ANZCTR search results

RCT of vitamin C versus glucosamine to improve ulcer healing in people attending the high-risk foot clinic. The hypothesis is that vitamin C will improve ulcer healing. We also predict that it will be more effective in people with diabetes, and people who are deficient in vitamin C at the beginning of the study.

Fractured neck of femur (#NOF) is a common, painful condition in the elderly for which regional nerve block (RNB) techniques provide effective and safe analgesia. Presently, RNBs are administered by doctors, usually later in the patient journey. RNB via Fascia Iliaca Nerve Block (FIB) has been demonstrated to be safe and effective when administered by trained nurses. We hypothesise that early, nurse-initiated FIB (ENI FIB) can be successfully introduced and sustained within a tertiary level Emergency Department (ED) and can be generalised to a regional ED. We aim to demonstrate that ENI FIB can be delivered to a higher proportion of eligible patients than current practice, is at least equi-analgesic and equivalently safe with standard medical RNB, and can be delivered significantly earlier than medically-initiated RNB. In the preparatory phase, data will be collected regarding current RNB/analgesic therapy whilst a core nurse FIB operator group is trained at RNSH. Subsequently the implementation phase will begin in early 2017 where ENI FIB will be introduced as the preferred RNB for #NOF. Data will be collected regarding enrollment rates, safety, pain levels and times to analgesia. Gosford ED will follow the protocol six months behind RNSH with implementation taking place in May 2017. After twelve months, ENI FIB will be re-evaluated at both sites with respect to embeddedness, safety and effective practice. The Implementation Package will be refined as indicated. Potential benefits are that significantly more patients with #NOF will have access to effective, safe and early pain relief. We aim to demonstrate that this model of care is generalisable to another ED whilst yielding similar positive clinical outcomes. Assuming adoption and sustainability of ENI FIB at both sites, there is potential to roll out a standardised, proven ENI FIB program across a large number of the State’s EDs in an economical fashion, utilising a ‘train the trainer’ model and our refined Implementation Package.

The study will assess the effects of a nutrient supplement (nutraceutical) combination in individuals with treatment-refractory obsessive-compulsive disorder. The study is a 5 month, open-label, multicentre pilot study.

Gut microbiota is highly influenced by environmental factors particularly the diet and its dietary fibre content. Dietary fibre is non-digestible polysaccharide fermented by gut bacteria, subsequently releasing short chain fatty acids, critical for health. Dietary fibre promotes beneficial gut microbiota. However, the potency of different types of fibre to reshape gut microbial population and to boost the release of short chain fatty acids is unknown. While fibre is found in grains and legumes it can be hard to evaluate which type of fibre is present and how much is consumed. The aim of the current study is to test dietary fibre supplements which are affordable and easily quantifiable to determine which type of fibre supplement might be the most beneficial for gut and overall health. 30 women aged between 35-65 years will be recruited. The study will be a randomised open crossover fibre supplementation trial. Each participant will be studied on 3 occasions, such that over the experiment they will receive all 3 fibre supplements in random order. The 3 fibre supplements will include Fibremax (New Image), Vitafiber (Myprotein) and Inulin (Myprotein). Participants will be asked to consume daily the 34g of FibreMax, 15g of Vitafiber or 12g of Inulin supplement per day during the treatment period. Participants will be requested to consume a standardised diet that excludes fibre rich foods (beans, high fibre cereals and bars), dietary supplements, pre and probiotic foods and supplements, antibiotics and anti-inflammatory drugs. Participants will attend an RPA blood collection centre where they will complete 6 x blood collections and the RPA clinic at the Charles Perkins Center on 7 occasions where they will be asked to complete 6 x stool collections and 6 x 4 d food diaries. Participants will first attend a screening interview where they will be asked to complete questionnaires on their medical history, medications, and eating behaviours. Two weeks before the start of the first supplementation period, participants will be asked to consume a standardized diet and will then to undergo 3 x 7 d fibre supplementation periods that will each be separated by 2week washout periods. The blood and stool samples will be used to measure short chain fatty acid levels, microbial diversity in response to dietary fibre supplementation.

This study is to find if one type of expander (a plate) is better at widening the upper jaw of children aged 10-16. The expander will be placed on their top teeth and will be one of the following: 1) Hyrax Expander: this is the common type of expander which requires a separate key to turn. 2) Hybrid-Hyrax Expander: this is the normal expander but it also includes two pins placed in the top of the upper jaw (palate) 3) Keles Expander: this is a new type of expander which has a built-in key to turn the expander. This new type of expander is not yet approved by Therapeutic Goods Administration. Our hypothesis is that the Keles expander will work as equally as effectively as the Hyrax, whereas the Hybrid-Hyrax will be more effective in expanding the jaw due to the use of the two palatal pins. Patients will be recruited at the Sydney Dental Hospital and will be included if they meet the inclusion criteria of having a narrow jaw and in the correct age range. Exclusion criteria include if patients have had previous orthodontic treatment and/or any serious health issues that may impact orthodontic treatment. 60 selected patients will be randomly placed into 3 groups of 20 patients each. Records of patients will be taken before treatment. The appliance will be constructed and installed on each patient. Patients will be taught to turn the expander and will continue expanding until the correct amount of expansion has been achieved. After this, the expander will be locked to prevent further turning and the patient left with the expander in-situ for 6 months to retain the changes in the expanded jaw. The expander is then removed and then new records taking. Patients are then followed up to continue with normal braces treatment as per normal. The records taken of participants will include: questionaires, photos, study casts, 3d photos, and Cone Beam CT images. The data retrieved from these records will be used to assess the dental, skeletal, facial and airyway changes as a result of the expansion. The primary outcome will be to assess the change in angulation of upper first molars relatve to the palate in cross section on Cone Beam CT images. Secondary outcomes include: easability of the difference appliances, airway changes, facial changes and skeletal changes measured on CT images..

