ANZCTR search results

This study aims to examine the efficacy of a training program at the University of Sydney. The training program is run each semester by the Counselling and Psychological Services. It aims to train students to respond effectively to situations where friends or family are experiencing emotional difficulties.

Flexible video fibreoptic bronchoscopy (FOB) is an important component of the airway skills required by doctors in the area of critical care, including anaesthetists, intensive care physicians, and in emergency medicine. Speed and accuracy of performance, as well as causing no trauma to the patient's airway, is essential to secure the airway for adequate oxygenation and ventilation. However, FOB skills are often learnt in an unstructured format by trainees, and clinical exposure is limited by their relative rarity, causing skills decay after initial training. In this study, we are examining if training in FOB skills can be improved based on the innate visuospatial and psychomotor abilities of doctors. Other procedural tasks in medicine, similar in complexity to FOB, have previously been shown to be associated with these cognitive abilities as they influence hand-eye dexterity and motor skills. An educational intervention will be provided to those novices identified with lower visuospatial and psychomotor abilities, to determine if these novices can be brought up to the same level of FOB performance as their higher ability colleagues. This training is based on mental rehearsal of the procedure, which has been used by professional athletes, musicians, and by surgeons where they "practice" the performance in their heads before they actually perform it in real life. This study will recruit doctors rotating into critical care areas where FOB skill is necessary (anaesthesia, intensive care, emergency medicine). Visuospatial and psychomotor ability will be assessed by a standardised test battery. For doctors stratified into the low ability cohort of visuospatial and psychomotor ability, mental imagery training will be provided. FOB performance is measured using an anatomically correct, benchtop manikin of the human airway. Primary endpoint of performance is time taken to successfully perform a FOB task, and secondary endpoint is proficiency as evaluated by blinded assessors using a validated global rating scale.

There will be three treatment groups: Group 1: 15 subjects receive 2 A/Cal Nanopatches delivering a total of 15 mcg of A/Cal Haemagglutinin (HA) protein and 5 subjects receive 2 placebo-coated Nanopatches to the volar forearm Group 2: 15 subjects receive 2 A/Cal Nanopatches delivering a total of 15 mcg of A/Cal HA protein and 5 subjects receive 2 placebo-coated Nanopatches to the deltoid. Group 3: 15 subjects receive intramuscular Fluvax containing 15 mcg of A/Cal HA protein and 5 subjects receive an intramuscular injection of sterile saline. Sentinel Group: The study will begin with sentinel dosing, with 2 subjects (1 active, 1 placebo) from each treatment group, with evaluation to day 7. After 7 days the subjects will be assessed for safety by adverse events, physical exam, vitals and local injection site reactions (halt criteria). In the absence of safety concerns the remainder of the subjects will be enrolled and randomised into the study. Safety assessments include: Blood pressure, aural temperature, heart rate, respiratory rate, biochemistry, haematology, pregnancy testing for females, serology (human immunodeficiency virus (HIV), Hepatitis B and C), adverse event monitoring and local tolerability and pain assessment of the Nanopatch application site and intramuscular injection site. The study is designed to test the hypothesis that Nanopatch application to the skin with a well characterised influenza vaccine antigen (A/California/7/2009 (H1N1)-like) results in comparable safety / local skin reaction to conventional intramuscular vaccination.

The proposed study would investigate the effectiveness of the graphic warning labels currently featured on tobacco products and whether they can be enhanced by adding messages which target self-efficacy. Self-efficacy can be understood as the level of confidence to which a person believes in their own capacity to carry out a given action, despite potentially arising difficulties. Manipulating self-efficacy beliefs and has been observed to enhance the effectiveness of confronting or threatening health messages (‘fear-appeals’), which are often found to backfire. The current tobacco warning labels used in Australia make extensive use of fear-appeals. This study would measure whether sticking self-efficacy messages onto current warning labels (while ensuring the graphic images remain visible) can influence intentions and behaviours observed to be related to quitting smoking among a group of sixty tobacco smokers. A study-provided smartphone would be used to assess perceptions of personal health risks due to smoking, intentions and behaviours several times a day over a three week period. The first week of the study would be a baseline phase in which all participants report their risk perceptions, intentions and behaviours while continuing to smoke from the standard tobacco packaging. The second and third week would be the experimental phase, during which participants would be randomly divided into two groups. The experimental group would smoke from packages with self-efficacy messages attached and the control group would smoke from packages with current warning labels. All participants would continue to report their risk perceptions, intentions and behaviours, allowing researchers to assess changes between the two groups as well as changes within individual participants by comparing the baseline phase to the experimental phase. Participants would visit the laboratory three times during the course of the study: an induction visit at the beginning; a visit at the end of the baseline phase during which randomisation will take place, and a visit at the end of the experimental phase. At each visit they would be required to give a sample of exhaled breath for the measurement of carbon monoxide content. Carbon monoxide levels provide an indication of how much a person smokes and allows researchers to check how reliably participants report their smoking behaviour. Moreover, they will complete a brief assessment of their overall risk perceptions, intention and smoking behaviour during the last week. This will allow us to compare stable measures of the proposed determinants of behaviour with real-time measures. During the final visit, participants will be debriefed and asked to provide feedback. Moreover, at this time, participants in the control group will receive the same set of study-specific labels the experimental group received during the experimental phase, thus they will have access to the same intervention material after the study is completed.

