ANZCTR search results

This randomised controlled trial (RCT) aims to compare clinical outcomes for patients with severe respiratory distress who receive continuous positive airway pressure (CPAP) in addition to usual care to those who only receive usual care in the pre-hospital setting. CPAP is a central part of treatment for patients with severe respiratory distress in the emergency department (ED) and in hospital. The evidence for the use of CPAP in the pre-hospital setting is weak and studies have measured outcomes such as in-hospital mortality that can be attributed to in-hospital care. Furthermore, there is a paucity of robust studies from pre-hospital settings that do not rely on physician or critical care specialist managed care. Robust studies are essential to demonstrate the benefit of CPAP in the pre-hospital setting before the widespread introduction of the therapy into Australian prehospital clinical practice. The study will be conducted in the Perth metropolitan area. St John Ambulance (SJA-WA) provides all road-based emergency ambulance services in WA. All emergency calls for an ambulance in WA are received by SJA-WA service operations centre located in Perth. Ambulances are staffed by paramedics with advanced life support skills. This study will use dyspnoea scores as a primary outcome. Dyspnoea (respiratory distress) is a highly distressing symptom: patients describe a sensation of air hunger or suffocation. Alleviating suffering from severe breathlessness is a top priority in the care of patients with severe respiratory distress. The American Thoracic Society stress dyspnoea can and should be measured. Dyspnoea scales have been shown to predict hospital admissions, in-hospital mortality and early readmission in acute exacerbations of COPD. As such, dyspnoea scales are an appropriate primary outcome measure for pre-hospital research in patients with respiratory distress. Any pre-hospital study that demonstrates a reduction in patient distress is likely to change ambulance practice in the same way that interventions that reduce pain would be implemented. In summary, severe respiratory distress is a medical emergency. CPAP improves outcomes in patients with severe respiratory distress in the ED and in-hospital setting but there is a paucity of information on the efficacy of CPAP initiated early in the Australian pre-hospital setting. It is incorrect to assume that interventions applied in-hospital have similar efficacy pre-hospital, due to the differences in capacity and capabilities between the two settings. Therapies shown to be efficacious in hospitals need to be evaluated in the pre-hospital setting to ensure their safety and effectiveness prior to introduction. This information is critical to establishing the evidence base underpinning this therapy prior to ambulance services incorporating CPAP as routine clinical practice.

Background and study aims The hip joint has two bones that fit together like a ball in a socket. In some people these bones press against each other and can cause pain called "femororacetabular impingement" (FAI). Parts of the hip called the 'labrum' and 'cartilage' cushion the hip joint and allow the smooth friction-free movement. FAI can injure both the labrum and cartilage and also cause pain. There is good evidence to suggest a link between FAI and the development of premature osteoarthritis of the hip, but we do not know the best treatment for FAI. There has been a rapid increase in the use of keyhole surgery to treat this condition called 'hip arthroscopy'. During hip arthroscopy the patient is put to sleep and the surgeon passes a small telescope and tools into the hip joint through small cuts in the skin. The tools are used to reshape bone around the hip to prevent further impingement. Many patients have already undergone surgery and had improvements in pain and hip function in the short to medium term. However, this research was not compared to conventional care and it is possible that they may have similar levels of improvement without an operation. An alternative treatment option for patients is a course of best conventional care (a structured programme of exercise-based care supervised by a physiotherapist - this has been called personalised hip therapy) aimed at improving the muscle strength and control around the hip joint. There are fewer risks associated with this type of treatment and it is less expensive. We therefore propose a study to find out which of these two treatments is most effective for treating patients with FAI up to 12 months after treatment. Who can participate? The study aims to recruit 140 patients in Australia with hip pain, aged 16 and above. What does the study involve? Patients are randomly allocated to either undergo arthroscopic surgery or receive usual care. Participants will receive their allocated treatment and will then be required to complete some questionnaires at baseline, 6 and 12 months. Participants will be asked about further procedures required for their hip condition at 2 and 3 years following recruitment. At 12 months we will conduct our first analysis to measure the effectiveness of the two treatments. Australian FASHIon study participants will have specialised MRI scans using a contrast agent (gadolinium) used to investigate changes in the hip joint cartilage health. We will ask participants to have these scans when they join the study and after 12 months. Participants at the Melbourne study centres will be asked to attend the gait laboratory at the University of Melbourne where hip range of motion, muscle strength and movement patterns will be assessed. These measures will be taken at baseline and 12 months. An addition subset of 20 participants will be asked to perform some functional tasks with fine wires inserted in their muscles to provide information about their muscle activity.

