ANZCTR search results

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

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32704 results sorted by trial registration date.
  • Comparison of McCoy and Airtraq Laryngoscopes in Patients with Cervical Spine Immobilisation

    Failure to immobilise the neck during tracheal intubation in patients with cervical spine injuries (CSI) can result in a devastating neurologic outcome. One method to immobilise the neck during laryngoscopy and tracheal intubation is manual in-line neck stabilisation (MILNS). With MILNS, however, it is often more difficult to visualise the larynx using conventional laryngoscopy. Consequently, the application of MILNS may result in failure to secure the airway, which may result in substantial morbidity or even mortality. These issues highlight the need to develop alternative approaches to securing the airway in patients with CSI. The purpose of the proposed study is to compare the performance of the Airtraq and McCoy laryngoscopes for tracheal intubation in patients with cervical spine immobilisation using MILNS. The McCoy laryngoscope, introduced into clinical practice in 1993, is a modification of the standard Macintosh blade. It is a familiar anaesthetic tool with an established place in the airway management of patients with immobilised cervical spines. The Airtraq, in contrast, is a novel intubation device. It is a single-use optical laryngoscope with a number of design features that suggest its utility in the setting of cervical spine immobilisation. A limited amount of research to date has generally supported this proposition. We hypothesise that, in comparison with the McCoy, the Airtraq laryngoscope will be associated with faster intubations of reduced complexity. We intend to test our hypothesis by conducting a randomised, single-blind, controlled clinical trial. All patients will receive a standardised general anaesthetic with routine non-invasive monitoring. The neck will be immobilised using MILNS applied by an experienced assistant. Participants will be randomly assigned to tracheal intubation with either the Airtraq or the McCoy laryngoscope. All intubations will be performed by one of two consultant anaesthetists experienced in the use of both laryngoscopes. The primary outcome measures will be intubation time and the Intubation Difficulty Scale score. Any complications or difficulties will be recorded.

  • Podiatry treatment to improve balance and prevent falls in older people

    The aims of this project are to determine the effectiveness of a multi-factorial podiatry intervention to prevent falls, enhance balance and mobility, and reduce disabling foot pain in older people

  • Randomised controlled trial of multimedia patient education approaches to preventing in-hospital falls – Pre-test survey of education materials.

  • ANTS Trial (Australian Neoadjuvant Therapy Study for Non-small Cell Lung Cancer)

    The primary objective of the study is to estimate the benefit of adding cetuximab to standard chemotherapy, administered prior to surgery. Cetuximab inhibits the Epidermal Growth Factor receptor. Additional objectives are to examine the relationships between various measures of tumour shrinkage and various molecular analyses of normal and cancer tissues. This may provide information on how cetuximab works, and which patients benefit most from the drug, as well as further information on the effects of chemotherapy.

  • A phase II/III study to evaluate the efficacy and safety of MD 920 (Gibberellic Acid and Salt 1:1) in patients with hard to heal chronic venous ulceration

  • A randomised, double blinded, placebo controlled trial of the effect of self administered methoxyflurane using the Penthrox® Inhaler on tolerance of the Computed Tomography (CT) Enteroclysis procedure

  • Dialysate calcium study in alternate night nocturnal haemodialysis

    Elevated calcium phosphate product (Ca x P) is an independent risk factor for vascular calcification and cardiovascular death in the end-stage renal disease (ESRD) population (Block et al, 1998). Conventional haemodialysis (4hrs x 3) may not successfully correct the profound disturbances in calcium and phosphate metabolism of ESRD, characterised by hyperphosphatemia and abnormal serum calcium levels. In general a low calcium dialysate (1.3 mmol/L) is used for patients on conventional haemodialysis in North West Dialysis Service (NWDS), at Monash Medical Centre (MMC) and Geelong Hospital and throughout Australia. The calcium and phosphate balance achieved with Quotidian Nocturnal Haemodialysis (8 hours x 6 days) differs significantly from conventional haemodialysis and is associated with marked improvements in the reduction of elevated serum phosphate levels. An observational study by Lindsay et al demonstrated that patients on quotidian haemodialysis utilising 1.25 mmol/L dialysate calcium exhibited calcium depletion and hypocalcemia thus exacerbating secondary hyperparathyroidism (Lindsay et al, 2003). In the same study they demonstrated that an increase in dialysate calcium concentration was associated with a return of bone alkaline phosphatase levels to baseline and a gradual fall of parathyroid hormone (PTH) levels to target range. In association with the increase in dialysate calcium, the use of activated vitamin D compounds fell. Based on the results of this study, it has been common practice to dialyse all nocturnal haemodialysis patients, regardless of whether they dialyse for 8 hrs x 6 or 8 hrs x 3.5, on higher calcium baths (>1.6 mmol/L). It is not clear however, what should be the optimal calcium bath for patients on 8 x 3.5nights/week, particularly as serum phosphate levels are not as tightly controlled with quotidian haemodialysis, and unlike the 6 nights/week group, many patients still require the use of calcium based phosphate binders. Ideally the optimal calcium bath should be such that the overall Ca x P product is <4mmol2/l2 and the PTH 15-30pmol/l, however the concern is that the use of a higher calcium bath in the alternate night group will lead to relative hypercalcemia and an overall increase in Ca x P. Recent evidence also supports the importance of the pleiotropic effects of Vitamin D in addition to its well-recognised role in bone metabolism. It is conceivable that patients being dialysed with a higher calcium bath may not be able to tolerate the addition of Vitamin D due to the development of hypercalcemia. In order to establish the optimal calcium bath in patients on alternate night haemodialysis, we propose a prospective observational study comparing predefined outcomes using >1.6mmol/L and 1.3mmol/L dialysate calcium.

