Restrictive Fluid Administration vs. Standard of Care in Emergency Department Sepsis Patients (REFACED Sepsis)-protocol for a multicenter, randomized, clinical, proof-of-concept trial.

BACKGROUND: Intravenous fluids are often used in the treatment of sepsis. The better strategy regarding fluid volume is debated, but preliminary data in patients with septic shock or sepsis-related hypotension favor restrictive fluid administration. We describe the protocol and statistical analysis plan for the Restrictive Fluid Administration vs. Standard of Care in Emergency Department Sepsis Patients (REFACED Sepsis)-a multicenter, randomized clinical proof-of-concept trial. The aim of the REFACED Sepsis trial is to test if a restrictive intravenous fluid protocol in emergency department patients with sepsis without shock is feasible and decreases the intravenous fluid volume administered in comparison to standard care. METHODS: This is an investigator-initiated, multicenter, randomized, parallel-group, open-labeled, feasibility trial investigating volumes of crystalloid fluid within 24 h in 124 patients with sepsis without shock enrolled at three emergency departments in the Central Denmark Region. Patients are allocated to two different intravenous fluid regimens: a restrictive approach using four trigger criteria for fluid administration vs. standard care. The primary, feasibility outcome is total intravenous, crystalloid fluid volume within 24 h, and key secondary outcomes include protocol violations, total fluids (intravenous and oral) within 24 h, and serious adverse reactions and suspected unexpected serious adverse reactions. Status: The trial started in November 2021, and the last patient is anticipated to be included in January 2022. DISCUSSION: Sepsis is very common in emergency department patients and fluid administration is very frequently administered in these patients. However, the evidence to guide fluid administration is very sparse. This feasibility trial will be the foundation for a potential future large-scale trial investigating restrictive vs. standard fluid administration in patients with sepsis. TRIAL REGISTRATION: EudraCT number: 2021-000224-35 (date: 2021 May 03), ClinicalTrials.gov number: NCT05076435 (date: 2021 October 13), Committee on Health Research Ethics - Central Denmark Region: 1-10-72-163-21 (date: 2021 June 28).

Early procedural training increases anesthesiology residents' clinical production: a comparative pre-post study of the payoff in clinical training.

BACKGROUND: Competency-based education has been shown to enhance clinical skills, improve patient care, and reduce number of complications resulting in a better return on investments. Residents constitute an important workforce at many hospitals. Yet, the effect of training on residents' contribution to production in patient care is scarcely studied. This study evaluated the effects of early competency-based procedural training on residents' contribution to patient care in central venous catheterization and spinal and epidural anesthesia. METHODS: The design was a non-randomized cohort study of first-year anesthesiology residents. The intervention group received additional early focused skills training while three control groups received traditional competency-based education. The residents' contributions to patient care were compared between the intervention group (n = 20), a historical control group (n = 19), and between a contemporary control group (n = 7) and a historical control group (n = 7) from different departments. The residents' vs specialists' procedural production share was compared between years within each study group. We calculated specialist time saved compared to the time spent providing additional skills training in the intervention group. RESULTS: We found statistically significant increases in residents' vs specialists' share of total production after the intervention for epidural anesthesia: 2015: 0.51 (0.23, 0.70) to 2017: 0.94 (0.78, 1.05), p = 0.011 and central venous catheterization: 2015: 0.30 (0.23, 0.36) to 2016: 0.46 (0.35, 0.55), p = .008; and to 2017: 0.64 (0.50, 0.79), p = 0.008. Comparison between residents and specialists on production of the three procedures before and after the intervention showed a surplus of 21 h of freed specialist time per year. CONCLUSIONS: Early procedural training results in more productive residents and freed specialist time for additional supervision, other clinical tasks or research. This provides empirical support for a positive correlation between early focused training and increased independent production among residents.

Association of Helicopter vs Ground Emergency Medical Transportation With 1-Year Mortality in Denmark.

