ObjectiveTo identify barriers and facilitators to pressure ulcer prevention behaviours in community-dwelling older people and their lay carers.DesignTheoretically informed qualitative interviews with two-phase, deductive then inductive, thematic analysis.SettingThe study was conducted in one geographical region in the UK, spanning several community National Health Service Trusts.ParticipantsCommunity-dwelling older patients at risk of pressure ulcer development (n=10) and their lay carers (n=10).ResultsSix themes and subthemes were identified: (1) knowledge and beliefs about consequences (nature, source, timing and taboo); (2) social and professional role and influences (who does what, conflicting advice and disagreements); (3) motivation and priorities (competing self-care needs and carer physical ability); (4) memory; (5) emotion (carer exhaustion and isolation, carergiver role conflict and patient feelings) and (6) environment (human resource shortage and equipment).ConclusionsThere is minimal research in pressure ulcer prevention in community-dwelling older people. This study has robustly applied the theoretical domains framework to understanding barriers and facilitators to pressure ulcer prevention behaviours. Our findings will support co-design of strategies to promote preventative behaviours and are likely to be transferable to comparable healthcare systems nationally and internationally.

Objective To codesign a theoretically underpinned, healthcare practitioner-mediated, tailored intervention to support housebound older patients and their lay carers to adopt pressure ulcer prevention behaviours.Design Theoretical domains framework informed codesign.Setting One geographical area in the UK, spanning several community National Health Service Trusts.Participants Community-dwelling older patients at risk of pressure ulcer development and their lay carers (n=4) and health practitioners (n=6) providing related care.Results Codesigners addressed five identified barriers to pressure ulcer prevention, knowledge and beliefs about consequences, social or professional role and influence, motivation and priorities, emotion and environment. Prioritised intervention components were (1) making every contact count, all health and social care workers to be conversant with basic prevention behaviours and to support and reiterate these at every visit (9.1/10), (2) signposting of existing support groups and sitting services (8.4/10), (3) accessible, timely, trustable and relatable written information including the role of patients, carers and staff in prevention and links to other resources (7.7/10) and (4) supporting close family involvement in some of the practical elements of care (5.6/10).Conclusions Our study sought to codesign a practitioner-mediated, tailored intervention to support housebound older patients and their lay carers to adopt pressure ulcer prevention behaviours. The process of barrier identification and selection of behaviour change techniques for intervention components was theoretically informed. However, further development will be needed to refine the prototype intervention to take into account the complexity of multiple health needs and priorities of patients. The principles of this study are likely to be transferable to similar national and international contexts.

Hyperosmolar solutions are widely used to treat raised intracranial pressure following severe traumatic brain injury. Although mannitol has historically been the most frequently administered, hypertonic saline solutions are increasingly being used. However, definitive evidence regarding their comparative effectiveness is lacking. The Sugar or Salt Trial is a UK randomised, allocation concealed open label multicentre pragmatic trial designed to determine the clinical and cost-effectiveness of hypertonic saline compared with mannitol in the management of patients with severe traumatic brain injury. Patients requiring intensive care unit admission and intracranial pressure monitoring post-traumatic brain injury will be allocated at random to receive equi-osmolar boluses of either mannitol or hypertonic saline following failure of routine first-line measures to control intracranial pressure. The primary outcome for the study will be the Extended Glasgow Outcome Scale assessed at six months after randomisation. Results will inform current clinical practice in the routine use of hyperosmolar therapy as well as assess the impact of potential side effects. Pre-planned longer term clinical and cost effectiveness analyses will further inform the use of these treatments.

