Kim Kirby

Design and implementation of the AIRWAYS-2 trial: A multi-centre cluster randomised controlled trial of the clinical and cost effectiveness of the i-gel supraglottic airway device versus tracheal intubation in the initial airway management of out of hospital cardiac arrest

Health outcomes after out of hospital cardiac arrest (OHCA) are extremely poor, with only 7-9% of patients in the United Kingdom (UK) surviving to hospital discharge. Currently emergency medical services (EMS) use either tracheal intubation or newer supraglottic airway devices (SGAs) to provide advanced airway management during OHCA. Equipoise between the two techniques has led to calls for a well-designed randomised controlled trial. The primary objective of the AIRWAYS-2 trial is to assess whether the clinical effectiveness of the i-gel, a second-generation SGA, is superior to tracheal intubation in the initial airway management of OHCA patients in the UK. Paramedics recruited to the AIRWAYS-2 trial are randomised to use either tracheal intubation or i-gel as their first advanced airway intervention. Adults who have had a non-traumatic OHCA and are attended by an AIRWAYS-2 paramedic are retrospectively assessed against eligibility criteria for inclusion. The primary outcome is the modified Rankin Scale score at hospital discharge. Secondary objectives are to: (i) estimate differences between groups in outcome measures relating to airway management, hospital stay and recovery at 3 and 6 months; (ii) estimate the cost effectiveness of the i-gel compared to tracheal intubation. Because OHCA patient needs immediate treatment there are several unusual features and challenges to the design and implementation of this trial; these include level of randomisation, the automatic enrolment model, enrolment of patients that lack capacity and minimisation of bias. Patient enrolment began in June 2015. The trial will enrol 9070 patients over two years. The results are expected to influence future resuscitation guidelines. Trial Registration ISRCTN: 08256118.

Effect of a Strategy of a Supraglottic Airway Device vs Tracheal Intubation During Out-of-Hospital Cardiac Arrest on Functional Outcome: The AIRWAYS-2 Randomized Clinical Trial

Importance The optimal approach to airway management during out-of-hospital cardiac arrest is unknown. Objective To determine whether a supraglottic airway device (SGA) is superior to tracheal intubation (TI) as the initial advanced airway management strategy in adults with nontraumatic out-of-hospital cardiac arrest. Design, Setting, and Participants Multicenter, cluster randomized clinical trial of paramedics from 4 ambulance services in England responding to emergencies for approximately 21 million people. Patients aged 18 years or older who had a nontraumatic out-of-hospital cardiac arrest and were treated by a participating paramedic were enrolled automatically under a waiver of consent between June 2015 and August 2017; follow-up ended in February 2018. Interventions Paramedics were randomized 1:1 to use TI (764 paramedics) or SGA (759 paramedics) as their initial advanced airway management strategy. Main Outcomes and Measures The primary outcome was modified Rankin Scale score at hospital discharge or 30 days after out-of-hospital cardiac arrest, whichever occurred sooner. Modified Rankin Scale score was divided into 2 ranges: 0-3 (good outcome) or 4-6 (poor outcome; 6 = death). Secondary outcomes included ventilation success, regurgitation, and aspiration. Results A total of 9296 patients (4886 in the SGA group and 4410 in the TI group) were enrolled (median age, 73 years; 3373 were women [36.3%]), and the modified Rankin Scale score was known for 9289 patients. In the SGA group, 311 of 4882 patients (6.4%) had a good outcome (modified Rankin Scale score range, 0-3) vs 300 of 4407 patients (6.8%) in the TI group (adjusted risk difference [RD], −0.6% [95% CI, −1.6% to 0.4%]). Initial ventilation was successful in 4255 of 4868 patients (87.4%) in the SGA group compared with 3473 of 4397 patients (79.0%) in the TI group (adjusted RD, 8.3% [95% CI, 6.3% to 10.2%]). However, patients randomized to receive TI were less likely to receive advanced airway management (3419 of 4404 patients [77.6%] vs 4161 of 4883 patients [85.2%] in the SGA group). Two of the secondary outcomes (regurgitation and aspiration) were not significantly different between groups (regurgitation: 1268 of 4865 patients [26.1%] in the SGA group vs 1072 of 4372 patients [24.5%] in the TI group; adjusted RD, 1.4% [95% CI, −0.6% to 3.4%]; aspiration: 729 of 4824 patients [15.1%] vs 647 of 4337 patients [14.9%], respectively; adjusted RD, 0.1% [95% CI, −1.5% to 1.8%]). Conclusions and Relevance Among patients with out-of-hospital cardiac arrest, randomization to a strategy of advanced airway management with a supraglottic airway device compared with tracheal intubation did not result in a favorable functional outcome at 30 days. Trial Registration ISRCTN Identifier: 08256118

Home or hospital for people with dementia and one or more other multimorbidities: What is the potential to reduce avoidable emergency admissions? the HOMEWARD Project Protocol

Introduction Older people with multimorbidities frequently access 999 ambulance services. When multimorbidities include dementia, the risk of ambulance use, accident and emergency (A&E) attendance and hospital admission are all increased, even when a condition is treatable in the community. People with dementia tend to do poorly in the acute hospital setting and hospital admission can result in adverse outcomes. This study aims to provide an evidence-based understanding of how older people living with dementia and other multimorbidities are using emergency ambulance services. It will also provide evidence of how paramedics make decisions about taking this group of patients to hospital, and what resources would allow them to make more person-focused decisions to enable optimal patient care. Methods and analysis Phase 1: retrospective data analysis: quantitative analysis of ambulance service data will investigate: how often paramedics are called to older people with dementia; the amount of time paramedics spend on scene and the frequency with which these patients are transported to hospital. Phase 2: observational case studies: detailed case studies will be compiled using qualitative methods, including non-participant observation of paramedic decision-making, to understand why older people with multimorbidities including dementia are conveyed to A&E when they could be treated at home or in the community. Phase 3: needs analysis: nominal groups with paramedics will investigate and prioritise the resources that would allow emergency, urgent and out of hours care to be effectively delivered to these patients at home or in a community setting. Ethics and dissemination Approval for the study has been obtained from the Health Research Authority (HRA) with National Health Service (NHS) Research Ethics Committee approval for phase 2 (16/NW/0803). The dissemination strategy will include publishing findings in appropriate journals, at conferences and in newsletters. We will pay particular attention to dissemination to the public, dementia organisations and ambulance services.

