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A pilot study assessing the effectiveness and safety of patient-controlled sedation during the insertion of a central venous line.
Diagnostic and therapeutic procedures performed in interventional radiology can provoke anxiety and may be painful. Mild sedation with analgesia is administered by the interventional radiologist to calm patient anxiety, reduce unwanted movements and alleviate patient discomfort. Central line placements are common, (including Hickman line placement, tunnelled dialysis catheter placement, injectable port implantation) and intravenous sedation would typically be used for these procedures. The most commonly used drug for sedation in radiology is midazolam, a benzodiazepine. Midazolam has a short half-life of 2-6 hrs, but very powerful anxiolytic (anti-anxiety), amnestic, hypnotic, anticonvulsant, skeletal muscle relaxant, and sedative actions. It is administered at 1 milligram per dose to the desired response, has a 2 minute onset time and duration of 45 to 60 minutes. The most common analgesic used is fentanyl, a short acting opioid that is administered at an incremental dose of 25 micrograms and repeated every 5 minutes to a maximum dose of 100 micrograms. Its onset time is 2-3 minutes and it has a duration time of 30-60 minutes. Midazolam and fentanyl are usually administered concurrently, with 1 milligram midazolam and 25 micrograms fentanyl being the standard single dose. Multiple doses are titrated carefully to achieve and maintain adequate sedation and alleviation of anxiety, while preserving cardio-respiratory function, protective reflexes and the ability to respond appropriately to verbal and/or tactile stimulation. Doses are given incrementally, often starting with a double dose with at least 5 minutes interval before the next dose to allow evaluation of drug effect. Oxygen saturation, blood pressure, heart rate, and respiratory rate are monitored continuously and documented every 10 minutes. Neurological response is also monitored continuously by observing the patients response to command or conversation. Reversal "antidote" agents for these medications are flumazenil and naloxone respectively. The current practice is that the radiologist takes a history from the patient, looking for patient factors that may affect the safety and practice of sedation. These would include patient size, age, prior cardiac and respiratory disease, diabetes, renal failure, obesity, allergies, drug interactions, previous anaesthetic history, and airway issues. There will be assessment of the patient’s level of anxiety and expectation of procedural discomfort. The radiologist will then decide on the appropriateness of midazolam/fentanyl sedation, and choose an initial dose. As the procedure starts, the level of sedation is assessed, and if needed, further aliquots of midazolam/fentanyl are administered at the radiologists’ discretion. Our hypothesis is that this practice has problems in that there is a fear of the effects of oversedation (eg low blood pressure or slower respiratory rate), and this results in many patients being undersedated. The patient may be apprehensive to ask for more sedation and thus their overall experience of the procedure is suboptimal. Based on prior evidence in the literature in other medical settings, we believe that by giving the control of sedation to the patient (within a safe dose and lockout period), that the patient is more likely to seek sedation when required and hence will be at less risk of undersedation. We expect that this will lead to an overall greater experience for the patient. The medical procedure being performed (ie insertion of a tunnelled central line) will not be affected by this study.
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Body composition assessment of children undergoing treatment for cancer
The aim of this study is to validate the Pediatric Oncology Nutrition Assessment Tool against body composition measurements of nutritional status. Once the Tool has been validated it will play an essential part in the overall assessment of pediatric oncology patient in centers throughout Australia and assist in the prevention of severe nutritional problems in pediatric oncology patients. Patients diagnosed with an oncological disease between the ages of 5.00 and 17.99 years will be recruited from the Royal Children’s Hospital. Caregivers will be asked to accompany the patient to the Body Composition Laboratory for approximately an hour and a half period. Firstly, the Paediatric Oncology Assessment Tool will be completed by the investigator. Height, weight, total body potassium, air displacement plethysmography, skinfolds and mid arm circumference measurements will then be taken on all patients. Children and/or parent, may choose to have all or any combination of measurements. All tests performed will be non-invasive, painless and pose no known physical risk to patients.
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The effectiveness of Dialectical Behaviour Skills Group as a school-based wellbeing and prevention program: A feasibility study
High school students from a Sydney school will be recruited to participate in the study. Students will be randomly allocated to either control or intervention condition. The intervention group will receive 10 hours of the intervention over a school term. The intervention is a Dialectical Behaviour Skills Group, which includes training of skills in 4 domains: Mindfulness, Interpersonal Effectiveness, Emotion Regulation, and Distress Tolerance. A large volume of studies have demonstrated the effectiveness of these skills in improving emotion regulation, interpersonal relationships, and wellbeing. It is expected that this evaluation will demonstrate an improvement of wellbeing and decrease in psychopathology symptoms in the intervention group compared to control participants.
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Minimising impairment: A multicentre randomized controlled trial of upper limb orthoses for children with cerebral palsy.
We will use a multicentre, single-blinded, randomised controlled trial (RCT) to evaluate the effectiveness of the provision of a wrist immobilising orthosis on impairment, activity and participation outcomes for children with cerebral palsy. This trial aims to maintain and/or increase range of movement in the wrist thumb and fingers of children aged 5-15 years.
