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The effect of the ABCDEF bundle on delirium, functional outcomes and quality of life in critically ill patients - a randomised controlled trial with embedded process evaluation
The purpose of this study is to find out whether ventilated adult patients admitted to the Intensive Care Unit (ICU) who receive the ABCDEF bundle of cares will have reduced prevalence and duration of delirium, improved functional ability, and improved health related quality of life when discharged from the ICU and hospital compared to patients who receive our usual care. Delirium is an acutely disturbed state of mind characterised by restlessness, illusions, and incoherence. Functional ability relates to the participant’s ability to mobilise and care for themself, while health related quality of life relates to the impact of the participant’s health status on their quality of life. Mechanical ventilation, bed rest, the use of pain medication and sedatives are usual practices for some patients in Intensive Care Units (ICU). Unfortunately, these practices can be associated with both physical and psychological complications such as muscle weakness and delirium. The ABCDEF bundle of cares refers to: • Assess, prevent and manage pain • Both spontaneous awakening and spontaneous breathing trials • Choice of sedation and analgesia • Delirium: assess, prevent and manage • Early mobility and exercise • Family engagement and empowerment This bundle of cares involves using protocols that give the least amount of sedatives and pain relief necessary to keep the participant comfortable and settled, encourages early and safe weaning from the ventilator, mobilises the participant at the earliest and safest time, and aims to enhance family satisfaction with the participant care.
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Lung ultrasound to predict invasive ventilation of patients with COVID-19 lung disease
Lung ultrasound (LUS) is known to be more sensitive for detection of lung pathology compared to plain radiography and comparable to computerised tomography (CT), particularly for peripheral or pleurally based lesions. For example, it can be used in diagnosing interstitial patterns including pulmonary edema, as well as consolidation and effusions. Point-of-care (POCUS) is readily available in most emergency departments (ED), where it can immediately supply clinical information at the bedside. SARS-CoV-2 viral pneumonia (COVID-19) has led some practitioners to assess if LUS has utility in its diagnosis or prognosis. There are specific findings which represent viral pneumonias, such as increasing density of B-lines, subpleural consolidations, and absence of pleural effusions. Unfortunately LUS is currently unable to distinguish COVID-19 from other viral pneumonias but may be possible with further description of findings in a large cohort of patients. Although the current de facto “gold standard” for COVID-19 diagnosis, reverse-transcriptase polymerase chain reaction (RT-PCR) has a delayed turnaround of results and lacks sensitivity, particularly early in the course of the illness. Although LUS is unlikely to replace nucleic acid testing for definitive diagnosis, it may have utility in predicting clinical deterioration indicating need for ventilatory support. If proven to be accurately predictive of clinical deterioration, LUS findings could be integrated with clinical findings at the time of ED presentation, to triage patients to either outpatient management (low risk features), ward admission (moderate risk features) or intensive care unit (ICU) admission (high risk features). This could impact patient outcomes, resource allocation, and departmental flow, particularly in times of crisis. Furthermore, the findings from this study may inform the use of LUS in future respiratory virus pandemics.
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Exercise interveNtion outdoor proJect in the cOmmunitY (ENJOY) program in Dementia
The Seniors Exercise Park program is, an evidence based, exercise and social program using an innovative design in outdoor exercise equipment specifically designed for older people to improve strength, balance, flexibility, mobility and function. The ENJOY program for Independence in Dementia aims to design, deliver and test a physical activity program for older people living with dementia in a residential aged care using the Seniors Exercise Park. The optimal physical activity program, its safety and supervision needs will be examined to determine its suitability for people diagnosed with mild to moderate stage dementia. Older people aged 60 years and over who reside in Leith Park aged care facility and who have a diagnosis of dementia (confirmed by a facility geriatrician) will be recruited. Participants will be randomized to either an exercise intervention group (Seniors Exercise Park) or to a control group. Participants from the intervention group will undergo 3 months supervised structured physical activity program followed by a 3 months maintenance phase. All participants will be assessed at baseline, 3 months and 6 months. Assessments will include physical and cognitive function, health related quality of life measures.
