Changes over time in characteristics, resource use and outcomes among ICU patients with COVID-19-A nationwide, observational study in Denmark

BACKGROUND: Characteristics and care of intensive care unit (ICU) patients with COVID‐19 may have changed during the pandemic, but longitudinal data assessing this are limited. We compared patients with COVID‐19 admitted to Danish ICUs in the first wave with those admitted later. METHODS: Among all Danish ICU patients with COVID‐19, we compared demographics, chronic comorbidities, use of organ support, length of stay and vital status of those admitted 10 March to 19 May 2020 (first wave) versus 20 May 2020 to 30 June 2021. We analysed risk factors for death by adjusted logistic regression analysis. RESULTS: Among all hospitalised patients with COVID‐19, a lower proportion was admitted to ICU after the first wave (13% vs. 8%). Among all 1374 ICU patients with COVID‐19, 326 were admitted during the first wave. There were no major differences in patient's characteristics or mortality between the two periods, but use of invasive mechanical ventilation (81% vs. 58% of patients), renal replacement therapy (26% vs. 13%) and ECMO (8% vs. 3%) and median length of stay in ICU (13 vs. 10 days) and in hospital (20 vs. 17 days) were all significantly lower after the first wave. Risk factors for death were higher age, larger burden of comorbidities (heart failure, pulmonary disease and kidney disease) and active cancer, but not admission during or after the first wave. CONCLUSIONS: After the first wave of COVID‐19 in Denmark, a lower proportion of hospitalised patients with COVID‐19 were admitted to ICU. Among ICU patients, use of organ support was lower and length of stay was reduced, but mortality rates remained at a relatively high level

Platform trials

Platform trials focus on the perpetual testing of many interventions in a disease or a setting. These trials have lasting organizational, administrative, data, analytic, and operational frameworks making them highly efficient. The use of adaptation often increases the probabilities of allocating participants to better interventions and obtaining conclusive results. The COVID-19 pandemic showed the potential of platform trials as a fast and valid way to improved treatments. This review gives an overview of key concepts and elements using the Intensive Care Platform Trial (INCEPT) as an example.</p

Furosemide versus placebo for fluid overload in intensive care patients—The randomised GODIF trial second version : Statistical analysis plan

Publisher Copyright: © 2023 The Authors. Acta Anaesthesiologica Scandinavica published by John Wiley & Sons Ltd on behalf of Acta Anaesthesiologica Scandinavica Foundation.Background: Fluid overload is associated with increased mortality in intensive care unit (ICU) patients. The GODIF trial aims to assess the benefits and harms of fluid removal with furosemide versus placebo in stable adult patients with moderate to severe fluid overload in the ICU. This article describes the detailed statistical analysis plan for the primary results of the second version of the GODIF trial. Methods: The GODIF trial is an international, multi-centre, randomised, stratified, blinded, parallel-group, pragmatic clinical trial, allocating 1000 adult ICU patients with moderate to severe fluid overload 1:1 to furosemide versus placebo. The primary outcome is days alive and out of hospital within 90 days post-randomisation. With a power of 90% and an alpha level of 5%, we may reject or detect an improvement of 8%. The primary analyses of all outcomes will be performed in the intention-to-treat population. For the primary outcome, the Kryger Jensen and Lange method will be used to compare the two treatment groups adjusted for stratification variables supplemented with sensitivity analyses in the per-protocol population and with further adjustments for prognostic variables. Secondary outcomes will be analysed with multiple linear regressions, logistic regressions or the Kryger Jensen and Lange method as suitable with adjustment for stratification variables. Conclusion: The GODIF trial data will increase the certainty about the effects of fluid removal using furosemide in adult ICU patients with fluid overload. Trial Registrations: EudraCT identifier: 2019-004292-40 and ClinicalTrials.org: NCT04180397.Peer reviewe

Prehospital prognosis is difficult in patients with acute exacerbation of chronic obstructive pulmonary disease

Abstract Background Patients with acute exacerbation of chronic obstructive pulmonary disease often require prehospital emergency treatment. This enables patients who are less ill to be treated on-site and to avoid hospital admission, while severely ill patients can receive immediate ventilatory support in the form of intubation. The emergency physician faces difficult treatment decisions, however, and prognostic tools that could assist in determining which patients would benefit from intubation and ventilator support would be helpful. The aim of the current study was to identify prehospital clinical variables associated with mortality from acute exacerbation of chronic obstructive pulmonary disease. As part of the study, we estimated the 30-day mortality for patients with this prehospital diagnosis. Methods A retrospective study was performed using data collected by the mobile emergency care unit in Odense, Denmark, combined with data from the patients’ medical records. Patients with the tentative diagnosis of acute exacerbation of chronic obstructive pulmonary disease between 1st July 2011 and 31st December 2013 were included in the study. Results Based on data from 530 patients, we found no statistically significant associations between prehospital clinical variables and mortality, apart from a minor association between older age and higher mortality. The overall 30-day mortality was 10%, while that for patients admitted to the intensive care unit was 30%. Conclusion No specific prehospital prognostic factors for mortality were identified. Prognostic assessment and the decision to withhold treatment for acute exacerbation of chronic obstructive pulmonary disease seem inadvisable in the prehospital setting

