Does programmed intermittent epidural bolus improve childbirth conditions of nulliparous women compared with patient-controlled epidural analgesia?: A multicentre, prospective, controlled, randomised, triple-blind study BACKGROUND Epidural analgesia may change the mechanics of childbirth. These changes are related to the concentration of the local anaesthetic used epidurally but probably also to its mode of delivery into the epidural space. OBJECTIVE To determine whether the administration of programmed intermittent epidural boluses (PIEB) improves the mechanics of second-stage labour compared with patient-controlled epidural analgesia (PCEA) with a background infusion. DESIGN Prospective, controlled, randomised, triple-blind study. SETTING Multicentre study including four level III maternity units, January 2014 until June 2016. PATIENTS A total of 298 nulliparous patients in spontaneous labour were randomised to a PIEB or PCEA group. INTERVENTION After epidural initiation with 15 ml of 0.1% levobupivacaine containing 10 μg of sufentanil, patients received either an hourly bolus of 8 ml (PIEB) or a continuous rate infusion of 8 ml h−1 (PCEA): the drug mixture used was levobupivacaine 0.1% and sufentanil 0.36 μg ml−1. MAIN OUTCOME MEASURES The primary outcome was a composite endpoint of objective labour events: a posterior occiput position in the second stage, an occiput position at birth, waiting time at full cervical dilatation before active maternal pushing more than 3 h, maternal active pushing duration more than 40 min, and foetal heart rate alterations. Vaginal instrumental delivery rates, analgesia and motor blockade scores were also recorded. RESULTS From the 298 patients randomised, data from 249 (124 PIEB, 125 PCEA) were analysed. No difference was found in the primary outcome: 48.0% (PIEB) and 45.5% (PCEA) of patients, P = 0.70. In addition, no difference was observed between the groups for each of the individual events of the composite endpoint, nor in the instrumental vaginal delivery rate, nor in the degree of motor blockade. Despite an equivalent volume of medication in the groups, a significantly higher analgesia score at full dilatation was observed in the PIEB group, odds-ratio = 1.9 (95% confidence interval, 1.0 to 3.5), P = 0.04. CONCLUSION The mechanics of the second stage did not differ whether PIEB or PCEA was used. Analgesic conditions appeared to be superior with PIEB, especially at full dilation. TRIAL REGISTRATION Clinical trial number: NCT01856166. Correspondence to Estelle Morau, CHU Arnaud de Villeneuve, 34295 Montpellier Cedex 5, France E-mail: estelle.morau@hotmail.fr © 2019 European Society of Anaesthesiology

Comparison of a simplified nasal continuous positive airways pressure device with nasal cannula in obese patients undergoing colonoscopy during deep sedation: A randomised clinical trial BACKGROUND Continuous positive airways pressure (CPAP) with a CPAP machine and mask has been shown to be more effective at minimising hypoxaemia than other devices under deep sedation. However, the efficacy of a new and simple CPAP device for spontaneously breathing obese patients during colonoscopy is unknown. OBJECTIVE We hypothesised that oxygenation and ventilation in obese patients under deep sedation during colonoscopy using CPAP via a new nasal mask (SuperNO2VA) would be better than routine care with oxygen supplementation via a nasal cannula. DESIGN Randomised study. SETTING Single-centre, June 2017 to October 2017. PATIENTS A total of 174 patients were enrolled and randomly assigned to Mask group or Control group. Thirty-eight patients were excluded and data from 136 patients underwent final analysis. INTERVENTION Patients in the Mask group were provided with nasal CPAP (10 cmH2O) at an oxygen flow rate of 15 l min−1. In the Control group, patients were given oxygen via a nasal cannula at a flow rate of 5 l min−1. MAIN OUTCOME MEASURES The primary outcome was elapsed time from anaesthesia induction to the first airway intervention. RESULTS The elapsed time from anaesthesia induction to the first airway intervention was 19 ± 10 min in the Mask group (n=63) vs. 10 ± 12 min in the Control group (n=73, P < 0.001). In all, 87.5% (56/64) of patients achieved the target CPAP value. More patients in the Control group (63%) received airway intervention than in the Mask group (22%) (P < 0.001). Hypoxaemia (pulse oximeter oxygen saturation, SpO2 < 90%) occurred more frequently in the Control group (22%) than in the Mask group (5%) (P = 0.004). Minute ventilationPostinduction/minute ventilationBaseline and minute ventilationProcedure-end/minute ventilationBaseline was lower in the Control group than in the Mask group (P = 0.007 and 0.001, respectively). CONCLUSION Application of a nasal mask at a target CPAP of 10 cmH2O improves ventilation and decreases the frequency and severity of hypoxaemia. TRIAL REGISTRATION NCT03139448, registered at ClinicalTrials.gov. Correspondence to Koffi Kla, MD, Department of Anaesthesiology, Vanderbilt University Medical Centre, 1301 Medical Centre Drive, 4648 TVC, Nashville, TN 37232-5614, USA Tel: +1 615 343 9419; e-mail: koffi.m.kla@vanderbilt.edu © 2019 European Society of Anaesthesiology

