ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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32814 results sorted by trial registration date.
  • A Study of Lying Face Down to Help Improve Oxygen Levels of Adults Not Needing Ventilators in Intensive Care with COVID-19

    Prone positioning (lying face down) is a recognised rescue therapy for ventilated patients with severe lung disease whose oxygen levels remain low despite optimal ventilation strategies. We look to investigate whether proning early during admission to the Intensive Care Unit, might improve oxygenation for patient with COVID-19. Objectives: To determine the efficacy and safety of early prone positioning, compared to usual care, on oxygenation for non intubated adults admitted to ICU with COVID-19. Hypothesis: That the intervention (prone positioning) will improve measured oxygen levels in patients with COVID-19

  • An evaluation of the reliability and ease of use of a remote foetal heart rate monitor as used by expectant mothers at home. The HeraBEAT Trial

    Monitoring of the heartrate of the developing foetus (FHR) is an essential component of antenatal care. Monitoring FHR is currently restricted to in-clinic consultations with trained obstetric staff and appropriate medical equipment (hand-held doppler or cardiotocography (CTG)). The HeraBeat device is a new medical FHR monitor designed for use at home by the expectant mother, has been shown to be equivalent to existing gold standard FHR monitoring equipment and is approved for use in Australia. This study will examine the accuracy, usability and clinical utility of the HeraBeat device in the antenatal clinic and at home. This is a pilot study enrolling 60 participants. We will compare data accuracy against existing FHR monitors and assess usability of the device as rated by expectant mothers and antenatal clinic staff. More regular monitoring of FHR may result in improved pregnancy care.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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

  • 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.

  • 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.

  • 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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