ANZCTR search results

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

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31247 results sorted by trial registration date.
  • End-tidal oxygen achieved with preoxygenation via non-rebreather mask at different flow rates in healthy volunteers

    Preoxygenation is critical to safe emergency airway management. Outside of the operating theatre and in prehospital environments, ‘Over flow’ from a standard wall/cylinder outlet has been proposed to greatly enhance preoxygenation via a Non-rebreather mask (NRB). Methods We performed a randomised crossover trial using two preoxygenation conditions; a NRB at 15lpm and the other a NRB with the 15lpm flowmeter with the dial turned all the way open (over-flow). End-tidal oxygen (ETO2) as a measure of preoxygenation/denitrogenating efficacy, was measured by single exhaled vital capacity breath.

  • Using eye movements to measure vision in children

    If eye problems occur in early childhood, they can affect the development of the brain areas that are responsible for sight and cause lifelong visual impairment. In addition, vision problems can affect the development of fine control over arm and hand movements and, in older children, impact on education. Many of the eye problems that affect young children can be treated effectively, however detecting these problems is challenging. Young children find it difficult to complete standard tests of vision because these tests require high levels of attention. Many tests also involve recognising shapes and letters and are therefore not suitable for young children. To address this problem we are developing a new computer-based vision test suitable for use with children as young as 2-years old. The test is simple and easy to use; carefully designed moving patterns are shown to the child that causes a reflexive, involuntary movement of the eyes if the child is able to see the pattern (which thereby yields a measure of visual performance). At the same time we record the movement of the eyes with a video camera attached to a computer and the software we are developing will identify whether the child is able to see the pattern or not. Finally, the visibility of the pattern will be varied to measure how well the child can see. In this project, we will develop and perform clinical validation tests in ophthalmology and optometry clinics in New Zealand and the USA. The overall aim of this research is to validate a device that we envisage could be used to rapidly and accurately test visual acuity in young children to allow for the early detection and treatment of vision problems. We propose here to conduct data collection of OKN eye movement using our prototype system developed from our own research to date. This study will involve three clinical sites: (1) the University of Auckland Optometry research clinic, (2) a private ophthalmology clinic (Eye Doctors, Ascot Hospital) led by co-investigator and ophthalmologist Dr Shuan Dai and his research assistant (orthoptist, Nia Stonex), and (3) the Retina Foundation of the Southwest (a non-profit eye research institute in Texas, USA) led by co-investigator Prof. Eileen Birch and her research team.

  • Addition of nasal cannula can either impair or enhance preoxygenation with a bag valve mask: a randomised crossover trial comparing oxygen flow rates

    Objectives A critical safety component of emergency anaesthesia is the avoidance of hypoxaemia during the apnoeic phase of a rapid sequence intubation. Preoxygenation with a bag valve mask (BVM) or anaesthetic circuit may be improved with supplemental oxygen by nasal cannulae (NC) if there is a mask leak. In addition, NC are recommended for apnoeic oxygenation after induction and may be placed prior to preoxygenation . However, the optimum NC flow rate for preoxygenation or whether presence of NC itself creates a mask leak remains unclear. Methods We performed a randomized crossover study on healthy volunteers comparing BVM alone and BVM with NC flow rates of 0 (NC-0), 5 (NC-5), 10 (NC-10) and 15 (NC-15) litres per minute . Our primary outcome was end tidal oxygen (ETO2) after 3-minutes preoxygenation.

  • The effects of continuous positive airway pressure (CPAP) treatment on brain activity during sleep in obstructive sleep apnea (OSA).

    This research study which will investigate the effect of continuous positive airway pressure (CPAP) treatment on brain wave activity recorded using high density electroencephalography (EEG) in patients diagnosed with moderate to severe obstructive sleep apnea. The study will examine changes in sleep and wake brain activity profiles and how these may relate to neurobehavioural function including memory following CPAP treatment.

  • A randomised stepped wedge control interventional trial assessing the impact of a novel disease management software module on disease risk factor detection, disease diagnosis rates and disease key management items in the primary care setting.