Conversion disorder is a health condition in which a person experiences problems with moving parts of their body or other nervous system symptoms that can’t be explained by a medical assessment. These symptoms are thought to be due to stress. This project wants to determine if different conversion disorder symptoms are associated with particular patterns of feeling and thinking, and managing stress and relationships. We also want to test whether a breathing technique aimed at reducing stress when practiced for 20 minutes a day for a month leads to greater calmness and a reduction in conversion disorder symptoms A useful treatment for those with Conversion Disorder is regular weekly Psychotherapy for the purpose of understanding a patient’s problems. It does not normally, however, involve specific breathing techniques. This study wants to find out if using the breathing techniques before and potentially during up to 2 years of “talking” psychotherapy makes the psychotherapy more effective in reducing conversion disorder symptoms. We also want to compare the way symptoms and stress change with standard Neurology treatment versus psychotherapy alone or with combined Neurology and psychotherapy treatments.

This study is designed to assess whether Pregabalin is an effective pain medication for patients recovering from shoulder surgery. Pregabalin is a type of medication proven to be effective at treating certain types of pain and it is currently being used by many shoulder surgeons for their patients, however, there is yet to be any published scientific proof that Pregabalin is effective in these patients. This study aims to determine whether this medication is effective for these patients and reduces their overall pain during the period from 5 days before their operation to two weeks after their operation.

Cannabis use disorder is the most common illegal substance use disorder in the general population and demand for assistance from health professionals is increasing internationally (EMCDDA, 2014). Despite this, only a minority of individuals with the disorder seek treatment. Study on the barriers to cannabis treatment has highlighted the importance of providing additional outpatient treatments that are specific to cannabis (Treloar et al., 2007) and delivered to the individual in a way which unwanted contact with other illicit drug users can be avoided (Gates, Copeland, Swift and Martin, 2012). To date no Australian data exists on the efficacy of such a telephone-based intervention with a specific focus on an illicit drug. This study has been funded by the Australian Government Department of Health to examine whether a brief telephone-based counselling service can act as a feasible treatment option for people with problems with their cannabis use. The results from the randomised trial may validate decisions to support the funding of telephone based services or introduce similar services for other illicit drugs.

Oxytocin is a hormone which stimulates the smooth muscle of the uterus, producing rhythmic contractions, towards the end of pregnancy, during labour and after delivery. Synthetic oxytocin is a drug which is given to women in a drip (intravenous infusion) to help start (induce) and continue labour. Synthetic oxytocin is used because it helps establish contractions in a pattern similar to that of normal labour. If a woman has a spontaneous vaginal birth, it is generally the midwife who decides when to stop the synthetic oxytocin infusion after the birth of the baby. However, if she has an assisted vaginal birth (such as a vacuum or forceps birth) or caesarean birth, it may be the obstetrician who decides when to stop the synthetic oxytocin infusion after the birth of the baby. We are investigating the best time for the midwife to stop the synthetic oxytocin infusion after a spontaneous vaginal birth. We want to investigate this topic as there is no current evidence to guide this clinical practice. The primary aim of this study is to determine the proportion of women who have a postpartum haemorrhage, when intravenous oxytocin is ceased at 15, 30 or 60 minutes following completion of the third stage of labour. We hypothesise women who have intrapartum, intravenous oxytocin ceased at 15, 30 or 60 minutes following completion of the third stage of labour will experience the same rates of postpartum haemorrhage. We estimate that a total of 312 participants will need to be recruited to adequately power this study