  • Positive feeding practices and food preferences in very early childhood: an innovative approach to obesity prevention

    One-fifth of Australian children are overweight and at increased risk of becoming overweight adults. This study will evaluate if an intervention to equip parents with the confdence and skills to intitiate and maintain positive early feeding practices can foster healthy food preferences, dietary intakes and eating patterns in young children. The 18-month study will use a randomised controlled design and aims to enrol 830 first time mothers with healthy term infants in Brisbane and Adelaide. The intervention will provide anticipatory guidance via 2x12 week parent education and peer support modules (6 x 1.5hr group sessions), each followed by 6xmonthly maintenance contacts (choice sms/email). The modules will commence at ages 4-7 and 13-16 months to coicide with establishment of solid feeding and development of autonomy and independence. The intervention will be delivered in established community child health clinics in Brisbane and Adelaide. The control group will have self-directed access to usual services provided by local Child Health Clinics. Outcome measures will be assessed at baseline (age 4-7m), 9 m (age 13-16m) and 18 m (final, age 2y) and will include infant food intake and preferences, feeding behaviour and growth and maternal feeding style/practices, parenting efficacy and BMI. Additional co-variate measures include: demographics, maternal mental health, dietary restraint and weight concern, and infant temperament. This study will provide the first Level II evidence for efficacy of a comprehensive, structured intervention to promote positive feeding practices on early childhood intake and food preferences. It is consistent with current community interest in early childhood as the foundation for health and well being and addresses National Research Priority 2: Promoting and maintaining heath – ‘A healthy start to life’ and ‘Preventive health care’.

  • Better outcomes for obese children in general practice: randomized controlled trial of a new shared-care model vs usual care

    Few management options are available to the 200,000 Australian children with established obesity. Paradoxically, whereas speciality obesity clinics improve body mass index (BMI) but are accessible to very few obese children, general practice is universally available - but so far frustratingly ineffectual. We aim to trial an innovative shared-care approach to the management of childhood obesity, drawing together four established lines of research: (i) specialist child obesity approaches that are known to be effective; (ii) positive aspects of our previous child obesity prevention general practice trials; (iii) computerised support and decision assistance in primary care; and (iv) the effectiveness of shared-care approaches. Because all elements are already in place, it has a high degree of feasibility and, we believe, a high chance of success. This trial addresses the urgent need identified in the 2003 NHMRC Clinical Practice Guidelines for the Management of Overweight and Obesity in Children and Adolescents for ‘simple, well-designed intervention studies which can be translated into usual clinical practice’. In the first year, the software support and clinical approaches will be customized and focus-tested. The trial itself will involve approximately 45 general practitioners and 172 obese children aged 3-9 years and their families in the second and third years. Half the children will attend a specialist multidisciplinary obesity session, followed by supported general practice care for 12 months. The other half will be offered usual care. After 12 months, we aim for reductions in BMI, percentage body fat, and waist girth in the shared care compared to the usual care group. We will also conduct an economic evaluation, to understand the costs of the new model, compared with usual care, to government and families against all outcomes at 12 months. If effective, benefits would include increased general practitioner identification of childhood obesity; a shift in focus towards younger obese children (for whom treatment is more effective and secondary prevention of morbidity is still possible); and a replicable, feasible, cost-effective primary care approach to childhood overweight/obesity tailored to the Australian health care system.

  • Comparison of 3 methods of continuous positive airway pressure titration for obstructive sleep apnoea

    The best way of determining a CPAP pressure to control sleep apnoea is not known. We are comparing 3 common methods of determining this pressure and assessing the effect on the compliance with CPAP and response to therapy

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