The overall objective of this study is to pilot test the feasibility of a community and consumer engagement strategy using design thinking and EBCD methodologies in the healthcare setting. This study aims to invite consumers, carers, healthcare workers and/or visitors to the hospital to attend collaborative workshops and/or the InstaBooth (an interactive booth) to share their experiences and suggestions for improving hand hygiene practices and/or reducing hospital-acquired infections and inform the design of possible solutions to these healthcare problems. After data analysis is completed, one of the possible solutions designed in the collaborative workshops will be implemented at the study site and its impact will be evaluated.

Individuals with a spinal cord injury do not participate in sufficient physical activity to meet the recommended guidelines for good health. To promote physical activity, physical activity interventions are needed. The aim of this study is to evaluate the efficacy of a physical activity promotion intervention for community-dwelling adults with a spinal cord injury who use a wheelchair as their primary means of locomotion. The aim of the intervention is increase physical activity participation. Primary outcomes of this study will be increased amount of physical activity that the participants are conducting during their daily living. The secondary outcomes will be self-efficacy, social support and decisional balance in physical activity and health-related quality of life. The study design will be based on the single-subject research design guidelines for determining sample size and protocol for sampling behaviour (Romeiser Logan, Hickman et al. 2008). Each participant will participate in the study for a total of 40 weeks. The study will be conducted in the home and community environment of the participant. During the 40-week study, participant will be asked to wear two physical activity monitors: the wheelchair mounted device (Wheeleri) and a wrist worn accelerometer which has the look and feel of a wristwatch (ActiGraph GT9X). Participants will also be asked to complete four questionnaires measuring mediators of physical activity participation (including self-efficacy, social support and decisional balance) and measures of health related quality of life. The study protocol comprises 3 phases: baseline phase (8 weeks); intervention phase (16 weeks); and post intervention phase (16 weeks). During the 8-week baseline phase, participant’s physical activity will be monitored while they continue with their normal behaviour in order to determine their baseline level of physical activity. The baseline phase will be followed by a 16-week intervention. The intervention combines a stage-matched lifestyle physical activity intervention, structured exercise prescription and community integration delivered utilising a community-based rehabilitation. During the 16-week intervention period, participants will receive 12 face to face visits of a one hour duration in their own home or local community. In between these sessions they will also receive phone/online support as required (Dunn, Andersen et al. 1998). Session frequency will diminish over the 16-week period, with a reduced number of sessions as a result of an increased emphasis on maintenance of physical activity participation including fostering independence and self-management. The intervention phase will be followed by a 16-week non-contact post intervention period during which physical activity will be monitored in order to determine the extent to which any increases in physically active behaviour achieved during the intervention are maintained.

In the event of a “can’t intubate, can’t oxygenate” (CICO) event during general anaesthesia, front of neck access (FONA) is definitive management. Faster FONA can reduce morbidity and mortality. Localisation of the cricothyroid membrane (CTM) is necessary for successful FONA. It ideally should be performed before induction in every patient, though in some time critical emergencies there is not the opportunity to do this in an elective fashion. Palpation of landmarks to localise the CTM has been shown to be very inaccurate, particularly in women and obese patients. Ultrasound has been shown to be very accurate, although slower. Ultrasound for procedural guidance has been shown to improve the rate of correct cricothyroidotomy device insertions with fewer complications. This study aims to show primarily if a new 2-level transverse airway ultrasonography technique to localise the CTM is quicker than a known 3-level technique. Accuracy of the technique will also be assessed and compared between the techniques. Scanning participants will be randomised to which technique they perform first, and both timing and accuracy observers will be blinded to which technique is performed.

The primary purpose of this trial is to evaluate the feasibility and acceptability of a pre-operative exercise program in people undergoing major pelvic cancer surgery. Who is it for? You may be eligible to enrol in this trial if you are aged 18-80 years and are scheduled to undergo major pelvic cancer surgery. Study details All participants enrolled in this trial will be randomly allocated (by chance) to receive either the exercise program or to receive usual care. Participants allocated to the exercise program will receive a supervised one hour one-on-one exercise session once per week for 2-6 weeks, occurring prior to surgery. They will also be asked to complete the hour-long exercise session at home four days per week in addition to 150 minutes of moderate exercise (walking, cycling, etc.) per week. Following surgery, participants will be asked for their opinion of the exercise program, and some additional tests and questionnaires will also be completed to assess physical activity, strength, complications and other outcomes following surgery. It is hoped that the findings from this trial will provide information on whether the pre-operative exercise program is feasible and acceptable to participants, as well as providing preliminary data on the efficacy of the program for improving health outcomes following major pelvic cancer surgery.

Footwear has the potential to influence balance in either a detrimental or beneficial manner, and is therefore an important consideration in relation to falls prevention. The objective of this study was to evaluate balance ability and gait patterns in older women while wearing prototype footwear and insoles designed to improve balance.