Objective: Does hyperosmolar therapy (mannitol or hypertonic saline) in traumatic brain injury (TBI) improve neurological function clinically and cost- effectively at 6 months? Design: Multi-centre, open label, randomised controlled clinical and cost effectiveness trial with an internal pilot Setting: Intensive Care Units (ICUs) within NHS hospitals treating patients with TBI Target population: Adult patients (aged >16 years) with severe TBI and raised intracranial pressure (ICP) Inclusion criteria: Patients aged ≥16 years old, admitted to ICU following TBI within 10 days from initial primary head injury, abnormal CT scan consistent with TBI and an ICP >20 mmHg for more than 5 mins despite stage 1 procedures Exclusion criteria: Devastating brain injury with withdrawal of life sustaining treatment anticipated in the next 24 hours, pregnancy and severe hypernatraemia (serum Na > 155 mmol/L) Planned sample size: 319 per group (638 in total) Interventions: 2 ml/kg 20% mannitol intravenous bolus and 2 ml/kg 3% hypertonic saline (HTS) intravenous bolus (or equivalent osmolar dose of HTS using the concentration used locally by participating study centres) Outcome measures: Primary outcome: Extended Glasgow Outcome Scale (GOS-E) measured at 6 months after randomisation. Secondary outcome measures: Efficacy – ICP control (during period of monitoring in ICU, progression to stage 3 therapies and requirement for stage 3 therapies to control ICP, Resource use – organ support requirements during ICU, critical care length of stay and hospital length of stay. Patient outcomes – longer term neurological outcomes (Modified Oxford Handicap Scale (mOHS) at discharge and GOS-E at 12 months), Survival (to hospital discharge – defined as the time at which the patient is discharged from the hospital regardless of neurological status, outcome or destination and at 3 months, 6 months and 12 months) and quality of life (EQ-5D-5L at hospital discharge, 3 months, 6 months and 12 months post-TBI) Blinding: Open label with blinded assessment of primary and secondary outcomes Follow up period: Up to 12 months post-randomisation Planned trial period: From 01/06/2019 to 01/12/2023 (total of 54 months) Trial Registration: ISRCTN16075091 Declaration of conflicting interests The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. Funding The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: National Institute of Health Research Health Technology Assessment Programme (HTA reference 17/120/01).

Aims: The Prehospital Optimal Shock Energy for Defibrillation (POSED) study will assess the feasibility of conducting a cluster randomised con-trolled study of clinical effectiveness in UK ambulance services to identify the optimal shock energy for defibrillation.Methods: POSED is a pragmatic, allocation concealed, open label, cluster randomised, controlled feasibility study. Defibrillators within a single UK ambulance service will be randomised in an equal ratio to deliver one of three shock strategies 120-150-200 J, 150-200-200 J, 200-200-200 J. Consecutive adults (>= 18 years) presenting with out of hospital cardiac arrest requiring defibrillation will be eligible. The study plans to enrol 90 patients (30 in each group). Patients (or their relatives for non-survivors) will be informed about trial participation after the initial emergency has resolved. Survivors will be invited to consent to participate in follow-up (i.e., at 30 days or discharge). The primary feasibility outcome is the proportion of eligible patients who receive the randomised study intervention. Secondary feasibility outcomes will include recruitment rate, adherence to allocated treatment and data completeness. Clinical outcomes will include Return of an Organised Rhythm (ROOR) at 2 minutes post-shock, refibrillation rate, Return of Spontaneous Circulation (ROSC) at hospital handover, survival and neurological out-come at 30 days.Conclusion: The POSED study will assess the feasibility of a large-scale trial and explore opportunities to optimise the trial protocol.Trial registration: ISRCTN16327029.

ABSTRACT Background Both continuous positive airway pressure (CPAP) and high-flow nasal oxygenation (HFNO) have been recommended for acute respiratory failure in COVID-19. However, uncertainty exists regarding effectiveness and safety. Methods In the Recovery-Respiratory Support multi-center, three-arm, open-label, adaptive, randomized controlled trial, adult hospitalized patients with acute respiratory failure due to COVID-19, deemed suitable for treatment escalation, were randomly assigned to receive CPAP, HFNO, or conventional oxygen therapy. Comparisons were made between each intervention and conventional oxygen therapy. The primary outcome was a composite of tracheal intubation or mortality within 30-days. Results Over 13-months, 1272 participants were randomized and included in the analysis (380 (29.9%) CPAP; 417 (32.8%) HFNO; 475 (37.3%) conventional oxygen therapy). The need for tracheal intubation or mortality within 30-days was lower in the CPAP group (CPAP 137 of 377 participants (36.3%) vs conventional oxygen therapy 158 of 356 participants (44.4%); unadjusted odds ratio 0.72; 95% CI 0.53 to 0.96, P=0.03). There was no difference between HFNO and conventional oxygen therapy (HFNO 184 of 414 participants (44.4%) vs conventional oxygen therapy 166 of 368 participants (45.1%); unadjusted odds ratio 0.97; 95% CI 0.73 to 1.29, P=0.85). Conclusions CPAP, compared with conventional oxygen therapy, reduced the composite outcome of intubation or death within 30 days of randomisation in hospitalized adults with acute respiratory failure due to COVID-19. There was no effect observed, compared with conventional oxygen therapy, with the use of HFNO. (Funded by the UK National Institute for Health Research; ISRCTN 16912075 ).

