ANZCTR search results

In patients who are unable to be safely taken off a mechanical ventilator a tracheostomy is often placed to help protect their airway gradually reduce the mechanical ventilator support. One-way valves can be used within a ventilator circuit to direct air through the upper airway during expiration, allowing speech and communication.  Research suggests the use of speaking valves during mechanical ventilation is safe, improves communication, may reduce time to weaning off ventilation and removal of tracheostomy. This project aims to evaluate whether the early use of a speaking valve within the ventilator circuit in suitable patients results in earlier weaning from mechanical ventilation and earlier communication.   The primary outcome will be feasibility and safety with the ability to pivot to a primary outcome of duration of mechanical ventilation post tracheostomy utilising the pilot results.  Secondary outcomes include mechanical ventilation duration, ease of communication, patient and family, satisfaction and length of stay.

This trial aims to determine if there is any difference in patient-reported health-related quality of life and other clinical outcomes for patients with early-stage non-small cell lung cancer (NSCLC) who will undergo surgical removal of their cancer by either robotic keyhole surgery (RTS) or video assisted keyhole surgery (VATS). Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with early-stage non-small cell lung cancer and you are able to undergo minimally invasive keyhole surgery for removal of your cancer. Your treating doctor will be able to review your lung images to determine whether this type of surgery is right for you. Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to undergo surgery by one of two methods. Participants allocated to the first group will undergo robotic-assisted keyhole surgery, it is anticipated this procedure take up to 3 hours. Robotic thoracic surgery (RTS) uses a similar minimally invasive approach, but the very precise instruments involved with RTS allow the surgeon to view the lung using 3-dimensional imaging. Participants allocated to the second group will undergo video-assisted keyhole surgery, it is anticipated that this procedure will take up to 3 hours. During video-assisted keyhole surgery (VATS), the surgeon inserts a small camera into the lung that puts the image onto a video screen. Instruments are inserted via small incisions, and the lung resection is completed. Both types of surgery are currently standard of care to successfully remove lung cancer. It is expected that participants in both groups will need to stay in hospital after their surgery to ensure there are no unexpected complications. If you choose to participate in this study, the research team will ask to review your medical records prior to the surgery and for up to 5 years after the surgery to follow your progress. It is hoped this research will demonstrate any differences in patient outcomes following each type of surgery. If one surgical method is found to be more effective for removal of cancer and less painful for patients, the evidence gathered from this trial may be used to promote use of that surgical method for future cancer patients.

The primary aim is to determine the safety, feasibility, and efficacy of the Wim Hof Method (WHM) for the treatment of pain associated with endometriosis. The study will measure self-reported pain and biological markers of inflammation. Objectives include assessing the impact of WHM on pelvic pain, psychological status, endometriosis lesion characteristics, autonomic nervous system, endocrine system responses and innate immune system responses.

All the patients with Rett Syndrome, previously on CBDV as part of the phase I trial, will be offered transition to Epidyolex, with monitoring for change in seizure frequency and severity, sleep behaviours and emergence of withdrawal symptoms. The study hypothesis is that patients with refractory epilepsy and Rett syndrome will respond to CBD (similar seizure frequency, seizure severity) when transitioned from CBDV.

Musculoskeletal pain is the second leading cause of disease burden in Australia and there is a need to investigate new models of care to cope with increasing demand on health services. This randomised controlled trial (RCT) will investigating whether a physiotherapist-led triage and treatment service is non-inferior for improving function at 6-months, and superior for reducing waiting times, compared to usual clinic-based care for adults with musculoskeletal pain referred to public hospital outpatient physiotherapy clinics. 368 participants (184 per arm) will be recruited from six public hospitals located in metropolitan Sydney, Australia. Adult patients will be eligible as new referrals (referred within the last 6 weeks) to a public hospital physiotherapy outpatient clinic with a musculoskeletal condition or musculoskeletal pain typically managed with physiotherapy. Example referrals include but are not limited to; back or neck pain, osteoarthritis, whiplash-associated disorders, ankle sprains, rehabilitation post-orthopaedic surgery, sporting injury (e.g. ankle sprains). Eligible patients will be randomised to either physiotherapist-led triage and treatment service or usual clinic-based care. The physiotherapist-led triage and treatment service group will be matched to different modes and types of care based on their risk of poor outcome (as assessed by the Keele STarT MSK tool), presence of potential non-progressive radiculopathy or requiring post-operative rehabilitation. The low-risk group will receive a telephone call, the medium risk group will receive telehealth (videoconference) physiotherapy and the high-risk group will receive clinic-based physiotherapy tailored to their presentation. Participants randomised to the usual care group will be offered a course of clinic-based (in-person) physiotherapy as is usually provided at the participating public hospital clinics. Clinic-based physiotherapy may include a combination of any advice and education to support self-management (e.g., advice to exercise, modify activities, lose weight, or take simple pain medications if needed), exercise tailored to patients’ activity goals and level of function, graded activity, graded exposure, and manual therapy. The co-primary outcomes are physical function as assessed by the Patient Specific Functional Scale (PSFS) at 6-months post-randomisation and treatment waiting time (from randomisation to first treatment). Secondary outcomes (e.g. physical function), health resource use (e.g. number of appointments), potential mediators (e.g. pain self-efficacy), process measures (e.g. adherence) and additional outcomes (e.g. harms) will also be assessed.