Functional MRI: basic principles and emerging clinical applications for anaesthesiology and the neurological sciences No abstract available

Validation of 3-minute diagnostic interview for CAM-defined Delirium to detect postoperative delirium in the recovery room: A prospective diagnostic study BACKGROUND Recent guidelines on postoperative delirium (POD) recommend POD screening in all patients, using a validated tool, starting in the recovery room. An operationalisation of the Confusion Assessment Method (CAM) criteria, the 3-Minute Diagnostic Interview for CAM-defined Delirium (3D-CAM), has been developed for use in general medical units. OBJECTIVES The aim of this study was to evaluate 3D-CAM performance in an adult patient population to detect POD in the recovery room. DESIGN A prospective diagnostic study. SETTING Recovery room of a tertiary care university hospital in Berlin, Germany, in 2017. PATIENTS Patients at least 18 years of age undergoing elective surgery. MAIN OUTCOME MEASURES Patients were subjected to evaluation by blinded investigators using the 3D-CAM and the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5, reference standard). Sensitivity, specificity and positive predictive value (PPV) and negative predictive value (NPV) were analysed for 3D-CAM, in addition to test–retest and inter-rater reliability analyses. RESULTS Sixteen out of 176 patients (9.1%) developed POD. The 3D-CAM demonstrated strong test performance (specificity 0.88, sensitivity 1.0, area under the curve 0.94, PPV 0.44 and NPV 1.0), with a test–retest reliability of 90% (n = 10) and inter-rater reliability of 80% (n = 10). CONCLUSION In this diagnostic study, 3D-CAM showed strong performance for detection of POD in the recovery room. Due to the low training requirements, fast application and high sensitivity, it might be particularly appropriate for clinical staff with limited experience in the assessment of POD. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02992717 Correspondence to Claudia D. Spies, MD, Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Augustenburger Platz 1, Berlin D-13353, Germany Tel: +49 30 450 551102/+49 30 450 531012; e-mail: claudia.spies@charite.de Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Website (www.ejanaesthesiology.com). © 2019 European Society of Anaesthesiology

Comparison of low and high positive end-expiratory pressure during low tidal volume ventilation in robotic gynaecological surgical patients using electrical impedance tomography: A randomised controlled trial BACKGROUND The appropriate level of positive end-expiratory pressure (PEEP) during intra-operative mechanical ventilation remains unclear. OBJECTIVE The aim of this study was to investigate the effects of different levels of PEEP with low tidal volume (low-VT) ventilation in a steep Trendelenburg position (30°) and pneumoperitoneum on oxygenation, respiratory mechanics and ventilation distribution using electrical impedance tomography. DESIGN A randomised controlled trial. SETTING Single university secondary care centre, conducted from January 2017 to December 2017. PATIENTS Forty female patients, aged 20 to 60 years, and of American Society of Anesthesiologists’ (ASA) physical status 1 or 2, undergoing elective robotic gynaecological surgery were included. INTERVENTION Forty patients were allocated randomly to a PEEP4 (PEEP 4 cmH2O) group or a PEEP8 (PEEP 8 cmH2O) group. MAIN OUTCOME MEASURES The primary outcomes were respiratory mechanics. The secondary outcomes included changes in ventilation distribution across the ventral and dorsal regions of interest and postoperative pulmonary complications (PPCs) using a modified clinical pulmonary infection score. RESULTS There was no difference in PaO2 at any time point. The peak inspiratory pressure (PIP) and mean airway pressure (Paw) of the PEEP4 group were lower than those of the PEEP8 group (P < 0.001). The oxygenation factor in the PEEP4 group was higher than that in the PEEP8 group during mechanical ventilation at all times. There was no difference in the fractional distribution of end-expiratory ventilation according to region of interest between the two groups. CONCLUSION Both 4 and 8 cmH2O of PEEP with low-VT ventilation can be used for robotic gynaecological surgery that requires a steep Trendelenburg position and pneumoperitoneum. However, 8 cmH2O of PEEP had no benefit over 4 cmH2O of PEEP with respect to oxygenation and improvement of dorsal regional ventilation. TRIAL REGISTRATION The trial was registered at the Clinical Trial Registry of Korea (KCT0002255). https://cris.nih.go.kr Correspondence to Hee Jung Baik, MD, PhD, Department of Anaesthesiology and Pain Medicine, College of Medicine, Ewha Womans University, 1071 Anyangcheon-ro, Yangcheon-gu, Seoul 07985, Republic of Korea Tel: +82 2 2650 2868; fax: +82 2 2655 2924; e-mail: baikhj@ewha.ac.kr © 2019 European Society of Anaesthesiology

