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STUDY OBJECTIVE: Chest pain is one of the most common reasons for emergency ambulance calls. Patients are routinely transported to the hospital to prevent acute myocardial infarction (AMI). We evaluated the diagnostic accuracy of clinical pathways in the out-of-hospital environment. The Troponin-only Manchester Acute Coronary Syndromes decision aid and History, ECG, Age, Risk Factors, Troponin score require cardiac troponin (cTn) measurement, whereas the History and ECG-only Manchester Acute Coronary Syndromes decision aid and History, ECG, Age, Risk Factors score do not. METHODS: We conducted a prospective diagnostic accuracy study at 4 ambulance services and 12 emergency departments between February 2019 and March 2020. We included patients who received an emergency ambulance response in whom paramedics suspected AMI. Paramedics recorded the data required to calculate each decision aid and took venous blood samples in the out-of-hospital environment. Samples were tested using a point-of-care cTn assay (Roche cobas h232) within 4 hours. The target condition was a diagnosis of type 1 AMI, adjudicated by 2 investigators. RESULTS: Of 817 included participants, 104 (12.8%) had AMI. Setting the cutoff at the lowest risk group, Troponin-only Manchester Acute Coronary Syndromes had 98.3% sensitivity (95% confidence interval 91.1% to 100%) and 25.5% specificity (21.4% to 29.8%) for type 1 AMI. History, ECG, Age, Risk Factors, Troponin had 86.4% sensitivity (75.0% to 98.4%) and 42.2% specificity (37.5% to 47.0%); History and ECG-only Manchester Acute Coronary Syndromes had 100% sensitivity (96.4% to 100%) and 3.1% specificity (1.9% to 4.7%), whereas History, ECG, Age, Risk Factors had 95.1% sensitivity (88.9% to 98.4%) and 12.1% specificity (9.8% to 14.8%). CONCLUSION: With point-of-care cTn testing, decision aids can identify patients at a low risk of type 1 AMI in the out-of-hospital environment. When used alongside clinical judgment, and with appropriate training, such tools may usefully enhance out-of-hospital risk stratification.
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Síndrome Coronariana Aguda , Infarto do Miocárdio , Humanos , Síndrome Coronariana Aguda/diagnóstico , Procedimentos Clínicos , Estudos Prospectivos , Infarto do Miocárdio/diagnóstico , Troponina , HospitaisRESUMO
OBJECTIVES: The Manchester Acute Coronary Syndromes ECG (MACS-ECG) prediction model calculates a score based on objective ECG measurements to give the probability of a non-ST elevation myocardial infarction (NSTEMI). The model showed good performance in the emergency department (ED), but its accuracy in the pre-hospital setting is unknown. We aimed to externally validate MACS-ECG in the pre-hospital environment. METHODS: We undertook a secondary analysis from the Pre-hospital Evaluation of Sensitive Troponin (PRESTO) study, a multi-centre prospective study to validate decision aids in the pre-hospital setting (26 February 2019 to 23 March 2020). Patients with chest pain where the treating paramedic suspected acute coronary syndrome were included. Paramedics collected demographic and historical data and interpreted ECGs contemporaneously (as 'normal' or 'abnormal'). After completing recruitment, we analysed ECGs to calculate the MACS-ECG score, using both a pre-defined threshold and a novel threshold that optimises sensitivity to differentiate AMI from non-AMI. This was compared with subjective ECG interpretation by paramedics. The diagnosis of AMI was adjudicated by two investigators based on serial troponin testing in hospital. RESULTS: Of 691 participants, 87 had type 1 AMI and 687 had complete data for paramedic ECG interpretation. The MACS-ECG model had a C-index of 0.68 (95% CI: 0.61 to 0.75). At the pre-determined cut-off, MACS-ECG had 2.3% (95% CI: 0.3% to 8.1%) sensitivity, 99.5% (95% CI: 98.6% to 99.9%) specificity, 40.0% (95% CI: 10.2% to 79.3%) positive predictive value (PPV) and 87.6% (87.3% to 88.0%) negative predictive value (NPV). At the optimal threshold for sensitivity, MACS-ECG had 50.6% sensitivity (39.6% to 61.5%), 83.1% specificity (79.9% to 86.0%), 30.1% PPV (24.7% to 36.2%) and 92.1% NPV (90.4% to 93.5%). In comparison, paramedics had a sensitivity of 71.3% (95% CI: 60.8% to 80.5%) with 53.8% (95% CI: 53.8% to 61.8%) specificity, 19.7% (17.2% to 22.45%) PPV and 93.3% (90.8% to 95.1%) NPV. CONCLUSION: Neither MACS-ECG nor paramedic ECG interpretation had a sufficiently high PPV or NPV to 'rule in' or 'rule out' NSTEMI alone.
