ANZCTR search results

We set out to assess the impact of ondansetron on the incidence of vomiting in children undergoing procedural sedation and analgesia (PSA) with the combination of intranasal fentanyl (INF) and inhaled nitrous oxide (N2O) compared with placebo. We hypothesize that ondansetron can significantly decrease the rate of vomiting associated with the combination of INF and N2O. Currently, there exists no report of any strategy to reduce the occurrence of vomiting in patients receiving INF and N2O. This is a phase III, double-blinded, placebo-controlled superiority trial of ondansetron for prevention of vomiting associated with PSA with the combination of INF and N2O. Participants will be randomized to receive one dose of ondansetron oral syrup (4 mg for patients 15-30 kg; 8 mg for patients >30 kg) or matched placebo during PSA. The treatment period will be limited to the participants’ emergency visit requiring PSA. The follow-up period will be of a maximum of one week (aiming for less than 72 hours) for each individual, ending at the time of the phone follow-up. The primary outcome is to determine if ondansetron decreases the incidence of vomiting during PSA with the combination of INF and N2O in children aged between 3 and less than 18 years compared with placebo. Secondary outcomes are to determine the effect of ondansetron compared with placebo on: a. Number of vomits during PSA b. Vomiting in the PED after PSA d. Vomiting within 24 hours of the start of the procedure c. Retching during PSA d. Procedure duration e. Procedure abandonment f. PSA-associated adverse events during the emergency visit g. To explore parental satisfaction h. To explore value parents put on vomiting

Diet and lifestyle have been identified as the leading modifiable risk factors in chronic disease, of particular relevance considering the cardiovascular burden in chronic kidney disease (CKD). People with CKD identify diet and lifestyle programs for preventing deteriorating kidney function as their highest ranked research priorities. However, dietary change can be considered complex for patients with CKD. Patients are frequently advised on the manipulation of single nutrients, which often conflicts with associated co-morbidities and advice from other health professionals. Evidence from our recent systematic reviews have indicated: healthy eating patterns in CKD are associated with lower risk of mortality; current evidence from clinical trials to support dietary change in CKD are limited. CKD patients prefer a repeated, coaching approach with frequent feedback to support dietary change; and telehealth strategies enhance adherence to dietary change compared with traditional models. This randomised controlled trial aims to determine the feasibility, patient acceptance, and clinical impact of telephone-based contact with additional or standalone tailored text messages compared with usual care to support dietary adherence among patients with chronic kidney disease.

Fatigue occurs in around 50% of individuals post-stroke often co-existing with sleep problems, which contribute to fatigue. Fatigue is further correlated with cognitive and functional disability and is associated with depression, anxiety, pain, sleep disturbance, unemployment and reduced quality of life. Despite this, there has been little empirical investigation into the management of fatigue and sleep disturbance following stroke and no treatments are indicated for use following stroke. Pharmacotherapy is ineffective in the long-term and may cause adverse effects. Graded exercise has shown modest gains in fatigue post-stroke. A review of chronic fatigue syndrome treatment studies concluded graded exercise and CBT were effective, but CBT was more effective where anxiety and depression were also present. To date there have been no controlled trials of CBT addressing fatigue and sleep disturbance following stroke. If successful, CBT for fatigue and sleep will result in reductions in fatigue, improved sleep quality, increased activity levels and thus improved quality of life and functional outcomes.