Patient safety and the role of the Helsinki Declaration on Patient Safety in Anaesthesiology: A European survey BACKGROUND The Helsinki Declaration on Patient Safety was launched in 2010 by the European Society of Anaesthesiology and the European Board of Anaesthesiology. It is not clear how widely its vision and standards have been adopted. OBJECTIVE To explore the role of the Helsinki Declaration in promoting and maintaining patient safety in European anaesthesiology. DESIGN Online survey. SETIING A total of 38 countries within Europe. PARTICIPANTS Members of the European Society of Anaesthesiology who responded to an invitation to take part by electronic mail. MAIN OUTCOME MEASURES Responses from a 16-item online survey to explore each member anaesthesiologist's understanding of the Declaration and compliance with its standards. RESULTS We received 1589 responses (33.4% response rate), with members from all countries responding. The median [IQR] response rate of members was 20.5% [11.7 to 37.0] per country. There were many commonalities across Europe. There were very high levels of use of monitoring (pulse oximetry: 99.6%, blood pressure: 99.4%; ECG: 98.1% and capnography: 96.0%). Protocols and guidelines were also widely used, with those for pre-operative assessment, and difficult and failed intubation being particularly popular (mentioned by 93.4% and 88.9% of respondents, respectively). There was evidence of widespread use of the WHO Safe Surgery checklist, with only 93 respondents (6.0%) suggesting that they never used it. Annual reports of measures taken to improve patient safety, and of morbidity and mortality, were produced in the hospitals of 588 (37.3%) and 876 (55.7%) respondents, respectively. Around three-quarters of respondents, 1216, (78.7%) stated that their hospital used a critical incident reporting system. Respondents suggested that measures to promote implementation of the Declaration, such as a formal set of checklist items for day-to-day practice, publicity, translation and simulation training, would currently be more important than possible changes to its content. CONCLUSION Many patient safety practices encouraged by the Declaration are well embedded in many European countries. The data have highlighted areas where there is still room for improvement. Correspondence to Andrew F. Smith, Department of Anaesthetics, Royal Lancaster Infirmary, Lancaster LA1 4RP, UK Tel: +00 44 7768 226361; e-mail: andrew.f.smith@mbht.nhs.uk © 2019 European Society of Anaesthesiology