This is an observational trial of functional outcomes and chronic pain after elective shoulder surgery. In this study, we will recruit adult patients admitted for elective shoulder surgery at Kareena Private Hospital. Baseline assessment will occur using the PostopQRS, modified Brief Pain Inventory (mBPI), Pain Catastrophizing Scale (PCS), Constant Shoulder Score (CSS), and the Western Ontario Rotator Cuff (WORC) scales. Major timepoints during follow up is Day 3 post-operative for cognitive recovery, Month 3 and 2 years for chronic pain rates, and shoulder function. The primary outcome is Day 3 cognitive domain recovery as assessed using the PostopQRS tool. The secondary outcomes include: 1. Quality of recovery in the individual and overall recovery PostopQRS domains across all time periods up to Month 3 post-operative, in shoulder surgery patients when stratified by age, duration of surgery, and shoulder pathology. 2. Incidence of chronic post-surgical pain (CPSP) at Month 3, Year 1, and Year 2 post-operative, assessed using the mBPI, when stratified by age, duration of surgery, shoulder pathology, and PCS score It is currently unknown what is the rate of medium to long term recovery after shoulder surgery. Our previous concept of recovery was limited to pain, nausea, and mobility in the first 24 hours, but relatively little is known about how patients recovery after major shoulder surgery over the ensuing weeks to months. This study aims to collect data to shed light into the rates of functional recovery and in particular, whether cognition is affected by anaesthesia. Similarly, the incidence of chronic post-surgical pain after shoulder surgery is relatively unknown. In other types of surgery, CPSP is common and impacts on quality of life, and has negative economic and social costs. As a secondary outcome, CPSP will be measured in this study at 3 months and 2 years post-operatively to determine the frequency of this complication.

The primary purpose of this trial is to evaluate the link between body composition and outcomes in pancreatic cancer. Who is it for? You may be eligible to participate in this study if you are aged 18 or over and have been diagnosed with pancreatic ductal adenocarcinoma within the last month. Study details All participants enrolled in this study will complete a number of assessments including hand grip strength testing, a questionnaire and lung function tests at enrolment and 3 and 6 months later. The researchers will also require access to CT scans which have been collected as a part of your cancer management. It is hoped that the findings from this study will inform researchers on the links between muscle mass and function, and cancer outcomes of chemotherapy toxicity and survival.

We have conducted pilot research in the significance of skin microorganisms in the conversion of AK to squamous cell carcinoma (SCC) in healthy volunteers and wish to compare these data to transplant recipients. Transplant patients, who are required to take immune-supressing drugs, are at a much higher risk of skin cancers than people in the general population. There is a necessity to study the relevance of the skin microbiome in transplant recipients as they are more vulnerable to the conversion of AK to SCC. We seek to compare the microbiome of transplant patients who have been immune-supressed for over 1 year, who have no AKs, many AKs, and those with suspected SCCs. The microbiome will be examined by taking skin swabs from participants and analysed by DNA extraction and microbe culture and isolation. In the case of suspected SCCs, patients will undergo routine care for their recommended removal, and the study team will request a copy of the subsequent pathology report to confirm SCC diagnosis. Who is it for? All participants in the study will need to have been immune-suppressed for over 1 year as a result of a kidney or liver transplant, prior to enrolling in the study. They will also need to be over the age of 40 years old. Participants are divided into three specific groups based on whether they have current SCCs (anywhere on the body) or AKs (on either forearm). Study details: Participants will be recruited during their routine follow up visits with the renal/liver transplant services at Princess Alexandra Hospital. If they consent to take part in the study, the study visit can occur after their follow up visit, or scheduled for a later date. Swabs will be taken from standardised control sites of sun-damaged skin on the patients forearm, SCCs, peri-lesional skin to SCCs and AKs. The swabbing technique has been tested in previous pilot studies. All suspected SCCs will be recommended for routine excision and histology. We will request a copy of the subsequent pathology report to confirm SCC diagnosis. The member of the study team will also record information on demographic, and relevant medical history from the patient. Clinical non-identifiable photographs of patient’s forearms and any SCCs will be taken.

