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The prevalence and impact of postprandial hypotension in elderly survivors of critical illness.
Expand descriptionIn older persons in the community postprandial hypotension (PPH) is an important clinical problem, being a potent predictor of falls, syncope, coronary events and stroke. Furthermore, the presence of PPH is strongly associated with dying independent of other risk factors. Older patients that have survived critical illness and been discharged from hospital have a greater mortality rate compared to younger populations. Older survivors of critical illness also experience a greater reduction in physical function post–ICU when compared to younger survivors. Given the prevalence and impact of PPH in older persons living in the community it is intuitively likely that PPH will occur frequently in survivors of critical illness aged 65 years and older and be associated with adverse outcomes. It is essential to obtain these epidemiological data prior to embarking on a program of work to evaluate potential treatments.
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Evaluating success rates of direct cardioversion for atrial fibrillation in patients with an elevated body mass index: a randomised controlled trial of adhesive patches vs hand-held paddles (DCR-BMI)
Expand descriptionDirect electrical cardioversion (DCR) is an important aspect of atrial fibrillation and/or atrial flutter (AF) management, and is routinely performed to restore normal sinus rhythm. Success rates range from 50 – 93% , depending on left atrial size, AF duration and transthoracic impedance. Total body weight is a key factor in determining transthoracic impedance and therefore cardioversion failure is more frequent in obese patients . In a randomised trial of 201 patients, hand-held paddle electrodes successfully cardioverted 98% patients,compared to 86% with self-adhesive patches (p = 0.001) . This is likely related to the fact that handheld paddles convey a lower transthoracic impedence and hence enable more efficient delivery of energy to the left atrium . The mean body mass index (BMI) in this trial was 28. It is likely that an even greater difference would be observed with paddles in patients with higher BMIs. While a recent large meta-analysis did not demonstrate a difference in cardioversion success rates for different electrode positions / shock vectors (anterior-posterior vs antero-apical, this may not be the case for obese patients. Currently, self-adhesive patches remain more widely utilized in Australian hospitals, due to their ease of use. However with the emerging obesity epidemic, we believe this practice is contributing to an increasing failure of DCR in this patient group. Our study is a multi-centre randomised controlled trial comparing hand-held paddle electrodes and self-adhesive patch electrodes in obese patients (BMI at least 30). We hope to determine whether rates of successful cardioversion for AF are higher in obese patients using hand-held paddle electrodes compared with self-adhesive patch electrodes. We hypothesise that handheld paddle electrodes have a significantly higher efficacy at restoring sinus rhythm in obese patients. Our 2 x 2 design will comprehensively evaluate the best way to cardiovert obese patients (patch vs paddle AND anteroapical vs anteroposterior). Patients will be randomised to one of four arms (2 paddle arms - 1 antero-posterior, 1 antero-apical shock vector & 2 patch arms - 1 antero-posterior, 1 antero-apical shock vector). Cardioversion will proceed until sinus rhythm is restored. Patients in each group will receive up to 2 shocks with the modality they are assigned to (patch or paddle), with the 3rd (final) shock being a cross-over to the alternative modality (patch or paddle). Additional shocks up to 360J may be delivered at the discretion of the clinician, and all patients with failed cardioversions will be offered a referral for an attempted shock up to 360J on a different date. Patients with successful cardioversions will also be contacted at 3 months to determine if they have had a recurrence of AF, and if not, will be asked to have an ECG performed.
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Evaluation of automated control of oxygen therapy in extremely preterm infants: the SCION trial
Expand descriptionThis research proposal seeks funding to conduct a vanguard randomised controlled trial (RCT) of automated control of oxygen therapy in preterm infants <28 weeks gestation in Australian neonatal Units. Our hypothesis is that automated oxygen control using a control device developed by our research team can produce a sustained improvement in time in the desired oxygen saturation (SpO2) target range over many weeks of hospitalisation, reduce blood markers of oxygen toxicity and oxygen debt, and thus have the potential to improve outcome. Background Almost all extremely preterm infants <28 weeks gestation receive supplemental oxygen during their first hospitalisation, with fraction of inspired oxygen (FiO2) titrated to target a preferred SpO2 range. Both hypoxia and hyperoxia are known to be associated with adverse outcomes, including mortality, chronic lung disease, retinopathy and necrotizing enterocolitis. SpO2 targeting is, however, fraught with difficulty, with manual oxygen control targeting the desired SpO2 range less than 50% of the time. Automated oxygen control may offer a solution, and existing control algorithms increase time in target range by around 10% in short term studies. Whether automated control can produce sustained improvements in SpO2 targeting, and do so in all individuals, are unknown. Research Proposal Preterm infants 23+0 to 27+6 weeks gestation (N=180) will be randomly allocated to automated oxygen control, or standard manual control, from early life until 36 weeks post-menstrual age (PMA). Automated control will be applied for as much of the time as possible, and with all manner of respiratory support modalities. FiO2 and SpO2 will be logged continuously, and blood markers of oxygen toxicity and debt examined at days 1, 7, 28 and at 36 weeks PMA. Time in the SpO2 target range (primary outcome), blood markers of oxidation and hypoxia, survival and complications of prematurity will be compared between groups.
