some can lead to life threatening hypoxemia. Various definitions of perioperative respiratory adverse events are in use, but they are commonly considered to be any adverse event impacting the respiratory system at the induction of anaesthesia, intraoperatively or early post operatively. This includes laryngospasm, bronchospasm, hypopnea or apnea, breath holding, hypoxemia or the prolonged need for supplemental oxygen, pulmonary aspiration, airway obstruction, severe cough, stridor or reintubation. These events can adversely affect perioperative outcomes, including increased resource utilization and costs. The induction of anaesthesia and the immediate post-operative periods are high risk times for PRAE. While multiple management strategies exist to prevent PRAE at these critical phases of patient care, there is a paucity of data on whether patient positioning on the surgical bed alters the incidence of PRAE. In this study we will investigate if positioning the patient’s head elevated at a 30- degree incline for induction and transfer to the operating room and again from the end of surgery through to fully awake in post anaesthesia care unit (PACU) results in a lower incidence of PRAE in children, as compared to flat positioning (0 degrees) throughout this period. Both patient positions are commonly used in routine clinical practice in our institution both in theatre and in PACU. There are no guidelines or evidence specifying the use of one over the other.

The main study aimed to explore men's reasons for transitioning from active surveillance to further treatment in prostate cancer management, and the factors which may have contributed to this decision. In this study within a trial, we investigated whether response rates to the questionnaire would differ by incentive amount (provided as an unconditional monetary incentive in the form of a gift card). All participants were required to complete a one-time survey (sent via mail but may be completed on paper, online, or via telephone). This survey consists of questions relating to social-ecological factors (i.e., personal, social, community, organisation, policy) and your experience with active surveillance. Participants in the main study were randomised to receive either a $20AUD or $10AUD unconditional incentive with their study materials. We aimed to investigate whether (a) response rates to a 30-minute questionnaire completed via mail, online, or phone would vary with different unconditional incentive amounts, and (b) demographics would vary in those who responded within the different incentive groups.

Chronic low back pain (CLBP) is associated with functional instability of the lumbar spine that results from impaired motor control and atrophy of the multifidus muscle. In previous research, ReActiv8 has shown preliminary efficacy, however, the individual mechanisms that can restore the multifidus muscle at a functional and biological level require further exploration. Therefore, the aim of this observational study is to evaluate changes in a) multifidus morphology, b) patient function and physical activity and c) patient-reported outcomes (PROMs) in patients eligible for ReActiv8. The hypothesis of this study is that patients treated with ReActiv8 experience measurable changes in a) multifidus morphology, b) patient function and physical activity and c) patient-reported outcomes.

The research project aims to investigate the effect of using a cold pack on any pain felt following an injection to the sacroiliac joint. We are also interested to see if the use of the cold pack changes any need for pain medications.

Since December 2019, the coronavirus disease (COVID-19) pandemic has affected millions of people worldwide. Modern hospital negative pressure rooms have high flow rates and negative pressure to prevent the spread of TB, measles etc. Nevertheless, such negative pressure rooms do not prevent droplet spread of the infectious disease to personnel within the room. Western Health and The University of Melbourne conceived and developed a small personalised ventilation hood device (the Mini Isolation Hood) to provide a physical barrier to droplet and aerosol spread. The device is based upon the already extant McMonty personal ventilation hood; the Mini Isolation Hood is significantly smaller, is mobile, and is designed to attach directly to an Emergency Department trauma trolley. The hood will provide health care workers with protection from droplets and aerosols during routine care, during the administration of specialised oxygen therapies (including high flow oxygen and non-invasive ventilation), and during the conduct of aerosol generating procedures. The hood has a plastic barrier to prevent droplet spread from a COVID-19 or other infectious patient, and a ventilation system to reduce aerosol spread. The hood relies upon air being drawn from the front near the patient’s legs etc. up to the rear, i.e. away from the healthcare worker, who is principally at the front/sides of the patient. The air passes through the fan and then a High Efficiency Particulate Air (HEPA) filter, thereafter returning to the local Emergency Department environment (similar to that for a patient’s mechanical ventilator). The entire Mini Isolation Hood is designed to be reusable in order to ensure security of supply during the COVID-19 pandemic. The SARS CoV-2 virus is susceptible, amongst other disinfection treatments, to bleach (chlorine based, e.g. ‘Actichlor’ one part per thousand= one tablet per litre), quaternary ammonium chloride based wipes (e.g. ‘Clinell’), and soap/detergent (exposure to soap for 15 minutes). We aim to evaluate the safety of the Mini Isolation Hood in a clinical setting on use with 20 Emergency Department patients.