Preterm birth, defined as birth before 37 weeks gestation, affects 22,000 pregnancies (7.5%) in Australia each year. While advances in neonatal care and treatments for preterm babies have greatly increased the chances of survival for even the smallest babies, preterm birth is still the leading cause of newborn death. Babies born before 37 weeks are also at risk for serious health problems including breathing difficulties, feeding problems, jaundice and effects on brain functions. Multiple pregnancy is a major risk factor for preterm birth, with 57% of twins born preterm compared to only 7% of singletons. Furthermore, 12% of twins are born before 32 weeks compared with only 2% of singletons. A short cervix, as measured by transvaginal ultrasound during the second trimester, is a powerful predictor of preterm birth. The risk of preterm delivery increases as the cervix shortens. When cervical length is less than 22 mm, women face a 20% probability of preterm delivery, which increases to 50% when the cervical length is less than 15 mm. Two currently available treatments used to reduce the incidence of preterm delivery in high risk women include the cerclage pessary and progesterone. Both of these interventions have been shown to effectively reduce the incidence of preterm birth in women with a short cervix. However, up until now, no study has directly compared the effectiveness of these two treatment options in women with twins. The purpose of this study is to directly compare the effectiveness of progesterone and cerclage pessaries in preventing preterm birth in women with a short cervix and twin pregnancy. Currently there is no standard treatment for short cervix in twin pregnancies. The standard treatment in singleton pregnancies is to offer progesterone. While the cerclage pessary is not widely used in Australia, it is widely used in Europe. A number of sites in Australia do use the cerclage pessary where they think it will be helpful. This study is similar to a larger one currently being conducted in the Netherlands. We will be watching that study closely to see if any of it’s outcomes inform us regarding the conduct of this study here in South Australia.

This pilot study will evaluate the feasibility and safety of a physical activity program in patients who are newly diagnosed with grade III or IV high grade glioma. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have been newly diagnosed with grade III or IV high grade glioma. Study details Participants will be allocated to the group depending on participants wishes and abilities , Participants in one group will receive a structured physical activity program plus usual medical care, while the other group will receive usual medical care only. The physical activity program includes 3 x [1hr] supervised sessions per week for 7 weeks followed by once weekly support for weeks 8-14. All participants will be assessed for suitability to determine which group they should go into. Results from this pilot study will guide development of future studies on physical activity intervention programs in brain cancer patients.

There is a biologically plausible mechanism to explain why pre-operative cerebral tissue oxygen saturation (ScO2) can be a surrogate measure of underlying cardiopulmonary function. ScO2, as measured by near-infrared spectroscopy, represents a dynamic balance between oxygen delivery and extraction by cerebral tissue. When not physically active, there is a stable rate of cerebral oxygen extraction. When ScO2 is measured in patients who are resting, breathing room air, and without the influence of medications, the ScO2 value is primarily determined by the effectiveness of oxygen delivery by the cardiopulmonary system. Low pre-operative ScO2 is thus an indication of poor cardiopulmonary reserve. This has been demonstrated in studies correlating pre-operative ScO2 values to existing measures of cardiopulmonary function, including left ventricular ejection fraction, pulmonary artery catheter cardiac output, and with cardiopulmonary exercise testing. Subsequent studies in cardiac surgery patients have found that low pre-operative ScO2 is associated with increased risk of death, delirium, and major adverse events. We performed a pilot study which showed that low pre-operative ScO2 below 68% is similarly observed to increase the risk of mortality or major morbidity in major non-cardiac surgery. To confirm these pilot study results, we intend to perform a prospective, double blinded, multicentre observational study on the predictive role of low pre-operative cerebral tissue saturation and major adverse outcomes in elderly, high risk patients undergoing major elective non-cardiac surgery. Aims The primary outcome of this study is to determine if low resting pre-operative ScO2, measured in room air and with oxygen supplementation, is associated with mortality or major morbidity. The secondary outcome of this study is to determine if low resting pre-operative ScO2 is associated with increased risk of post-operative delirium.