Perioperative anaemia leads to impaired oxygen supply with a risk of vital organ ischaemia. In healthy and fit individuals, anaemia can be compensated by several mechanisms. Elderly patients, however, have less compensatory mechanisms because of multiple co-morbidities and age-related decline of functional reserves. The purpose of the study is to evaluate whether elderly surgical patients may benefit from a liberal red blood cell (RBC) transfusion strategy compared to a restrictive transfusion strategy. The LIBERAL Trial is a prospective, randomized, multicentre, controlled clinical phase IV trial randomising 2470 elderly (≥ 70 years) patients undergoing intermediate- or high-risk non-cardiac surgery. Registered patients will be randomised only if Haemoglobin (Hb) reaches ≤9 g/dl during surgery or within 3 days after surgery either to the LIBERAL group (transfusion of a single RBC unit when Hb ≤ 9 g/dl with a target range for the post-transfusion Hb level of 9–10.5 g/dl) or the RESTRICTIVE group (transfusion of a single RBC unit when Hb ≤ 7.5 g/dl with a target range for the post-transfusion Hb level of 7.5–9 g/dl). The intervention per patient will be followed until hospital discharge or up to 30 days after surgery, whichever occurs first. The primary efficacy outcome is defined as a composite of all-cause mortality, acute myocardial infarction, acute ischaemic stroke, acute kidney injury (stage III), acute mesenteric ischaemia and acute peripheral vascular ischaemia within 90 days after surgery. Infections requiring iv antibiotics with re-hospitalisation are assessed as important secondary endpoint. The primary endpoint will be analysed by logistic regression adjusting for age, cancer surgery (y/n), type of surgery (intermediate- or high-risk), and incorporating centres as random effect. The LIBERAL-Trial will evaluate whether a liberal transfusion strategy reduces the occurrence of major adverse events after non-cardiac surgery in the geriatric population compared to a restrictive strategy within 90 days after surgery. ClinicalTrials.gov (identifier: NCT03369210 ).
In infants, securing the airway is time-critical because of anatomical and physiological differences related to airway management in children less than 1 year old. The aim of this study was to compare the time to ventilation using two different hyperangulated video laryngoscope blades with the time to ventilation via conventional direct laryngoscopy in a normal airway [NA] and in a simulated difficult airway [DA]. This study was a comparative, bicentric, open-label, randomized controlled evaluation. An infant high-fidelity simulator (SimBaby™; Laerdal® Medical, Stavanger, Norway) was used, and two scenarios were proposed, as follows: NA and DA evoked with tongue edema and cervical collar. After theoretical and practical briefing, each participant compared in the two airway scenarios the novel King Vision™ Pediatric aBlade (KV) (Ambu® A/S, Bad Nauheim, Germany) video laryngoscope and the C-MAC™ D-blade Ped (DB) (Karl Storz® SE & Co. KG, Tuttlingen, Germany) video laryngoscope to conventional laryngoscopy using the Miller Blade (MiB) and the Macintosh Blade (MaB) in a random sequence. Eighty physicians (65 AN and 15 PCCM staff) were included. In the NA scenario, the median [IQR] time to successful time to ventilation (TTV) was significantly shorter for the KV at 13 s [12–15 s] than for the MaB at 14.5 s [13–16 s], DB at 14.5 s [13–16] and MiB at 16 s [14–19] (p < 0.001). In DA, the KV also shortened TTV to 14 s [13–16], whereas TTV was 23 s with the MaB [20–26], 19 s with the DB [16–21], and 27 s with the MiB [22–31] (p < 0.001). There were no differences in first-pass intubation success rates (FPAs) between hyperangulated blades and direct laryngoscopes in NA. In DA, the hyperangulated blades enabled 92 (DB) to 100% (KV) FPAs compared with 65 (MiB) to 76% (MaB) for conventional laryngoscopy (p < 0.001). Video laryngoscopes with hyperangulated blades were associated with shorter TTV in normal and difficult infant airway situations. The higher FPAs of hyperangulated blades in DA may avoid desaturations and decrease adverse events in pediatric airway management.
26 January 2024 in Deutsches Ärzteblatt international
Approximately 1% to 2% of all hospitalized children receive a transfusion of blood products, in Germany as in other countries. High-quality scientific evidence on transfusions in children is scarce. The available evidence is discussed in this review. This review is based on publications on blood product transfusions in children that were retrieved by a literature search, including clinical studies, international guideline recommendations, the recommendations of the German cross-sectional guideline, and results of other recent, relevant publications. A restrictive transfusion strategy is recommended for all children, including those who are critically ill. Randomized controlled trials have shown that a restrictive strategy for erythrocyte concentrate transfusion in the intensive care unit is safe for children, including neonates. No robust data are available to enable the definition of a suitable threshold for the intraoperative administration of red blood cell concentrates in children undergoing extracardiac surgery. On the basis of studies from pediatric intensive care units, transfusions for hemodynamically stable children with a hemoglobin concentration of more than 7 g/dL are recommended only in exceptional cases. Therapeutic plasma is not recommended as volume replacement, except in massive transfusion. Platelet concentrate transfusions are indicated in case of active hemorrhage, and only rarely for prophylaxis. There is a broad lack of evidence from randomized controlled trials concerning the indications for transfusions in children. A restrictive transfusion strategy, which has been found safe in the intensive-care setting, is favored by the guidelines in the perioperative setting as well. Further studies are needed to evaluate transfusion triggers and indications for all types of blood products, especially therapeutic plasma. Until more evidence is available, physicians should be aware of what the current evidence supports, and blood products should be given restrictively, and not prophylactically.
Summary: Non‐invasive haemoglobin measurement using absolute values lacks the precision to be the sole basis for the treatment of pre‐operative anaemia. However, it can possibly serve as a screening test, indexing ‘anaemia’ with high sensitivity when values remain under prespecified cut‐off values. Based on previous data, non‐invasive haemoglobin cut‐off values (146 g.l −1 for women and 152 g.l −1 for men) detect true anaemia with 99% sensitivity. An index test with these prespecified cut‐off values was verified by prospective measurement of non‐invasive and invasive haemoglobin pre‐operatively in elective surgical patients. In 809 patients, this showed an estimated sensitivity (95%CI) of 98.9% (94.1–99.9%) in women and 96.4% (91.0–99.0%) in men. This saved invasive blood tests in 9% of female and 28% of male patients. In female patients, a lower non‐invasive haemoglobin cut‐off value (138 g.l −1 ) would save 28% of invasive blood tests with a sensitivity of 95%. The target 99% sensitivity would be reached by non‐invasive haemoglobin cut‐off values of 152 g.l −1 in female and 162 g.l −1 in male patients, saving 3% and 9% of invasive blood tests, respectively. Bias and limits of agreement between non‐invasive and laboratory haemoglobin levels were 2 and − 25 to 28 g.l −1 , respectively. Patient and measurement characteristics did not influence the agreement between non‐invasive and laboratory haemoglobin levels. Although sensitivity was very high, the index test using prespecified cut‐off values just failed to reach the target sensitivity to detect true anaemia. Nevertheless, with respect to blood‐sparing effects, the use of the index test in men may be clinically useful, while an index test with a lower cut‐off (132 g.l −1 ) could be more clinically appropriate in women.