ANZCTR search results

Transnasal humidified rapid insufflation ventilatory exchange (THRIVE) is an oxygen insufflation method that has been widely accepted for both preoxygenation and apnoeic oxygenation. The use of THRIVE in laryngeal surgeries has advantages over endotracheal intubation in providing surgeons with excellent access to the surgical field. Additionally, the main benefit of THRIVE over subglottic or supraglottic manual jet ventilation is absence of movement artefact within the surgical field, humidification of delivered gases and decreased risk of high-pressure injuries from jet ventilation. However, the use of THRIVE at 100% oxygen concentration renders a risk of ignition and fire during laser surgeries. It is therefore necessary to investigate the safety of using different laser-safe oxygenation deliveries. No study has compared desaturation rates, real-time laryngeal oxygen concentration, and vital parameters between different oxygenation deliveries via THRIVE across 100%, 30%, and apneic conditions with rescue jet ventilation. In the present clinical trial, we aim to: 1) Compare apnoea time and real-time laryngeal oxygen concentration between 30% oxygen and apnoeic conditions following pre-oxygenation with THRIVE at 100% oxygen concentration; and 2) Explore patient factors which predict successful application of THRIVE at 100% and 30% oxygenation vs apnoeic conditions during microlaryngeal surgery. Recruited patients indicated to undergo microlaryngeal surgery will be randomly allocated to one of two groups, either Group A: ‘Apnoea Group’ (no delivery of high-flow oxygen, environmental room air oxygen only) or Group B: ‘30% Oxygen Group’ (Delivery of high-flow oxygen at 30% concentration). Both groups will have initial pre-oxygenation at 100% oxygen concentration with THRIVE. Laryngeal oxygen concentration, oxygen saturation data, and vital parameters will be collected during the procedure and will be compared between the two groups.

In earlier work, we contextually adapted an evidence-based brief treatment for common mental disorders (depression, anxiety) to support adolescents (13-19 years old) who are considering seeking or waiting to access mental health services in Western Australia (WA). This is called the "Help while you wait" intervention. It comprises four structured counselling sessions delivered in an individual format by non-clinicians (e.g. youth workers). The intervention is designed to equip adolescents experiencing mental health difficulties with problem-solving strategies and coping skills to help them manage their mental health while they wait for specialist services. Study Aims: This study aims to initially evaluate the feasibility, acceptability and the appropriateness of the intervention from the perspective of adolescents who receive the intervention and the intervention facilitators. We also aim to explore whether intervention yields clinical benefits for adolescents’ psychological distress, emotional regulation and problem solving relative to usual care. Finally, we will evaluate the feasibility, acceptability, appropriateness, and effectiveness of the training provided to individuals who deliver the intervention. Methods: We will conduct a two-arm randomized hybrid Type 1 implementation-effectiveness pilot trial of the intervention. The intervention will be implemented in youth-focused community services. These services will refer adolescents (13-19 years old) to the research program. We will recruit 80 adolescents who will be randomly assigned in a 1:1 ratio to the intervention or a usual care comparison condition (waiting lists). The intervention comprises four sessions of individual counselling delivered by trained non-specialist providers. Outcomes will be assessed at baseline, six-week, and 10-weeks post-intervention commencement via electronic surveys. Qualitative interviews will be conducted with interventionists, caregivers, and adolescents allocated to the intervention. Primary outcomes will be feasibility and acceptability of the intervention. Clinical outcomes (psychological distress) will be collected as secondary outcomes. Participants assigned to usual care will be offered the intervention after their final follow up assessment. Outcomes: Findings will be used to improve the intervention training, the intervention materials and approach, and the implementation strategies and to inform scale-up and wider implementation of the intervention. Other anticipated outputs include short reports and briefs for providers and policymakers; conference presentations and webinars; and peer-reviewed publications in scientific journals

This study aims to assess the feasibility and acceptability of a co-designed online tool used to collect information on quality of life for children with cancer. Who is it for? You may be eligible for this study if you are the parent of a child aged between 5-12 years who is engaged with any stage of cancer care (e.g. diagnosis, active treatment or follow-up) at either the Women’s and Children’s Hospital (Adelaide) or the Royal Adelaide Hospital. Clinicians who are treating children who choose to participate may also be eligible for this study. Study details All participants who choose to enrol in this study will be given a login for the online ‘Ripple’ platform where they will answer questions about their health and quality of life. It is anticipated that the questions will take 5-10 minutes to complete. Participants and/or their parents will be asked to complete these questions 2-3 times over a 6-12 month period, depending on when they join the study. After 6 months have passed, parent and clinician participants will also be asked to complete a survey about their experience using the online platform. It is anticipated that this survey will take 10-15 minutes to complete. It is hoped this research will determine whether an online portal for cancer patients to provide ratings of their health and quality of life is easy to use and acceptable to patients, their families and the clinicians treating them. If the portal is found to be useful and acceptable to patients, a larger rollout of the portal may occur to assist a greater number of cancer patients on their treatment journey.

