Early and Empirical High-Dose Cryoprecipitate for Hemorrhage After Traumatic Injury: The CRYOSTAT-2 Randomized Clinical Trial.

Importance: Critical bleeding is associated with a high mortality rate in patients with trauma. Hemorrhage is exacerbated by a complex derangement of coagulation, including an acute fibrinogen deficiency. Management is fibrinogen replacement with cryoprecipitate transfusions or fibrinogen concentrate, usually administered relatively late during hemorrhage. Objective: To assess whether survival could be improved by administering an early and empirical high dose of cryoprecipitate to all patients with trauma and bleeding that required activation of a major hemorrhage protocol. Design, Setting, and Participants: CRYOSTAT-2 was an interventional, randomized, open-label, parallel-group controlled, international, multicenter study. Patients were enrolled at 26 UK and US major trauma centers from August 2017 to November 2021. Eligible patients were injured adults requiring activation of the hospital's major hemorrhage protocol with evidence of active hemorrhage, systolic blood pressure less than 90 mm Hg at any time, and receiving at least 1 U of a blood component transfusion. Intervention: Patients were randomly assigned (in a 1:1 ratio) to receive standard care, which was the local major hemorrhage protocol (reviewed for guideline adherence), or cryoprecipitate, in which 3 pools of cryoprecipitate (6-g fibrinogen equivalent) were to be administered in addition to standard care within 90 minutes of randomization and 3 hours of injury. Main Outcomes and Measures: The primary outcome was all-cause mortality at 28 days in the intention-to-treat population. Results: Among 1604 eligible patients, 799 were randomized to the cryoprecipitate group and 805 to the standard care group. Missing primary outcome data occurred in 73 patients (principally due to withdrawal of consent) and 1531 (95%) were included in the primary analysis population. The median (IQR) age of participants was 39 (26-55) years, 1251 (79%) were men, median (IQR) Injury Severity Score was 29 (18-43), 36% had penetrating injury, and 33% had systolic blood pressure less than 90 mm Hg at hospital arrival. All-cause 28-day mortality in the intention-to-treat population was 26.1% in the standard care group vs 25.3% in the cryoprecipitate group (odds ratio, 0.96 [95% CI, 0.75-1.23]; P = .74). There was no difference in safety outcomes or incidence of thrombotic events in the standard care vs cryoprecipitate group (12.9% vs 12.7%). Conclusions and Relevance: Among patients with trauma and bleeding who required activation of a major hemorrhage protocol, the addition of early and empirical high-dose cryoprecipitate to standard care did not improve all cause 28-day mortality. Trial Registration: ClinicalTrials.gov Identifier: NCT04704869; ISRCTN Identifier: ISRCTN14998314.

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.

Airway management during cardiopulmonary resuscitation.

PURPOSE OF REVIEW: This article evaluates the latest scientific evidence regarding airway management during in-hospital and out-of-hospital cardiopulmonary resuscitation (CPR). RECENT FINDINGS: In the in-hospital setting, observational research suggested that the quality of CPR using 'no flow ratio' as a surrogate marker was improved when advanced airway techniques were used. A registry study demonstrated that an initial failed intubation attempt was associated with an average delay of 3 min in time to return of spontaneous circulation. A prospective observational study showed that the Glide Scope videolaryngoscope was associated with a first-pass success rate of 93%, with no differences between less and more experienced physicians. In the out-of-hospital setting, a registry study suggested that intubation leads to a better outcome compared with supraglottic airway devices. However, no advanced airway devices showed a better outcome than basic airway techniques. An observational study reported that the i-gel supraglottic airway device offers a first-pass insertion success rate of 90%, and was easier to establish than the Portex Soft Seal laryngeal mask airway. Other out-of-hospital observational studies showed that the laryngeal tube offers a lower first-pass insertion success rate than expected, and complications of this device may influence later definitive airway management and the outcome as a whole. SUMMARY: Recent studies of airway management during CPR rely mostly on registry and observational designs. Prospective randomized trials are needed to determine the optimal approach to airway management during cardiac arrest, but have not yet been completed.

Paediatric ED reattendance rates: comparing nurse practitioners and other clinicians.

