ANZCTR search results

Umbilical Cord Blood derived cells have the potential for use in the treatment of acute COVID-19 associated pneumonia which can lead to Acute Respiratory Distress Syndrome (ARDS). The capacity to obtain expanded, off the shelf, cord blood units, containing highly potent anti-inflammatory and immune-modulatory cells, will provide a therapeutic option for patients displaying a compromised respiratory system following COVID-19 infection, before the disease progresses to ARDS and death.

We herein propose a simple, achievable and safe method of assisting ventilation using a high throughput device, which can be operated without specific skills in ventilator management. The device is a modernised version of the Both Respirator created in 1939. A Modern commercial version has been FDA approved in the United States by Hayek Medical, but currently lacks Australian distribution. As advertised by Hayek Medical, a cuirass ventilator does not require skilled medical professionals. Our simplified device has also been designed to not require a skilled medical professional. Moreso, this device is specifically designed with simplified parts so it can be built quickly and easily in regional areas.

Obesity is the leading public health challenge in Australia. Approximately 3,300 patients who undergo elective surgery in the Illawarra and Shoalhaven Local Health District each year are obese.. This area does not currently offer a comprehensive multi-disciplinary weight management clinic. The waiting time for many patients with obesity booked for common operations is three months or longer. Losing weight and increasing cardio-respiratory fitness can improve aerobic capacity and physiological reserve. The majority of people routinely carry a ‘smart’ mobile phone. We will design, build, pilot, and evaluate a mobile application to provide patient-centered interactive health coaching specifically designed for patients with obesity who are waiting for surgery. Our hypothesis is that mobile health coaching via an app utilising the time that patients with obesity spend on surgical waiting lists will improve their health, fitness, and motivation at the time of operation.

Introduction: The aim of this 2-arm randomized controlled clinical trial (RCT) was to assess the effect of Dental Monitoring (DM) on the efficiency of clear aligner therapy (CAT) as well as the patient experience, compared to the conventional monitoring (CM) protocol of regularly scheduled clinical appointments. Methods: 56 patients with a full permanent dentition and treated with CAT participated in this RCT. They were recruited from a single private practice and treated by 1 experienced orthodontist. Randomization was performed with permutated blocks of 8 patients assigned to either a (CM) or DM group with allocations concealed in opaque, sealed envelopes. It was not feasible to blind the subjects or investigators. The primary treatment efficiency outcome assessed was the number of appointments. Secondary outcomes included time to reach first refinement, number of refinements, total number of aligners, and treatment duration. The patient experience was assessed using a visual analogue scale (VAS) questionnaire administered at the end of CAT. Results: No patients were lost to follow-up. There was no significant difference in the number of refinements (mean 0.1; 95% CI, -0.2, 0.5; p = 0.43) and number of total aligners (median 5; 95% CI, -1, 13; p = 0.09). There was a significant difference in the number of appointments, with the DM group requiring 1.5 fewer visits (95% CI, -3.3, -0.7; p = 0.02) as well as overall treatment duration, with the DM group taking 1.9 months longer (95% CI, 0.0, 3.6; p = 0.04). There was a difference between study groups regarding the importance of face-to-face appointments, with the DM group not perceiving face-to-face appointments as important (p = 0.030). Conclusions: The use of DM with CAT resulted in 1.5 fewer clinical appointments and a longer treatment duration by 1.9 months. There were no significant intergroup differences with the number of refinements or total aligners. Both CM & DM groups had similarly high levels of satisfaction with CAT. This research project aims to evaluate these claims by conducting a randomised controlled trial comparing a control group of patients undergoing Invisalign treatment only to an intervention group of patients undergoing Invisalign treatment with Dental Monitoring GoLive over 140 days. Participants will be from Newwave Orthodontics, a private orthodonitc practice in Caloundra. We expect DM will reduce the number of appointments by 1 over this time frame.

Prior research has suggested that in adult patients requiring mechanical ventilation for hypoxic respiratory failure, that airway pressure release ventilation (APRV) is associated with a mortality benefit and improved oxygenation when compared to conventional ventilation strategies. The Western Australian Intensive Care clinical community has extensive experience with APRV, including during the H1N1 epidemic. The aim of this observational study is to record the outcomes for mechanically ventilated patients with COVID-19, with the expectation that a significant proportion of WA intensive care clinicians will choose APRV. Analysis will compare APRV with non-APRV ventilation modes.