It is estimated that approximately 80% of major burns involve one or both hands. Occupational therapists have a major role in providing hand and upper limb orthoses and instigating exercise and functional activities when structures are adequately healed. Although there are agreed occupational therapy treatment approaches for patients with upper limb burns, there has been no research into the optimal dose of therapy. This project aims to compare two different doses of inpatient occupational therapy for inpatients with upper limb/hand burns in terms of the impact on hand function, self care and length of stay. We will do this by creating two separate groups of participants (group allocation is based on admission dates); 1 control group (admitted between 1/9/15 and 31/12/15) who have received usual occupational therapy care, which is approximately one x 30 minute session daily. 2 Intervention group (admitted between 1/2/16 and 31/5/16) will receive usual occupational therapy care, plus an additional 30 minutes of daily therapy. Outcomes achieved will then be compared between groups.

Patients who undergo total hip replacement surgery traditionally have long surgical incisions, routine urinary catheters and wound drain tubes. Anesthesia involves 12 hours of oral restriction before and after surgery, a combination of local anesthetic blocks, spinal anaesthesia and sedation or general anesthesia. After surgery, patients have varying degrees of immobilization to avoid the risk of early hip dislocation and opioid pain relief which results in slow recovery and hospital discharge at day 4-6. Enhanced Recovery After Surgery (ERAS) principles for joint replacement surgery involve patient education, less invasive surgery, reduced fasting, regular oral analgesia and early ambulation. These principles are packaged together in a ‘bundle’ individualised for a particular hospital unit to account for local practices and preferences. Most ERAS programs have shown a remarkable improvement in patient recovery after joint replacement as measured by decreased hospital length of stay, improved mobilisation and patient satisfaction, with no increase in complications. This study aims to implement and evaluate a tailored ERAS program at Epworth HealthCare, a large private hospital with patients undergoing one-sided THR surgery by a single surgeon. Patients enrolled in the study will be evaluated from the time they are seen in the hospital preoperatively to discharge and followed up by a telephone call at 6 weeks. WHODAS 2.0 and QoR-15 questionnaires will assess patients’ return to health. The recovery of this group of patients will be compared to the recovery of a group of patients who underwent THR before the ERAS program was implemented.

The primary purpose of this study is to assess the safety and tolerability of combining imatinib (Glivec) with lenalidomide (Revlimid) and to determine whether the combination may improve the likelihood of maintaining a treatment-free remission in the future. Who is it for? You may be eligible to participate in this study if you are aged 18 or over, have been diagnosed with chronic myeloid leukaemia for which imatinib has been prescribed. Patients must have previously had a trial cessation of imatinib and needed to go back on treatment. Patients who may be eligible for this study must have been able to re-achieve and maintain at least 12 months of undetectable or very low levels of leukaemia cells after restarting their treatment with imatinib. Study details? All participants enrolled in this study will receive six months combination therapy of a daily oral dose of 10mg lenalidomide in addition to their existing imatinib medication. After six months, patients will then stop taking imatinib and continue to take the lenalidomide alone for another six months. Patients will then stop taking lenalidomide and enter a monitoring period on no medication which lasts up to two and a half years. If at any point a relapse occurs then imatinib will be re-started, or an alternative therapy if required. Patients will then be followed up for a further three years, giving a total study duration of up to six and a half years. Throughout this period, blood samples will be taken at weekly to six monthly intervals. Patient outcomes will be assessed by evaluating blood samples, bone marrow samples and physical examinations to monitor safety of the drug combination and to monitor disease progression. It is hoped that the findings of this study will provide information regarding the safety and efficacy of lenalidomide in combination with imatinib for improving the chance of chronic myeloid leukaemia patients achieving a treatment-free remission.

This is a first in human study for the DMTS. This study is evaluating a different formulation of dexmedetomidine by determining the bioavailability and pharmacokinetics of dexmedetomidine following a single 3-day application of the DMTS compared with a 24 hour IV infusion of Precedex and assessing the safety and tolerability. This is an open-label, randomized, two-period, cross-over study.