scholarly journals INtravenous iron to treat anaemia following CriTical care (INTACT): A protocol for a feasibility randomised controlled trial

2021 ◽  
Vol 22 (2) ◽  
pp. 182-182
Author(s):  
Akshay Shah ◽  
Ioana Marian ◽  
Susan J Dutton ◽  
Vicki S Barber ◽  
David M Griffith ◽  
...  
Keyword(s):  
Critical Care ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Intravenous Iron ◽  
Feasibility Randomised Controlled Trial ◽  
Randomised Controlled

scholarly journals Protocol for a feasibility randomised controlled trial of targeted oxygen therapy in mechanically ventilated critically ill patients

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e021674 ◽  
Author(s):  
Daniel S Martin ◽  
Chris Brew-Graves ◽  
Neil McCartan ◽  
Gavin Jell ◽  
Ingrid Potyka ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Critical Care ◽  
Randomised Controlled Trial ◽  
Critically Ill ◽  
Oxygen Therapy ◽  
Controlled Trial ◽  
Mechanically Ventilated ◽  
Systemic Oxidative Stress ◽  
Feasibility Randomised Controlled Trial ◽  
Randomised Controlled

IntroductionOxygen is the most commonly administered drug to mechanically ventilated critically ill adults, yet little is known about the optimum oxygen saturation (SpO2) target for these patients; the current standard of care is an SpO2of 96% or above. Small pilot studies have demonstrated that permissive hypoxaemia (aiming for a lower SpO2than normal by using a lower fractional inspired oxygen concentration (FIO2)) can be achieved in the critically ill and appears to be safe. This approach has not been evaluated in a National Health Service setting. It is possible that permissive hypoxaemia may be beneficial to critically ill patients thus it requires robust evaluation.Methods and analysisTargeted OXygen therapY in Critical illness (TOXYC) is a feasibility randomised controlled trial (RCT) to evaluate whether recruiting patients to a study of permissive hypoxaemia is possible in the UK. It will also investigate biological mechanisms that may underlie the links between oxygenation and patient outcomes. Mechanically ventilated patients with respiratory failure will be recruited from critical care units at two sites and randomised (1:1 ratio) to an SpO2target of either 88%–92% or ≥96% while intubated with an endotracheal tube. Clinical teams can adjust FIO2and ventilator settings as they wish to achieve these targets. Clinical information will be collected before, during and after the intervention and blood samples taken to measure markers of systemic oxidative stress. The primary outcome of this study is feasibility, which will be assessed by recruitment rate, protocol adherence and withdrawal rates. Secondary outcomes will include a comparison of standard critical care outcome measures between the two intervention groups, and the measurement of biomarkers of systemic oxidative stress. The results will be used to calculate a sample size, likely number of sites and overall length of time required for a subsequent large multicentre RCT.Ethics and disseminationThis study was approved by the London - Harrow Research Ethics Committee on 2 November 2017 (REC Reference 17/LO/1334) and received HRA approval on 13 November 2017. Results from this study will be disseminated in peer-reviewed journals, at medical and scientific meetings, in the NIHR Journals Library and patient information websites.Trial registration numberNCT03287466; Pre-results.

scholarly journals Bathing adaptations in the homes of older adults (BATH-OUT): results of a feasibility randomised controlled trial (RCT)

2018 ◽  
Vol 18 (1) ◽  
Author(s):  
Phillip J. Whitehead ◽  
Miriam R. Golding-Day ◽  
Stuart Belshaw ◽  
Tony Dawson ◽  
Marilyn James ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Feasibility Randomised Controlled Trial ◽  
Randomised Controlled

scholarly journals Dexamethasone versus prednisone for children receiving asthma treatment in the paediatric inpatient population: protocol for a feasibility randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (12) ◽  
pp. e025630 ◽  
Author(s):  
Catherine M Pound ◽  
Jaime McDonald ◽  
Ken Tang ◽  
Gillian Seidman ◽  
Radha Jetty ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Clinical Outcome ◽  
Controlled Trial ◽  
Asthma Treatment ◽  
Treatment Regimens ◽  
Asthma Exacerbations ◽  
Feasibility Randomised Controlled Trial ◽  
Short Course ◽  
Inpatient Population ◽  
Randomised Controlled

IntroductionAsthma exacerbations are a leading cause of paediatric hospitalisations. Corticosteroids are key in the treatment of asthma exacerbations. Most current corticosteroids treatment regimens for children admitted with asthma exacerbation consist of a 5-day course of prednisone or prednisolone. However, these medications are associated with poor taste and significant vomiting, resulting in poor compliance with the treatment course. While some centres already use a short course of dexamethasone for treating children hospitalised with asthma, there is no evidence to support this practice in the inpatient population.Methods and analysisThis single-site, pragmatic, feasibility randomised controlled trial will determine the feasibility of a non-inferiority trial, comparing two treatment regimens for children admitted to the hospital and receiving asthma treatment. Children 18 months to 17 years presenting to a Canadian tertiary care centre will be randomised to receive either a short course of dexamethasone or a longer course of prednisone/prednisolone once admitted to the inpatient units. The primary clinical outcome for this feasibility study will be readmission to hospital or repeat emergency department visits, or unplanned visits to primary healthcare providers for asthma symptoms within 4 weeks of hospital discharge. Feasibility outcomes will include recruitment and allocation success, compliance with study procedures, retention rate, and safety and tolerability of study medications. We plan on recruiting 51 children, and between-group comparisons of the clinical outcome will be conducted to gain insights on probable effect sizes.Ethics and disseminationResearch Ethics Board approval has been obtained for this study. The results of this study will inform a multisite trial comparing prednisone/prednisolone to dexamethasone in inpatient asthma treatment, which will have the potential to improve the delivery of asthma care, by improving compliance with a mainstay of treatment. Results will be disseminated through peer-reviewed publications, organisations and meetings.Trial registration numberNCT03133897; Pre-results.

scholarly journals A feasibility randomised controlled trial of the DECIDE intervention: Dementia carers making informed decisions

BJPsych Open ◽  
2017 ◽  
Vol 3 (1) ◽  
pp. 12-14 ◽  
Author(s):  
Kathryn Lord ◽  
Gill Livingston ◽  
Claudia Cooper
Keyword(s):  
Randomised Controlled Trial ◽  
Family Conflict ◽  
Decision Aid ◽  
Controlled Trial ◽  
Intervention Group ◽  
Decisional Conflict ◽  
Manual Aiming ◽  
Family Carers ◽  
Feasibility Randomised Controlled Trial ◽  
Randomised Controlled

SummaryFamily carers report high levels of decisional conflict when deciding whether their relative with dementia can continue to be cared for in their own home. We tested, in a feasibility randomised controlled trial, the first decision aid (the DECIDE manual) aiming to reduce such conflict. Twenty family carers received the DECIDE intervention, and 21 received usual treatment. The intervention group had reduced decisional conflict compared with controls (mean difference −11.96, 95% confidence interval −20.10 to −3.83, P=0.005). All carers receiving the intervention completed and valued it, despite some still reporting difficulties with family conflict and problems negotiating services.

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