The effects of preoperative focused cardiac ultrasound in high-risk patients: A randomised controlled trial (PREOPFOCUS).

BACKGROUND: Surgery is the third most common cause of mortality worldwide. Focused cardiac ultrasound (FOCUS) yields information on cardiac status and discloses the presence of unknown pathology. Preoperative FOCUS changes patient treatment, allowing for a patient-tailored anaesthesia. We hypothesised that preoperative FOCUS would reduce the proportion of patients who were either admitted to hospital for more than 10 days or who were dead within 30 days after high-risk, non-cardiac surgery. METHODS: This was a randomised, controlled, multi-center study. Patients ≥65 years of age, admitted for urgent orthopaedic- or abdominal surgery, scheduled for general- or neuraxial anaesthesia and with ASA 3/4 were eligible for inclusion. Patients were randomised in a 1:1 ratio to preoperative FOCUS or no preoperative FOCUS performed in accordance with a predefined protocol. Primary endpoint was the proportion of patients admitted more than 10 days or who were dead within 30 days. Secondary endpoints included major complications, days of admission and changes in anaesthesia handling. RESULTS: During the second COVID-19 wave the study monitoring committee terminated the study prematurely. We included 338 patients of which 327 were included in the final analysis. In the FOCUS group, 41/163 (25%) patients met the criteria for the primary endpoint versus 35/164 (21%) for the control group, adjusted odds ratio 1.37 (95% CI 0.86-2.30), p = .36. The proportions of patients who developed major complications did not differ significantly between groups. Length of hospital stay was 4 (3-8) days in the FOCUS group and 4 (3-7) days on the control group (adjusted p = .24). CONCLUSION: The routine availability of preoperative FOCUS assessment in this cohort does not appear to reduce the risk for hospitalisation exceeding 10 days or 30-day mortality, although study enrolment was prematurely terminated.

Effect of calcium vs. placebo on long-term outcomes in patients with out-of-hospital cardiac arrest.

OBJECTIVE: The Calcium for Out-of-hospital Cardiac Arrest (COCA) trial was a randomized, placebo-controlled, double-blind trial of calcium for out-of-hospital cardiac arrest. The primary and secondary outcomes have been reported previously. This article describes the long-term outcomes of the trial. METHODS: Patients aged ≥18 years were included if they had a non-traumatic out-of-hospital cardiac arrest during which they received adrenaline. The trial drug consisted of calcium chloride (5 mmol) or saline placebo given after the first dose of adrenaline and again after the second dose of adrenaline for a maximum of two doses. This article presents pre-specified analyses of 6-month and 1-year outcomes for survival, survival with a favorable neurological outcome (modified Rankin Scale of 3 or less), and health-related quality of life. RESULTS: A total of 391 patients were analyzed. At 1 year, 9 patients (4.7%) were alive in the calcium group while 18 (9.1%) were alive in the placebo group (risk ratio 0.51; 95% confidence interval 0.24, 1.09). At 1 year, 7 patients (3.6%) were alive with a favorable neurological outcome in the calcium group while 17 (8.6%) were alive with a favorable neurological outcome in the placebo group (risk ratio 0.42; 95% confidence interval 0.18, 0.97). Outcomes for health-related quality of life likewise suggested harm of calcium but results were imprecise with wide confidence intervals. CONCLUSIONS: Effect estimates remained constant over time suggesting harm of calcium but with wide confidence intervals. The results do not support calcium administration during out-of-hospital cardiac arrest. TRIAL REGISTRATION: ClinicalTrials.gov-number, NCT04153435.

Effect of Intravenous or Intraosseous Calcium vs Saline on Return of Spontaneous Circulation in Adults With Out-of-Hospital Cardiac Arrest: A Randomized Clinical Trial.