    Chronic diseases can be burdensome and are often interrelated. Chronic Kidney Disease (CKD), Cardiovascular Disease (CVD) and Type 2 Diabetes Mellitus (T2DM) are a cluster of interrelated chronic diseases sharing cardio-metabolic risk factors including obesity, hypertension and dyslipidaemia. Each are burdensome with around 10% of Australians (1.7 million) showing measured biomedical signs of CKD, an estimated 4.9% (just over 1 million) with diabetes and 22% of adult Australians (3.7 million) reporting that they had 1 or more CVD, including hypertensive disease, stroke, heart failure or heart disease. As many as 1 in 300 of the population have Familial Hypercholesterolemia (FH), the commonest autosomal dominant disorder in the community. Untreated FH can lead to death from coronary heart disease before age 60 while treated patients have a normal life expectancy. CKD, CVD and T2DM are in the top 10 for leading causes of death in Australia. They can have complex causal relationships between them leading to more severe illness and poorer prognosis. For example, CKD and T2DM are strong risk factors for future coronary events and all-cause mortality. With CKD, CVD and T2DM requiring intensive management often over a long period of time the costs to the Australian community and health-care system is immense. They can lead to disability, loss of quality of life and premature death. In 2009, CKD accounted for approximately 2% of total health care expenditure, equivalent to ~ $900 million. In 2008-09 health care costs attributable to heart disease was $2.03 Billion. Diabetes directly costs the health care system approximately $1.7 billion per year, and indirectly, $14 billion per year. It is known that 85% of Australians visit a general practitioner (GP) each year. As such, efforts to increase awareness of chronic diseases and their risk factors amongst GPs as well as providing opportunities for improved screening and management in the general practice setting is essential in combating this growing public health concern. Chronic Disease IMPACT (Chronic Disease early detection and Improved Management in PrimAry Care ProjecT) is an extension of the CKD-EMAP project and an initiative of Western Health, Victoria University the University of Melbourne. It is supported by a legacy grant from the former Macedon Ranges and North Western Melbourne Medicare Local. The Chronic Disease IMPACT project aims to further enhance primary care software to aid detection and management of chronic diseases focussing on CKD, CVD, Heart Failure, T2DM and risk factors such as Familial Hypercholesterolemia

  • Does application of the sepsis scoring system qSOFA and early notification to senior medical staff in a Remote Australian Emergency Department improve the outcomes of patients presenting with sepsis

    In order to validate the sepsis-3 quick Sequential Organ Dysfunction Assessment (qSOFA) score in a remote ED population and setting, it will be compared retrospectively by case note review against the Systemic Inflammatory Response Syndrome (SIRS), Remote Early Warning Score (REWS) and Medical Emergency Warning Score (MEWS) for rates of Intensive Care Unit/High Dependency Unit (ICU/HDU) admission and in-hospital mortality. A prospective introduction of the qSOFA score with and without point of care lactate as an early warning tool at the first point of contact with ASH ED triage and its use as an alert for early senior medical staff involvement, will attempt identify the most efficient way to shorten the time to treatment of patients with severe infections.

  • Comprehensive endoscopic lung cancer staging to optimize radiation planning in patients with locally advanced non-small cell lung cancer

    The primary purpose of this trial is to evaluate whether endoscopic examination of the chest is useful for identifying disease sites in non-small cell lung cancer, which are not visible on standard care PET scans. Who is it for? You may be eligible to participate in this trial if you are aged 18 to 80 years, with known/suspected non-small cell lung cancer (NSCLC) and suspected/known mediastinal metastases (stage III A-B based on mediastinal nodal involvement). Study details All participants enrolled in this trial will receive the endoscopic staging procedure in addition to the standard care PET scan. The endoscopic staging procedure will involve an endoscopy procedure (performed under deep intravenous sedation) where examination of all lymph nodes in the mediastinum will be performed, and sampling of any identified nodes perfomred. The procedure is required on the basis of your PET findings. The procedure lasts 20-30 minutes and is usually performed as a day procedure. The results of the staging procedure will be used to guide planning the dose of radiotherapy received. Researchers will compare the results obtained from the endoscopic staging procedure with the results from the PET scan to evaluate whether the staging procedure may be able to detect additional cancer sites which are not detected on the PET scan. If so, this will improve targeting of radiation treatment in non-small cell lung cancer patients with mediastinal metastases by ensuring that all disease sites receive adequate radiation doses, thereby minimizing the risk of under-treatment and disease recurrence.