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Síndrome Coronariana Aguda , Infarto do Miocárdio sem Supradesnível do Segmento ST , Humanos , Síndrome Coronariana Aguda/diagnóstico , Troponina T , Estudos Prospectivos , Técnicas de Apoio para a Decisão , Troponina , Serviço Hospitalar de Emergência , Hospitais , Eletrocardiografia , Dor no Peito/diagnóstico , Sensibilidade e EspecificidadeRESUMO
BACKGROUND: Tranexamic acid (TXA) is an antifibrinolytic drug used to prevent bleeding. It was introduced as an intervention for post-traumatic haemorrhage across emergency medical services (EMS) in the UK during 2012. However, despite strong evidence of effectiveness, prehospital TXA administration rates are low. This study used the theoretical domains framework (TDF) to identify barriers and facilitators to the administration of TXA to trauma patients by EMS providers (paramedics) in the UK. METHODS: Interviews were completed with 18 UK paramedics from a single EMS provider organisation. A convenience sampling approach was used, and interviews continued until thematic saturation was reached. Semistructured telephone interviews explored paramedics' experiences of administering TXA to trauma patients, including identifying whether or not patients were at risk of bleeding. Data were analysed inductively using thematic analysis (stage 1). Themes were mapped to the theoretical domains of the TDF to identify behavioural theory-derived barriers and facilitators to the administration of TXA to trauma patients (stage 2). Belief statements were identified and assessed for importance according to prevalence, discordance and evidence base (stage 3). RESULTS: Barriers and facilitators to paramedics' administration of TXA to trauma patients were represented by 11 of the 14 domains of the TDF. Important barriers included a lack of knowledge and experience with TXA (Domain: Knowledge and Skills), confusion and restrictions relating to the guidelines for TXA administration (Domain: Social/professional role and identity), a lack of resources (Domain: Environmental context and resources) and difficulty in identifying patients at risk of bleeding (Domain: Memory, attention and decision processes). CONCLUSIONS: This study presents a behavioural theory-based approach to identifying barriers and facilitators to the prehospital administration of TXA to trauma patients in the UK. It identifies multiple influencing factors that may serve as a basis for developing an intervention to increase prehospital administration of TXA.
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Antifibrinolíticos , Serviços Médicos de Emergência , Ácido Tranexâmico , Pessoal Técnico de Saúde , Antifibrinolíticos/uso terapêutico , Hemorragia/tratamento farmacológico , Humanos , Pesquisa Qualitativa , Ácido Tranexâmico/uso terapêuticoRESUMO
OBJECTIVE: Patient and family liaison practitioners are a relatively recent addition to UK helicopter emergency medical services to support patients with their recovery. A service evaluation was completed that mapped the current provision of patient and family liaison practitioner roles in helicopter emergency medical services in the United Kingdom. METHODS: An online survey was distributed to key stakeholders involved with UK helicopter emergency medical service patient and family liaison practitioner roles. Quantitative survey results were described, and open-ended questions were analyzed using content analysis. RESULTS: Twenty UK helicopter emergency medical services responded to the survey. Nine of these services employ patient and family liaison practitioners with 4 additional helicopter emergency medical services planning to initiate the role. There is variation in the employment models used between the services. The patient and family liaison practitioner role provides important benefits to patients and their families, clinicians, and the helicopter emergency medical service. CONCLUSION: Nine UK helicopter emergency medical services employ patient and family liaison practitioners. This role benefits patients, their families, helicopter emergency medical service clinicians, and helicopter emergency medical service charities. Further research is required to understand how the role works in practice and to understand how to maximize the benefits to stakeholders.
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Resgate Aéreo , Serviços Médicos de Emergência , Aeronaves , Humanos , Inquéritos e Questionários , Reino UnidoRESUMO
BACKGROUND: Paramedics are increasingly required to make complex decisions as to whether they should convey a patient to hospital or manage their condition at the scene. Dementia can be a significant barrier to the assessment process. However, to our knowledge no research has specifically examined the process of decision-making by paramedics in relation to people with dementia. This qualitative study was designed to investigate the factors influencing the decision-making process during Emergency Medical Services (EMS) calls to older people with dementia who did not require immediate clinical treatment. METHODS: This qualitative study used a combination of observation, interview and document analysis to investigate the factors influencing the decision-making process during EMS calls to older people with dementia. A researcher worked alongside paramedics in the capacity of observer and recruited eligible patients to participate in case studies. Data were collected from observation notes of decision-making during the incident, patient care records and post incident interviews with participants, and analysed thematically. FINDINGS: Four main themes emerged from the data concerning the way that paramedics make conveyance decisions when called to people with dementia: 1) Physical condition; the key factor influencing paramedics' decision-making was the physical condition of the patient. 2) Cognitive capacity; most of the participants preferred not to remove patients with a diagnosis of dementia from surroundings familiar to them, unless they deemed it absolutely essential. 3) Patient circumstances; this included the patient's medical history and the support available to them. 4) Professional influences; participants also drew on other perspectives, such as advice from colleagues or information from the patient's General Practitioner, to inform their decision-making. CONCLUSION: The preference for avoiding unnecessary conveyance for patients with dementia, combined with difficulties in obtaining an accurate patient medical history and assessment, mean that decision-making can be particularly problematic for paramedics. Further research is needed to find reliable ways of assessing patients and accessing information to support conveyance decisions for EMS calls to people with dementia.