Introduction: People in higher income countries are living longer, with higher burden of chronic disease, disability and psychosocial distress. People affected by this are more likely to present to hospital, where they may receive inefficient and fragmented care. Northern Patient Watch (NPW)was implemented with the aim of better meeting the needs of these patients. This program utilizes trained lay telecare guides, who monitor the patient and health coaches who aid the patient with self-management of their conditions, guided by a rules-based algorithm called the Patient Journey Record. This evaluation will determine whether NPW is effective in reducing acute hospital usage, its effects on participant quality of life, and the quality of the participant’s experience. Methods and Analysis: Emergency department and hospital length of stay will be determined for NPW participants, and compared with these metrics in propensity-matched patients who were eligible for but declined the program. Participant reported outcomes will be measured using EQol-5D-5L, and their experience of the program will be measured using a visual analogue scale and net promoter score. NPW participants and Northern Health staff will be offered the opportunity to participate in interviews and focus groups, to obtain qualitative data regarding the program. Ethics and Dissemination: Patient Watch, and the accompanying collection of hospital usage and patient reported outcome and experience measures, is established as standard care, hence audit-level ethics approval has been obtained. Low-risk ethics approval was obtained for patient/staff interviews and focus groups - see public note below.

This is an 18-week open-label study to evaluate the efficacy of Full-Spectum Medicinal Cannabis Plant Extract 0.08% THC (NTI164) on the severity of Rett syndrome (RTT) in children and young people. The purpose of this study is to determine how effective NTI64 is in patients with RTT when treated for 16 weeks. Participants will commence treatment with a daily dose of 5mg/kg of NTI164. This will gradually be increased over a four-week period until the maximum tolerated daily dose or 20mg/kg per day is achieved (Up-titration phase). Participants will continue to receive their respective maximum dose for eight weeks (Treatment phase). At the end of the Treatment phase, participants will be gradually decreased by 5mg/kg for a period of 4 weeks until the end of their participation (Down-titration phase). Efficacy will be measured and monitored by appropriate and releant questionnaires specific to measuring changes in patients. Full blood examinations will be conducted at various points of the study.

The aim of this research is to evaluate the potential role of Body Surface Gastric Mapping (Alimetry Ltd., New Zealand) in a multidisciplinary integrated care pathway for functional gastroduodenal disorders, to determine whether Body Surface Gastric Mapping test biomarkers are predictive of therapeutic response to a 12 week structured program of care. Hypotheses: Patients with neuromuscular disorders identified by BSGM will demonstrate reduced clinical response to an integrated care program incorporating psychological and behavioural interventions. Conversely, patients with normal BSGM tests will be more likely to respond to the integrated care program. They will also be more likely to also register reduced anxiety and depression scores.

Many babies and infants admitted to hospital need fluids or medicines delivered directly into their veins using an intravenous (IV) catheter. Over time, IV's can dislodge from the veins and some cases, the medicine or fluid can leak into the child's tissue around the vein, causing damage to the skin, tissue and the vein itself. This is called an extravasation injury. An early sign of extravasation injury is pain, however babies and infants cannot always communicate that the IV site is painful making early detection painful. The IV biosensor is a new device that may help detect extravasation injury sooner. A biosensor is a special light similar to an oxygen saturation probe that is placed on the child's skin above the IV site. It uses near infra-red light to scan the tissues to detect extravasation injury and alerts clinicians so the infusion can be stopped to limit damage caused to the surrounding tissue. This trial will examine whether the IV biosensor helps to detect extravasation injury in babies and infants earlier than compared to standard care. It will also assess whether it is safe and easy to use, and whether it decreases the severity of extravasation injuries.

New home spirometer devices (the SpiroHome device) have not yet been tested for accuracy compared to hospital-standard devices. We are assessing the accuracy of new home spirometers, and whether they are easy to use in the community. Participants also have the option to trial new technology called "EIT" which looks at ventilation across the lung using sensors placed on the skin.

The SWAP IT program is integrated within an app-based communication platform used by schools to communicate with parents and consists of text-messages sent to parents targeting barriers to packing healthier lunchboxes. SWAP IT has proven to be effective in improving child nutrition and weight outcomes, is acceptable to parents and principals, and is cost effective. Although SWAP IT has the potential to improve child health at a population-level, little evidence exists to guide efforts to encourage school adoption of these programs at scale. This research aims to maximise the impact of the SWAP IT program through a scale-up involving 1341 primary schools across 10 NSW local health districts. A modified platform trial design will be used to test the effectiveness of a series of scale-up strategies that have been tailored to context to maximise the adoption of an effective healthy lunchbox program within NSW primary schools located within 10 Local Health Districts of NSW. Adoption of the SWAP IT program will be the primary outcome of the trial. This research will result in new knowledge to inform how school-based nutrition programs can be successfully tailored to the local context and scaled-up at a population level.

The primary aim of this pilot study is to assess the feasibility and acceptability of conducting an RCT to evaluate the CREATE intervention in Queensland health services, and to inform the primary outcome measures and sample size for the full RCT. Our proposed intervention CREATE (Co-designed Retail Tools for healthier food Environments) directly addresses these factors through the provision of a Retailer Toolkit and Practitioner Training which have been co-designed with end-users to support the implementation of ‘A Better Choice’ healthy food retail targets. ‘A Better Choice’ Strategy aims to increase the provision of healthy food and drinks for staff, visitors, and patients within Queensland hospital and health services (HHS). The trial will determine the feasibility and acceptability of the implementation support tools, and that of the RCT study design, and will inform future full size RCTs.