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Is moderate intensity cardiovascular fitness training in addition to usual care feasible following stroke? A pilot randomized controlled trial.
This project is a pilot randomised controlled trial. The main aim is to test whether it is possible to recruit and follow trial procedures in addition to working out how much benefit may come from the treatment in order to make sure enough participants are recruited for a future large randomised controlled trial. The main hypothesis is that adding cardiovascular (or fitness) training to normal rehabilitation in people who have had a stroke will be possible to do and safe for the patient. The next aim is to test the effect of the fitness training on cardiovascular fitness, walking speed and endurance; quality of life (QOL) and depression. The objective of the future randomised controlled trial will be to determine whether the moderate-intensity CV training program significantly improves the defined outcomes compared to ‘usual’ rehabilitation care. The trial will be run in an outpatient rehabilitation service of a tertiary public hospital in metropolitan Melbourne. People will be eligible to be in the trial if they have been diagnosed with a stroke more than six weeks prior; are over 18 years old; able to walk by themselves with or without a gait aid or supervision of another person; and do not have medical or other limitations to exercise. Participants currently taking medications that may affect heart rate response to exercise will be included in the trial. 20 people will be selected to receive either the treatment or normal care. People measuring outcomes won't know which group the patient is in. All participants will be tested for fitness (VO2 peak); walking speed; and quality of life and depression. The treatment group will receive two supervised sessions of moderate-intensity fitness training each week for twelve weeks. Exercise will commence at 10 minutes, and progress incrementally, as tolerated, to 30 mintues duration, prior to progression of exercise intensity. Progression of duration and intensity will be determined by trained physiotherapists, using the Karvonen method (ACSM 2010). People will either exercise with a recumbent or standard stationary bike, treadmill, stepper or cross-trainer. Participants currently taking heart rate control medications will utilise a scale of how hard they are working to monitor exercise intensity. A home exercise program of CV training will be prescribed, and gradually increased in frequency. People should progress to doing a total of 150 minutes of CV exercise in weeks 9-12 of the trial, as recommended by the NHF guidelines for aerobic exercise (Briffa et al 2006). People assigned to the usual rehab group will receive two sessions per week of a light strengthening and balance exercise program. These participants will have heart rate monitoring at five-minute intervals to maintain low-intensity exercise. Session length will be progressed from 10 minutes for 4 weeks, to 20 minutes for 4 weeks, and 30 minutes for final 4 weeks. A general home exercise program will also be given to this group.
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Assessment of radiation dose reduction and image quality of single acquisition, two contrast-injection computed tomography chest/abdomen/pelvis scans compared to the standard two phase imaging protocol for disease staging of oncology patients.
The aim of this research is to determine the way to obtain the best possible images of the chest, abdomen, and pelvis with Computed Tomography (CT) that delivers the lowest amount of radiation to patients. We will be comparing the standard way we take images to a new protocol (protocol means the way the images are taken). The standard CT protocol of the chest, abdomen and pelvis is done in two steps, the chest and abdomen is scanned followed by the lower part of the abdomen and the pelvis. This results in a part of the abdomen being scanned twice. The new protocol that we would like to test takes all the images in one step, from the chest to the pelvis with no overlap. This is why the amount of radiation used can be reduced. The image quality of your CT using the new protocol will be compared to the image quality of the CT which was done with the standard protocol. If the image quality of this research protocol is deemed optimal, it may be adopted as the standard way of performing CT of the chest, abdomen and pelvis.
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A Prospective Study on Warfarin Management Post Heart Valve Replacement or Heart Valve Repair Surgery
Patients undergoing surgery for mechanical heart valve replacement require post-operative anticoagulation with warfarin as they are at a higher risk of thrombosis and clot formation. To monitor for therapeutic or optimal anticoagulation status, the extent of blood-thinning is measured by a blood test called the International Normalised Ratio (INR). Depending on the type of heart valve surgery, there are two distinct recommended therapeutic INR ranges, either from 2 to 2.5 for patients receiving mechanical aortic valve replacement, or 3 to 3.5 for patients receiving mechanical mitral valve replacement. There are two issues with post-mechanical valve surgery patients that distinguish them with respect to warfarin management: (1) Their immediate post-operative warfarin sensitivity is about 50% higher than normal; (2) This increased sensitivity to warfarin returns slowly to normal over the 12 week post-operative period. Using the current empirical dosing method, that is, dosing by the prescriber using his/her clinical judgement, some patients require up to 3 weeks monitoring, when the average for attaining a stable therapeutic INR in patients other than post heart valve surgery with warfarin is less than 1 week, using the current, proven initiation protocols. We therefore propose that two revised age-adjusted, warfarin management protocols be used, specifically designed to meet the needs of the post-mechanical aortic and mitral heart valve surgery patients. These protocols, designed to cover the 12 weeks post-surgery period, will include the first four days of warfarin dosing not previously discussed by Meijer, where we will reduce warfarin dosing by 30% for patients receiving a mechanical aortic valve replacement, so as to achieve an INR range of 2 to 2.5, and reduce warfarin dosing by 25% for patients receiving a mechanical mitral valve replacement so as to achieve an INR of 3 to 3.5. Then from day 5, if the optimal anticoagulation status or therapeutic INR has reached a relative degree of steady-state or stability, we have added to the protocols the incremental dose adjustment approach described by Meijer et al., whereby dosing is adjusted up or down on a percentage basis depending on the INR. For patients not in the therapeutic INR range by day 5, empirical dosing will be recommended until INR steady state is achieved before the incremental dose adjustment approach as defined by Meijer et al, is applied.