Most children with cerebral palsy (CP) have a speech difficulty called dysarthria, which makes their speech unclear and difficult to understand. Sometimes dysarthria is so severe that the child is unable to speak at all. Dynamic Tactile Temporal Cuing (DTTC) is a motor speech intervention designed for young children with severe motor speech disorders including childhood apraxia of speech (CAS), a similar condition to dysarthria in CP. DTTC focusses on learning how to move the muscles required for speaking while learning to say words. This may be particularly suitable for children with CP and dysarthria, as CP is primarily a disorder of movement so the individual has difficulty is in moving and coordinating muscles, including the muscles used for speech. This study aims to investigate if DTTC improves speech clarity and intelligibility, leading to increased participation in conversations, and if these improvements last beyond therapy. We will also explore the perspectives of he parents/ guardians and the speech pathologists with DTTC via semi-structured interviews and a questionnaire. If the study confirms that DTTC improves speech, we will conduct a larger, externally funded study. This research aims to improve the lives of these children by enhancing their communication abilities and overall participation in daily conversations.

Post-concussion syndrome (PCS) impacts the injured and their families. Symptoms can occur at the time of injury or may be delayed and develop some time after the initial injury. Standard care for people with PCS includes sub-threshold exercise. Evidence also exists for the use of vestibular rehabilitation and manual therapy (mobilisation and manipulation of the neck and spine) in the management of PCS. As active management is becoming the preferred approach for patients with PCS, the aim of this study is to assess the feasibility of administering two combinations of active interventions to people with PCS: vestibular rehabilitation with exercise and manual therapy with exercise. The study will recruit 30 participants between the ages of 18 and 50 with sports-related PCS. Participants will be randomly allocated to one of three groups: exercise only; exercise plus vestibular rehabilitation; or exercise plus manual therapy. Participants will receive 8 intervention sessions over a 4-week period at the rate of 2 sessions per week. Outcome measurements will be administered at baseline,4, 8 and 12 weeks post-intervention.

Perceptual decision making is a fundamental cognitive process whereby sensory information is converted into meaningful perceptual interpretations of the environment for action. At a synaptic-level, the components of the decision process rely on a complex neuropharmacology, but the specific role of signalling pathways in supporting perceptual decisions is not well understood. Ketamine disrupts the brain's primary excitatory neurotransmitter, glutamate, by blocking glutamate receptors. This project will investigate the neuropharmacological basis of perceptual decisions by characterising the impact of glutamate challenge on key electrophysiological signatures of the decision process.

Caring for patients with behavioural concerns in the Emergency Department (ED) is a common occurrence. The aim of this project is to test the feasibility of the addition of the Emergency pharmacist to a multidisciplinary BOC response team. This will be a pilot un-blinded randomised controlled trial comparing EM pharmacist attendance at BOC calls versus standard care. It is expected that the pharmacist will provide additional resources for adherence to the guidelines, reducing subsequent distress and agitation.

Collaborative Assessment and Management of Suicide (CAMS) is a psychological therapy that outperforms other active interventions in reducing suicidal ideation, improving distress and hopelessness, reducing treatment disengagement and higher consumer satisfaction. Only two trials have investigated CAMS delivered within inpatient settings and neither have been conducted in Australia. Within this context, the aim of this study is to investigate whether it is feasible to deliver CAMS in the Australian inpatient setting, whether the treatment is acceptable to consumers and clinicians and ensure outcomes are in line with what would be expected. CAMS may be a good fit for Australian psychiatric inpatient settings, but the relevance and feasibility of this approach is yet to be established here.