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The effect of hyaluronic acid injections into the base of thumb joint on pain and function for osteoarthritis
Basal thumb osteoarthritis is common, painful and debilitating disease with no current prevention or cure. There are a number of surgical options which include bone (trapezium) removal, joint replacement, ligament reconstruction or a combination of these. The recovery is slow, often painful and requires prolonged splinting and physical therapy. Before getting to surgery, conservative treatments include lifestyle modification, taking over the counter pain killers, splinting or occupational hand therapy with mixed success. Corticosteroids injections into the joint can provide pain relief but typically for 3 months only. Hyaluronic acid treatment has proved successful in many joints but often requires multiple injections, increasing the risk of joint infection. A new, stabilised hyaluronic acid is now available that has a longer half life than other hyaluronic compounds, extending its residence in joints and thus its benefit. This hyaluronic acid compound has been shown to relieve pain, improve joint function and help to restore quality of life when injected into knee, shoulder, hip and ankle joints and requires one injection only, avoiding complications associated with multiple injections. These qualities should also be of benefit for the treatment of osteoarthritis symptoms in the basal thumb joint but have yet to be trialed. We aim to conduct a prospective trial to compare hyaluronic acid injections with methylprednisolone acetate (steroid injections) and placebo to see if it reduces pain from osteoarthritis and improves function when injected into the base of thumb joint. We will assess changes in pain and function before and after a once off injection with assessments 2, 4, 12 and 26 weeks after treatment and compare use of pain killers before and after injection by requiring participants to keep a diary of their pain killer usage.
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Will treating the overwhelming patient response with medications affect COVID-19 mortality?
There are many current health and social needs in the COVID pandemic. From both a health and and economic perspective, the best population policy is to vaccinate. However, in the absence of a vaccine, a combination of minimizing exposure and using proven therapies to prevent flulike symptoms becoming lung failure requiring ventilation and ICU beds is the only strategy. The key to respiratory illness is the viral attack on the pulmonary Renin Angiotensin System (RAS), which drives a substantial inflammatory process. This has reached a zenith with SARS-CoV-2, which comprehensively dysregulates the pulmonary RAS processes by targeting a vital RAS component, the angiotensin-converting enzyme 2 (ACE2). It is this enzyme that becomes the molecular target or receptor for SARS-CoV-2 (COVID) infection with the concurrent loss of its role in physiologically countering RAS induced inflammation. We aim to study in an open label randomised trial the safety of a range of identifed, currently used ARB and ACEI's. The first compound selected is Losartan, a drug that interferes with the renin angiotensin system. Many retrospective studies have now reported significant mortality benefits for patients who are on RAS drugs when admitted to hospital. We aim to undertake a prospective study in patients not usually on such drugs to describe the safety, tolerability and efficacy of adding Losartan to the treatment regime in Australian hospitalised COVID patients
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Comparing blood levels of two preparations of 2% lignocaine for airway anaesthesia.
This double-blinded, randomised controlled clinical trial of healthy physician volunteers is designed to determine if a difference exists in the median and range of plasma lignocaine concentrations (mcg/ml) in healthy volunteers for two preparations of lignocaine [topical 4% lignocaine diluted to 2% (as currently used by the Gosford awake fibreoptic intubation course) and alkalinised 2% intravenous lignocaine (1ml 8.4% sodium bicarbonate per 10ml 2% IV lignocaine)] when used for topicalisation of the airway for endoscopy. We will also look at comfort scores of participants.
