The effectiveness of a de-implementation strategy to reduce low-value blood management techniques in primary hip and knee arthroplasty: A pragmatic cluster-randomized controlled trial

Background: Perioperative autologous blood salvage and preoperative erythropoietin are not (cost) effective to reduce allogeneic transfusion in primary hip and knee arthroplasty, but are still used. This study aimed to evaluate the effectiveness of a theoretically informed multifaceted strategy to de-implement these low-value blood management techniques. Methods: Twenty-one Dutch hospitals participated in this pragmatic cluster-randomized trial. At baseline, data were gathered for 924 patients from 10 intervention and 1040 patients from 11 control hospitals undergoing hip or knee arthroplasty. The intervention included a multifaceted de-implementation strategy which consisted of interactive education, feedback on blood management performance, and a comparison with benchmark hospitals, aimed at orthopedic surgeons and anesthesiologists. After the intervention, data were gathered for 997 patients from the intervention and 1096 patients from the control hospitals. The randomization outcome was revealed after the baseline measurement. Primary outcomes were use of blood salvage and erythropoietin. Secondary outcomes included postoperative hemoglobin, length of stay, allogeneic transfusions, and use of local infiltration analgesia (LIA) and tranexamic acid (TXA). Results: The use of blood salvage (OR 0.08, 95% CI 0.02 to 0.30) and erythropoietin (OR 0.30, 95% CI 0.09 to 0.97) reduced significantly over time, but did not differ between intervention and control hospitals (blood salvage OR 1.74 95% CI 0.27 to 11.39, erythropoietin OR 1.33, 95% CI 0.26 to 6.84). Postoperative hemoglobin levels were significantly higher (β 0.21, 95% CI 0.08 to 0.34) and length of stay shorter (β -0.36, 95% CI -0.64 to -0.09) in hospitals receiving the multifaceted strategy, compared with control hospitals and after adjustment for baseline. Transfusions did not differ between the intervention and control hospitals (OR 1.06, 95% CI 0.63 to 1.78). Both LIA (OR 0.0, 95% CI 0.0 to 0.0) and TXA (OR 0.3, 95% CI 0.2 to 0.5) were significantly associated with the reduction in blood salvage over time. Conclusions: Blood salvage and erythropoietin use reduced over time, but not differently between intervention and control hospitals. The reduction in blood salvage was associated with increased use of local infiltration analgesia and tranexamic acid, suggesting that de-implementation is assisted by the substitution of techniques. The reduction in blood salvage and erythropoietin did not lead to a deterioration in patient-related secondary outcomes. Trial registration: www.trialregister.nl, NTR404

Ventilation management and clinical outcomes in invasively ventilated patients with COVID-19 (PRoVENT-COVID): a national, multicentre, observational cohort study

Background: Little is known about the practice of ventilation management in patients with COVID-19. We aimed to describe the practice of ventilation management and to establish outcomes in invasively ventilated patients with COVID-19 in a single country during the first month of the outbreak. Methods: PRoVENT-COVID is a national, multicentre, retrospective observational study done at 18 intensive care units (ICUs) in the Netherlands. Consecutive patients aged at least 18 years were eligible for participation if they had received invasive ventilation for COVID-19 at a participating ICU during the first month of the national outbreak in the Netherlands. The primary outcome was a combination of ventilator variables and parameters over the first 4 calendar days of ventilation: tidal volume, positive end-expiratory pressure (PEEP), respiratory system compliance, and driving pressure. Secondary outcomes included the use of adjunctive treatments for refractory hypoxaemia and ICU complications. Patient-centred outcomes were ventilator-free days at day 28, duration of ventilation, duration of ICU and hospital stay, and mortality. PRoVENT-COVID is registered at ClinicalTrials.gov (NCT04346342). Findings: Between March 1 and April 1, 2020, 553 patients were included in the study. Median tidal volume was 6·3 mL/kg predicted bodyweight (IQR 5·7–7·1), PEEP was 14·0 cm H2O (IQR 11·0–15·0), and driving pressure was 14·0 cm H2O (11·2–16·0). Median respiratory system compliance was 31·9 mL/cm H2O (26·0–39·9). Of the adjunctive treatments for refractory hypoxaemia, prone positioning was most often used in the first 4 days of ventilation (283 [53%] of 530 patients). The median number of ventilator-free days at day 28 was 0 (IQR 0–15); 186 (35%) of 530 patients had died by day 28. Predictors of 28-day mortality were gender, age, tidal volume, respiratory system compliance, arterial pH, and heart rate on the first day of invasive ventilation. Interpretation: In patients with COVID-19 who were invasively ventilated during the first month of the outbreak in the Netherlands, lung-protective ventilation with low tidal volume and low driving pressure was broadly applied and prone positioning was often used. The applied PEEP varied widely, despite an invariably low respiratory system compliance. The findings of this national study provide a basis for new hypotheses and sample size calculations for future trials of invasive ventilation for COVID-19. These data could also help in the interpretation of findings from other studies of ventilation practice and outcomes in invasively ventilated patients with COVID-19. Funding: Amsterdam University Medical Centers, location Academic Medical Center