The Covid-19 pandemic causes mild illness in most but when it spreads to the lungs it may cause a severe illness with acute respiratory distress syndrome (ARDS), severe systemic inflammation, respiratory failure and death in some. Front line Healthcare Workers (HCW) are at particularly high risk of contracting Covid-19 and sadly many HCW have died in the worst affected areas. Personal protective equipment such as masks are in short supply and surgical masks are unlikely to protect HCW from contracting the disease. Therefore we propose to treat healthy HCW with a drug which simultaneously targets front-line innate anti-viral immune defences, together with the core mechanism that controls immune response intensity in the airways. Our hypothesis is that development of severe SARS-Cov-2 (COV)-associated ARDS in front-line health workers, even in those who have contracted this disease, can be prevented via a regimen of daily dosing with the bacterial-derived immunomodulatory agent OM85. We propose a clinical trial to demonstrate reduction in acute respiratory illnesses in HCW necessitating workforce removal. 1000 HCW will be recruited in Brisbane and treated for 3 months using a wait-list study design. If successful, this trial will produce a treatment to protect doctors, nurses, and other frontline healthcare workers from developing the most serious form of the disease.

Covid 19 disease, caused by the SARS COV2 virus, is highly infectious. Patients presenting to hospital suspected or proven to have this condition may be at risk of spreading the virus to visitors and staff. The Decathlon BreatheEasy snorkel mask has been adapted to both cover your face and, if required administer O2 or air pressure. This mask has been tested in a laboratory setting at Monash University to demonstrate its safety and it demonstrates a very low level of leakage. We believe the use of this mask on patients with suspected or confirmed Covid 19 disease may reduce the likelihood of transmission of Covid 19 disease to hospital workers and other patients. Currently there is no medical grade device designed to perform these tasks and consequently a non-medical device has been adapted. We aim to test comfort, tolerability adherence to usage of this mask in the clinical setting to determine its feasibility for more widespread use. This will help us to determine if this mask or a subsequent purpose build version with similar specifications will be able to be deployed in hospital settings on a larger scale.

The primary purpose of this pilot study is to provide an indication that the in vitro disinfectant activity seen against the SARS-CoV-2 virus translates to disinfection of the nasal cavity in vivo of COVID-19 patients. Other objectives include collecting data to guide follow-on clinical studies and to provide insights as to mode of action. Overall, the study will provide important insights into the potential role for a PVP-I nasal spray in managing the risk of infection by the virus.

Closure of percutaneous access sites is a crucial part of modern day diagnostic and interventional angiography. Failure to achieve closure of arterial puncture sites can lead to multiple complications including haematomas, pseudoaneurysms, AV fistulas and retroperitoneal haemorrhages, some of which can be life-threatening. While it is currently used in Australia, FemoSeal is a relatively new technology. As such, there is a paucity of quality research comparing this device with other, more established devices in a variety of clinical settings. The proposed RCT will compare the procedural efficiency and clinical outcomes between Starclose and FemoSeal. This study aims to assess arterial access-related complications at 25 - 35 days after randomisation, along with the efficacy, safety and efficiency of the vascular closure devices in participants who have undergone diagnostic and/or interventional angiography. The hypothesis to be tested is that FemoSeal is not inferior to Starclose for access site-related complications.

The global impact of COVID-19 has been profound, and the public health threat it represents is the most serious seen in recent pandemic history. Thus, concerns about COVID-19 are pervasive and have several serious adverse impacts on the mental health of health workers and the general community. There is an urgent demand for programs that can address the stress experienced by people during the COVID-19 pandemic. This situation does not require therapy because these personnel do not necessarily suffer from a mental disorder. Instead, there are huge numbers of people who are facing unprecedented levels of stress and require strategies to manage this stress. A suitable and evidence-based program that helps to cope with stress in times of crisis is the Problem Management Plus (PM+), which was developed by the World Health Organization. As a low-intensity intervention for adults affected by adversity, this program teaches people well-documented strategies to manage stress. This project aims to conduct a rapid trial of a brief psychological intervention, termed Problem Management Plus (PM+) to reduce distress associated with concerns about COVID-19. There is an urgent need for publicly available strategies to reduce COVID-19 related distress. This project does not aim to treat a mental disorder but rather alleviate distress and improve coping in people with distress about COVID-19. This brief program will be offered via teleconferencing to allow for social distancing on a group basis. We hypothesise that PM+ will result in greater reductions in distress and worry relative to provision of currently available online resources to manage distress. Adults who screen positive for psychological distress will be randomized to PM+ or a control condition. PM+ will comprise 6 x 60-minute sessions delivered by a clinical psychologist via teleconferencing to groups of 4 people at a time. The control arm will direct people to a portal with stress coping strategies. All participants will be assessed at baseline, post-intervention, and 2 and 6 months follow-up.