Importance: Appropriate use of helicopter emergency medical service (HEMS) is important in ensuring that patients with critical illness or injury receive adequate treatment. Objective: To investigate the association between use of HEMS compared with use of ground EMS (GEMS) and mortality overall and in a subgroup of patients with critical illness or injury. Design, Setting, and Participants: This register-based, nationwide cohort study used data retrieved from Danish registries from October 1, 2014, to April 30, 2018. Patients receiving GEMS originated from dispatched HEMS missions for which a helicopter was unavailable. For the primary analysis, patients from accepted HEMS missions and patients from missions in which HEMS was dispatched but unavailable were included. The secondary analysis included patients assigned a hospital International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) diagnosis considered a critical illness or injury. These patients were selected via a consensus-based agreement among all authors by reviewing the Danish version of the World Health Organization's ICD-10 classification. Data were analyzed from March to June 2020. Exposures: Dispatch of HEMS vs GEMS unit (primary analysis) and treatment and transport by HEMS vs GEMS unit among patients with critical illness or injury (secondary analysis). Main Outcomes and Measures: One-year mortality was retrieved from the Danish Civil Registration System. Results: Among 10 618 patients (median [interquartile range] age, 60 [42-72] years; 6834 [64.4%] men) included in the primary analysis, 9480 patients (89.3%) received HEMS and 1138 patients (10.7%) received GEMS. Median (interquartile range) age was 60 (42-72) years, and 6834 patients (64.4%) were men. Adjusted cumulative 1-year mortality was 23.2% (95% CI, 22.4%-24.1%) among patients receiving HEMS vs 24.5% (95% CI, 21.9%-27.1%) among patients receiving GEMS. The difference in mortality risk for HEMS compared with GEMS was not statistically significant (hazard ratio, 0.94 [95% CI, 0.84-1.06]). Among 2260 patients with critical illness or injury receiving HEMS, compared with 315 patients with critical illness or injury receiving GEMS, adjusted cumulative 1-year mortality was 25.1% (95% CI, 23.5%-26.7%) vs 27.1% (95% CI, 22.0%-32.1%). The difference in mortality risk for HEMs compared with GEMs was not statistically significant (hazard ratio, 0.91 [95% CI, 0.73-1.14]). Conclusions and Relevance: This study found that 1 year after dispatch, the use of HEMS, compared with the use of GEMS, was not associated with a statistically significant difference in mortality overall or mortality among patients with critical illness or injury. Further research is needed to determine whether optimized dispatch systems may be associated with further improvements in survival among selected patients.

Mortality and hospitalisation in the Danish Helicopter Emergency Medical Service (HEMS) population from 2014 to 2018: a national population-based study of HEMS triage.

OBJECTIVE: To describe characteristics and outcomes for patients where the Danish Helicopter Emergency Medical Service (HEMS) either transported the patient to hospital, treated the patient on scene but did not transport the patient or was dispatched but cancelled en route to the patient (aborted mission), and to assess the field triage by comparing these outcomes. DESIGN: National population-based study. SETTING AND PARTICIPANTS: HEMS dispatches are undertaken from the five Danish emergency dispatch medical centres according to national guidelines. The study analysed all primary missions with helicopter take off where the patient was admitted to hospital between 1st October 2014 and 30th April 2018. MAIN OUTCOME MEASURES: Mortality rates, admittance to an intensive care unit (ICU), need of mechanical ventilation and length of hospital stay (LOS). RESULTS: 6931 patients were admitted to hospital; 3311 patients were air lifted, 164 patients were ground escorted by a HEMS physician, 1421 were assisted on scene by HEMS, but escorted by the ground units and 2035 missions were aborted. The mortality was highest among the airlifted and ground escorted patients, and lowest among the patients in the aborted mission group. Mortality for the airlifted patients increased from 8.2% (95% CI; 7.3 to 9.2) at day 1 to 19.5% (95% CI; 18.2 to 20.9) after 1 year. The airlifted and ground escorted patients were frequently admitted to ICU and subsequently mechanically ventilated and they also had an increased LOS compared with the patients only assisted on scene by HEMS and the patients in the aborted mission group. CONCLUSION: Patients to whom HEMS are dispatched are often critically ill or injured and have a relatively high mortality. The patients airlifted or ground escorted to hospital by HEMS appear more critically ill or injured compared with the assisted patients and the patients in the aborted mission group. The on-scene triage seems appropriate.

Characteristics of patients treated by the Danish Helicopter Emergency Medical Service from 2014-2018: a nationwide population-based study.

BACKGROUND: A national Helicopter Emergency Medical Service (HEMS) was introduced in Denmark in 2014 to ensure the availability of physician-led critical care for all patients regardless of location. Appropriate dispatch of HEMS is known to be complex, and resource utilisation is a highly relevant topic. Population-based studies on patient characteristics are fundamental when evaluating and optimising a system. The aim of this study was to describe the patient population treated by the Danish HEMS in terms of demographics, pre-hospital diagnostics, severity of illness or injury, and the critical care interventions performed. METHOD: The study is a retrospective nationwide population-based study based on data gathered from the Danish HEMS database. We included primary missions resulting in a patient encounter registered between October 1st 2014 and April 30th 2018. RESULTS: Of 13.391 dispatches registered in the study period we included 7133 (53%) primary missions with patient encounter: 4639 patients were air lifted to hospital, 174 patients were escorted to hospital by the HEMS physician in an ambulance, and in 2320 cases HEMS assisted the ground crew on scene but did not escort the patient to hospital. Patient age ranged from 0-99 years and 64% of the population were men. The median age was 60 years. The main diagnostic groups were cardio-vascular emergencies (41%), trauma (23%) and neurological emergencies (16%). In 61% of the cases, the patient was critically ill/injured corresponding to a NACA (National Advisory Committee for Aeronautics) score between 4 and 7 (both included). In more than one third of the missions a critical care intervention was performed. Ultrasound examination and endo-tracheal intubation were the critical care interventions most frequently performed (21% and 20%, respectively). CONCLUSION: The national Danish HEMS primarily attends severely ill or injured patients and often perform critical care interventions. In addition, the Danish HEMS provides rapid transport to highly specialised treatment for patients in the more rural parts of the country. Patients with cardio-vascular emergencies, trauma and neurological emergencies are among those patient groups most commonly seen. We conclude that the overall dispatch profile appears appropriate but emphasise that continuous development and refinement is essential.