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Communication with Families regarding Organ and Tissue Donation after Death in Intensive Care study
The overarching aim of this study is to examine the process of organ donation decision-making and to determine whether changes in requesting practices may effect changes in consent for donation, and family-based outcomes. This study uses a single arm design with current ‘controls’ to explore an intervention, the procedure for providing information and requesting consent for donation, that uses new agreed best practice procedures led by specially trained intensive care health professionals. Discussing the possibility of organ donation with families of patients who are potential organ and/or tissue donors is usual care by staff in the intensive care unit. The study intervention is a staff education and training module intended to provide a framework and preparation for select critical care staff to conduct organ donation discussions in line with best practice. Donation decision-making processes will be compared before (‘control’) and after (‘intervention’) staff have received this training. In addition to standard bereavement follow-up provided by the hospital, senior next of kin who declined donation will be offered bereavement aftercare provided by the NSW Organ and Tissue Donation Service. This longer term bereavement support is usual care for those who agreed to donation and will be offered to those who declined donation. Evaluation of the intervention will include audit data on adherence to core elements of the requesting process. Critical care staff will be asked to complete a form to record details of request conversations and procedures. Clinical and administrative data will be collected from databases and paper records. Senior next of kin who agreed to bereavement aftercare will be invited to participate in a structured telephone interview 90 days post bereavement to evaluate their perceptions of their donation decision, and to provide some personal information. A sample of 400 potential donation scenarios are possible over the intervention study period from approximately 10 NSW hospitals.
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Clinical features, patterns of care and outcome of children with empyema: A retrospective review at a Regional Tropical Hospital
Pneumonia, an infection of the lung, is a common reason for admission to hospital, and worldwide is still the leading cause of mortality in children under 5 years. Relatively rarely, a complication of this is infected fluid surrounding the lung, termed an empyema. Empyemas are very rare in metropolitan areas, but anecdotally are more common in rural and remote regions. This is currently unreported. This audit will help us to find out exactly how many children are at risk, and which mode of management appears to confer the shortest hospital stay and with minimal complications.
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Outcomes 7 to 10 years following total hip replacement
At 7-10 years after total hip replacement, this study will determine the incidence of bone loss around a primary total hip prosthesis with a metal head and polyethylene liner, as determined by CT, as well as the wear of the polyethylene and the movement of the acetabular cup, as determined by plain radiographs. The study will also examine the incidence of dislocation and other symptoms of hip instability, as well as the reasons for revision or re-operation. In addition, the study will show if there are any differences in these outcomes between prostheses with standard 28 mm and large 36 mm femoral heads.
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Assessing normal bowel function and impact of bowel care medications in children in an intensive care setting
Aims: We would like to describe what the normal bowel function is in severely unwell children who are managed in our intensive care unit. Our current management protocol is based on that from the Royal Children's Hospital, Brisbane, and we want to investigate the effectiveness, or not, of this protocol in our population. We hypothesise that it is normal for the gut to behave differently when unwell compared to in good health, and that management strategies may lead to over-treatment and potential longer hospital stay. This is previously unpublished in children's intensive care literature. Research design: This is a prospective, observational study involving no deviation from current treatment received in our unit. This is a pilot study, which may lead on to a larger multi-centre trial to be run by a larger research group, such as ANZICS CTG, which would investigate the effect of non-intervention in those with slower bowel function, rather than escalating intervention. Methods: We will approach all admissions to our unit to be enrolled in this study. Participation will involve no change to management, only completion of the study questionnaire by the researcher every day until hospital discharge. Results will then be analysed prior to publication.
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Chatter Matters Study: Early Language Intervention for Children Admitted for an Extended Stay in Hospital.
