ANZCTR search results

This is a parallel, single-blinded, randomised clinical trial evaluating the effectiveness, cost-effectiveness and safety of 8 weeks of treatment with a vaporised nicotine product (VNP) and nicotine liquid/pods compared to traditional oral nicotine replacement therapy (NRT; gum or lozenge) for smoking cessation among low-socioeconomic smokers. We hypothesize a higher 6-month cessation rate among the VNP, compared with the NRT group.

Low dose atropine eye drops of various concentrations are used to slow the rate of myopic refractive error (short-sightedness) progression in children and adolescents. Atropine is an anticholinergic agent (inhibits the parasympathetic nervous system) which when used as an eye drop, leads to pupil dilation and cycloplegia (reduction or temporary elimination of focusing ability). While these side effects are desirable when treating certain ocular conditions like uveitis or amblyopia, when atropine is used in treating myopia progression, only very low concentrations are used to minimise these side effects. While the effect of low dose atropine on pupil dilation and cycloplegia are widely documented, the implications for single and clear binocular vision when taking this medication have not specifically been studied. The objective of this research project is to examine the effect of nightly dosing of 0.05% atropine sulfate eye drops for 10 days with respect to the binocular vision characteristics of young adult myopes. Outcome measures will include: distance and near heterophoria (measures the coordination of the aiming between the two eyes at distance and near), positive and negative relative accommodation (measures the range of the focusing system over which clear focus is maintained when performing near tasks), accommodative posture (accuracy of focusing when reading), positive and negative fusional vergence (measures the range of the focusing system over which single vision is maintained when performing near tasks), binocular accommodative facility (a measure of the flexibility of the focusing system), and near point of convergence (a measure of the degree to which the two eyes can focus inwards while still maintaining single vision). The outcomes of this research would be expected to inform the development of clinical protocols for assessing patient suitability for low dose atropine treatment, through determination of effects on binocular vision, and identification of patients who would be most impacted by these side effects. This will help to identify potentially unsuitable candidates for treatment and any contraindications to treatment.

Brief statement: Two types of general anaesthesia are given to patients to keep them asleep during the removal of clots causing large vessel strokes, most commonly either an anaesthetic gas (sevoflurane) delivered via inhalation, or medication (propofol) administered continuously through a drip. This study is a preliminary study looking to determine whether the choice of which of these methods used during the procedure makes a difference to how well a patient recovers. PROSPER will assess the feasibility of conducting a multi-site randomised control trial comparing two general anaesthetic techniques- volatile anaesthesia and total intravenous anaesthesia (TIVA) during endovascular thrombectomy for acute ischaemic stroke. PROSPER will primarily assess the hypothesis that the trial protocol is feasible. Secondary outcome measures will include functional recovery at 90 days primarily using modified Rankin scale (mRS). We will assess the data for potential relationships between mRS scores and intra and post-operative blood pressures, near infrared spectrometry (NIRS) calculated optimal blood pressure, pre- and post-operative risk factors and thrombolysis. PROSPER will be a pilot study prospective randomised controlled trial. Prospective data will be collected by the anaesthetic and stroke teams at the PA hospital. This data will include: • Baseline patient characteristics • Details of anaesthetic drugs administered • Physiological parameters measured during the clot retrieval procedure • Radiological outcome of procedure (TICI (thrombolysis in cerebral infarction) score) • Clinical outcome measures • Procedural complications, death rate and cause of death Data will be analysed in 2 groups – Volatile anaesthetic only after induction versus TIVA only after induction. Patients who change groups during the procedure (becoming a mixed group) will be treated with intention to treat analysis. We will report both feasibility for RCT and secondary outcomes.

With the general ageing of the population attributed to Baby Boomers and the increase in life expectancy, attention of health consumers is turning from simply the treatment of chronic illness to increasing the span of good health (healthspan) as people age. The inflamma-ageing hypothesis proposes that much of the ageing process per se as well as chronic disease, even in healthy persons, is underpinned by chronic low-level inflammation. In pilot human studies undertaken by NatMed Research looking at their proprietary green-lipped mussel-based products as an anti-inflammatory treatment of osteoarthritis, the observation was made of changes in body composition in those persons receiving active medication. The current proposal is to undertake a randomised controlled trial in middle-aged healthy study population (without osteoarthritis) to determine if improvements in body composition and strength can be determined under double-blind conditions.