Opioid analgesic PCA is an alternative that provides pain relief for women who have contraindications to epidural analgesia such as women who are undergoing vaginal birth for fetal death in utero. In our hospital we use the opioid fentanyl, however evidence suggests that remifentanil, a much more quickly acting opioid, provides superior pain relief compared to fentanyl. One of the major issues with remifentanil PCA however is maternal hypoxaemia from opioid-induced ventilatory impairment. This trial would be a first step towards investigating whether we can demonstrate remifentanil PCA to be a safer option for labour pain relief with the addition of HFNO therapy to minimise hypoxaemia. It would have very significant positive clinical implications if this is the case and significant benefits for this group of women undergoing life’s most painful experience.

This research study in BV patients is testing the safety, tolerability, preliminary evidence of efficacy and pharmacokinetics (the levels of drug in the blood and in vaginal fluid) of a bilayer tablet formulation of a drug called Metrodora Therapeutics Low Iron bovine Lactoferrin (Low Iron MTbLF) when it is given Intravaginally (into the vagina) after patients’ completion of primary treatment with antibiotics. Lactoferrin is a naturally occurring protein present in milk, saliva, tears, and other bodily fluids that has antimicrobial activity and may have an important therapeutic effect for the treatment of recurrent Bacterial Vaginosis (BV). The overall goal of this study is to optimize the duration of Low Iron MTbLF treatment post antibiotics for the prevention of recurrence of BV and the evaluation of different diagnostics to follow recurrence during the treatment period. BV patients will receive antibiotic treatment (metronidazole 0.75% intravaginal daily for 5 days at bedtime) for symptomatic BV. Then, they will self-administer daily doses of study medication for 12 weeks. They will self-collect three vaginal swabs weekly at home for the duration of the 12-week treatment and then the 12-week follow up period. A series of vaginal swabs and blood samples will be collected by a healthcare practitioner during 4 in-clinic visits that will take place in the 12-week treatment period and at the end of the study on week 24. Patients will use a patient diary to record symptoms, dosing of study medication and other study-related information daily during treatment (weeks 1 to 12) and twice a week during weeks 13-24.

The purpose of this study is to evaluate the effectiveness of the combination of zanubrutinib and tislelizumab in patients with brain or spinal cord cancer (CNS lymphoma). Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have CNS lymphoma that has re-occured, or stopped responding to treatment, or you are deemed unfit for chemotherapy treatment. Study details All participants will be treated with Zanubrutinib 320mg once daily continuously, as an oral capsule together with Tislelizumab 200mg intravenously every 3-weeks (starting after week 4 of Zanubrutinib). Blood tests and questionnaires will be performed at baseline and every 3 weeks during treatment for up to 2 years. Magnetic Resonance Imaging (MRI) scan will be performed at baseline, after 4 and 12 weeks of treatment and then every 12 weeks for up to 2 years. The purpose of the MRI scan is to assess your response to the treatment. It is hoped that this research will find out if the combination of zanubrutinib and tislelizumab is able to treat CNS lymphoma, and improve patient outcomes.

Middle ear infections, known as otitis media (OM), are the leading cause of hearing loss in children and are estimated to affect over 90% of children at least once before their second birthday. Persistent otitis media with effusion (OME) and its associated hearing loss can have long-term impacts on a child’s language, communication, behavioural skills, literacy and educational experience, that will affect their relationships with others, educational outcomes and later employment prospects. Whilst the prevalence of OME is high, we know that some children will experience spontaneous resolution of OME (i.e. return to having an intact and well-functioning eardrum), and therefore will not require Ventilation Tube Insertion surgery (more commonly known as grommets). Currently, we do not know how many children could be expected to experience spontaneous resolution of OME. Some simple, low-cost, family-led health promotion programs have been developed to help improve resolution of OME without surgical intervention. This project aims to determine whether the implementation of these health promotion programs within an innovative telehealth service model will increase the non-surgical resolution of OME.

This is a single blind, placebo-controlled clinical trial to determine the safety and tolerability and to gather additional data to define the recommended phase II dose (RP2D) of MTx-COVAB36 after single administration in a dose escalation, dose limiting toxicity (DLT)-driven approach in healthy volunteers. MTx-COVAB36 is a fully human monoclonal IgG1 antibody derived from the memory B cells of convalescent COVID-19 donors and directed against SARS-CoV-2 spike protein with potent virus neutralising activity. It is indicated for the treatment of patients with mild to moderate COVID-19 disease and with high risk for progression to severe disease. The trial will comprise four dose cohorts, each composed of 6 participants receiving MTx-COVAB36 and 2 participants receiving placebo, with pre-defined dose levels. The pre-defined investigational medicinal product (IMP) doses are: 100 mg, 500 mg, 1,000 mg and 2,000 mg, respectively. Participants will be administered a single dose of either IMP or placebo on Day 1 of the study and will be followed up until 63 days post administration.