Importance: It is unclear whether administration of calcium has a beneficial effect in patients with cardiac arrest. Objective: To determine whether administration of calcium during out-of-hospital cardiac arrest improves return of spontaneous circulation in adults. Design, Setting, and Participants: This double-blind, placebo-controlled randomized clinical trial included 397 adult patients with out-of-hospital cardiac arrest and was conducted in the Central Denmark Region between January 20, 2020, and April 15, 2021. The last 90-day follow-up was on July 15, 2021. Interventions: The intervention consisted of up to 2 intravenous or intraosseous doses with 5 mmol of calcium chloride (n = 197) or saline (n = 200). The first dose was administered immediately after the first dose of epinephrine. Main Outcomes and Measures: The primary outcome was sustained return of spontaneous circulation. The secondary outcomes included survival and a favorable neurological outcome (modified Rankin Scale score of 0-3) at 30 days and 90 days. Results: Based on a planned interim analysis of 383 patients, the steering committee stopped the trial early due to concerns about harm in the calcium group. Of 397 adult patients randomized, 391 were included in the analyses (193 in the calcium group and 198 in the saline group; mean age, 68 [SD, 14] years; 114 [29%] were female). There was no loss to follow-up. There were 37 patients (19%) in the calcium group who had sustained return of spontaneous circulation compared with 53 patients (27%) in the saline group (risk ratio, 0.72 [95% CI, 0.49 to 1.03]; risk difference, -7.6% [95% CI, -16% to 0.8%]; P = .09). At 30 days, 10 patients (5.2%) in the calcium group and 18 patients (9.1%) in the saline group were alive (risk ratio, 0.57 [95% CI, 0.27 to 1.18]; risk difference, -3.9% [95% CI, -9.4% to 1.3%]; P = .17). A favorable neurological outcome at 30 days was observed in 7 patients (3.6%) in the calcium group and in 15 patients (7.6%) in the saline group (risk ratio, 0.48 [95% CI, 0.20 to 1.12]; risk difference, -4.0% [95% CI, -8.9% to 0.7%]; P = .12). Among the patients with calcium values measured who had return of spontaneous circulation, 26 (74%) in the calcium group and 1 (2%) in the saline group had hypercalcemia. Conclusions and Relevance: Among adults with out-of-hospital cardiac arrest, treatment with intravenous or intraosseous calcium compared with saline did not significantly improve sustained return of spontaneous circulation. These results do not support the administration of calcium during out-of-hospital cardiac arrest in adults. Trial Registration: ClinicalTrials.gov Identifier: NCT04153435.

The effects of preoperative point-of-care focused cardiac ultrasound in high-risk patients: study protocol for a prospective randomised controlled trial.

INTRODUCTION: Perioperative mortality and morbidity remain substantial in acute surgery. Risk factors include known cardiovascular disease, but preoperative screening is insensitive to occult cardiopulmonary conditions. Focused cardiac ultrasound (FOCUS) can disclose both structural and functional cardiac disease and provides insight into the patient's haemodynamic status. This study aims to clarify whether preoperative FOCUS changes clinical outcomes in high-risk patients. METHODS: This is a multi-centre, randomised, controlled, prospective study including patients ≥ 65 years of age scheduled for acute/emergency abdominal- or orthopaedic surgery. A total of 800 patients will be randomised to ± application of preoperative FOCUS. The primary endpoint is the proportion of patients admitted to hospital > 10 days or death within 30 days of surgery. The secondary endpoints include changes in the anaesthesia approach facilitated by FOCUS, biomarkers of organ function and perioperative complications. CONCLUSIONS: The knowledge generated from this study may facilitate changes in the anaesthesia evaluation and decision process and, consequently, in the entire perioperative anaesthesia clinical practice. The study has the potential to reduce the risk of perioperative cardiopulmonary complications which directly implies improved patient outcome and reduced hospital costs. FUNDING: The Research Fund of the Department of Anaesthesiology, Randers Regional Hospital, The Central Denmark Region's Medical Research Fund and the Hospital of Southern Jutland. TRIAL REGISTRATION: NCT03501927.

Trends in the incidence of nonmelanoma skin cancer in Denmark 1978-2007: Rapid incidence increase among young Danish women.

Nonmelanoma skin cancer (NMSC) is the most common cancer among Caucasian populations worldwide, and incidence rates are increasing. However, NMSC data are not routinely collected by cancer registries, but Denmark has extensive registration of NMSC in two nationwide population-based registries. We assessed incidence trends of NMSC in Denmark from 1978 to 2007. Data for basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) were obtained from the Danish Cancer Registry and the Danish Registry of Pathology. For both genders, age-specific incidence rates and overall incidence rates, age-adjusted according to the World standard population were calculated based on combined data from the two registries. For both genders, a high increase in both BCC and SCC incidence was observed over time. Between 1978 and 2007, the age-adjusted BCC incidence increased from 27.1 to 96.6 cases per 100,000 person-years for women and from 34.2 to 91.2 cases for men. The SCC incidence increased from 4.6 to 12.0 cases per 100,000 person-years for women and from 9.7 to 19.1 cases for men. For both BCC and SCC, women experienced a higher average annual percentage incidence change than men. Furthermore, the average annual percentage change in BCC incidence among persons below 40 years was significantly higher compared to older persons, especially for women. These trends may lead to an alarming NMSC incidence increase over time as population ages and will have major implications for future healthcare services. Our findings underline the need for improved preventive strategies to hamper the increasing NMSC incidence.