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Safety and efficacy of automated targeting of oxygen therapy in premature infants
Expand descriptionMany preterm infants receive supplemental oxygen during their first hospitalisation, with fraction of inspired oxygen (FiO2) titrated to target a preferred oxygen saturation (SpO2) range. Both hypoxia and hyperoxia are known to be associated with adverse outcomes, including mortality, chronic lung disease, retinopathy and necrotizing enterocolitis. SpO2 targeting is, however, fraught with difficulty, with manual oxygen control targeting the desired SpO2 range less than 50% of the time. Automated oxygen control may offer a solution, with existing control algorithms increase time in target range by around 10% in short term studies. We have developed an adaptive and intuitive algorithm (VDL1.1) for automated control of inspired oxygen in the preterm infant, which is to be used in the study outlined in this proposal. A forerunner version of the algorithm (VDL1.0), has been found to be very effective in SpO2 targeting, both in pre-clinical studies using a simulation of oxygenation, and in a 4 hour crossover study in preterm infants. We propose to evaluate the effectiveness of the VDL1.1 algorithm in a 24 hour crossover study under standard clinical conditions. Preterm infants <32 weeks gestation at birth will be eligible if less than 4 months of age, receiving non-invasive respiratory support and showing the need or potential need for supplemental oxygen. In a non-randomised crossover study, a 24 hour period of automated oxygen control will be compared with two flanking 12 hour periods of standard manual control of inspired oxygen (total 24 hours). Additionally, within the 24 hour automated control period the function of the VDL1.1 algorithm with an apnoea-responsive element active or inactive (12 hours each in random order) will be evaluated. Primary outcome for the main study is eupoxia - the proportion of time with oxygen saturation in the desired target range, or above the desired target range when no supplemental oxygen is being administered. Secondary outcomes include i) proportion of time, and episodes of, hypoxia (SpO2 <80%, 80-84%, 85-88%) and hyperoxia (SpO2 >96% and >98%) when in supplemental oxygen; and ii) number of manual FiO2 adjustments per 24 hours. A total of 60 crossover periods will be studied.
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Pectoral nerve blocks and quality of recovery following breast surgery
Expand descriptionOBJECTIVES: To compare patient quality of recovery following breast surgery in those who receive pectoral nerve (Pecs) II blockade versus local anaesthetic infiltration by surgeons. DESIGN, SETTING, PARTICIPANTS: Prospective, triple-masked, randomised controlled trial of 104 female, adult, non-pregnant participants with an allocation ratio of 1:1. This will be conducted at St Vincent’s Hospital Melbourne and Peter MacCallum Cancer Centre. Recruitment of participants is planned from March 2016 to January 2018. Patients, investigators and all staff caring for patients and those making postoperative assessments will be blinded to group allocation. INTERVENTIONS: Patients will receive: a) Pecs II block and placebo surgical infiltration or b) Placebo Pecs II block and local anaesthetic surgical infiltration. Both will receive a standardised general anaesthetic and multimodal analgesia technique. MAIN OUTCOME MEASURES: The primary outcome measure will be patient quality of recovery (QoR) using the QoR-15 questionnaire at 24 hours. Secondary outcomes include assessment of pain related physical and functional interference using the Brief Pain Inventory three months post surgery and opioid consumption presented as oral morphine equivalent (OME) in the first 24 hour post-operative period.
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A randomised controlled trial investigating the efficacy of online continuing education for health professionals to improve the management of Chronic Fatigue Syndrome (CFS).