Data quality and 30-day survival for out-of-hospital cardiac arrest in the UK out-of-hospital cardiac arrest registry: a data linkage study

Objectives The Out-of-Hospital Cardiac Arrest Outcomes (OHCAO) project aims to understand the epidemiology and outcomes of out-of-hospital cardiac arrest (OHCA) across the UK. This data linkage study is a subproject of OHCAO. The aim was to establish the feasibility of linking OHCAO data to National Health Service (NHS) patient demographic data and Office for National Statistics (ONS) date of death data held on the NHS Personal Demographics Service (PDS) database to improve OHCAO demographic data quality and enable analysis of 30-day survival from OHCA. Design and setting Data were collected from 1 January 2014 to 31 December 2014 as part of a prospective, observational study of OHCA attended by 10 English NHS Ambulance Services. 28 729 OHCA cases had resuscitation attempted by Emergency Medical Services and were included in the study. Data linkage was carried out using a data linkage service provided by NHS Digital, a national provider of health-related data. To assess data linkage feasibility a random sample of 3120 cases was selected. The sample was securely transferred to NHS Digital to be matched using OHCAO patient demographic data to return previously missing demographic data and provide ONS date of death data. Results A total of 2513 (80.5%) OHCAO cases were matched to patients in the NHS PDS database. Using the linkage process, missing demographic data were retrieved for 1636 (72.7%) out of 2249 OHCAO cases that had previously incomplete demographic data. Returned ONS date of death data allowed analysis of 30-day survival status. The results showed a 30-day survival rate of 9.3%, reducing unknown survival status from 46.1% to 8.5%. Conclusions In this sample, data linkage between the OHCAO registry and NHS PDS database was shown to be feasible, improving demographic data quality and allowing analysis of 30-day survival status.

How do people with dementia use the ambulance service? A retrospective study in England: the HOMEWARD project

Objectives An increasing number of older people are calling ambulances and presenting to accident and emergency departments. The presence of comorbidities and dementia can make managing these patients more challenging and hospital admission more likely, resulting in poorer outcomes for patients. However, we do not know how many of these patients are conveyed to hospital by ambulance. This study aims to determine: how often ambulances are called to older people; how often comorbidities including dementia are recorded; the reason for the call; provisional diagnosis; the amount of time ambulance clinicians spend on scene; the frequency with which these patients are transported to hospital. Methods We conducted a retrospective cross-sectional study of ambulance patient care records (PCRs) from calls to patients aged 65 years and over. Data were collected from two ambulance services in England during 24 or 48 hours periods in January 2017 and July 2017. The records were examined by two researchers using a standard template and the data were extracted from 3037 PCRs using a coding structure. Results Results were reported as percentages and means with 95% CIs. Dementia was recorded in 421 (13.9%) of PCRs. Patients with dementia were significantly less likely to be conveyed to hospital following an emergency call than those without dementia. The call cycle times were similar for patients regardless of whether or not they had dementia. Calls to people with dementia were more likely to be due to injury following a fall. In the overall sample, one or more comorbidities were reported on the PCR in over 80% of cases. Conclusion Rates of hospital conveyance for older people may be related to comorbidities, frailty and complex needs, rather than dementia. Further research is needed to understand the way in which ambulance clinicians make conveyance decisions at scene.

PARAMEDIC RESUSCITATION DECISION-MAKING IN OUT OF HOSPITAL CARDIAC ARREST: AN EXPLORATORY STUDY

Background There are approximately 60,000 out-of-hospital cardiac arrests (OHCA) in the United Kingdom (UK) each year. Within the UK there are well-established clinical practice guidelines that define when resuscitation should be commenced in OHCA, and when resuscitation should cease. This study explored the influences on paramedic decision-making when commencing and ceasing resuscitation attempts in OHCA. Methods Four focus groups were convened with 16 clinically active paramedics from emergency response vehicles and specialist teams as well as teaching and management staff. Four case vignettes were discussed in these focus groups to explore paramedic decision-making. The initial three focus groups were formulated to test and refine the research methodology and consisted of non-standard paramedics (i.e. those in management, teaching or specialist paramedic roles). The final focus group consisted of ‘standard’ paramedics. The focus group discussions were audio recorded and transcribed in full. Thematic analysis was used after the focus groups had taken place and for final reporting. Results There are three stages in the paramedic decision-making process when deciding whether to commence or cease resuscitation attempts in OHCA. These stages are: the call; arrival on scene; the protocol. Influential factors present at each of the three stages can lead to different decisions and variability in practice. These are: factual information available to the paramedic; structural factors such as protocol, guidance and research; cultural beliefs and values; interpersonal factors; risk factors; personal values and beliefs. Variations in context and circumstance are vast, and therefore simple guidance cannot suit every case. Conclusions An improved understanding of the circumstantial, individual and interpersonal factors that mediate the decision-making process in practice could inform the development of more effective guidelines, leading to greater consistency and paramedic confidence, with the potential for improved patient outcome.