ANZCTR search results

Aim: The aim of this project is to investigate whether pleth variability index (PVI), derived from the Masimo Rainbow (Registered Trademark) SET Pulse CO-Oximetry, can predict fluid responsiveness in mechanically ventilated patients during general anaesthesia for non-cardiac surgery. Significance: The significance of assessing PVI is that it is completely non-invasive (it only requires a probe on the finger), it provides a dynamic indicator of fluid responsiveness, and the PVI is displayed as a continuously monitored number, which makes it simple and user-friendly. Hypothesis: The main hypothesis is that PVI can accurately and consistently predict fluid responsiveness in mechanically ventilated patients during general anaesthesia following a standard fluid challenge. Objective: The main objective is to assess the accuracy and consistency of PVI as an indicator of assessing fluid responsiveness, when measured against the more well-established oesophageal Doppler/fluid challenge method. This will determine whether PVI can be used reliably as an indicator of fluid responsiveness. Methods: In this observational study, a total of 30 participants will be assessed as being fluid responsive or fluid non-responsive according to stroke volume changes (measured via the minimally invasive oesophageal Doppler monitor) following the administration of a standard fluid challenge. The two main measurements including PVI and stroke volume index will be recorded along with other variables. Using appropriate statistical analysis, we will determine the consistency and accuracy of PVI in detecting fluid responsiveness. Likely benefit of the research: The significance of assessing PVI in the current study is that it may provide a non-invasive and continuous way of determining which patients are likely to respond and thus benefit from fluid therapy, a measurement that previously requires much more invasive techniques.

This study looks at whether receiving extra chemotherapy during a waiting period between radiotherapy and surgery can assist in shrinking a patient’s tumour even more when compared to just the waiting period alone and without any additional treatment. Who is it for? You are eligible for this study if you are 18 years and over, have a histologically proven adenocarcinoma, distal rectum (defined as being less than 12 cms from the anal verge on rigid sigmoidoscopy), and have non-metastatic (M0) disease. You may also be eligible if your health care professional recommends that you undergo long course preoperative chemoradiotherapy prior to surgery. More details on the eligibility criteria for this study can be found in the Inclusion Criteria field of this form. Trial Details Normally between radiotherapy and surgery there is a 6 week wait period to see if the tumour shrinks. Recent studies have suggested it may be beneficial to have chemotherapy in this period – although this experimental approach has only been tried in a small number of patients. The aim of this study is to see whether extra chemotherapy given in this wait period shrinks the tumour even more. The waiting period in this study will be 10 weeks. We will assess this at the time of surgery by clinical response (no tumour visible by eye) and by pathological response (no tumour visible under the microscope). We will also use the samples we take from the tumour to see whether we can identify any factors which might predict better outcomes for all patients with rectal cancer. If you choose to take part in this study, you will be randomised to either the standard preoperative chemoradiotherapy followed by a 10 week wait period without any additional chemotherapy (the SCRT group) OR the standard chemoradiotherapy followed by a 10 week wait period with additional chemotherapy (the XCRT group). Chemotherapy will be fluropyrimidine based using a standard regimen of infusional 5FU continuous throughout radiotherapy, at a dose of 225 mg/m2/day. A Picc line will be inserted prior to treatment and the infusional 5FU will be given through a Baxter infuser pump, in an ambulatory fashion, and will be changed once a week, for the duration of radiotherapy. A full blood count and MBA20 test will be performed weekly during chemoradiotherapy. For patients on the standard arm (the SCRT group), no further preoperative chemotherapy is planned. Patients on the investigational arm (XCRT group) will receive further chemotherapy as bolus 5FU (450 mg/m2 with leucovorin at 50mg/m2, on each of 3 days, 3 weekly for 3 cycles (week 9, 12, 15).

Some people have problems with a profound lack of energy (fatigue) after finishing cancer treatment known as post cancer fatigue. They also commonly have difficulties in concentration, sleep disturbance and low mood. The experts in the Lifestyle Clinic have developed an exercise and support program for people with post cancer fatigue which will now be evaluated in a trial. Who are the clinicians? The exercise physiologist helps with: - Activity pacing - helping to better manage day to day symptoms and activity levels; - Graded exercise therapy - increasing capacity for activity to improve health. The clinical psychologist helps with: - Memory, concentration and attention problems; - Sleep issues ; - Anxiety, mood and coping. What is involved? Those eligible will be randomized into either a simple education group or an intervention group. Regardless of what group you are allocated to you will be interviewed and asked to complete a series of questionnaires about your health and lifestyle at the beginning, at 12weeks and then 3 months later. Participation is free of charge. The education group will receive a booklet describing the principles of the treatment program and will meet with the clinicians to ensure they understand the plan. They will provide clear advice on how to implement these principles yourself at home over the 12 weeks. Those in the intervention group will receive this booklet but will also participate in regular sessions implementing the 12 week program. What is the 12 week intervention? The 12 week program is run by an exercise physiologist and clinical psychologist, designed to better manage your fatigue and related symptoms and to increase your day to day function. The program includes: - Assessment of symptoms and activity patterns with an exercise physiologist. - Assessment of your well-being with a clinical psychologist The treatment program is ‘home-based’ and is designed to suit your individual needs and current level of activity. This includes fortnightly consults either in the Clinic or by phone with your clinicians to review your progress. What happens after the trial if I get randomized into the education group? If the intervention proves to be effective and you were allocated to the education group you will be offered the intervention without cost to you. Who can participate? - People who have completed adjuvant treatment (chemotherapy, radiotherapy or hormonal treatment) for breast or bowel cancer, who have symptoms of unexplained fatigue reducing activity levels. - People who have finished treatment at least 3 months ago but less than 12 months ago. -Aged at least 18 years