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Tomada de Decisões , Demência/epidemiologia , Auxiliares de Emergência/psicologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Cognição , Feminino , Nível de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Pesquisa Qualitativa , Adulto JovemRESUMO
BACKGROUND: Hyperoxia following out of hospital cardiac arrest (OHCA) is associated with a poor outcome. Animal data suggest the first hour post resuscitation may be the most important. In the UK the first hour usually occurs in the prehospital environment. METHODS: A prospective controlled trial, cluster randomised by paramedic, comparing titrated oxygen with 100% oxygen for the first hour after return of spontaneous circulation (ROSC) following OHCA. The trial was done in a single emergency medical services (EMS) system in the United Kingdom (UK) admitting patients to three emergency departments. This was a feasibility trial to determine whether EMS staff (UK paramedics) can be successfully recruited and deliver the intervention. RESULTS: One hundred and fifty seven paramedics were approached and 46 (29%) were consented, randomised and trained. During the study period 624 patients received a resuscitation attempt. A study paramedic was in attendance at 73 (12%) of these active resuscitations. Thirty-five patients were recruited to the trial, 32 (91%) were transported to hospital and 13 (37%) survived to 90 days. The intervention was initiated in 27/35 (77%) of enrolled patients. A reliable oxygen saturation trace was obtained in 22/35 (69%) of patients. Data collection was complete in 33/35 (94%) of patients. CONCLUSIONS: It may be feasible to complete a randomised trial of titrated versus unrestricted oxygen in the first hour after ROSC following OHCA in the UK. However, the relatively few eligible patients and incomplete initiation of the allocated intervention are challenges to future research. TRIAL REGISTRATION: ISRCTN 49548506 retrospectively registered on 24.11.2016.
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Serviços Médicos de Emergência/métodos , Parada Cardíaca Extra-Hospitalar/fisiopatologia , Parada Cardíaca Extra-Hospitalar/terapia , Oxigênio/administração & dosagem , Idoso , Circulação Sanguínea , Reanimação Cardiopulmonar , Estudos de Viabilidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Oxigênio/sangue , Estudos Prospectivos , Taxa de Sobrevida , Fatores de TempoRESUMO
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.
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Manuseio das Vias Aéreas/métodos , Glote , Intubação Intratraqueal/métodos , Parada Cardíaca Extra-Hospitalar/terapia , Idoso , Idoso de 80 Anos ou mais , Manuseio das Vias Aéreas/instrumentação , Pessoal Técnico de Saúde , Reanimação Cardiopulmonar , Inglaterra , Feminino , Humanos , Intubação Intratraqueal/instrumentação , Masculino , Pessoa de Meia-Idade , Parada Cardíaca Extra-Hospitalar/mortalidade , Taxa de Sobrevida , Resultado do TratamentoRESUMO
This study examines trends in adolescent substance use disorders (SUDs) and treatment utilization in the US using data from the National Household Survey on Drug Use and Health (NSDUH) and data from the National Survey of Substance Abuse Treatment Services (N-SSATS). Results indicate an overall decrease in the percent of adolescents meeting past year criteria for an alcohol or illicit drug disorder between 2003 and 2010, but the percent of adolescents meeting criteria who had not received any treatment in the past year was substantial and has remained stable since 2003. In 2010, less than 30% of facilities participating in the N-SSATS survey indicated that they offered special programming for adolescents, reflecting an overall decrease since 2003.
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Background: There are increasing demands on Emergency Medical Services. More efficient treatment pathways are required to support conveyance decision making and patient referral in prehospital care. Point of Care testing is increasingly available and utilised across the NHS to support optimal ways of working. We aimed to design and conduct a Multiple Criteria Decision Analysis to prioritise in vitro point of care tests and use cases for inclusion in a platform trial of in vitro point of care testing in UK Emergency Medical Services. Methods: We designed a Multiple Criteria Decision Analysis that included systematic scoping reviews stakeholder recruitment, two stakeholder surveys and two stakeholder workshops to scope the use cases, explore criteria and map use cases, evaluate the criteria and measure the use cases against the criteria. Results: We recruited 32 stakeholders. We developed a scoring matrix with 4 criteria for scoring the use cases and 8 criteria for scoring the point of care tests and applied weighting determined from survey results. Use cases were scored by the stakeholders against 4 criteria. The 3 highest scoring use cases were point of care troponin testing in: possible Acute Myocardial Infarction, lactate testing in suspected sepsis and in trauma. We developed the process for scoring the point of care tests to be completed close to a proposed trial to allow for a changes in technology. Conclusions: We successfully designed a Multiple Criteria Decision Analysis to identify use cases and candidate tests for inclusion in a future platform trial of in vitro point of care testing in UK Emergency Medical Services. We identified 3 use cases for evaluation in a platform trial of in vitro point of care testing: troponin testing in possible acute myocardial infarction, lactate testing in suspected sepsis and lactate testing to identify occult haemorrhage in trauma.