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iWHOTrial (infant Wrist Hand Orthoses Trial): A multicentre randomized controlled trial of rigid wrist hand orthoses for young children with cerebral palsy.
We will use a multicentre, single-blinded, randomised controlled trial (RCT) to evaluate the effectiveness of the provision of a wrist immobilising orthosis on impairment, activity and participation outcomes for young children with cerebral palsy. The trial aims to prevent the occurrence of contracture and deformity in the wrist, fingers and/or thumb in children less than 3 years of age.
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An investigation of the therapeutic effect of electrical impulses with short pulse width on pain relief and quality of the spinal cord stimulation in patients with intractable back and/or leg pain.
Prospective, observational study. Subjects who have inadequate pain relief from their currently implanted conventional spinal cord stimulator (Boston Scientific Corp.) will be evaluated for eligibility in this study. The study aims at investigating alternative programming combinations for these spinal cord devices. The programming algorithms are within the currently approved limits for the device. We hope to reduce the stimulation (paraesthesia) to a level in which it is no longer felt by the patient (subthreshold stimulation) but still provides improved pain relief and prolonged optimal therapy for patients with chronic back and leg pain. The potential outcomes of this project have vast applications in chronic pain patients, where patients will often tolerate side effects such as uncomfortable stimulation sensations, so that their pain may be controlled.
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Efficacy of the Power Sleep Oral Device in the Management of Snoring and Sleep Apnoea
Latest research demonstrates that up to 40 million Americans (17%), and 4 million Australians (17%) suffer from snoring and/or Obstructive Sleep Apnoea (Kryger, Roth, Rement Principles and Pracice of Sleep Medicine, 5th Ed.). Nevertheless, only a small percentage have received treatment (5% in America and less than 1% in Australia; American Society of Sleep Medicine, USA, 2014). Current treatments are costly, time-consuming and difficult to tolerate. The Power Sleep (PS) oral device is a non-customised, self-fitted intra-oral mandibular advancement splint designed to manage snoring and sleep apnoea. This product has the potential to deliver a clinically effective outcome while reducing cost and increasing comfort levels. The current study aims to examine the efficacy and safety of the Power Sleep (PS) oral device in the management of snoring and sleep apnoea. A pre-post test design involving measures at baseline and using the oral device will be employed using approximately 30 participants aged 18-65 with sleep apnoea. It is hypothesized that the Power Sleep (PS) oral device will have a salutatory effect compared to baseline measures on: (a) snoring loudness; (b) snoring frequency; (c) Apnoea Hypopnea Index-REM (AHI-REM); (d) Apnoea Hypopnea Index-Total (AHI-Total); and (e) mean minimum oxygen saturation (min SaO2).
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Better understanding the role of thinking styles and family factors in the treatment of children and adolescents with Obsessive Compulsive Disorder.
The study seeks to further understand the role of thinking styles and family factors in children and adolescents suffering from obsessive compulsive disorder (OCD). The study will achieve this by providing Cognitive Behavioural Treatment to a small number of children with OCD while adopting a session by session tracking method. An approved treatment protocol will be applied by an experienced clinician(s), and a variety of measures will be used each session to allow for a thorough investigation into the relationship between thinking styles and family factors and the nature of OCD symptom change.
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Assessing alcohol use and a brief intervention using the Audit C and the 5As for people with chronic viral Hepatitis B and C: A randomised controlled trial
Alcohol consumption is a foremost determinant for the prognosis of people with chronic viral hepatitis. There are vital benefits in providing assessment and brief intervention for reducing alcohol consumption and associated harms in people attending primary care settings. This randomised controlled trial aims to identify the effectiveness of an evidence based assessment and brief intervention in reducing or stopping harmful alcohol consumption in people with chronic viral hepatitis. Participants will be randomly allocated to three groups: Group1. (assessment and brochure), Group2. (assessment and brief intervention) or Group3. (routine care with no formalised intervention).
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Effect of purple Plum juice on blood pressure in overweight/obese participants.
Metabolic syndrome is characterised by a cluster of cardiovascular risk factors, including central obesity, elevated blood pressure, dyslipidemia (low HDL cholesterol, high triglyceride levels & LDL cholesterol) and elevated plasma glucose levels. Individuals with metabolic syndrome have central obesity and at least one other risk factor to be clinical diagnosed with the syndrome. Metabolic syndrome is an emerging clinical challenge and imperative public health issue. Subjects with metabolic syndrome have a markedly increased risk of cardiovascular mortality. Prunus salicina, Queen Garnet plum (QGP), is a fruit that was naturally bred to have a high anthocyanin and antioxidant content, in a Queensland Government agriculture initiative. Queen Garnet plums showed anti-obesigenic properties. Studies in laboratory animals have shown that treatment with Queen Garnet plum juice improved the unhealthy blood lipid profile caused by a high-carbohydrate, high-fat diet. The primary object for this study is to monitor blood pressure changes with Queen Garnet plum juice. Blood pressure is measured by using an automatic sphygmomanometer for 12 weeks of duration.