The Danish helicopter emergency medical service database: high quality data with great potential.

BACKGROUND: The Danish Helicopter Emergency Medical Service (HEMS) is part of the Danish pre-hospital response offering advanced patient care on scene and during rapid transport to definitive care. Monitoring HEMS performance and the quality of critical care has high national as well as international priority underlining the need for research in this field. The data quality of the Danish HEMS database is unknown. Furthermore, a set of quality indicators (QI) developed by an international collaboration group (EQUIPE) potentially for use in physician-staffed EMS, has recently been presented. The aim of the current study was to present the design and data quality of the Danish helicopter database, and to evaluate the coverage of available variables in the database according to the QIs proposed. METHOD: The study included all helicopter dispatches between October 1st 2014 and April 30th 2018. The database layout and data entering procedure, as well as the key variables and data completeness were described. Furthermore, missing data and misclassifications were addressed. Lastly, the 26 QIs proposed by the EQUIPE-collaboration were evaluated for coverage in the HEMS database. RESULTS: A total of 13,392 missions were included in the study. The database includes a broad spectrum of mission- and patient-specific data related to the pre-hospital pathway of acutely ill or injured patients in a national coverage. Missing data for the majority of variables is less than 6.5%. The percentage of completed report forms has increased over time and reached 99.9% in 2018. Misclassification were observed for 294 patients in the study period corresponding to 3,7%. Less than half of the QIs proposed by the EQUIPE-collaboration group were directly available from the database. CONCLUSIONS: Helicopter Emergency Medical Services in Denmark are a new and sparsely investigated health care provider. The database contains nearly all missions dispatched by the five regional Emergency Medical Dispatch Centres. Generally, the data quality is considered high with great potential for future research. Potential quality indicators as proposed by the EQUIPE-collaboration group could inspire the configuration and design of the next version of Hemsfile creating an even more solid basis for research and quality improvement.

The effects of graduate competency-based education and mastery learning on patient care and return on investment: a narrative review of basic anesthetic procedures.

BACKGROUND: Despite the widespread implementation of competency-based education, evidence of ensuing enhanced patient care and cost-benefit remains scarce. This narrative review uses the Kirkpatrick/Phillips model to investigate the patient-related and organizational effects of graduate competency-based medical education for five basic anesthetic procedures. METHODS: The MEDLINE, ERIC, CINAHL, and Embase databases were searched for papers reporting results in Kirkpatrick/Phillips levels 3-5 from graduate competency-based education for five basic anesthetic procedures. A gray literature search was conducted by reference search in Google Scholar. RESULTS: In all, 38 studies were included, predominantly concerning central venous catheterization. Three studies reported significant cost-effectiveness by reducing infection rates for central venous catheterization. Furthermore, the procedural competency, retention of skills and patient care as evaluated by fewer complications improved in 20 of the reported studies. CONCLUSION: Evidence suggests that competency-based education with procedural central venous catheterization courses have positive effects on patient care and are both cost-effective. However, more rigorously controlled and reproducible studies are needed. Specifically, future studies could focus on organizational effects and the possibility of transferability to other medical specialties and the broader healthcare system.

[Headache: a rare manifestation of angina pectoris]. / Hovedpine: en sjaelden angina pectoris-aekvivalent.

Typical angina pectoris rarely produces pain above the mandible. We report a patient with exertional headache, which was relieved by nitrates and revascularisation. The explanation is speculative; 1) anatomic convergence of cardiac nerve fibres and somatic efferents from the head; 2) increased intracranial pressure secondary to decreased cardiac output during ischaemia; and 3) unidentified headache eliciting mediators released by cardiac ischaemia. We conclude that headache may be a (the only) manifestation of myocardial ischaemia. The suspicion should arise, if the headache is exercise-induced and relieved by nitrates.