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OBJECTIVES: To examine inequalities in birth before arrival (BBA) at hospitals in South West England, understand which groups are most likely to experience BBA and how this relates to hypothermia and outcomes (phase A). To investigate opportunities to improve temperature management advice given by emergency medical services (EMS) call-handlers during emergency calls regarding BBA in the UK (phase B). DESIGN: A two-phase multimethod study. Phase A analysed anonymised data from hospital neonatal records between January 2018 and January 2021. Phase B analysed anonymised EMS call transcripts, followed by focus groups with National Health Service (NHS) staff and patients. SETTING: Six Hospital Trusts in South West England and two EMS providers (ambulance services) in South West and North East England. PARTICIPANTS: 18 multidisciplinary NHS staff and 22 members of the public who had experienced BBA in the UK. RESULTS: 35% (64/184) of babies conveyed to hospital were hypothermic on arrival. When compared with national data on all births in the South West, we found higher percentages of women with documented safeguarding concerns at booking, previous live births and 'late bookers' (booking their pregnancy >13 weeks gestation). These women may, therefore, be more likely to experience BBA. Preterm babies, babies to first-time mothers and babies born to mothers with disability or safeguarding concerns at booking were more likely to be hypothermic following BBA. Five main themes emerged from qualitative data on call-handler advice: (1) importance placed on neonatal temperature; (2) advice on where the baby should be placed following birth; (3) advice on how to keep the baby warm; (4) timing of temperature management advice and (5) clarity and priority of instructions. CONCLUSIONS: Findings identified factors associated with BBA and neonatal hypothermia following BBA. Improvements to EMS call-handler advice could reduce the number of babies arriving at hospital hypothermic.
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Serviços Médicos de Emergência , Hipotermia , Humanos , Inglaterra , Hipotermia/terapia , Recém-Nascido , Feminino , Serviços Médicos de Emergência/estatística & dados numéricos , Gravidez , Adulto , Masculino , Grupos FocaisRESUMO
Introduction: There is little research on the triage of patients who are not yet in cardiac arrest when the emergency call is initiated, but who deteriorate and suffer a cardiac arrest during the prehospital phase of care. The aim of this study was to investigate Emergency Operation Centre staff views on ways to improve the early identification of patients who are at imminent risk of cardiac arrest, and the barriers to achieving this. Methods: A qualitative interview and focus group study was conducted in two large Emergency Medical Services in England, United Kingdom. Twelve semi-structured interviews and one focus group were completed with Emergency Operations Centre staff. Data were analysed using reflexive thematic analysis. Results: Three main themes were identified: The dispatch protocol and call-taker audit; Identifying and responding to deteriorating patients; Education, knowledge and skills. Barriers to recognising patients at imminent risk of cardiac arrest include a restrictive dispatch protocol, limited opportunity to monitor a patient, compliance auditing and inadequate education. Clinician support is not always optimal, and a lack of patient outcome feedback restricts dispatcher learning and development. Suggested remedies include improvements in training and education (call-takers and the public), software, clinical support and patient outcome feedback. Conclusions: Emergency Operation Centre staff identified a multitude of ways to improve the identification of patients who are at imminent risk of out-of-hospital cardiac arrest during the Emergency Medical Service call. Suggested areas for improvement include education, triage software, clinical support redesign and patient outcome feedback.
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OBJECTIVE: In the UK there are around 5400 deaths annually from injury. Tranexamic acid (TXA) prevents bleeding and has been shown to reduce trauma mortality. However, only 5% of UK major trauma patients who are at risk of haemorrhage receive prehospital TXA. This review aims to examine the evidence regarding factors influencing the prehospital administration of TXA to trauma patients. DESIGN: Systematic literature review. DATA SOURCES: AMED, CENTRAL, CINAHL, Cochrane Database of Systematic Reviews, Conference Proceedings Citation Index-Science, Embase and MEDLINE were searched from January 2010 to 2020; searches were updated in June 2022. CLINICALTRIALS: gov and OpenGrey were also searched and forward and backwards citation chasing performed. ELIGIBILITY CRITERIA: All primary research reporting factors influencing TXA administration to trauma patients in the prehospital setting was included. DATA EXTRACTION AND SYNTHESIS: Two independent reviewers performed the selection process, quality assessment and data extraction. Data were tabulated, grouped by setting and influencing factor and synthesised narratively. RESULTS: Twenty papers (278 249 participants in total) were included in the final synthesis; 13 papers from civilian and 7 from military settings. Thirteen studies were rated as 'moderate' using the Effective Public Health Practice Project Quality Assessment Tool. Several common factors were identified: knowledge and skills; consequences and social influences; injury type (severity, injury site and mechanism); protocols; resources; priorities; patient age; patient sex. CONCLUSIONS: This review highlights an absence of high-quality research. Preliminary evidence suggests a host of system and individual-level factors that may be important in determining whether TXA is administered to trauma patients in the prehospital setting. FUNDING AND REGISTRATION: This review was supported by Research Capability Funding from the South Western Ambulance Service NHS Foundation Trust and the National Institute for Health Research Applied Research Collaboration South West Peninsula. PROSPERO REGISTRATION NUMBER: CRD42020162943.
