Improvement of the safety of a clinical process using failure mode and effects analysis: Prevention of venous thromboembolic disease in critical patients. / Mejora en la seguridad de un proceso clínico utilizando el análisis modal de fallos y efectos: profilaxis de la enfermedad tromboembólica venosa en pacientes críticos.

OBJECTIVE: To improve critical patient safety in the prevention of venous thromboembolic disease, using failure mode and effects analysis as safety tool. DESIGN: A contemporaneous cohort study covering the period January 2014-March 2015 was made in 4 phases: phase 1) prior to failure mode and effects analysis; phase 2) conduction of mode analysis and implementation of the detected improvements; phase 3) evaluation of outcomes, and phase 4) (post-checklist introduction impact. SETTING: Patients admitted to the adult polyvalent ICU of a third-level hospital center. PATIENTS: A total of 196 patients, older than 18 years, without thromboembolic disease upon admission to the ICU and with no prior anticoagulant treatment. INTERVENTIONS: A series of interventions were implemented following mode analysis: training, and introduction of a protocol and checklist to increase preventive measures in relation to thromboembolic disease. VARIABLES OF INTEREST: Indication and prescription of venous thrombosis prevention measures before and after introduction of the measures derived from the failure mode and effects analysis. RESULTS: A total of 59, 97 and 40 patients were included in phase 1, 3 and 4, respectively, with an analysis of the percentage of subjects who received thromboprophylaxis. The failure mode and effects analysis was used to detect potential errors associated to a lack of training and protocols referred to thromboembolic disease. An awareness-enhancing campaign was developed, with staff training and the adoption of a protocol for the prevention of venous thromboembolic disease. The prescription of preventive measures increased in the phase 3 group (91.7 vs. 71.2%, P=.001). In the post-checklist group, prophylaxis was prescribed in 97.5% of the patients, with an increase in the indication of dual prophylactic measures (4.7, 6.7 and 41%; P<.05). There were no differences in complications rate associated to the increase in prophylactic measures. CONCLUSIONS: The failure mode and effects analysis allowed us to identify improvements in the prevention of thromboembolic disease in critical patients. We therefore consider that it may be a useful tool for improving patient safety in different processes.

Evaluation of the registry DIALYREG for the assessment of continuous renal replacement techniques in the critically ill patient.

Continuous renal replacement techniques (CRRT) can induce complications and monitoring is crucial to ensure patient safety. We designed a prospective multicenter observational and descriptive study using the DIALYREG registry, an online database located on a REDCap web-based platform that allows real-time data analysis. Our main objective was to identify CRRT-related complications in our intensive care units (ICUs) and implement security measures accordingly. From January 2019 to December 2020, we included 323 patients with admission diagnoses of medical illness (54%), sepsis (24%), postoperative care (20%), and trauma (2%). CRRT indications were homeostasis (42%), oliguria (26%), fluid overload (15%), and hemodynamic optimization (13%). The median initial therapy dose was 30 ml/kg/h (IQR 25-40), and dynamic adjustment was performed in 61% of the treatments. Sets were anticoagulated with heparin (40%), citrate (38%) or no anticoagulation (22%). Citrate anticoagulation had several advantages: more frequent dynamic CRRT dose adjustment (77% vs. 58% with heparin and 56% without anticoagulation, p < 0.05), longer duration of set (median of 55 h, IQR 24-72 vs. 23 h, IQR 12-48 with heparin and 12 h, IQR 12-31 without anticoagulation, p < 0.05), less clotting of the set (26% vs. 46.7% with heparin, p < 0.05), and lower incidence of hypophosphatemia (1% citrate vs. 6% with heparin and 5% without anticoagulation). It was also safe and effective in subgroup analysis of patients with liver disease or sepsis. The main global complications were hypothermia (16%), hypophosphatemia (13%) and metabolic acidosis (10%). Weaning of the therapy was achieved through early discontinuation (56%), nocturnal therapy transition (26%) and progressive SLED (18%). 52% of the patients were discharged from the hospital, while 43% died in the ICU and 5% died during hospitalization. We can conclude that the DIALYREG registry is a feasible tool for real-time control of CRRT in our ICU.

Outcomes of very elderly trauma ICU patients. Results from the Spanish trauma ICU registry.

OBJECTIVE: To analyze outcomes and factors related to mortality among very elderly trauma patients admitted to intensive care units (ICUs) participating in the Spanish trauma ICU registry. DESIGN: A multicenter nationwide registry. Retrospective analysis. November 2012-May 2017. SETTING: Participating ICUs. PATIENTS: Trauma patients aged ≥80 years. INTERVENTIONS: None. MAIN VARIABLES OF INTEREST: The outcomes and influence of limitation of life sustaining therapy (LLST) were analyzed. Comparisons were established using the Wilcoxon test, Chi-squared test or Fisher's exact test as appropriate. Multiple logistic regression analysis was performed to analyze variables related to mortality. A p-value <0.05 was considered statistically significant. RESULTS: The mean patient age was 83.4±3.3 years; 281 males (60.4%). Low-energy falls were the mechanisms of injury in 256 patients (55.1%). The mean ISS was 20.5±11.1, with a mean ICU stay of 7.45±9.9 days. The probability of survival based on the TRISS methodology was 69.8±29.7%. The ICU mortality rate was 15.5%, with an in-hospital mortality rate of 19.2%. The main cause of mortality was intracranial hypertension (42.7%). The ISS, the need for first- and second-tier measures to control intracranial pressure, and being admitted to the ICU for organ donation were independent mortality predictors. LLST was applied in 128 patients (27.9%). Patients who received LLST were older, with more severe trauma, and with more severe brain injury. CONCLUSIONS: Very elderly trauma ICU patients presented mortality rates lower than predicted on the basis of the severity of injury.

Rotational thromboelastometry (ROTEM) profile in a cohort of asystole donors. / Perfil de tromboelastometría rotacional (ROTEM) en una cohorte de asistolia no controlada.

BACKGROUND: Hypoperfusion plays a central role in shock states, and has been proposed as a coagulopathy trigger. The study of the rotational thromboelastometry (ROTEM) profile during cardiac arrest could offer new insights to the role of hypoperfusion in coagulation during shock states. OUTCOME: To describe the ROTEM profile in a cohort of asystole donors and elucidate the incidence of hyperfibrinolysis. DESIGN: A prospective observational study was carried out in 18 patients consecutively admitted to the ICU after out-of-hospital non-recovered cardiac arrest (CA). Initial rhythm and time between CA and admission were recorded. Conventional coagulation and ROTEM (EXTEM, APTEM, FIBTEM) tests were performed within 30minutes after blood sample collection. SCOPE: An asystole donor reference hospital. PARTICIPANTS: Patients admitted to the ICU after out-of-hospital non-recovered CA. RESULTS: The median age was 50years, and 14 of the patients were men (77.8%). The time from CA to hospital admission expressed as the median (interquartile range) was 91minutes (75-104). The results of the routine tests were: INR 1.25 (1.19-1.34), aPTT 55s (45-73) and fibrinogen 161mg/dl (95-295). For the ROTEM APTEM assay the results were: CT 126s (104-191), CFT 247s (203-694). Hyperfibrinolysis criteria were recorded in 15 patients (83.3%). In addition, MCF improved in APTEM versus EXTEM. Prolonged CA times were associated to lower fibrinogen levels and lower values for MCF FIBTEM (P<.05). CONCLUSIONS: The ROTEM assays revealed severe alterations of the clot formation parameters and a high incidence of hyperfibrinolysis.