Sarah Voss

Randomised comparison of the effectiveness of the laryngeal mask airway supreme, i-gel and current practice in the initial airway management of prehospital cardiac arrest (REVIVE-Airways): a feasibility study research protocol

Introduction Effective cardiopulmonary resuscitation with appropriate airway management improves outcomes following out-of-hospital cardiac arrest (OHCA). Historically, tracheal intubation has been accepted as the optimal form of OHCA airway management in the UK. The Joint Royal Colleges Ambulance Liaison Committee recently concluded that newer supraglottic airway devices (SADs) are safe and effective devices for hospital procedures and that their use in OHCA should be investigated. This study will address an identified gap in current knowledge by assessing whether it is feasible to use a cluster randomised design to compare SADs with current practice, and also to each other, during OHCA. Methods and analysis The primary objective of this study is to assess the feasibility of a cluster randomised trial to compare the ventilation success of two newer SADs: the i-gel and the laryngeal mask airway supreme to usual practice during the initial airway management of OHCA. The secondary objectives are to collect data on ventilation success, further airway interventions required, loss of a previously established airway during transport, airway management on arrival at hospital (or termination of the resuscitation attempt), initial resuscitation success, survival to intensive care admission, survival to hospital discharge and patient outcome at 3 months. Ambulance paramedics will be randomly allocated to one of the three methods of airway management. Adults in medical OHCA attended by a trial paramedic will be eligible for the study. Ethics and dissemination Approval for the study has been obtained from a National Health Service Research Ethics Committee with authority to review proposals for trials of a medical device in incapacitated adults. The results will be made publicly available on an open access website, and we will publish the findings in appropriate journals and present them at national and international conferences relevant to the subject field. Trial registration ISRCTN: 18528625.

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.

Randomised comparison of the effectiveness of the laryngeal mask airway supreme, i-gel and current practice in the initial airway management of out of hospital cardiac arrest: a feasibility study

BACKGROUND The best initial approach to advanced airway management during out of hospital cardiac arrest (OHCA) is unknown. The traditional role of tracheal intubation has been challenged by the introduction of supraglottic airway devices (SGAs), but there is contradictory evidence from observational studies. We assessed the feasibility of a cluster-randomized trial to compare the i-gel SGA vs the laryngeal mask airway supreme (LMAS) vs current practice during OHCA. METHODS We conducted a cluster-randomized trial in a single ambulance service in England, with individual paramedics as the unit of randomization. Consenting paramedics were randomized to use either the i-gel or the LMAS or usual practice for all patients with non-traumatic adult OHCA, that they attended over a 12-month period. The primary outcome was study feasibility, including paramedic and patient recruitment and protocol adherence. Secondary outcomes included survival to hospital discharge and 90 days. RESULTS Of the 535 paramedics approached, 184 consented and 171 attended study training. Each paramedic attended between 0 and 11 patients (median 3; interquartile range 2-5). We recruited 615 patients at a constant rate, although the LMAS arm was suspended in the final two months following three adverse incidents. The study protocol was adhered to in 80% of patients. Patient characteristics were similar in the three study arms, and there were no differences in secondary outcomes. CONCLUSION We have shown that a prospective trial of alternative airway management strategies in OHCA, cluster randomized by paramedic, is feasible. CLINICAL TRIAL REGISTRATION Registered on the International Standard Randomised Controlled Trial Registry ( ISRCTN 18528625).

How do paramedics manage the airway during out of hospital cardiac arrest

Aim The best method of initial airway management during resuscitation for out of hospital cardiac arrest (OHCA) is unknown. The airway management techniques used currently by UK paramedics during resuscitation for OHCA are not well documented. This study describes the airway management techniques used in the usual practice arm of the REVIVE-Airways feasibility study, and documents the pathway of interventions to secure and sustain ventilation during OHCA. Method Data were collected from OHCAs attended by paramedics participating in the REVIVE-Airways trial between March 2012 and February 2013. Patients were included if they were enrolled in the usual practice arm of the study, fulfilled the main study eligibility criteria and did not receive either of the intervention supraglottic airway devices during the resuscitation attempt. Results Data from 196 attempted resuscitations were included in the analysis. The initial approach to airway management was bag-mask for 108 (55%), a supraglottic airway device (SAD) for 39 (20%) and tracheal intubation for 49 (25%). Paramedics made further airway interventions in 64% of resuscitations. When intubation was the initial approach, there was no further intervention in 76% of cases; this compares to 16% and 44% with bag-mask and SAD respectively. The most common reason cited by paramedics for changing from bag-mask was to carry out advanced life support, followed by regurgitation and inadequate ventilation. Inadequate ventilation was the commonest reason cited for removing a SAD. Conclusion Paramedics use a range of techniques to manage the airway during OHCA, and as the resuscitation evolves. It is therefore desirable to ensure that a range of techniques and equipment, supported by effective training, are available to paramedics who attend OHCA.

Education about dementia in primary care: Is person-centredness the key?