Expand descriptionChronic fatigue syndrome (CFS) is a serious and debilitating illness that affects between 0.2-2.6% of the world’s population (Prins et al, 2006). There is Level One evidence indicating that graded exercise therapy (GET) and cognitive behavioural therapy (CBT) is currently the most effective means to manage CFS (for review see Larun et al, 2015; Prince et al, 2008). Despite GET and CBT being widely acknowledged as best-practice interventions for CFS, the great majority of patients in Australia are not receiving these appropriate evidence-based interventions. Recent studies have demonstrated that the reason for this documented gap between research and practice is largely due to practicing health professionals lacking the knowledge and skills to provide appropriate care. In order to address this lack of knowledge, our group has developed a CFS Treatment Manual and accompanying DVD aimed at providing clinicians with the knowledge and skills required to effectively manage CFS. However, recent studies have documented that seeking to train clinicians simply by providing a manual is ineffective (Wiborg et al, 2014). Other barriers to continuing education of practicing clinicians include the financial expense of courses and the geographical constraints of attending training (McHugh & Barlow, 2010). The proposed study aims to conduct a randomised controlled trial (RCT) to evaluate the efficacy of the eLearning activity in improving clinician knowledge of CFS and their confidence and skills in implementing evidence-based CFS interventions.
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Cannulation Rates in the Emergency Department Intervention Trial
Expand descriptionPeripherally inserted intravenous catheters (PIVC) are commonly used in Emergency Departments, however their use is not without cost or risk. Current literature suggests that a considerable proportion of PIVC placed in the emergency department remain unused, thereby increasing the number of patients who are unnecessarily exposed to the risks of PIVC including increased risk of infection. We will conduct a historically controlled trial that has two major aims. The first is to provide accurate baseline data on PIVC placement and PIVC use in patents in a tertiary emergency department (ED). The second is to assess the effect of an educational campaign on reducing the number of PIVC placed and the number of unused PIVC in ED patients. Within the Department of Emergency Medicine, we will collect data on the number of PIVC placed and used before an educational campaign. We will then run an education campaign that aims to reduce unnecessary PIVC use. We will then collect data on the number of PIVC placed and used one month after the education program to identify whether there has been a reduction in the number of PIVC placed and the number of unused PIVC in patients presenting to the Emergency Department.
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Safety and efficacy of AKP-11 for atopic dermatitis.
Expand descriptionThis is a Phase I study to determine the safety, tolerability and efficacy of topical doses of AKP-11 when administered to participants with atopic dermatitis. AKP-11 is a Sphingosine-1-phosphate receptor 1 (S1P1) agonist, developed by Akaal Pharma PTY LTD. AKP-11 targets the immune activity, inhibits the over-expression of pro-inflammatory cytokines and factors including the inflammation. AKP-11 has been tested in several immune/ inflammatory diseases including psoriasis patients in order to establish its efficacy. The twice daily topical application of 1 g ointment containing 30 mg AKP-11 or matching placebo in up to 21 participants. Participants will be randomized as groups of 2 (AKP-11) and 1 (Placebo). The dosing is proposed for up to 28 days or one week post complete clearance, confirmed by the physician, whichever comes first.
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Safety,tolerability and efficacy of topical AKP-11 for plaque psoriasis
Expand descriptionThis is a Phase II study to determine the safety, tolerability and efficacy of topical doses of AKP-11 when administered to participants with mild to moderate psoriasis. AKP-11 is a Sphingosine-1-phosphate receptor 1 (S1P1) agonist, developed by Akaal Pharma PTY LTD. AKP-11 targets the immune activity, inhibits the over-expression of pro-inflammatory cytokines and factors including the inflammation. AKP-11 has been tested in several immune/ inflammatory diseases including psoriasis patients (Phase I) in order to establish its efficacy. The twice daily topical application of 0.5 g of 3% ointment containing 15 mg AKP-11 or matching placebo in up to 65 participants for 41 days. Participants will be randomized 1 to 1 into 3% AKP-11 and Placebo groups respectively.
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Procedural Sedation in the Emergency Department: Prospective Data Collection
Expand descriptionEmergency Department Procedural Sedation is performed many times each day in Emergency Departments around the country. It is becoming an increasingly important skill in the practice of Emergency Medicine. It allows the performance of procedures (including reduction of fractures and dislocations, suturing of wounds, draining of abscesses etc) which in the absence of sedation would be painful and distressing for patients and or technically more difficult or impossible for Doctors. This sedation is increasingly valuable in health systems which demand more efficient use of resources. Effective, safe procedural sedation offers this by saving operating theatres (which are resource intensive) for more complicated procedures. This study aims to add to the current knowledge base by ongoing data collection on procedural sedation done in the Emergency Department. The actual procedural sedation for the patients in the study period will not be influenced by this study. This study will simply document techniques and outcomes of sedation which is done in the normal practice of Emergency Medicine at our Hospital. Complications of the sedation and the procedure will be recorded.