OBJECTIVE: The aim of this project is to establish the unplanned reattendance rate for paediatric emergency nurse practitioners (PENPs) working in a designated paediatric emergency department (PED) while identifying the case mix of patients seen by PENPs compared with their medical counterparts. DESIGN: Quantitative data regarding patient characteristics and reattendance were collected during retrospective review of case notes across two representative 2-week periods. SETTING: The study site is a tertiary urban PED with an annual attendance of 32 000 patients aged from birth to 15 years. MAIN OUTCOME MEASURES: Reattendance rates, patient characteristics, triage scores, presenting complaint and numbers of patients discussed with a paediatric emergency medicine consultant were evaluated. RESULTS: The results showed that PENPs have a lower reattendance rate (1.75%) when compared with senior and junior doctors in training (4.29%, 5.76%); however, PENPs treat a different population of children. When the odds of PENP reattendance are adjusted for this, the significance of the difference becomes less certain. CONCLUSIONS: PENPs work autonomously when seeing children presenting with minor trauma and make a positive contribution in achieving the reattendance Clinical Quality Indicator.

Conservative management versus invasive management of significant traumatic pneumothoraces in the emergency department (the CoMiTED trial): a study protocol for a randomised non-inferiority trial.

INTRODUCTION: Traumatic pneumothoraces are present in one of five victims of severe trauma. Current guidelines advise chest drain insertion for most traumatic pneumothoraces, although very small pneumothoraces can be managed with observation at the treating clinician's discretion. There remains a large proportion of patients in whom there is clinical uncertainty as to whether an immediate chest drain is required, with no robust evidence to inform practice. Chest drains carry a high risk of complications such as bleeding and infection. The default to invasive treatment may be causing potentially avoidable pain, distress and complications. We are evaluating the clinical and cost-effectiveness of an initial conservative approach to the management of patients with traumatic pneumothoraces. METHODS AND ANALYSIS: The CoMiTED (Conservative Management in Traumatic Pneumothoraces in the Emergency Department) trial is a multicentre, pragmatic parallel group, individually randomised controlled non-inferiority trial to establish whether initial conservative management of significant traumatic pneumothoraces is non-inferior to invasive management in terms of subsequent emergency pleural interventions, complications, pain, breathlessness and quality of life. We aim to recruit 750 patients from at least 40 UK National Health Service hospitals. Patients allocated to the control (invasive management) group will have a chest drain inserted in the emergency department. For those in the intervention (initial conservative management) group, the treating clinician will be advised to manage the participant without chest drain insertion and undertake observation. The primary outcome is a binary measure of the need for one or more subsequent emergency pleural interventions within 30 days of randomisation. Secondary outcomes include complications, cost-effectiveness, patient-reported quality of life and patient and clinician views of the two treatment options; participants are followed up for 6 months. ETHICS AND DISSEMINATION: This trial received approval from the Wales Research Ethics Committee 4 (reference: 22/WA/0118) and the Health Research Authority. Results will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ISRCTN35574247.

Characteristics of patients transported by an air ambulance critical care team.

BACKGROUND: The aim of this study was to review patients conveyed by the Great Western Air Ambulance to its main receiving hospital. METHODS: Retrospective data were collected for all patients transferred to Frenchay Hospital by the Great Western Air Ambulance between 1 June 2008 and 1 March 2010. RESULTS: 115 patients were included in the review. Patients were conveyed up to 85 km, 79% bypassing the closest emergency department (ED). 51% of these patients had major trauma and 35% were intubated at the scene. On arrival, the mean time to CT scan was 78 min, reduced to 63 min for those with a head injury. 16% of patients were discharged from the ED. CONCLUSIONS: This review provides an overview of the characteristics of patients transferred to a major receiving hospital by a prehospital critical care team.

Serial high-sensitivity troponin measurements for the rapid exclusion of acute myocardial infarction in low-risk patients.

UNLABELLED: High-sensitivity troponin assays facilitate the rapid exclusion of acute myocardial infarction (AMI). However, elevated results are also seen in other conditions causing myocardial injury. Serial measurements increase the specificity for AMI, helping to rapidly identify patients for whom revascularisation may be appropriate. In this study, we explore a strategy for rapidly excluding AMI in symptomatic patients using serial high-sensitivity troponin measurements. MAIN FINDINGS: (1) all patients presenting more than 3 h after symptom onset with a negative result had a second negative result; (2) AMI was excluded in all patients with two results falling below the lower limit of detection of a standard troponin assay by 8 h post-symptom onset.

Factors associated with enrolment into a national COVID-19 pulse oximetry remote monitoring programme in England: a retrospective observational study.

