ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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32121 results sorted by trial registration date.
  • 20% Human Albumin Solution Fluid Bolus Administration Therapy in Patients after Cardiac Surgery-II

    HAS FLAIR-II is a multi-centre, randomised controlled trial, looking at patients who require fluid bolus therapy (FBT) after cardiac surgery. FBT after cardiac surgery is a common intervention used to correct hypotension +/- optimise cardiac function. There are several types of intravenous fluid used for fluid resuscitation, which are broadly classified into crystalloids and colloids. After cardiac surgery, patients receive a combination of crystalloid and the colloid albumin in the form of 4% albumin. 20% albumin corrects low blood volume more rapidly and requires less volume to do so than crystalloid fluids and 4% albumin, and by doing so reduces the amount of chloride and fluid the body receives. This may avoid harm associated with chloride and large fluid administrations. Participants will be allocated in a 1:1 ratio to either the treatment group (FBT with 20% albumin) or to usual care (FBT with whatever fluid the treating clinicians consider appropriate and no use of 20% albumin in the first 7 days). We will evaluate the duration of vasopressor use in those who received 20% albumin compared to those that received usual care. We plan to enroll 470 patients post cardiac surgery from Intensive Care Units in Australia.

  • Efficacy of a one-week overcoming shyness program

    This pilot study seeks to explore the feasibility of a novel treatment format for social anxiety disorder: online cognitive behavioural therapy delivered in an intensive format across just one week. Outcomes will be compared from pre- to post-treatment. Data will also be examined at one month follow-up.

  • Fundoscopy Use in Neurology Departments and the Utility of SmartPhone photography (FUNDUS)

    Fundoscopy (looking at the back of the eye) offers a non-invasive glimpse of the brain and vasculature. Fundoscopy is therefore a core component of the general physical examination and critical to any neurological exam. Direct fundoscopy is technically challenging and difficult to interpret. This has resulted in a low rate of fundoscopy observed in retrospective studies of hospital inpatients. Neurology patients have an increased likelihood of fundus pathology which could alter their management. Novel fundus imaging technologies are available which minimise the current limitations of fundoscopy. This project will prospectively identify fundoscopic pathology amongst neurology inpatients, and compare practice patterns and diagnostic accuracy of current practice with available novel technologies to detect this pathology. The study aims are to evaluate the current fundoscopy practice in neurology departments, and assess the diagnostic accuracy of this current practice compared with systematic screening with smartphone funduscopy (SF) or portable non-mydriatic fundus photography (NMFP).

  • Effect of different ventilation strategies on patient outcomes post-cardiopulmonary bypass

    We aim to ascertain if there is a correlation between differing ventilation techniques post-CPB and associated post-operative outcomes. We propose to deliver PEEP at pressures that are currently practised (7 cmH2O) and change tidal volumes delivered to these patients. We hypothesise that higher tidal volumes (10ml/kg IBW) with current moderate PEEP settings correlate with reduced use of Continuous Positive Airway Pressure or Non-Invasive Ventilation (CPAP/NIV) post extubation.

  • Comparison between two methods for teaching the procedure of renal biopsy

    Kidney biopsy is an important test to diagnose and monitor many kidney conditions. It is performed with ultrasound to allow continuous vision of the biopsy needle passing into the kidney. This requires the operator to hold the ultrasound probe with one hand whilst manipulating the biopsy needle with the other, which can be difficult for newcomers. A needle guide attached to the ultrasound probe ensures the needle and ultrasound probe are always aligned to provide optimal images of both the kidney and needle simultaneously. Junior doctors will be randomly assigned to perform an ultrasound guided kidney biopsy in a synthetic model, with or without the aid of a needle guide. The impact of the needle guides will be assessed according to safety and adequacy as well as user feedback, to determine which method is superior for teaching this skill to junior doctors.

  • Effect of cash incentives on preoperative nicotine replacement therapy use and smoking cessation before elective surgery.

    Smoking increases the risk of surgical complications such as wound infections and stopping smoking before surgery can reduce this risk, while smokers who remain quit after surgery are likely to have significant health benefits. We are currently conducting a trial where half the smokers on the wait list or offered free mailed nicotine replacement therapy (NRT) plus quitline support at the time they are wait-listed for surgery. Others get standard care (just a leaflet). We have found uptake of the offer at just 30-40%, and not all offer acceptors use the NRT well. The new trial is to see if a small financial incentive for being quit by surgery works with similar effectiveness as offering NRT before surgery. Offerring no NRT, but a small amount of money, could achieve similar quit results without the cost and complexity of mailing packages of NRT. Smokers (10+) per day are randomized at time of going on the elective surgery wait list to one of four groups: (1) standard care, control group (2) no NRT, just $70 cash if quit by surgery, plus some printed information on how to access own NRT from GP or pharmacy. A change was made to increase the incentive to $140 after the study was commenced (after 454 smokers had been randomised, though most had not had day of surgery data collection due to COVID related delays in elective surgery). The increased incentive applied only to those newly randomised (not the 454 randomised at the $70 level), with a plan to compare the offer uptake (Percentage saying yes to accept the challenge of quiting before surgery and potentially receive the gift) at the $70 level with the $140 level. To prove being quit on day of surgery, smokers claiming to have quit must have <8 parts per million carbon dioxide on breath testing. The study will determine if adding a cash incentive improves quitting, and whether it is a feasible approach for a healthcare service for preoperative smoking reduction