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Antifibrinolíticos , Serviços Médicos de Emergência , Ácido Tranexâmico , Humanos , Ácido Tranexâmico/uso terapêutico , Antifibrinolíticos/uso terapêutico , Hemorragia/tratamento farmacológico , Serviços Médicos de Emergência/métodosRESUMO
Background: Following the emergence of COVID-19, there have been local and national changes in the way emergency medical service (EMS) staff respond to and treat patients in out-of-hospital cardiac arrest (OHCA). The views of EMS staff on the impact of COVID-19 and management of OHCA have not previously been explored. This study aimed to explore the views of staff, with a specific focus on communication during resuscitation, resuscitation procedures and the perception of risk. Methods: A qualitative phenomenological enquiry was conducted. A purposive sample of n = 20 participants of various clinical grades was selected from NHS EMS providers in the United Kingdom. Data were collected using semi-structured interviews, transcribed verbatim and inductive thematic analysis was applied. Results: Three main themes emerged which varied according to clinical grade, location and guidelines.Decision making: Staff generally felt supported to make best-interest termination of resuscitation decisions. Staff made informed decisions to compromise on recommended levels of personal protective equipment (PPE), since it felt impractical in the pre-hospital context, to improve communication or to reduce delays to care.Service pressures: Availability of operational staff and in-hospital capacity were reduced. Staff felt pressure and disconnect from the continuous updates to clinical guidelines which resulted in organisational change fatigue.Moral injury: The emotional impacts of prolonged and frequent exposure to failed resuscitation attempts and patient death caused many staff to take time away from work to recover. Conclusion: This qualitative study is the first known to explore staff views on the impacts of COVID-19 on OHCA resuscitation, which found positive outcomes but also negative impacts important to inform EMS systems. Staff felt that COVID-19 created delays to the delivery of resuscitation, which were multi-faceted. Staff developed new ways of working to overcome the barriers of impractical PPE. There was little impact on resuscitation procedures. Moving forwards, EMS should consider how to limit organisational change and better support the ongoing emotional impacts on staff.
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BACKGROUND: When a cardiac arrest occurs, cardiopulmonary resuscitation should be started immediately. However, there is limited evidence about the best approach to airway management during cardiac arrest. OBJECTIVE: The objective was to determine whether or not the i-gel® (Intersurgical Ltd, Wokingham, UK) supraglottic airway is superior to tracheal intubation as the initial advanced airway management strategy in adults with non-traumatic out-of-hospital cardiac arrest. DESIGN: This was a pragmatic, open, parallel, two-group, multicentre, cluster randomised controlled trial. A cost-effectiveness analysis accompanied the trial. SETTING: The setting was four ambulance services in England. PARTICIPANTS: Patients aged ≥ 18 years who had a non-traumatic out-of-hospital cardiac arrest and were attended by a participating paramedic were enrolled automatically under a waiver of consent between June 2015 and August 2017. Follow-up ended in February 2018. INTERVENTION: Paramedics were randomised 1 : 1 to use tracheal intubation (764 paramedics) or i-gel (759 paramedics) for their initial advanced airway management and were unblinded. MAIN OUTCOME MEASURES: The primary outcome was modified Rankin Scale score at hospital discharge or 30 days after out-of-hospital cardiac arrest, whichever occurred earlier, collected by assessors blinded to allocation. The modified Rankin Scale, a measure of neurological disability, was dichotomised: a score of 0-3 (good outcome) or 4-6 (poor outcome/death). The primary outcome for the economic evaluation was quality-adjusted life-years, estimated using the EuroQol-5 Dimensions, five-level version. RESULTS: A total of 9296 patients (supraglottic airway group, 4886; tracheal intubation group, 4410) were enrolled [median age 73 years; 3373 (36.3%) women]; modified Rankin Scale score was known for 9289 patients. Characteristics were similar between groups. A total of 6.4% (311/4882) of patients in the supraglottic airway group and 6.8% (300/4407) of patients in the tracheal intubation group had a good outcome (adjusted difference in proportions of patients experiencing a good outcome: -0.6%, 95% confidence interval -1.6% to 0.4%). The supraglottic airway group had a higher initial ventilation success rate