ANZCTR search results

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

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32696 results sorted by trial registration date.
  • Optimising shoulder and trunk movement and the ability to conduct daily activities after open heart surgery: A pilot study comparing 2 Physiotherapy treatments.

    Open heart surgery involves a sternotomy, where the breast bone is cut through to open up the chest and expose the heart, resulting in significant soft tissue and bony damage of the chest wall during surgery. The current physiotherapy management of patients post open heart surgery includes a walking program in conjunction with a series of trunk and upper limb exercises, globally referred to as thoracic exercises. This study aims to compare two post operative physiotherapy regimens, one with and one without thoracic exercises, in the acute hospital setting to assess the effect of open heart surgery on a patient’s physical function as well as the available movement of the trunk and shoulders. It is hypothesised that a program including thoracic mobilisation exercises will result in a more favourable outcome. Subjects will be assessed on a range of measures before surgery, and several times after surgery, including prior to discharge, four weeks post discharge and three months post surgery.

  • Randomised comparison of the Ambu® Laryngeal Mask with the Laryngeal Mask Airway UniqueTM during anaesthesia in spontaneously breathing adult patients

    Randomised trial of two supraglottic airway devices by measuring objective outcomes in spontaneously breathing adult patients. Our hypothesis is that there will be no identifiable difference (null hypothesis).

  • Pharmacokinetics of 0.25% levobupivacaine with adrenaline following caudal epidural administration in children

    Brief Synopsis Levobupivacaine, the S(-) enantiomer of racemic bupivacaine, has been shown to be less cardiotoxic than racemic bupivacaine and its R(+) enantiomer while retaining equipotent local anaesthetic properties, and is commonly used by paediatric anaesthetists. The pharmacokinetics of levobupivacaine in children under 2 years of age (1), and of children less than 3 months of age (2) after caudal epidural blockade have been published; pharmacokinetics in children after levobupivacaine administration via lumbar epidural catheter and ilioinguinal nerve block have also been examined (3, 4). Adrenaline is commonly added to local anaesthetic solutions, both to provide a marker of inadvertent intravascular injection of solution, and with the intention to induce vasoconstriction thereby reducing the rate of systemic absorption of local anaesthetic (resulting in both lower peak plasma levels and therefore potential for toxicity, and longer duration of local anaesthetic effect). The pharmacokinetics of levobupivacaine administered with adrenaline have not been examined. We propose a study of the pharmacokinetics of levobupivacaine when administered via the caudal epidural route, with the addition of adrenaline. We plan to enroll 50 subjects up to 18 years of age undergoing elective sub-umbilical surgical procedures for which caudal epidural analgesia is indicated. Subjects will receive 2mg/kg levobupivacaine, as a 0.25% solution with adrenaline 5 mcg/mL (1:200 000), via the caudal route, under general anaesthesia. Peripheral venous blood samples will be taken from a dedicated intravenous catheter inserted at the time of surgery. Up to 5 blood samples per subject will be taken in the period up to six hours post caudal injection. Samples will be assayed for plasma levobupivacaine. Analysis of raw data will use a population, rather than individual, pharmacokinetic model (NONMEM), allowing accurate estimation of population parameters from data taken from a small number of subjects, and allowing inclusion of incomplete sample data from individual subjects (5). Sample timing is not crucial where this form of analysis is used, so proposed sampling times need not be strictly adhered to.

  • The Paediatric Trauma Care Case Management Study

    The aim for the proposed study is to evaluate the effectiveness of a case management approach using senior trauma nurses in providing trauma care services to children who have been moderately or severely injured and hospitalised. We aim to determine the effectiveness of such an approach using a randomised control trial with outcomes of improving clinical information gathering, service quality, and clinician-patient-parent communication and thus patients’ satisfaction. It is hypothesised that the case management approach can achieve twice the clinical information gathered in comparison to the controls. It is further hypothesised that the case management approach can improve both patient and family satisfaction significantly.

  • Non-weight bearing exercise in people with diabetes and foot complications

    We aim to assess whether undertaking a structured, non-weightbearing exercise program over 20 weeks will accelerate healing in people with chronic diabetic foot ulcers. We also aim to assess whether this program improves glycaemic control, body mass index, wound bed substrate and quality of life.

  • Measurement of tissue oxygen to assess healing potential of chronic wounds.

