ANZCTR search results

The proportion of elderly patients presenting to intensive care units following complex surgery or life threatening medical illness requiring mechanical ventilation, cardiovascular and other organ support is rising. More than 180,000 patients are admitted to intensive care units in Australia every year. More than 50% are over the age of 65. The SPICE III study, evaluated the use of early dexmedetomidine (DEX) as primary sedative agent in ventilated critically ill patients compared with usual care. In a pre-specified subgroup analysis, SPICE III found a significant interaction between age and DEX treatment on 90-day mortality with a significant reduction of mortality in mechanically ventilated adults older than the cohort median age of 63.7 yrs. These compelling findings, need to be urgently confirmed because their confirmation will change the practice of sedation in older adults worldwide. Accordingly, we will conduct a complementary multicentre randomised controlled trial in ventilated patients, who are older than 65 years, and expected to remain ventilated for longer than 24 hours. Patients will be randomised to receive DEX infusion started at 1 µg/kg/h or Usual-Care and titrated to target Richmond Agitation Sedation Score of -1 to +1. The primary outcome will be 90-day mortality. A sample size of 3500 will be recruited to detect a 5% reduction in mortality (baseline 37%). Such a cohort will then be merged into a harmonised individual patient based meta-analysis with the 1834 patients of > 63 years of age randomized in the recently completed SPICE III study to provide the most efficient and robust (90% power to detect 4.4% difference) assessment of the effect of dexmedetomidine on mortality in older ventilated adults to date, transform sedation practice, and save thousands of lives in Australia and worldwide.

This study aims to evaluate the validity of a pain psychology therapy delivered by virtual reality to volunteers, by measuring metrics of presence and factual information recall. Who is it for? You may be eligible for this study if you are 18 years or older, healthy without acute or chronic pain Study details: Participants will be randomly allocated (50/50 chance) to either the intervention group or control group. The intervention group will receive 2 x 30 min modules of VR-delivered pain therapy. This will be done in one session totaling 70 minutes - 30 minutes for one module, 10 minutes rest break and 30 minutes for the other module. The pain therapy program is self-contained and consists of 2 modules: (1) Progressive muscle relaxation (2) Guided pain visualisation Participants will be required to answer questionnaires about their presence whilst using the VR hardware immediately after the session is complete. They will also be asked to complete a set of multiple choice questions designed to test information recall immediately after the session and also 2 weeks after the session. It is hoped that this validation study will strengthen the evidence base for clinical use of the VR-delivered therapy.

Non-invasive, continuous positive airway pressure (CPAP) immediately after birth of a very preterm infant (“VPTI,” <32 weeks’ gestational age at birth) is currently recommended as the standard of care during the stabilisation of preterm infants following birth. After birth, the infant must rapidly transition from a fluid filled lung, and dependence on the placenta for oxygenation and the elimination of carbon dioxide, to an aerated lung that successfully exchanges gases. CPAP supports the transition from fetal to newborn physiology by providing a distending pressure to the lung, thus maintaining a functional residual capacity (FRC) and enabling oxygenation and ventilation. Preterm infants who are successfully managed with CPAP versus mechanical ventilation via an endotracheal tube have increased survival without chronic lung disease, which improves long-term neurodevelopmental outcomes. Caffeine, and minimally invasive surfactant therapy (MIST) are other key treatments after admission to the NICU to avoid intubation and mechanical ventilation. Following stabilisation on CPAP, caffeine and MIST may be administered to further optimise respiratory support and reduce the risk of requiring intubation and mechanical ventilation, ultimately reducing the incidence of death and chronic lung disease in our patients. 97% of VPTIs at Monash require respiratory support to facilitate stabilisation. Current neonatal resuscitation training programs advocate a trial of CPAP via a facemask that covers the infant’s nose and mouth. An adequate seal is difficult to achieve and the use of a facemask has the additional adverse effect of high compressive forces being applied to the infant’s face and head during resuscitation regardless of which brand of facemask is used, and even with the use of adjunct respiratory monitoring. Ninety percent of VPTIs will initiate spontaneous breathing by 1 minute after birth. Despite VPTIs commonly having a good respiratory drive, respiratory support is nearly always indicated because of respiratory distress syndrome caused by the immature lungs. In this situation, facemask CPAP has a high failure rate due to stimulation of the trigeminal nerves which cause apnea, bradycardia, and hypoxia. Our multidisciplinary team has over a year of experience with nasal CPAP at birth and we have equipoise between providing initial respiratory support in the delivery room with nasal CPAP versus facemask CPAP. We believe that nasal CPAP may be a more effective method of supporting the VPTI than facemask CPAP, specifically maintaining adequate spontaneous breathing and reducing the need for PPV, supplemental oxygen, and intubation in the delivery room. We believe a randomised controlled trial is warranted to test this hypothesis, in order to improve outcomes for high-risk, preterm infants, inform local practice, and provide critically important evidence to the global neonatal community.