than the tracheal intubation group [87.4% (4255/4868) vs. 79.0% (3473/4397), respectively; adjusted difference in proportions of patients: 8.3%, 95% confidence interval 6.3% to 10.2%]; however, patients in the tracheal intubation group were less likely to receive advanced airway management than patients in the supraglottic airway group [77.6% (3419/4404) vs. 85.2% (4161/4883), respectively]. Regurgitation rate was similar between the groups [supraglottic airway group, 26.1% (1268/4865); tracheal intubation group, 24.5% (1072/4372); adjusted difference in proportions of patients: 1.4%, 95% confidence interval -0.6% to 3.4%], as was aspiration rate [supraglottic airway group, 15.1% (729/4824); tracheal intubation group, 14.9% (647/4337); adjusted difference in proportions of patients: 0.1%, 95% confidence interval -1.5% to 1.8%]. The longer-term outcomes were also similar between the groups (modified Rankin Scale: at 3 months, odds ratio 0.89, 95% confidence interval 0.69 to 1.14; at 6 months, odds ratio 0.91, 95% confidence interval 0.71 to 1.16). Sensitivity analyses did not alter the overall findings. There were no unexpected serious adverse events. Mean quality-adjusted life-years to 6 months were 0.03 in both groups (supraglottic airway group minus tracheal intubation group difference -0.0015, 95% confidence interval -0.0059 to 0.0028), and total costs were £157 (95% confidence interval -£270 to £583) lower in the tracheal intubation group. Although the point estimate of the incremental cost-effectiveness ratio suggested that tracheal intubation may be cost-effective, the huge uncertainty around this result indicates no evidence of a difference between groups. LIMITATIONS: Limitations included imbalance in the number of patients in each group, caused by unequal distribution of high-enrolling paramedics; crossover between groups; and the fact that participating paramedics, who were volunteers, might not be representative of all paramedics in the UK. Findings may not be applicable to other countries. CONCLUSION: Among patients with out-of-hospital cardiac arrest, randomisation to the supraglottic airway group compared with the tracheal intubation group did not result in a difference in outcome at 30 days. There were no notable differences in costs, outcomes and overall cost-effectiveness between the groups. FUTURE WORK: Future work could compare alternative supraglottic airway types with tracheal intubation; include a randomised trial of bag mask ventilation versus supraglottic airways; and involve other patient populations, including children, people with trauma and people in hospital. TRIAL REGISTRATION: This trial is registered as ISRCTN08256118. FUNDING: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and supported by the NIHR Comprehensive Research Networks and will be published in full in Health Technology Assessment; Vol. 26, No. 21. See the NIHR Journals Library website for further project information.
BACKGROUND: Cardiac arrest is a serious medical emergency in which the heartbeat and breathing stop suddenly. Every year in the UK, a large number of patients (around 123 per 100,000) suffer a cardiac arrest outside hospital. Only 79% of these patients survive to leave hospital. The best initial treatment in cardiac arrest is cardiopulmonary resuscitation (commonly known as CPR), during which it is vital to give chest compressions and maintain a clear airway. Two main techniques are used to keep the airway clear: tracheal intubation (inserting a breathing tube into the windpipe) and a supraglottic airway device (a newer device that is inserted less deeply and sits just above the voicebox). Both techniques are used routinely by paramedics in the UK when treating a cardiac arrest, but there is no evidence about which technique is best. The AIRWAYS-2 trial aimed to find out whether or not a supraglottic airway device is better than tracheal intubation. WHO PARTICIPATED AND WHAT WAS INVOLVED?: Paramedics from four UK ambulance services were put into one of two groups at random. One group was randomly chosen to use tracheal intubation and the other group was randomly chosen to use a supraglottic airway device at all adult cardiac arrests they attended for approximately 2 years. Paramedics were able to apply their clinical judgement and use a different device if they felt that this would be best for the patient. A total of 1523 paramedics took part and enrolled 9296 patients. Following cardiac arrest, a patient's recovery was assessed as good or poor (including patients who did not survive). WHAT DID THE TRIAL FIND?: A similar percentage of patients in both groups had a good recovery. There was no evidence to suggest that the supraglottic airway device was any better than tracheal intubation for treating a cardiac arrest.