Purpose of the study: To describe duration in chest compression pauses associated with deployment of a mechanical chest compression device in a randomised controlled trial.

Purpose of the study: To describe how patients and members of the public (patient research ambassadors- PRAs) supported the design and management of the COMPRESS-RCT study.

Objectives To evaluate the effect of training strategy on team deployment of a mechanical chest compression device. Design Randomised controlled manikin trial. Setting Large teaching hospital in the UK. Participants Twenty teams, each comprising three clinicians. Participating individuals were health professionals with intermediate or advanced resuscitation training. Interventions Teams were randomised in a 1:1 ratio to receive either standard mechanical chest compression device training or pit-crew device training. Training interventions lasted up to 1 h. Performance was measured immediately after training in a standardised simulated cardiac arrest scenario in which teams were required to deploy a mechanical chest compression device. Primary and secondary outcome measures Primary outcome was chest compression flow fraction in the minute preceding the first mechanical chest compression. Secondary outcomes included cardiopulmonary resuscitation quality and mechanical device deployment metrics, and non-technical skill performance. Outcomes were assessed using video recordings of the test scenario. Results In relation to the primary outcome of chest compression flow fraction in the minute preceding the first mechanical chest compression, we found that pit-crew training was not superior to standard training (0.76 (95% CI 0.73 to 0.79) vs 0.77 (95% CI 0.73 to 0.82), mean difference −0.01 (95% CI −0.06 to 0.03), P=0.572). There was also no difference between groups in performance in relation to any secondary outcome. Conclusions Pit-crew training, compared with standard training, did not improve team deployment of a mechanical chest device in a simulated cardiac arrest scenario. Trial registration number ISRCTN43049287; Pre-results.

Background Mechanical chest compression devices consistently deliver high-quality chest compressions. Small very low-quality studies suggest mechanical devices may be effective as an alternative to manual chest compressions in the treatment of adult in-hospital cardiac arrest patients. The aim of this feasibility trial is to assess the feasibility of conducting an effectiveness trial in this patient population. Methods COMPRESS-RCT is a multi-centre parallel group feasibility randomised controlled trial, designed to assess the feasibility of undertaking an effectiveness to compare the effect of mechanical chest compressions with manual chest compressions on 30-day survival following in-hospital cardiac arrest. Over approximately two years, 330 adult patients who sustain an in-hospital cardiac arrest and are in a non-shockable rhythm will be randomised in a 3:1 ratio to receive ongoing treatment with a mechanical chest compression device (LUCAS 2/3, Jolife AB/Stryker, Lund, Sweden) or continued manual chest compressions. It is intended that recruitment will occur on a 24/7 basis by the clinical cardiac arrest team. The primary study outcome is the proportion of eligible participants randomised in the study during site operational recruitment hours. Participants will be enrolled using a model of deferred consent, with consent for follow-up sought from patients or their consultee in those that survive the cardiac arrest event. The trial will have an embedded qualitative study, in which we will conduct semi-structured interviews with hospital staff to explore facilitators and barriers to study recruitment. Discussion The findings of COMPRESS-RCT will provide important information about the deliverability of an effectiveness trial to evaluate the effect on 30-day mortality of routine use of mechanical chest compression devices in adult in-hospital cardiac arrest patients. Trial registration ISRCTN38139840 , date of registration 9th January 2017.