Primary care is ideally placed to recognise and manage dementia and yet dementia can be overlooked or misattributed by primary care practitioners and is underdiagnosed. This might be explained by a lack of formal training in the diagnosis of dementia combined with a reluctance to diagnose due to its associated stigma. This paper describes focus group work with service users, carers and health professionals, conducted to develop an educational intervention for primary care promoting person-centred responses to people experiencing cognitive decline and dementia. Data was analysed thematically and four themes emerged: Reframing dementia as cognitive decline (Individual level); triggers for the recognition of dementia (Practitioner level); engaging the whole primary care team (Practice level); the relationship between primary and secondary care (Service level). Findings are discussed in the context of their contribution to challenging attitudes to dementia in primary care and the positive aspects of person-centred primary care for dementia.

Methods for evaluating cervical range of motion in trauma settings

Immobilisation of the cervical spine is a common procedure following traumatic injury. This is often precautionary as the actual incidence of spinal injury is low. Nonetheless, stabilisation of the head and neck is an important part of pre-hospital care due to the catastrophic damage that may follow if further unrestricted movement occurs in the presence of an unstable spinal injury. Currently available collars are limited by the potential for inadequate immobilisation and complications caused by pressure on the patient’s skin, restricted airway access and compression of the jugular vein. Alternative approaches to cervical spine immobilisation are being considered, and the investigation of these new methods requires a standardised approach to the evaluation of neck movement. This review summarises the research methods and scientific technology that have been used to assess and measure cervical range of motion, and which are likely to underpin future research in this field. A systematic search of international literature was conducted to evaluate the methodologies used to assess the extremes of movement that can be achieved in six domains. 34 papers were included in the review. These studies used a range of methodologies, but study quality was generally low. Laboratory investigations and biomechanical studies have gradually given way to methods that more accurately reflect the real-life situations in which cervical spine immobilisation occurs. Latterly, new approaches using virtual reality and simulation have been developed. Coupled with modern electromagnetic tracking technology this has considerable potential for effective application in future research. However, use of these technologies in real life settings can be problematic and more research is needed.

An exploration of the views of paramedics regarding airway management.

BackgroundParamedics are a skilled group of clinicians with expertise in airway management. Our research group has completed a trial comparing supraglottic airway devices with tracheal intubation during out of hospital cardiac arrest. This is a contentious topic amongst paramedics in the United Kingdom (UK). We explored the customs and beliefs of UK paramedics in relation to airway management, and whether tracheal intubation contributes to and sustains paramedic professional identity.MethodsThe study took place within South Western Ambulance Service NHS Foundation Trust. We used a qualitative approach, conducting interviews and focus groups with paramedics. The themes arising from interviews were discussed in focus groups, developing a deeper understanding and providing insight and recommendations for future research and policy. Purposive sampling accounted for differing training and for participation in the main trial. There were 17interviews and five focus groups with a further 17 participants. Data saturation was achieved.ResultsFour domains were identified. Pride - The ability to use a life-saving skill in austere conditions. Utility - Different training routes and experience have led to different attitudes towards airway management. Inconsistent expectations - Paramedics felt that there were different perceptions of their abilities amongst hospital staff and the general public. Professionalization - Debate over airway management is not founded on good evidence.ConclusionWe have demonstrated that UK paramedics have a wide range of views regarding airway management, and that these are based on evidence and experience rather than dogma. Airway management contributes to paramedics’ professional identity, but is not reliant on this.

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

The development and evaluation of an educational intervention for primary care promoting person-centred responses to dementia

Background Early diagnosis of dementia within primary care is important to allow access to support. However, dementia remains under-detected in general practice. Aim This work aimed to develop and evaluate an educational intervention for primary care promoting person-centred responses to people experiencing cognitive decline. Method A prototype educational intervention was pilot tested and refined; the final version of the educational intervention was then evaluated in four volunteer practices. A questionnaire was administered pre- and post-training to 94 practice staff to assess knowledge and attitudes to dementia. The responses of general practitioners (who make diagnostic, referral and treatment decisions) were compared with those from other staff who do not have such roles. Findings Post-training, there were statistically significant improvements in understanding of person-centred care for people with dementia; attitudes to early diagnosis; awareness of non-cognitive dementia symptoms; and awareness of the role that non-clinical staff may have in recognising dementia. Conclusions A dementia education intervention for primary care which fosters person-centred attitudes can involve all members of a primary care team. Further research is needed to ascertain if improvements in knowledge and attitudes translate into improved practice.

Psychological wellbeing in survivors of cardiac arrest, and its relationship to neurocognitive function

OBJECTIVE To characterise psychological wellbeing in survivors of out-of-hospital cardiac arrest (OHCA), and examine its relationship to cognitive function. PATIENTS Forty-one highly functioning cardiac arrest survivors were drawn from the follow-up cohort of a randomised controlled trial of initial airway management in OHCA (ISRCTN:18528625). DESIGN Psychological wellbeing was assessed with a self-report questionnaire (the Depression Anxiety and Stress Scale; DASS) and cognitive function was examined using the Delayed Matching to Samples (DMS) test from the Cambridge Neuropsychological Test Automated Battery (CANTAB). RESULTS Mean anxiety levels were significantly higher in this patient group than normative data drawn from the general population (p=0.046). Multiple regression analyses showed that cognitive function, measured by the DMS, did not predict any of the DASS scales. CONCLUSIONS Anxiety plays an important role in determining perceived QoL in high functioning survivors, but psychological wellbeing is unrelated to cognitive function in this group. To achieve a comprehensive assessment of wellbeing, resuscitation research should consider outcomes beyond neurological function alone.