Introduction: Children who are hospitalised for an extended time frame are often cared for in a ward environment that does not provide input to promote speech and language development. These children are at an increased risk for language delay. Other barriers to early communication development for children who are hospitalised for a long stay include limited opportunities to develop early language skills and learn to make sounds. Speech Pathology services at the Royal Children’s Hospital are provided in order of priority to the most urgent and severe cases first. This often means that the assessment and treatment of children with feeding and swallowing disorders are prioritised first, and there is little time left to provide early speech and language therapy for children who are hospitalised for a long stay. Early intervention is important to give children the best chance of developing speech and language skills. It is important for Speech Pathologists to use their time wisely when providing services to children on the wards, so a new model of providing language therapy has been developed. Group therapy and parent education sessions will be trialled to see how beneficial they are for parents and children. Aims: This project aims to compare the usefulness of individual speech-language therapy with group therapy for children who are hospitalised for an extended stay (longer than 5 weeks). Specifically the aims are: (a) To trial a new group speech-language therapy model for young children admitted to hospital for a long stay. This will be compared individual speech-language therapy. (b) To provide parents of children admitted to hospital for a long stay with strategies and support to encourage their child’s speech and language development. Methods: Two groups of participants will be invited to be involved in this study: approximately 34 infants who are admitted to the Royal Children’s Hospital for a long stay (5+ weeks) and referred to the Allied Health Infant Team or the Speech Pathology Department. After consent has been gained, both groups will be asked to complete an age appropriate communication screen (including assessments of early language skills, receptive and expressive language and early speech sound production). Parent’s interaction style with their child will be formally measured and parents will be asked to complete a survey about how confident they are in encouraging their child’s early speech and language development. After initial assessment, children on the general medical ward will be allocated to participate in group speech-language therapy. Children who are from other wards will be provided with individual speech-language therapy because they will be unable to freely mix with other patients due to infection control rules. Each group will receive 5 weeks of therapy 2 x a week. After the therapy, children’s speech and language will be assessed again, using the same tests as before. Parent’s interaction style with their child will be formally measured again and parents will be asked to complete a survey about how confident they are in encouraging their child’s early language development and how beneficial they found the therapy.
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'Test, Treat ANd GO': a trial of point-of-care testing for sexually transmitted infections (STIs) in remote Aboriginal communities.
Many remote Aboriginal communities experience high rates of curable sexually transmitted infections, with chlamydia and gonorrhoea being of particular importance. Untreated infection can lead to pelvic inflammatory disease and, over longer time periods, infertility, as well as increasing the potential for further transmission to sexual partners. Early diagnosis and timely treatment of STIs are therefore important from both a clinical and public health perspective. In many remote communities there may be considerable time, sometimes a month or more, between testing for STIs and the provision of treatment, primarily as a result of the time taken to transport and process specimens for routine testing at central laboratories. Once results are available and communicated back to the health centre, there may be further delays resulting from difficulty locating and recalling patients with infection back to the clinic for treatment. Point-of-care (POC) tests are simple to use and are able to provide a diagnostic result using routinely collected specimens while a patient waits. For chlamydia and gonorrhoea this type of test could help reduce the time to treatment by providing test results in the clinic, soon after the sample is collected from the patient, ensuring that those with infection are treated promptly. Such tests could potentially result in great improvements in the management and control of these infections. Point-of-care tests for a variety of illnesses have been used widely in other countries, but have had limited use to date in Australia. This project, the first of its kind in Australia- will trial the addition of POC testing to standard diagnostic procedures in remote communities. Health services in SA,WA and QLD will be recruited to participate in the trial. During the study, each health service will clinically manage chlamydia and gonorrhoea using two different approaches for one year each. In the first year, half of the health services will be randomly assigned to manage these infections under current guidelines (standard practice phase), and the other half will supplement standard guidelines with POC testing (POC phase), such that treatment is offered at the time of diagnosis for those found to be positive by the POC test. In the second year, the health services will cross over to the opposite management approach. The overall aim of the TTANGO trial will be to see whether POC tests reduce the time to treatment, increase uptake of partner notifications and reduce the percentage of young people re-infected with chlamydia or gonorrhoea in remote communities in WA, SA and QLD. We will also examine the cost-effectiveness and cultural and operational acceptability of POC testing in remote health services.
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The effect of routine pantoprazole administration when compared to placebo on gastrointestinal bleeding, ventilator-associated pneumonia and Clostridium difficile infection in enterally-fed mechanically ventilated critically ill patients: A prospective randomised study
To evaluate whether routine administration of proton pump inhibitor (intravenous pantoprazole) to mechanically-ventilated critically ill patients: (1) Reduces the incidence and severity of gastrointestinal bleeding; and (2) Increases the incidence of ventilator-associated pneumonia and/or Clostridium difficile infection