BACKGROUND: Hypoxaemia is an important predictor of severity in individuals with COVID-19 and can present without symptoms. The COVID Oximetry @home (CO@h) programme was implemented across England in November, 2020, providing pulse oximeters to higher-risk people with COVID-19 to enable early detection of deterioration and the need for escalation of care. We aimed to describe the clinical and demographic characteristics of individuals enrolled onto the programme and to assess whether there were any inequalities in enrolment. METHODS: This retrospective observational study was based on data from a cohort of people resident in England recorded as having a positive COVID-19 test between Oct 1, 2020, and May 3, 2021. The proportion of participants enrolled onto the CO@h programmes in the 7 days before and 28 days after a positive COVID-19 test was calculated for each clinical commissioning group (CCG) in England. Two-level hierarchical multivariable logistic regression with random intercepts for each CCG was run to identify factors predictive of being enrolled onto the CO@h programme. FINDINGS: CO@h programme sites were reported by NHS England as becoming operational between Nov 21 and Dec 31, 2020. 1 227 405 people resident in 72 CCGs had a positive COVID-19 test between the date of programme implementation and May 3, 2021, of whom 19 932 (1·6%) were enrolled onto the CO@h programme. Of those enrolled, 14 441 (72·5%) were aged 50 years or older or were identified as clinically extremely vulnerable (ie, having a high-risk medical condition). Higher odds of enrolment onto the CO@h programme were found in older individuals (adjusted odds ratio 2·21 [95% CI 2·19-2·23], p<0·001, for those aged 50-64 years; 3·48 [3·33-3·63], p<0·001, for those aged 65-79 years; and 2·50 [2·34-2·68], p<0·001, for those aged ≥80 years), in individuals of non-White ethnicity (1·35 [1·28-1·43], p<0·001, for Asian individuals; 1·13 [1·04-1·22], p=0·005, for Black individuals; and 1·17 [1·03-1·32], p=0·015, for those of mixed ethnicity), in those who were overweight (1·31 [1·26-1·37], p<0·001) or obese (1·69 [1·63-1·77], p<0·001), or in those identified as clinically extremely vulnerable (1·58 [1·51-1·65], p<0·001), and lower odds were reported in those from the least socioeconomically deprived areas compared with those from the most socioeconomically deprived areas (0·75 [0·69-0·81]; p<0·001). INTERPRETATION: Nationally, uptake of the CO@h programme was low, with clinical judgment used to determine eligibility. Preferential enrolment onto the pulse oximetry monitoring programme was observed in people known to be at the highest risk of developing severe COVID-19. FUNDING: NHS England, National Institute for Health Research, and The Wellcome Trust.

Randomised trial of the clinical and cost effectiveness of a supraglottic airway device compared with tracheal intubation for in-hospital cardiac arrest (AIRWAYS-3): Protocol, design and implementation.

Survival from in-hospital cardiac arrest is approximately 18%, but for patients who require advanced airway management survival is lower. Those who do survive are often left with significant disability. Traditionally, resuscitation of cardiac arrest patients has included tracheal intubation, however insertion of a supraglottic airway has gained popularity as an alternative approach to advanced airway management. Evidence from out-of-hospital cardiac arrest suggests no significant differences in mortality or morbidity between these two approaches, but there is no randomised evidence for airway management during in-hospital cardiac arrest. The aim of the AIRWAYS-3 randomised trial, described in this protocol paper, is to determine the clinical and cost effectiveness of a supraglottic airway versus tracheal intubation during in-hospital cardiac arrest. Patients will be allocated randomly to receive either a supraglottic airway or tracheal intubation as the initial advanced airway management. We will also estimate the relative cost-effectiveness of these two approaches. The primary outcome is functional status, measured using the modified Rankin Scale at hospital discharge or 30 days post-randomisation, whichever occurs first. AIRWAYS-3 presents ethical challenges regarding patient consent and data collection. These include the enrolment of unconscious patients without prior consent in a way that avoids methodological bias. Other complexities include the requirement to randomise patients efficiently during a time-critical cardiac arrest. Many of these challenges are encountered in other emergency care research; we discuss our approaches to addressing them. Trial registration: ISRCTN17720457. Prospectively registered on 29/07/2022.

Supraglottic airway device versus tracheal intubation in the initial airway management of out-of-hospital cardiac arrest: the AIRWAYS-2 cluster RCT.

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.

Cost-effectiveness of the i-gel supraglottic airway device compared to tracheal intubation during out-of-hospital cardiac arrest: Findings from the AIRWAYS-2 randomised controlled trial.

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.

Endotracheal intubation during out-of-hospital cardiac arrest: New insights from recent clinical trials.

Airway management is an important intervention during resuscitation of out-of-hospital cardiac arrest (OHCA). Endotracheal intubation is commonly used by emergency medical services paramedics in the advanced airway management of OHCA, but numerous studies question its safety and effectiveness. Furthermore, there is now increasing use of supraglottic airway devices. In this review, we provide an overview of 3 recent randomized clinical trials of advanced airway management (Pragmatic Airway Resuscitation Trial [PART], AIRWAYS-2, and Cardiac Arrest Airway Management [CAAM]) and highlight new information that is available to guide OHCA airway management practices.