    The study aims to measure skin oxygen tension of skin adjacent to chronic wounds and assess whether low oxygen tension occurs in wounds that have delayed healing. If there is a relationship, this measurement device may be used as a screening tool to identify those people who require additional therapies in order to improve healing rates.

  • A Phase 1 Single-Center, Randomized, Placebo-Controlled, Double-Blind Pilot Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of a Candidate Topical Antimicrobial (NEO101) in the Reduction of Propionibacterium acnes among Healthy Young Adult Men

    This study will evaluate the safety of a new anti-infective gel, and will also measure how well it is tolerated when applied two times a day to the forehead for 28 days.

  • Vietnam Veterans - Real Partners in Health: Does self-management support improve your health?

    This project includes researching the benefits of applying a chronic disease management model to veterans with alcohol use issues. It will assess the effects of increasing self management (the Flinders model of chronic condition self management) for veterans who have alcohol related conditions compared to usual care. Alcohol use has been identified as a significant issue for the veteran community. It is reported that alcohol dependence is one of the four most common mental health disorders among veterans who have an accepted mental health disability. In addition, the level of co-morbidity between alcohol and other health problems among veterans, particularly mental health problems, is high. Methods for increasing self management and positive behaviour change in veterans with alcohol related conditions are needed. This will be a randomised control trial (50:50 randomisation) with measurement of repeated measures of quality of life in 160 patients. VV will be randomized either to Group A (Flinders group) or Group B (usual care group with a waiting list option to have the FM after nine months). a fifteen-month recruitment and intervention phase with a thirteen month follow up phase for between-group comparisons. Recruitment will be through the RGH, general practitioners in the Southern area, community health care centres, Vietnam Veterans Counselling Service (VVCS) and advertised through VV groups. Veterans will either be approached by their health professional or will volunteer themselves after hearing of the study.

  • A comparison of three techniques for analgesia following total knee joint replacement: Continuous femoral nerve block or spinal morphine or a combination.

  • An investigation of current pressure bandage methods for snake bite.

    We think that the bandaging people put in place when someone is bitten by a snake is not stopping that person getting sick. We want to test if this is because of the bandages we use not being very good, or if the first aid is just difficult to put in place correctly. We will test different materials and a different way of bandaging. We know that the bandages need to be tight, but not too tight and we can measure the pressure inside the bandage to see if they are likely to help someone who has been bitten. We can use the measurments we get to judge which method and/or material is easiest to use. Experimentally first aid has been recommended with certain pressures corresponding to the different techniques. For the pressure immobilization method this corresponds to 40-70 mmHg in the upper limb and 55-70mmHg in the lower limb. In the Monash method, pressures greater than 70mmHg were found to be neccessary on all limbs. We believe that if these pressures cannot be achieved then neither can effective bandaging. 1/ We will first do a pilot study on mannequin's and ourselves to work out the standard deviation and spread of the variance between typical bandage applications. This initial study will also allow us to decide what material we would like to compare to crepe (eg. thicker crepe, elastic compression bandage, pantihose). 2/ We will then conduct a study to find out the spread of pressures generated by five separate subpopulations. a. Emergency nursing staff (4 to 6 people) putting a bandage on 6 times each on a leg and arm. b. Ambulance officers (4 to 6 people) putting a bandage on 6 times each on a leg and arm. c. Doctors (4 to 6 people) putting a bandage on 6 times each on a leg and arm. d. Snake handlers (4 to 6 people) putting a bandage on 6 times each on a leg and arm. e. General public (4 to 6 people) putting a bandage on 6 times each on a leg and arm. This group to have never put on a bandage before. 3/ Then once we have calculated the variance within an individual, within groups and between groups and can calculate a sample size we will compare materials in a randomised study. We will test our preferred material against crepe with the help of volunteers who will bandage alternate lower limbs on the same subject with each material, eg. left crepe and right gold standard. 4/ The other trial will compare pressure immobilization to the new Monash method. We will ask health professionals to perform the first aid in the same way as we compared materials. We will measure all pressures to ascertain which is more often correctly applied. 5/ In a small subset of volunteers we will ask them to keep the bandages on for longer while stationary or travelling and will compare the changes in pressure between these two groups. We aim to find out if a better material could be used, or if there is a technique that is easier to put in place, or if extra training improves the application of the current first aid technique.

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