Chronic obstructive pulmonary disease (COPD) is a systemic disease linked with a multitude of extrapulmonary manifestations, including low bone mineral density (BMD). The prevalence of low BMD in people with COPD is significantly higher when compared with the general population. Studies have also demonstrated that people with COPD have impaired balance, an increased risk of falls and higher mortality rates following falls-related fractures. These factors highlight the need to prevent and manage the loss of BMD in this population. Optimal management of treatable-traits (i.e. extrapulmonary manifestations) is now widely recognised as a priority for people with COPD. To date, there are no guidelines for the maintenance and management of BMD in this population. Thus, there is an urgent need to explore strategies that can optimise BMD in people with COPD. In addition, interventions to address impairments in balance and falls risk must also be considered. Impact loading training has been identified as an intervention that improves or maintains BMD in both post-menopausal women and men with prostate cancer undergoing androgen deprivation therapy. Exercise prescription in people with COPD has largely been focused on aerobic and resistance exercise, offered within the framework of a pulmonary rehabilitation program (PRP). Currently, impact loading training is not part of PRP and there are no clinical guidelines for this type of exercise in this population. This study aims to i) investigate the feasibility and tolerance of adding impact loading training to a standard PRP and (ii) estimate the effects of adding impact loading training to a standard PRP on bone health, balance and falls risk.

Recurrent Vulvovaginal Candidiasis (RVVC) is a dermatological and sexual health disorder impacting 5-10% of the female population. The management of RVVC often requires ongoing drug management called maintenance therapy. Even with maintenance regimes, up to 57% of women may experience a relapse of symptoms within 3-6 months of therapy completion. The ongoing and recurrent symptom presentations associated with RVVC have significant impacts on health status and quality of life, as well as pose an economic burden. The proposed trial will assess whether "Intravaginal Combination Therapy of Acetic and Lactic Acid" (ICTALA) is effective and well-tolerated for the prevention of RVVC. ICTALA will be utilised to ultimately provide an intervention that can reduce antimicrobial drug usage and decrease relapse.

The purpose of this study is to test the feasibility and acceptability of a shared-care model involving specialists and GPs for post-radiotherapy treatment cancer follow-up. Who is it for? You may be eligible for this study if you are aged 18 or older, and have completed radiotherapy treatment for breast, prostate or colorectal cancer at least two and a half years ago. Study details Participants in this study will attend a series of post-treatment follow-up appointments with their regular GP who will assess their health and reviews for signs of cancer recurrence. The GP will complete a follow-up review with the patient using a system that is directly linked to the hospital so the radiation oncologist can oversee the results and assess if further medical intervention or support is required. The patient maintains their standard care with their radiation oncologist, with one appointment of 15 minutes. Over the six months, the patient is being offered an additional two review appointments with their general practitioner, 20 to 30 minutes each. As part of the study all participants will be asked to attend two interviews, before and after the study period to discuss how they felt about the shared-care model of cancer follow-up care. It is hoped this research will demonstrate the feasibility and usefulness of the new model of care which could influence future post-treatment cancer care.