Complex effects of continuous vasopressor infusion on fluid responsiveness during liver resection: A preliminary randomised controlled trial BACKGROUND Fluid responsiveness is an important factor to consider for fluid volume loading during major surgery. The effect of continuous vasopressor infusion on fluid responsiveness during prolonged major surgery is a concern. OBJECTIVE We hypothesised that continuous vasopressor infusion during major surgery might not exert significant effects on changes in stroke volume variation (SVV) following fluid bolus infusion, and thereby on fluid responsiveness. DESIGN Randomised controlled trial. SETTING University hospital from April 2014 to August 2016. PATIENTS Patients undergoing liver resection who were randomised to receive continuous intravenous infusion of phenylephrine (P group), norepinephrine (N group), or no vasopressor (C group) (n=17/group). Exclusion criteria were cardiac arrhythmia and severe cardiac, pulmonary or renal dysfunction. INTERVENTION Patients received 4 ml kg−1 fluid boluses of 6% hydroxyethyl starch solution when SVV was at least 12%. Vasopressors were administered continuously to maintain the systemic vascular resistance index at more than 1900 dyn s cm−5 m−2. MAIN OUTCOME MEASURES Cardiac index and SVV were measured using the FloTrac™/Vigileo™ system (Version 4.00). The number of fluid boluses with fluid responsiveness (i.e. >15% increase in cardiac index) was compared between groups using multilevel logistic regression analysis. RESULTS Numbers of fluid responsive boluses in the C, P and N groups were 12 (14%), 22 (34%) and 19 (27%), respectively. Odds ratios on fluid responsiveness for phenylephrine and norepinephrine compared with the control were 3.65 (97.5% confidence interval, 1.15 to 11.6; P = 0.012) and 2.56 (97.5% confidence interval, 0.82 to 8.00; P = 0.064), respectively. Decreases in SVV after fluid bolus infusion for the P and N groups were comparable with the C group (P = 0.23 and 0.53, respectively). CONCLUSION Continuous administration of phenylephrine increased fluid responsiveness during liver resection, suggesting complex effects of continuous vasopressor infusion involving changes in cardiac preload and afterload. TRIAL REGISTRATION UMIN000011024. Correspondence to Tsuneo Tatara, MD, Department of Anaesthesiology and Pain Medicine, Hyogo College of Medicine, 1-1 Mukogawa-cho, Nishinomiya 663-8501, Hyogo, Japan Tel: +81 798 45 6392; fax: +81 798 45 6393; e-mail: ttatara@hyo-med.ac.jp © 2019 European Society of Anaesthesiology

Effectiveness of a visual noise warning system on noise levels in a surgical ICU: A quality improvement programme BACKGROUND The effects of noise are harmful to patients in the ICU environment, and the latter are particularly noisy places. High noise levels seem to be a factor in sleep disturbance, which can, in turn, result in increased morbidity. LOCAL PROBLEM High noise levels are a recognised problem in ICUs worldwide. OBJECTIVE(S) The goal was to estimate the effect of a visual noise-warning system on noise levels in a surgical ICU before and after its implementation. DESIGN A quality improvement initiative. SETTING A 12-bedded surgical ICU in a tertiary care university hospital. PATIENTS A total of 148 adult nonintubated and nonsedated patients completed the study, during a 6-week period. INTERVENTION Noise levels were continuously recorded using a Type II sound level meter for 6 weeks. The study was divided into three phases. The first 2 weeks, baseline noise levels were measured (phase I). In week 3 of the study, a visual noise warning system (SoundEar II) that changed colour depending on noise levels within the ICU was installed and implemented (phase II). The alarm system was set to light up green at levels below 55 dBA, orange at levels between 55 and 60 dBA and red at levels above 60 dBA. The device was switched off at the beginning of week 5 and the sound level meter continued recording noise levels for another 2 weeks (phase III). RESULTS Mean night-time noise level was 55.98 dBA in the preintervention phase, 54.14 dB during the intervention, and 54.98 dBA in the postintervention phase. Mean noise level was reduced statistically significantly by 1.35 dBA, and there was a sustained reduction of 0.86 dBA from the baseline noise level 2 weeks after SoundEar II was switched off. CONCLUSION Visual noise warning systems can be effective in achieving a reduction in noise levels in critical care units. Correspondence to Miriam de Nadal, Department of Anesthesiology and Intensive Care, Hospital Universitari Vall d’Hebron, Ps Vall d’Hebron 119-129, 08035 Barcelona, Spain Tel: +34 932746004; e-mail: minadal@vhebron.net © 2019 European Society of Anaesthesiology