  • Do ankle braces affect functional performance?

    Ankle braces have been proven to prevent ankle sprain, in both people who have never sprained an ankle and those who are recurrent sprainers (Doherty et al, 2017). The downside is that braces affect the mobility of the foot as they restrict all joints they pass over, and so often affect performance in activities such as walking, jumping and hopping (Doherty et al, 2017). This is of concern as braces are often applied in potential ankle spraining situations, such as sport, where performance should be optimal. To address this issue, the KISS® ankle brace was designed to allow unrestricted ankle and foot joint movement within normal ranges, whilst supporting the subtalar joint and restricting only end-range joint motion. To date, there are no studies investigating whether this claim is true. Thus, the aim of this study is to investigate whether the KISS® ankle brace maintains functional performance, immediately after application and after a period of adaption to the brace, compared with a standard brace condition. Additionally, to identify whether the KISS® ankle brace achieves the aim of being easy to apply, light weight, comfortable, and unnoticeable during activity.

  • A smartphone-and Internet-based app to allow for the remote management of patients with a diagnosis of gestational diabetes.

    Gestational Diabetes mellitus (GDM) is becoming more common in Australia, affecting thousands of pregnant women. Between 12% and 14% of pregnant women will develop GDM, with diagnosis usually occurring around the 24th to 28th week of pregnancy. Scientific evidence shows that controlling glucose levels can result in reduced risk of foetal complications (such as macrosomia) and increased maternal quality of life. However, due to increasing rates, and earlier diagnosis of GDM, and a number of systemic (associated increased health care costs, finite economic and staffing resources;) and patient barriers (non-adherence to blood glucose level (BGL) testing as per clinical guidelines; inconvenience in attending clinic visits), impediments to optimal maternal health exist. The project aims to evaluate the real-world implementation of a smartphone- and Internet-based interactive system (called M?THer) to support women with diagnosis of GDM. The project will evaluate the adoption and acceptability of the platform, as well as the impact of using the system on service delivery. The project will implement and evaluate a previously piloted and enhanced M?THer system at Metro South Health Antenatal Services (including Redland, Logan and Beaudesert Hospitals) as well as at the Mater Mother’s Public Hospital.

  • Engage! A pilot study of brief behavioural activation to promote engagement and wellbeing in older adults.

    This pilot program aims to boost wellbeing and engagement among people aged 65 years and older. It supports participants to plan and do personally meaningful and enjoyable activities to lead a more rewarding life. This behavioural activation approach has been demonstrated to help people become happier in studies around the world and is also a very effective treatment for depression. Our goal in this pilot is to test whether a tailored version of this well established wellbeing intervention increases engagement, valued activity, health, and wellbeing in an older adult population.

  • Using a mouth rinse to suppress acute appetite and ad libitum food intake

    Forty healthy adult subjects will be recruited to attend three data collection sessions at the CASS labs at Deakin University Burwood Campus. During any session, participants will be provided with any one mouth rinse in a random order: containing fatty acid (oleic acid 20mM), containing triglyceride (vegetable oil isocaloric to the fatty acid wash; positive control), or containing neither (negative control). They will then return to the lab after 90 minutes for an ad libitum buffet lunch, where they will be able to consume as much or as little food as they like. Food intake will be measured to assess the effect of the mouth rinse on intake. Participants will return to the CASS lab on separate days to complete the same methods, but with the other two remaining mouth rinses (cross-over design). Data will be collected via the researcher weighing food and plates to calculate the exact quantity of food intake. This will be performed in a separate room to the buffet to ensure there is no influence on the participants. Additional measures: • Participants will keep a food record of their intake on the morning of each session. This will be completed using an online tool – ASA24 Australia • Participants will complete satiety questionnaires before and after lunch to ensure they are comfortably full following buffet. These will be completed using an online survey software – Compusense Cloud The aim is to assess the effects of a fatty acid-based mouth rinse on acute appetite and ad libitum food intake. We hypothesise that the fatty acid-based mouth rinse will reduce food intake compared to a control rinse.

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