This research project is to investigate the feasibility and efficacy of a multi-component exercise program in patients with borderline removable or locally advanced (irremovable) pancreatic cancer receiving preoperative therapy. Who is it for? You may be eligible to join this study if you are aged 18 years or over, have a diagnosis of borderline removable or locally advanced pancreatic cancer, and are scheduled to receive or within four weeks after starting the neoadjuvant chemotherapy. Study details: Eligible participants will be randomly allocated 1:1 to either an intervention group or a usual care control group. The intervention group will undertake supervised exercise training for a maximum period of 6 months along with their neoadjuvant therapy, while participants in the control group will receive usual care and be offered advice on physical activity through a printed exercise booklet. The intervention group will be required to attend two sessions per week for 45-60 minutes/session. In each session, participants will perform 20-30 minutes of resistance training, with the addition of either a maximum of 20 minutes of aerobic exercise or adapted sport-related activities/drills, which will be alternated from session to session. All participants will be closely monitored by the investigator, study clinicians and themselves throughout the intervention period for adverse events and other feasibility variables. In addition, they will undergo assessments at baseline (prior to intervention) and post-intervention (prior to elective surgical resection or at completion/permanent discontinuation of prescribed neoadjuvant therapy) for physiological and psychosocial outcomes as well as for a range of clinical-relevant outcomes. For patients with more than four months of neoadjuvant therapy and potentially distinct treatment modalities (i.e., chemotherapy and chemoradiation), an additional assessment will be scheduled before the alteration of treatment modality (~4 months post-intervention commencement). All participants will be followed-up for 6 months after completion of the post-intervention tests. This study will provide information on the feasibility of the exercise program and its preliminary efficacy in patients with borderline resectable or locally advanced pancreatic cancer receiving preoperative therapy.

There has been growing interest in whether open-label placebo (i.e. placebos given honestly) can improve health outcomes. Some studies have shown that open-label placebo is effective for conditions such as depression and chronic pain. This study aims to test whether open-label placebos can improve insomnia symptoms, compared to conventional placebos and a no-treatment control condition. We are using an innovative trial design, called a multiple cohort randomized controlled trial, to overcome some of the issues with current research into open-label placebos. Using this design, we will also be able to find out how many people with insomnia would accept open-label or conventional (deceptive) placebo treatment.

The study is about comparing two techniques of inserting central venous lines and ports. These are special catheters inserted into a large vein in the neck for the purpose of administration of parenteral nutrition, chemotherapy or administration of other medications. Traditionally, this is performed by open surgery through a cut in the neck to expose the vein. The catheter is tunnelled from the chest up into the neck and inserted into the vein. This will be compared with ultrasound guided insertion. Using ultrasound the vein is identified and a needle inserted into the vein and then a wire threaded through. The tract will be dilated and the catheter passed through a sheath. This is an established technique of central vein access and we have used this at this Hospital for over 3 years now. Safety of this technique is now well established at our Hospital and internationally. There are no prospective studies comparing these two techniques. In children requiring long term treatment, infection and clotting of the vein may happen necessitating change of line and at times there is difficulty with access. We are comparing the two techniques to identify which of these is associated with lesser complications and loss of vein in the long term.

In 2017-18, seasonal allergic rhinitis or hayfever affected about 4.6 million (19%) of Australians. Hayfever manifests in runny and/or blocked nose, and often itchy/sore/swollen eyes, with symptoms greatly impacting the quality of life. Rescue medication such as anti-histamines are often needed to restore function, but may trigger some other unwanted side effects. Probiotics have been shown to reduce hayfever symptoms in a number of RCTs. In this randomised double-blind placebo-controlled 12-week trial we aim to assess the tolerability and efficacy of the Nutrition-Care Probiotic Formula ‘Seasonal Biotic’ on symptoms, quality of life, and immunological and microbial factors.