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Reanimação Cardiopulmonar , Parada Cardíaca Extra-Hospitalar , Adulto , Idoso , Manuseio das Vias Aéreas , Criança , Análise Custo-Benefício , Feminino , Humanos , Intubação Intratraqueal/métodos , Masculino , Parada Cardíaca Extra-Hospitalar/terapia , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de VidaRESUMO
Friedreich's ataxia (FRDA) is a neurodegenerative disorder arising from a deficit of the mitochondrial iron chaperone, frataxin. Evidence primarily from yeast and mammalian cells is consistent with the hypothesis that a toxic hydroxyl radical generated from hydrogen peroxide (H2O2) via iron-catalyzed Fenton chemistry at least partially underlies the pathology associated with this disease. However, no whole-organism studies have been presented that directly test this hypothesis. We recently developed a Drosophila model that recapitulates the principal hallmarks of FRDA [Anderson PR, Kirby K, Hilliker A, Phillips JP (2005) Hum Mol Genet 14:3397-3405]. Using the Drosophila FRDA model, we now report that ectopic expression of enzymes that scavenge H2O2 suppresses the deleterious phenotypes associated with frataxin deficiency. In contrast, genetic augmentation with enzymes that scavenge superoxide is without effect. Augmentation of endogenous catalase restores the activity of the reactive oxygen species (ROS)-sensitive mitochondrial enzyme, aconitase and enhances resistance to H2O2 exposure, both of which are diminished by frataxin deficiency. Collectively, these data argue that H2O2 is an important pathogenic substrate underlying the phenotypes arising from frataxin deficiency in Drosophila and that interventions that reduce this specific ROS can effectively ameliorate these phenotypes. The therapeutic implications of these findings are clear and we believe warrant immediate clinical investigation.
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Antioxidantes/farmacologia , Catalase/química , Drosophila melanogaster/genética , Ataxia de Friedreich/genética , Peróxido de Hidrogênio/farmacologia , Proteínas de Ligação ao Ferro/genética , Proteínas de Ligação ao Ferro/fisiologia , Mitocôndrias/enzimologia , Animais , Catalase/metabolismo , Catálise , Densitometria , Modelos Animais de Doenças , Drosophila melanogaster/fisiologia , Sequestradores de Radicais Livres/farmacologia , Ferro/química , Ferro/farmacologia , Longevidade , Mitocôndrias/metabolismo , Espécies Reativas de Oxigênio , FrataxinaRESUMO
AIM: To identify and appraise evidence relating to the features of an Emergency Medicine System call interaction that enable, or inhibit, an Emergency Medical Dispatcher's recognition that a patient is in out-of-hospital cardiac arrest, or at imminent risk of out-of-hospital cardiac arrest. METHODS: All study designs were eligible for inclusion. Data sources included Medline, BNI, CINAHL, EMBASE, PubMed, Cochrane Database of Systematic Reviews, AMED and OpenGrey. Stakeholder resources were screened and experts in resuscitation were asked to review the studies identified. Studies were appraised using the Mixed Methods Appraisal Tool. Synthesis was completed using a segregated mixed research synthesis approach. RESULTS: Thirty-two studies were included in the review. Three main themes were identified: Key features of the Emergency Medical Service call interaction; Managing the Emergency Medical Service call; Emotional distress. CONCLUSION: A dominant finding is the difficulty in recognising abnormal/agonal breathing during the Emergency Medical Service call. The interaction between the caller and the Emergency Medical Dispatcher is critical in the recognition of patients who suffer an out-of-hospital cardiac arrest. Emergency Medical Dispatchers adapt their approach to the Emergency Medical Service call, and regular training for Emergency Medical Dispatchers is recommended to optimise out-of-hospital cardiac arrest recognition. Further research is required with a focus on the Emergency Medical Service call interaction of patients who are alive at the time of the Emergency Medical Service call and who later deteriorate into OHCA.PROSPERO registration: CRD42019155458.
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AIM: Optimal airway management during out-of-hospital cardiac arrest (OHCA) is uncertain. Complications from tracheal intubation (TI) may be avoided with supraglottic airway (SGA) devices. The AIRWAYS-2 cluster randomised controlled trial (ISRCTN08256118) compared the i-gel SGA with TI as the initial advanced airway management (AAM) strategy by paramedics treating adults with non-traumatic OHCA. This paper reports the trial cost-effectiveness analysis. METHODS: A within-trial cost-effectiveness analysis of the i-gel compared with TI was conducted, with a six-month time horizon, from the perspective of the UK National Health Service (NHS) and personal social services. The primary outcome measure was quality-adjusted life years (QALYs), estimated using the EQ-5D-5L questionnaire. Multilevel linear regression modelling was used to account for clustering by paramedic when combining costs and outcomes. RESULTS: 9296 eligible patients were attended by 1382 trial paramedics and enrolled in the AIRWAYS-2 trial (4410 TI, 4886 i-gel). Mean QALYs to six months were 0.03 in both groups (i-gel minus TI difference -0.0015, 95% CI -0.0059 to 0.0028). Total costs per participant up to six months post-OHCA were £3570 and £3413 in the i-gel and TI groups respectively (mean difference £157, 95% CI -£270 to £583). Based on mean difference point estimates, TI was more effective and less costly than i-gel; however differences were small and there was great uncertainty around these results. CONCLUSION: The small differences between groups in QALYs and costs shows no difference in the cost-effectiveness of the i-gel and TI when used as the initial AAM strategy in adults with non-traumatic OHCA.