Noise exposure during prehospital emergency physicians work on Mobile Emergency Care Units and Helicopter Emergency Medical Services

Abstract Background Prehospital personnel are at risk of occupational hearing loss due to high noise exposure. The aim of the study was to establish an overview of noise exposure during emergency responses in Mobile Emergency Care Units (MECU), ambulances and Helicopter Emergency Medical Services (HEMS). A second objective was to identify any occupational hearing loss amongst prehospital personnel. Methods Noise exposure during work in the MECU and HEMS was measured using miniature microphones worn laterally to the auditory canals or within the earmuffs of the helmet. All recorded sounds were analysed in proportion to a known tone of 94 dB. Before and after episodes of noise exposure, the physicians underwent a hearing test indicating whether the noise had had any impact on the function of the outer sensory hair cells. This was accomplished by measuring the amplitude level shifts of the Distortion Product Otoacoustic Emissions. Furthermore, the prehospital personnels’ hearing was investigated using pure-tone audiometry to reveal any occupational hearing loss. All prehospital personnel were compared to ten in-hospital controls. Results Our results indicate high-noise exposure levels of ≥80 dB(A) during use of sirens on the MECU and during HEMS operations compared to in-hospital controls (70 dB(A)). We measured an exposure up to ≥90 dB(A) under the helmet for HEMS crew. No occupational hearing loss was identified with audiometry. A significant level shift of the Distortion Product Otoacoustic Emissions at 4 kHz for HEMS crew compared to MECU physicians was found indicating that noise affected the outer hair cell function of the inner ear, thus potentially reducing the hearing ability of the HEMS crew. Discussion Further initiatives to prevent noise exposure should be taken, such as active noise reduction or custom-made in-ear protection with communication system for HEMS personnel. Furthermore, better insulation of MECU and ambulances is warranted. Conclusion We found that the exposure levels exceeded the recommendations described in the European Regulative for Noise, which requires further protective initiatives. Although no hearing loss was demonstrated in the personnel of the ground-based units, a reduced function of the outer sensory hair cells was found in the HEMS group following missions

Post-Hypoxic Myoclonus Status following Out-of-Hospital Cardiac Arrest—Does It still Predict a Poor Outcome? A Retrospective Study

In patients with out-of-hospital cardiac arrest (OHCA), the initial prehospital treatment and transfer of patients directly to intervention clinics—bypassing smaller hospitals—have improved outcomes in recent years. Despite the improved treatment strategies, some patients develop myoclonic status following OHCA, and this phenomenon is usually considered an indicator of poor outcome. With this study, we wanted to challenge this perception. The regional prehospital database in Odense in the Region of Southern Denmark was searched for patients with OHCA from the period of 2011–2016. All 900 patients presenting with a diagnosis of OHCA were included in the study. Patients surviving to the hospital and presenting with myoclonic status were followed for up to one year. Only 2 out of 38 patients with myoclonic status and status epilepticus verified by an EEG survived more than one year. Eleven out of 36 patients with myoclonic status but without status epilepticus survived for more than one year. We found no evidence that myoclonic status is an unmistakable sign of poor outcome when not associated with EEG-verified status epilepticus. The conclusion for clinicians involved in post-resuscitation care is that myoclonic status is uncomfortable to witness but does not necessarily indicate that further treatment is futile

Long term cognitive and functional status in Danish ICU patients with COVID-19

BACKGROUND: ICU admission due to COVID‐19 may result in cognitive and physical impairment. We investigated the long‐term cognitive and physical status of Danish ICU patients with COVID‐19. METHODS: We included all patients with COVID‐19 admitted to Danish ICUs between March 10 and May 19, 2020. Patients were the contacted prospectively at 6 and 12 months for follow‐up. Our primary outcomes were cognitive function and frailty at 6 and 12 months after ICU admission, estimated by the Mini Montreal Cognitive Assessment, and the Clinical Frailty Scale. Secondary outcomes were 6‐ and 12‐month mortality, health‐related quality of life (HRQoL) assessed by EQ‐5D‐5L, functional status (Barthel activities of daily living and Lawton–Brody instrumental activities of daily living), and fatigue (Fatigue Assessment Scale). The study had no information on pre‐ICU admission status for the participants. RESULTS: A total of 326 patients were included. The 6‐ and 12‐month mortality was 37% and 38%, respectively. Among the 204 six‐month survivors, 105 (51%) participated in the 6‐month follow‐up; among the 202 twelve‐month survivors, 95 (47%) participated in the 12‐month follow‐up. At 6 months, cognitive scores indicated impairment for 26% (95% confidence interval [CI], 11.4–12.4) and at 12 months for 17% (95% CI, 12.0–12.8) of participants. Frailty was indicated in 20% (95% CI, 3.4–3.9) at 6 months, and for 18% (95% CI, 3.3–3.8) at 12 months. Fatigue was reported by 52% at 6 months, and by 47% at 12 months. For HRQoL, moderate, severe, or extreme health problems were reported by 28% at 6 months, and by 25% at 12 months. CONCLUSION: Long‐term cognitive, functional impairment was found in up to one in four of patients surviving intensive care for COVID‐19. Fatigue was present in nearly half the survivors at both 6 and 12 months. However, pre‐ICU admission status of the patients was unknown