Babies with low birth weight, thinness or short body length at birth have increased risk of cardiovascular disease and Type 2 Diabetes in adult life. The foetal origins hypothesis suggests that these diseases originate through changes that the foetus makes during pregnancy when it is undernourished. These changes can permanently alter the structure and function of the developing body. Prevention of these diseases may depend on optimising foetal growth and nutrient supply to the foetus. Sleep can alter energy balance. Short sleep (<7 hrs) during pregnancy has been linked to higher rates of caesarean section, preterm birth, intrauterine growth restriction, risk of gestational diabetes mellitus and postnatal depression. No research has examined the relationship between sleep, diet and maternal child weight related outcomes or tested the benefits of increasing sleep opportunity in pregnancy. The aim of this study is to test the benefits of increasing sleep opportunity during pregnancy on maternal glucose tolerance, gestational weight gain and foetal body composition from 12 to 37 weeks gestation in a randomised controlled trial. Pregnant women booked to deliver at the Monash Medical Centre Clayton will be randomised to: (i) Intervention group: night sleep opportunity increased to 10hr time in bed, with tailored advice around sleep practices; or (ii) Control group: normal sleep patterns. After a 1week baseline period, women will be evaluated seven times during pregnancy from 12 weeks gestation (i.e. at 12,18,22,25,28,31 and 37 weeks). Sleep data will be collected using Inhome Electroencephalography Sleep Monitoring. Adherence to the intervention will be monitored through Actigraphy and sleep diaries. Glucose tolerance, gestational weight gain and foetal body composition will be measured at each visit. This is the first RCT to test the effect of increased sleep opportunity in pregnancy. Findings will provide high quality evidence for the effect of sleep in pregnancy on important prenatal predictors of maternal and child obesity, a noval insight into the feasibility of increasing sleep in pregnancy and a cost effective intervention to improve sleep practices.

Cigarette smoking produces inflammation in small airways and development of emphysema in about 20-40% of susceptible individuals. The presence of small airway pathology leads to uneven distribution of ventilation in the lungs as well as excessive airway closure which may produce excessive biomechanical stress leading to further progression of pathology. These changes produce a greater than the normal age-related rate of decline of lung function as measured by the FEV1 and this can lead to the clinical features of COPD. We hypothesise that: 1. The early pathological changes can be identified by tests derived from the multiple breath nitrogen washout (MBNW) and these tests may identify individuals at risk of developing COPD. 2. Bronchodilatation will reduce airway closure and normalise the distribution of ventilation thereby reducing biomechanical stress and may thus lead to reduction in the rate of decline of lung function. The primary objective is to asses the rate of decline of FEV1 during and at the end of a 12 month intervention with or without active study treatment. The secondary objective is to assess the change from baseline in small airway function and ventilation heterogeneity, change in FOT, and the effect of bronchodilators on spirometry, DLCO and BCSS symptoms. The study is a double-blind, placebo controlled, parallel design study comparing: 1. Umeclidinium bromide with vilanterol (Anoro) via the Ellipta dry powder inhalation device at a dose of 62.5mcg/25mcg once daily with 2. Matched placebo once daily A total of 100 participants will be randomised from four centres in NSW, Australia. Subject will attend clinic visits at screening, randomisation, 26 weeks and 52 weeks. Monthly telephone calls will be made to each participant to record adverse events, concomitant medications, adherence to medication and current smoking status. Study measurements will include spirometry pre and post bronchodilator, body plethysmography to measure lung volumes and DLCO, MBNW, FOT and BCSS symptoms. The student t-test will be used to compare the annual rate of decline of the FEV1 between the active treatment and placebo groups. Statistical methods for analysing the secondary outcomes will be by a linear regression model adjusted for baseline measurements if applicable

Synergy-enabled Spanish version of the Mental Health eClinic is a real-time primary care online clinic that offers young people immediate self-report assessment, as well as timely support and programs, via a ‘video-visit’ with a health professional that results in a share plan. By using the Internet, this online clinic aims to deliver best practice clinical services to native Spanish-speaking young people (aged 16 to 30 years) currently living in Australia. Primary objective: To naturalistically evaluate (engagement, efficacy and effectiveness) the MHeC-S. Secondary objectives: To inform the beta build of the MHeC-S (which in turn informs the original version of the MHeC); and, to evaluate social return on investment (SROI) of the MHeC-S. The study design includes three parts: 1. The naturalistic (clinical trial) evaluation wherein potential participants (n=100 young people aged 16 to 30 years; native Spanish speakers currently living in Australia; with regular access to a smartphone [iPhone or Android] and the Internet) will be given access to the MHeC-S to use of their own accord for a period of up to 30 days. Participants are then able to navigate the online clinic at their own accord, naturally engaging with the self-report assessment, dashboard of results, ‘video visit’ and recommended apps, etools and other resources. At two time points (Day 1 and Day 30) participants will be asked to complete a pre/post- questionnaire using LimeSurvey – this questionnaire will include items regarding engagement with, efficacy and effectiveness of, the MHeC-S. 2. One-on-one 90-minute user-testing sessions where young people/ supportive others and health professionals will be invited to test the MHeC-S using scenarios and lists of tasks. (n= 15) 3. A total of four (three-hour) focus groups will be conducted to explore SROI via Theory of Change (including inputs, activity, outputs, outcomes and impacts). Two focus groups will be conducted prior to the naturalistic (clinical trial) evaluation of the MHeC-S – one with young people/ supportive others and one with health professionals; and two focus groups will be conducted post the naturalistic (clinical trial) evaluation of the MHeC-S – one with young people/ supportive others and one with health professionals. (n= 15)