Comparison between the new fully automated viscoelastic coagulation analysers TEG 6s and ROTEM Sigma in trauma patients: A prospective observational study BACKGROUND Viscoelastic coagulation testing is increasingly used to diagnose trauma-induced coagulopathy. Two fully automated analysers, TEG 6s and ROTEM Sigma, were launched recently. No previous studies have compared these devices in trauma paients. OBJECTIVE The aim of this study was to evaluate whether both fully automatic devices deliver comparable results. DESIGN Prospective observational study. SETTING Level one trauma centre from August 2017 to September 2018. PATIENTS A total of 105 blood samples from 67 trauma patients were analysed simultaneously on TEG 6s and ROTEM Sigma. MAIN OUTCOME MEASURES TEG 6s assays kaolin (CK), RapidTEG (CRT), kaolin with heparinase (CKH) and functional fibrinogen were compared with ROTEM Sigma assays INTEM, EXTEM, HEPTEM and FIBTEM. TEG 6s functional fibrinogen level was compared with plasma fibrinogen concentration, measured using the Clauss method. Correlations were classified as weak (Spearman correlation coefficient 0.20 to 0.39), moderate (0.40 to 0.59), strong (0.60 to 0.79) or very strong (≥0.80). RESULTS The TEG 6s parameters reaction time, kinetic time and α-angle (CK, CRT and CKH assays) mostly showed strong correlations with the corresponding ROTEM parameters clotting time, clot formation time and α-angle (INTEM, EXTEM and HEPTEM assays). The exceptions were CRT reaction time vs. EXTEM clotting time, and CK α-angle vs. INTEM α-angle, which correlated moderately. Absolute values for many of these parameters showed significant differences between the two devices. Very strong correlations and similar absolute values were observed between TEG 6s maximum amplitude (CRT, CK and CKH assays) and ROTEM maximum clot firmness (EXTEM, INTEM and HEPTEM assays). Correlations were also very strong for functional fibrinogen maximum amplitude vs. FIBTEM maximum clot firmness and functional fibrinogen level vs. Clauss fibrinogen concentration, but absolute values were significantly different. CONCLUSION Strong to very strong correlations were observed between corresponding TEG 6s and ROTEM Sigma parameters. However, absolute values showed significant differences for most of the measurements. Correspondence to Herbert Schöchl, MD, Department of Anaesthesiology and Intensive Care Medicine, AUVA Trauma Centre Salzburg, Academic Teaching Hospital of the Paracelsus Medical University, Dr Franz Rehrl Platz 5, 5020 Salzburg, Austria; Ludwig Boltzmann Institute for Experimental and Clinical Traumatology, AUVA Trauma Research Centre, Vienna, Austria E-mail: herbert.schoechl@auva.at Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Website (www.ejanaesthesiology.com). © 2019 European Society of Anaesthesiology

A systematic review of randomised controlled trials investigating prehabilitation before major intra-abdominal cancer surgery: An analysis of prehabilitation content and outcome measures BACKGROUND Although prehabilitation programmes for patients undergoing major intra-abdominal cancer surgery have been shown to improve pre-operative physical fitness, the conclusions regarding any postoperative benefits are inconsistent. OBJECTIVES The aim of this study was to evaluate the content of and the outcome measures used in studies of prehabilitation programmes for these patients. It was hypothesised that the content of prehabilitation programmes is often therapeutically invalid, and that the postoperative outcomes assessed are inadequate to evaluate the impact of complications. DESIGN A systematic review of randomised controlled trials. DATA SOURCES Studies published between January 2009 and January 2019 were retrieved from PubMed, Embase and PEDro. ELIGIBILITY CRITERIA Studies were included when they investigated the effects of prehabilitation in patients undergoing intra-abdominal surgery for cancer, reported pre-operative and/or postoperative outcome measures and were conducted as a randomised controlled trial. Studies for which the full text was not available were excluded, as were studies of patients undergoing nonabdominal cancer surgery. RESULTS Eight studies (565 patients) were included. Therapeutic validity was low in five studies. Most studies included low-risk surgical patients and considerable variation was observed between prehabilitation programmes in terms of supervision, training context, frequency, intensity, duration and training type. Objective monitoring of training progression was typically not performed, and most trials did not include nutritional or psychological support. Postoperative complications were reported in seven studies, but no study reported the impact of postoperative complications, nor on long-term postoperative outcomes. CONCLUSION The content of prehabilitation programmes was heterogeneous. Studies with a high therapeutic validity found unequivocal evidence that prehabilitation had beneficial effects on postoperative outcomes. Future research should focus on adequate selection and inclusion of high-risk surgical patients and provide personalised and probably multimodal (partly) supervised prehabilitation, with objective monitoring of progress. Measuring the incidence and impact of postoperative complications may contribute to demonstrating the clinical value of prehabilitation. This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0 Correspondence to Bart C. Bongers, PhD, Maastricht University, Department of Nutrition and Movement Sciences, P.O. Box 616, 6200 MD Maastricht, The Netherlands Tel: +0031433882236; e-mail: bart.bongers@maastrichtuniversity.nl Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Website (www.ejanaesthesiology.com). © 2019 European Society of Anaesthesiology