  • A pilot study to investigate the impact of a new pharmacy service on new medicine adherence

    Based on a pilot study conducted in England the New Medicines Service (NMS) was introduced under the NHS community pharmacy contract in the UK in October 2011 as an “Advanced Service” to provide support for people newly prescribed a medicine for a chronic condition including: asthma/chronic obstructive pulmonary disease; type 2 diabetes; hypertension; and conditions requiring antiplatelet/anticoagulant therapy. The primary aim of the service is to improve medicines adherence and a randomised controlled trial demonstrated that the service was effective at improving patients’ adherence to their new medicine by 10%. NPS MedicineWise piloted this service to determine how it could be adapted for delivery in Australia and integrated into the workflow of community pharmacy. Evaluation of the pilot demonstrated that implementation in pharmacies across Australia is feasible and that the service was valued by both pharmacists and consumers. Following the successful pilot, this service is now being extended to a larger number of pharmacies. It aims to improve health outcomes by increasing patient adherence to new medicines for chronic conditions. This second phase will explore the ability to scale the service up to a larger number of pharmacies and measure consumer adherence to newly prescribed medicines through a randomised controlled trial.

  • Anticoagulant therapy for cancer-associated blood clots

    The primary purpose of this trial is to evaluate the safety of rivaroxaban for the treatment of thrombosis associated with cancer, in comparison to the standard care treatment with low molecular weight heparin (LMWH). Who is it for? You may be eligible to enroll in this trial if you are aged 18 or over and have active cancer and require therapeutic anticoagulation for a new diagnosis of deep vein thrombosis or pulmonary embolism. The duration of anticoagulant treatment should be for at least 6 months. Study details All participants enrolled in this trial will be randomly allocated (by chance) to receive either treatment with rivaroxaban or treatment as per standard care with LMWH for at least 6 months. Patients can either be enrolled within 72 hours of diagnosis, or at day 30 +/- 2 days. Participants will be assessed six months later for side effects of treatment, including any bleeding which has occurred. It is hoped that the findings from this trial will provide information on whether rivaroxaban is a safe alternative to LMWH for the treatment of cancer-associated thrombosis.

  • A Feasibility Study: A Safety Evaluation of the Gala Airway Treatment System on Patients with Chronic Bronchitis in Australia

    The Gala Therapeutics Airway Treatment System for Chronic Bronchitis in Australia will evaluate the safety and efficacy of the technology in up to 24 adult patients across three sites in Australia, Patients with chronic bronchitis for a minimum of 2 years will be enrolled. Patients with a history of pacemaker / implantable defibrillator and cardiac arrhythmias as well as prior lung surgery, such as lung transplant, LVRS, lung implant/prosthesis, metal stent, valves, coils, bullectomy, segmentectomy, or lobectomy will not be considered for the trial Exception to this is patients who have had a valve removed greater than 30 days prior to being enrolled in the trial provided that the airway is sufficiently accessible for the Gala treatment.. The trial is single arm / non randomised (it is intended that each patient enrolled in the trial will receive the treatment under investigation) and is non blinded (patients and clinicians will be aware that the treatment is being delivered). The trial will subject consented participants to treatment by the Gala Therapeutics Airway Treatment system over 2 bronchoscopies that will be performed by trained respiratory physicians (interventional pulmonologists) in tertiary teaching hospitals. Patients will be anaesthetised for these procedures. A third bronchoscopy will be performed in order to take airway biopsies to assess the effect of the treatment on the cells that produce mucous in the airways. Subjects will also be required to undertake several tests during the study including 2 CT scans (Lung), respiratory function tests, exercise testing and blood tests. Subjects will be followed for 1 year following the second bronchoscopy.

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