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EDUCATE-AF - A clinician-developed, video-based educational intervention to improve health knowledge in people with atrial fibrillation
Atrial fibrillation (AF) is the most common cardiac arrhythmia globally. Patient knowledge of AF and approaches to medical therapy for AF is poor. This study aims to test the utility and scalability of an AF educational program developed by staff at Westmead Hospital. Hypothesis: Patients exposed clinician-developed educational videos prior to and post clinic appointment will higher knowledge of AF, medication adherence and satisfaction with clinical care compared to usual care. Primary Objective: The primary objective of this study is to assess whether simple, clinician designed educational program can improve knowledge of AF at 90 day follow up compared to usual care. Design Randomised clinical trial amongst 360 patients accessing clinical care for atrial fibrillation within Westmead Hospital. Randomisation to intervention and control will be in a 2:1 ratio. Intervention participants (n = 240) will receive a series of 4 clinician-developed educational videos on atrial fibrillation. Control (n = 120) will receive usual care. Intervention participants will be randomised again in a 1:1 ratio such that half (n = 120) receive further reinforcement education, and half (n = 120) receive only pre-clinic education. Specific Aims: To examine, among patients with atrial fibrillation accessing clinical care whether a series of clinician-designed educational videos delivered prior to clinic improves: 1. Knowledge of AF 2. Adherence to AF-related medication 3. Satisfaction with clinical care And to investigate the impact, if any, of further reinforcement education.
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PUnCQ; Pain Understanding and Confidence in undergraduate Healthcare Professional Students and General Practitioners in Australia.
A questionnaire, in three parts, will aim to assess students' and General Practitioners' knowledge, confidence and their attitudes to provision of undergraduate education on persistent pain management. The first section, relating to a case scenario of a patient with persistent pain will seek to elucidate students and GP's knowledge of the principles of persistent pain management, based on the International Association for the Study of Pain (IASP) proposals for an undergraduate curriculum. The second asks respondents to rate their confidence in components of the curriculum and the third asks for their views on the current provision of undergraduate education on pain management. Separate versions of the questionnaire will be tailored to apply to undergraduate students and to GP's.
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The Efficacy of Focused Shockwave Therapy on Knee Osteoarthritis related Bone Marrow Oedema.
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A randomized, double-blind, placebo-controlled dose-escalation study of AND017 capsules in healthy subjects following oral single and multiple dose administration
This is a phase I, randomized, double-blind, placebo-controlled, dose-escalation study to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD)of AND017 in healthy subjects. The study will involve two sequential parts: a single dose phase (SAD cohorts, Part A) followed by a multiple dose phase (MAD cohorts, Part B). Single doses of 1, 4, 10, 20, 30, and 50 mg AND017(n=6/dose) or placebo (n=2/dose) will be assessed in six consecutive cohorts of 8 subjects each in SAD cohorts (Part A) except Cohort 1 (4 subjects randomized at 1:1 to receive AND017 or placebo). Multiple doses of 4, 10, 20, and 30 mg AND017 (n=6/dose) or placebo (n=2/dose) will be administered daily for 10 days and assessed in four consecutive cohorts of 8 subjects each in MAD cohorts (Part B). Subjects will be fasted for at least 10 hours before administrating the investigational medicine with 240 mL water on dosing days. Subjects in SAD cohorts (Part A) will be inpatient for approximately 4 days with study drug administered on Day 1, and subjects in MAD cohorts (Part B) will be inpatient for approximately 14 days with study drug administered on Days 1-10. Subjects will be enrolled only in one study part and randomized to one cohort per the randomization schedule. For safety purpose, a sentinel dosing design will be applied in Cohort 1 (SAD cohort, Part A). The first 2 subjects will be dosed with one subject receiving AND017 and the other receiving placebo. After an interval of 48 h and review of all safety data of sentinel subjects, the remaining 4 subjects will be randomized at 3:1 to receive AND017 or placebo. There will be also a safety review (4 and 10 days in SAD (Part A) and MAD cohorts (Part B), respectively) before dose escalation for each cohort. Dose escalation will be stopped when predefined safety or pharmacodynamic criteria are met. This study allows some alteration from the currently outlined dosing schedule to reduce risk of subjects. Additional dosing cohorts may also be added to further evaluate the safety, PK and/or PD of AND017.