Assuntos
Reanimação Cardiopulmonar , Serviços Médicos de Emergência , Parada Cardíaca Extra-Hospitalar , Adulto , Análise Custo-Benefício , Humanos , Intubação Intratraqueal , Parada Cardíaca Extra-Hospitalar/terapia , Medicina EstatalRESUMO
BACKGROUND: General practice in the UK faces continuing challenges to balance a workforce shortage against rising demand. The NHS England GP Forward View proposes development of the multidisciplinary, integrated primary care workforce to support frontline service delivery, including the employment of paramedics. However, very little is known about the safety, clinical effectiveness, or cost-effectiveness of paramedics working in general practice. Research is needed to understand the potential benefits and drawbacks of this model of workforce organisation. AIM: To understand how paramedics are deployed in general practice, and to investigate the theories and drivers that underpin this service development. DESIGN & SETTING: A mixed-methods study using a literature review, national survey, and qualitative interviews. METHOD: A three-phase study was undertaken that consisted of: a literature review and survey; meetings with key informants (KIs); and direct enquiry with relevant staff stakeholders (SHs). RESULTS: There is very little evidence on the safety and cost-effectiveness of paramedics working in general practice and significant variation in the ways that paramedics are deployed, particularly in terms of the patients seen and conditions treated. Nonetheless, there is a largely positive view of this development and a perceived reduction in GP workload. However, some concerns centre on the time needed from GPs to train and supervise paramedic staff. CONCLUSION: The contribution of paramedics in general practice has not been fully evaluated. There is a need for research that takes account of the substantial variation between service models to fully understand the benefits and consequences for patients, the workforce, and the NHS.
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INTRODUCTION: AIRWAYS-2 was a cluster randomised controlled trial (RCT) comparing the clinical and cost effectiveness of the i-gel supraglottic airway device with tracheal intubation in the initial airway management of out-of-hospital cardiac arrest (OHCA). In order to successfully conduct this clinical trial, it was necessary for research paramedics to overcome multiple challenges, many of which will be relevant to future emergency medical service (EMS) research. This article aims to describe a number of the challenges that were encountered during the out-of-hospital phase of the AIRWAYS-2 trial and how these were overcome. METHODS: The research paramedics responsible for conducting the pre-hospital phase of the trial were asked to reflect on their experience of facilitating the AIRWAYS-2 trial. Responses were then collated by the lead author. A process of iterative revision and review was undertaken by the research paramedics to produce a consensus of opinion. RESULTS: The main challenges identified by the trial research paramedics related to the recruitment and training of paramedics, screening of eligible patients and investigation of protocol deviations / reporting errors. Even though a feasibility study was conducted prior to the commencement of AIRWAYS-2, the scale of these challenges was underestimated. CONCLUSION: Large-scale pragmatic cluster randomised trials are being successfully undertaken in out-of-hospital care. However, they require intensive engagement with EMS clinicians and local research paramedics, particularly when the intervention is contentious. Feasibility studies are an important part of research but may fail to identify all potential challenges. Therefore, flexibility is required to manage unforeseen difficulties.
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AIM: The AIRWAYS-2 cluster randomised controlled trial compared the i-gel supraglottic airway device (SGA) with tracheal intubation (TI) as the first advanced airway management (AAM) strategy used by Emergency Medical Service clinicians (paramedics) treating adult patients with non-traumatic out-of-hospital cardiac arrest (OHCA). It showed no difference between the two groups in the primary outcome of modified Rankin Scale (mRS) score at 30 days/hospital discharge. This paper reports outcomes to 6 months. METHODS: Paramedics from four ambulance services in England were randomised 1:1 to use an i-gel SGA (759 paramedics) or TI (764 paramedics) as their initial approach to AAM. Adults who had a non-traumatic OHCA and were attended by a participating paramedic were enrolled automatically under a waiver of consent. Survivors were invited to complete questionnaires at three and six months after OHCA. Outcomes were analysed using regression methods. RESULTS: 767/9296 (8.3%) enrolled patients survived to 30 days/hospital discharge and 317/767 survivors (41.3%) consented and were followed-up to six months. No significant differences were found between the two treatment groups in the primary outcome measure (mRS score: 3 months: odds ratio (OR) for good recovery (i-gel/TI, OR) 0.89, 95% CI 0.69-1.14; 6 months OR 0.91, 95% CI 0.71-1.16). EQ-5D-5L scores were also similar between groups and sensitivity analyses did not alter the findings. CONCLUSION: There were no statistically significant differences between the TI and i-gel groups at three and six months. We therefore conclude that the initially reported finding of no significant difference between groups at 30 days/hospital discharge was sustained when the period of follow-up was extended to six months.