This study will compare four different techniques for reducing the incidence of shoulder tip pain after total laparoscopic hysterectomy. Shoulder tip pain occurs commonly after the procedure and although the exact cause is unknown, it is thought that the carbon dioxide (CO2) gas that is introduced into the abdomen to allow laparoscopic surgery to be performed safely may be the cause. We believe that by combining two techniques - closed drainage and the pulmonary recruitment maneuver - after surgery may allow CO2 gas to be removed more effectively from the abdomen and allow patients to experience less shoulder tip pain than if these techniques are used on their own or not used at all.

Fractured neck of femur (FNF) is a common condition, affecting 25,000 Australians per annum. Total hip arthroplasty (THA), which involves replacing the ball and socket of the hip joint, is the current standard of care for fractured neck of femur in community-dwelling patients with minimal co-morbidities. However, despite superior pain and functional scores compared to the alternative treatment, partial hip replacement (hemiarthroplasty), THA exposes patients to an increased risk of prosthesis dislocation. Prosthesis dislocation involves separation of the prosthetic head and acetabular cup, and may require a patient to undergo revision THA, a procedure associated with increased costs and morbidity. Dual mobility cups (DMC) are an alternative THA design in common use in Australia, and are hypothesised to reduce the risk of dislocation. This trial will compare the outcomes of conventional THA versus DMCs in the FNF population.

We hypothesise that, in a surgical setting for hip arthroplasty, the PENG (pericapsular nerve group) regional block is more effective in reducing post-operative pain than placebo. We propose a study to investigate the effect of the PENG block, compared to placebo in a blinded format The participant, anaesthetist and surgeon will be blinded to the study medication administered. The post-operative pain team, at FMC and Noarlunga known as the Acute Pain Service (APS), will also be blinded. This team routinely follows up all participants who have undergone a hip arthroplasty. They will know that the participant has received a regional technique, but not whether it is with ropivacaine or placebo. Post-operatively, each participant will be visited on the ward by the Acute Pain Service which is a routine part of their care. In this consultation they will discuss their pain levels, pain medication use, and ability to mobilise since their surgery, all part of the standard questions asked by this service. As part of this study, Dr Lin (study investigator) shall post-operatively conduct a series of questionnaires, including one or more of the anxiety, depression and delirium assessments. In addition to this, we shall collect general information from the medical records, which will be kept confidential.

The aim of this study is to confirm earlier studies demonstrating safety and tolerability of inhaled aerosolised ethanol in adult volunteer participants. The ethanol will be administered to the upper and lower airways using a specifically-designed closed-circuit nebuliser system which improves delivery efficiency by minimising escape of volatile ethanol vapor during nebulisation and at the same time meets WHO requirements for safety and protection of nearby personnel from environmental aerosol exposure and exhaled virus particles. Confirmation of safety and tolerability will reassure physicians that inhaled ethanol can be used to treat COVID-19 and other viral and bacterial respiratory infections.

Osteoarthritis is a common joint disorder for which there is no cure. Knee osteoarthritis is the most common form of osteoarthritis. Exercise is a core treatment for knee osteoarthritis. Muscle strengthening exercise has been shown to improve pain and function and is recommended by clinical guidelines. Yoga is a mind-body exercise intervention that can provide increased flexibility, muscle strength, physical balancing, improved fitness, and has demonstrated pain-relieving properties. Yoga, with its potential for improving musculoskeletal function, nervous system, and sympathetic activity, may therefore have greater benefits than commonly used strengthening exercise. Previous studies of yoga in knee osteoarthritis patients have been of low-quality with a high risk of bias and did not perform subgroup analyses to identify patients who may specifically benefit from yoga. This randomised controlled trial aims to compare the effectiveness of the 24-week yoga program vs strengthening exercise (12 weeks (2x/week of group-based + 1x/week of home-based) + 12 weeks of (3x/week) home-based) on knee pain in knee osteoarthritis patients with a priori subgroup analysis of knee osteoarthritis patients with neuropathic pain compared to strengthening exercise. If successful, yoga can be easily implemented as a complementary treatment along with conventional treatment to improve the management of knee osteoarthritis.

Current guidelines in Victoria do not recommend fit testing of N95 respirators (tight fitting face masks). In addition they recommend use of N95 respirators for 4 hours before changing. Therefore we sought to test this as our hypothesis. The purpose of the study was to test the N95 fit test rates after 4 hours of use in a real-world intensive care unit setting to help assess if they adequately protected healthcare workers.