Does the Alexis Wound Retractor increase the risk of conjunctival contamination from blood splashes during surgery? Background: Blood splashes to the face/ eyes are a recognised risk to the surgeon and assistants Alexis retractor is commonly used during laparotomy, laparoscopic operations and caesareans Increase exposure, protect wound, reduce wound infection Concern: blood droplets spraying into the air/ face/ eyes during removal Aim: Assess whether there is an increased risk of blood splashes during operations when the Alexis retractor is used Design: Double blinded randomised trial including all abdominal operations in which Alexis retractor may be used Surgeons and assistants will wear visors Randomised to Alexis or no Alexis End point: number of blood splashes on visors Power calculations 44 in each group Aim to recruit 50 in each group

The central purpose of this research is to examine the feasibility of a self-administered mobile intervention (App) for traumatic stress in humanitarian emergencies. The intervention will be initially examined with African refugees in Australia that meet the clinical or subclinical diagnostic criteria for posttraumatic disorder (PTSD). The App was created as part of this project, and comprises of body stabilization, cognitive mindfulness and interpersonal exercises across seven blocks. Objective electrophysiological and cognitive measures have been selected to predict intervention outcome alongside clinical measures.

This is a prospective, randomised controlled trial designed to investigate the effect of a standardised Tai Chi intervention on psychological stress and cardiovascular function in patients with coronary heart disease and/or hypertension. The primary outcome will be psychosocial status of stress measured by Perceived Stress Scale 10-item (PSS-10). The secondary outcomes will include psychosocial status of anxiety measured by Zung Self-Rating Anxiety Scale (SAS), and depression measured by Beck Depression Inventory-II (BDI-II), cardiovascular function including blood pressure, heart rate, heart rate variability (HRV), blood tests (lipid and glucose profiles and C-creative protein (CRP), quality of life measured by Seattle Angina Questionnaire (SAQ), and physical fitness using the 6-Minute Walk test. Approximately 126 participants with coronary heart disease and/or hypertension will be included in this trial to participate a 24-week Tai Chi intervention, comprising of a 12-week intensive intervention and 12-week sustained intervention. This study will be conducted in Sydney, Australia and Beijing, China.

Study design: Prospective, single-centre, patient-blinded, non-randomised, clinical study. The study will enrol 80 patients over a 12-month recruitment period between three surgeons. Objectives: To determine the relationship between ambulation (daily step count) preoperatively/post-operatively and patient reported outcomes after total knee arthroplasty (TKA). To investigate if component alignment affects ambulation and clinical outcomes after TKA. To investigate if post-op ambulation after total knee replacement affects other parameters such as return to work and patient satisfaction. The study will also demonstrate safety, and equivalent clinical outcomes on pain and function to other published data. Group: Apex Total Knee Replacement (single study group) Number of subjects to be enrolled: 80 patients will be enrolled into this study. Medical Devices: The Apex Knee is intended for use as a primary total knee replacement device consisting of a femoral, tibial, tibial bearing and optional patellar component. The Vivofit is an activity tracker, a wrist-worn band that counts steps and monitors active time. Regulatory status: The Apex Knee is CE marked, TGA approved and has a rebate code on the Prostheses List. Clinical evaluations: Standard, functional parameters will be assessed pre-operatively, and post-operatively at 6 weeks, and 12 months. Patient outcome assessments: The Oxford Knee Score, The Knee Injury and Osteoarthritis Score (KOOS), Forgotten Joint Score and VAS satisfaction scale will be assessed pre-operatively, and post-operatively at 6 weeks, and 12 months. Radiographic evaluations: X-Rays will be assessed pre-operatively, post-operatively and at 12 months to evaluate femoral and tibial components coronal and saggital orientation. A CT-Scan will be performed preoperatively and at 6 weeks post-operatively to verify implant positioning axially.