Trabeculectomy surgery for Glaucoma establishes a connection between the inside of the eye and the subconjunctival space which lies just below the surface of the eye. Flow of fluid through this connection forms a subconjunctival blister known as a bleb. Aqueous humor (fluid inside the front of the eye )is absorbed from the bleb into the blood stream. A significant casue of failure of trabeculectomy is scarring of the bleb. If the bleb develops an excessive amount of scar tissue then fluid is prevented from exiting and the eye pressure is increased. Cataract surgery has been shown in research trials to increase the risk of trabeculectomy failure. Control of postoperative scar formation after cataract surgery is a significant challenge in the surgical management of glaucoma in patients who have had previous Trabeculectomy surgery. Current practice is to use topical steroids and antiscarring agents such as 5-fluorouracil (5-FU). Although the use of 5-FU is widespread, scar tissue remains a problem in many patients and treatment is associated with side effects including wound leaks and disruption of the ocular surface. Active scarring is associated with inflammation. Triamcinolone is a synthetic corticosteroid that inhibits the inflammatory process and may therefore reduce scar formation. Injection of triamcinolone into the vitreous jelly of the eye has been widely used as a treatment for various diabetic and inflammatory conditions which are unresponsive to topical corticosteroids. It has been used as a mono-therapy and co-therapy for various back of eye conditions, and is also indicated for visualisation during vitrectomy.

Alcohol abuse continues to be a major contributor to injury related hospitalisations in Australia. The objective of the present study was to investigate the effectiveness of brief intervention in reducing harmful alcohol use in a group of patients admitted under the trauma service at a tertiary hospital. We conducted a randomised control trial of trauma patients who were screened with the AUDIT tool (Alcohol Use Disorders Identification Test) and deemed to be at risk drinkers. Groups were assigned to brief intervention or standard care. We compared AUDIT scores between groups and before and after intervention controlling for factors such as age, gender, injury severity and mechanism of injury.

The study will look at whether brief cognitive therapy is effective in helping individuals deal with food cravings.

This cluster randomised controlled trial (RCT) aims to provide evidence of the efficacy and sustainability of the 6-PACK program for preventing fall-related injuries in acute hospitals. Twenty-four acute medical and surgical wards from six to eight hospitals throughout Australia will be recruited. Wards will be matched by type and baseline fall-related injury rates then randomly allocated to either the 6-PACK intervention (12 wards) or the usual care control group (12 wards).The 6-PACK program includes completion of a nine-item falls risk assessment and six nursing interventions: ‘‘falls alert’’ sign above the patient’s bed; supervision of patients while in the bathroom; ensuring that the patient’s walking aid is within reach; establishment of a toileting regime; use of a low-low bed and use of bed/chair alarm. Intervention wards will receive 6-PACK equipment (falls alert signs, low-low beds and bed/chair alarms) and there will be a supported implementation (small group training and assignment of clinical leaders) and review strategy (audit, feedback and reminders). A cost effectiveness study of the 6-PACK program will also be conducted. The effectiveness of the 6-PACK implementation will also be examined using a structured mixed methods evaluation. Sustainability will be assessed in the year after the RCT when there will be a staged withdrawal of the research staff from the sites. The primary outcome measures are fall and fall-related injury rates in the 12 months after the 6-PACK is implemented. The cost-effectiveness outcome is “cost or saving per fall prevented” and “cost or saving per fall-related injury prevented” calculated from differences in mean costs and effects in the intervention and control groups to generate an incremental cost-effectiveness ratio. Outcome analyses will be undertaken on an intention to treat basis. Differences in fall and fall-related injury rates will be compared between groups using negative binomial regression where data are adjusted for clustering and pairing of wards. Primary analysis will be unadjusted. Secondary analyisis that adjusts for age and cognitive impairment will also be conducted. This study is planned to be the largest hospital falls prevention RCT to be undertaken and is the first to be powered to the important primary outcome of falls injuries.

The aim of this project is test the effects of an intervention we have designed that targets behavioural changes in relation to eating and physical activity as well as changes in psychological factors such as motivation, confidence, mood, and body image concerns, with the aim of maintaining healthy weight gain during pregnancy.

Pulmonary arterial hypertension (PAH) is a devastating condition with a poor prognosis. There are currently no widely available imaging modality to assess lung perfusion, which is decreased in PAH. Single photon emission computed tomography (SPECT) is a nuclear medicine technique which can assess three dimensional lung perfusion. We wish to evaluate the utility of SPECT in the assessment and early detection of PAH.

Doctors know that seizures occur more often in babies than older children. Seizures in babies may result in damage to their brain that may lead to epilepsy or affect their learning, thinking and memory. There is not a lot of research as to the best way to treat seizures in babies and to protect their brain function. The aim of this research project is to compare the treatment of seizures that are physically seen by doctors and nurses (standard clinical care) to when seizures are detected using an amplitude integrated electroencephalograph monitor (aEEG), to see which method is better at protecting brain function in the longer term. We hope a total of 630 babies will take part in this study. Half of the babies will receive standard treatment and half will be treated when a seizure is seen on the aEEG monitor. After the babies have been discharged from hospital we will follow them up at 2 years of age to assess their development. This research project is important because it may change the way doctors treat seizures in babies in the future, and we want to make sure that our treatment is protecting the babies brain.