Randomized trial of the i-gel supraglottic airway device versus tracheal intubation during out of hospital cardiac arrest (AIRWAYS-2): Patient outcomes at three and six months.

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.

Design and implementation of a large and complex trial in emergency medical services.

BACKGROUND: The research study titled "Cluster randomised 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 (AIRWAYS-2)" is a large-scale study being run in the English emergency medical (ambulance) services (EMS). It compares two airway management strategies (tracheal intubation and the i-gel) in out-of-hospital cardiac arrest. We describe the methods used to minimise bias and the challenges associated with the set-up, enrolment, and follow-up that were addressed. METHODS: AIRWAYS-2 enrols adults without capacity when there is no opportunity to seek prior consent and when the intervention must be delivered immediately. We therefore adopted a cluster randomised design where the unit of randomisation is the individual EMS provider (paramedic). However, because paramedics could not be blinded to the intervention, it was necessary to automatically enrol all eligible patients in the study to avoid bias. Effective implementation required engagement with four large EMS and 95 receiving hospitals. Very high levels of data capture were required to ensure study integrity, and this necessitated collaborative working across multiple organisations. We sought to manage these processes by using a large and comprehensive electronic study database, implementing efficient trial procedures and comprehensive training. RESULTS: Successful implementation of the study design was facilitated by the approaches used. The necessary regulatory and ethical approvals to conduct the study were secured, and benefited from strong patient and public involvement. Early and continued consultation with decision makers within the four participating EMS resulted in a coordinated approach to study set-up. All receiving hospitals gave approval and agreed to collect data. A comprehensive database and programme of training and support were implemented. More than 1500 paramedics have been recruited to the study, and patient enrolment and follow-up has proceeded as planned. CONCLUSION: Care provided by EMS needs to be based on evidence. Although participants may be experiencing life-threatening emergencies, high-quality pre-hospital research is possible in well-designed and well-managed studies. The approaches described here can be used to support successful research that will lead to improved treatment and outcomes in similar patient groups. TRIAL REGISTRATION: ISRCTN08256118 . Registered on 22 July 2014.

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.

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.

A cost-consequences analysis of minor injuries telemedicine.

A cost-consequences analysis of minor injuries telemedicine was performed alongside a randomized controlled trial in a UK peripheral emergency department. The main outcome measures were safety and clinical effectiveness at seven days after presentation. Costs to the National Health Service (NHS) and patients and their families, for 253 patients, were estimated for seven days following randomization. The mean cost to the NHS for the telemedicine patients was 78.61 pounds and for those assessed routinely was 39.15 pounds. For costs incurred by patients and their families the respective figures were 58.24 pounds and 43.95 pounds. Sensitivity analysis showed the initial results to be robust. Telemedicine was a more expensive option for providing minor injuries care in a general-practitioner-supported peripheral emergency department, while consequences did not vary greatly between the different options.

Prehospital anaesthesia by a physician and paramedic critical care team in Southwest England.

OBJECTIVES: Prehospital anaesthesia using rapid sequence induction (RSI) is carried out internationally and in the UK despite equivocal evidence of clinical benefit. It is a core skill of the prehospital critical care service established by the Great Western Ambulance Service NHS Trust (GWAS) in 2008. This retrospective analysis of the service's first 150 prehospital RSIs describes intubation success rates and complications, thereby contributing towards the ongoing debate on its role and safety. METHODS: Within the GWAS critical care team, RSI is only carried out in the presence of a qualified physician and critical care paramedic (CCP). The role of the intubating practitioner is interchangeable between physician and CCP. Data were collected retrospectively from RSI audit forms and electronic patient monitor printouts. RESULTS: GWAS physician and CCP teams undertook 150 prehospital RSIs between June 2008 and August 2011. The intubation success rate was 82, 91 and 97% for the first, second and third attempts, respectively. Successful intubation on the first attempt was achieved in 58 (85%) and 64 (78%) patients for physicians and CCPs, respectively. RSI complications included hypoxaemia (10.2%), hypotension (9.7%) and bradycardia (1.3%). CONCLUSION: Prehospital RSI can be carried out safely, with intubation success rates and complications comparable with RSI in the emergency department. The variation in the intubation success rates between individual practitioners highlights the importance of ongoing performance monitoring, coupled with high standards of clinical governance and training.