An interrater reliability analysis of preoperative mortality risk calculators used for elective high-risk noncardiac surgical patients shows poor to moderate reliability.

BACKGROUND: Multiple preoperative calculators are available online to predict preoperative mortality risk for noncardiac surgical patients. However, it is currently unknown how these risk calculators perform across different raters. The current study investigated the interrater reliability of three preoperative mortality risk calculators in an elective high-risk noncardiac surgical patient population to evaluate if these calculators can be safely used for identification of high-risk noncardiac surgical patients for a preoperative multidisciplinary team discussion. METHODS: Five anesthesiologists assessed the preoperative mortality risk of 34 high-risk patients using the preoperative score to calculate postoperative mortality risks (POSPOM), the American College of Surgeons surgical risk calculator (SRC), and the surgical outcome risk tool (SORT). In total, 170 calculations per calculator were gathered. RESULTS: Interrater reliability was poor for SORT (ICC (C.I. 95%) = 0.46 (0.30-0.63)) and moderate for SRC (ICC = 0.65 (0.51-0.78)) and POSPOM (ICC = 0.63 (0.49-0.77). The absolute range of calculated mortality risk was 0.2-72% for POSPOM, 0-36% for SRC, and 0.4-17% for SORT. The coefficient of variation increased in higher risk classes for POSPOM and SORT. The extended Bland-Altman limits of agreement suggested that all raters contributed to the variation in calculated risks. CONCLUSION: The current results indicate that the preoperative risk calculators POSPOM, SRC, and SORT exhibit poor to moderate interrater reliability. These calculators are not sufficiently accurate for clinical identification and preoperative counseling of high-risk surgical patients. Clinicians should be trained in using mortality risk calculators. Also, clinicians should be cautious when using predicted mortality estimates from these calculators to identify high-risk noncardiac surgical patients for elective surgery.

In pursuit of a better transition to selected residencies: a quasi-experimental evaluation of a final year of medical school dedicated to the acute care domain.

BACKGROUND: Medical schools seek the best curricular designs for the transition to postgraduate education, such as the Dutch elective-based final, 'transitional' year. Most Dutch graduates work a mean of three years as a physician-not-in-training (PNIT) before entering residency training. To ease the transition to selected specialties and to decrease the duration of the PNIT period, UMC Utrecht introduced an optional, thematic variant of the usual transitional year, that enables the development of theme-specific competencies, in addition to physicians' general competencies. METHODS: We introduced an optional transitional year for interested students around the theme of acute care, called the Acute Care Transitional Year (ACTY). This study aimed to evaluate the ACTY by judging whether graduates meet postgraduate acute care expectations, indicating enhanced learning and preparation for practice. In a comprehensive assessment of acute care knowledge, clinical reasoning, skills, and performance in simulations, we collected data from ACTY students, non-ACTY students interested in acute care, and PNITs with approximately six months of acute care experience. RESULTS: ACTY graduates outperformed non-ACTY graduates on skills and simulations, and had higher odds of coming up to the expectations faculty have of a PNIT, as determined by global ratings. PNITs did better on simulations than ACTY graduates. DISCUSSION: ACTY graduates show better resemblance to PNITs than non-ACTY graduates, suggesting better preparation for postgraduate acute care challenges. CONCLUSION: Transitional years, offering multidisciplinary perspectives on a certain theme, can enhance learning and preparedness for entering residency.

Adaptive threshold-based alarm strategies for continuous vital signs monitoring.

Continuous vital signs monitoring in post-surgical ward patients may support early detection of clinical deterioration, but novel alarm approaches are required to ensure timely notification of abnormalities and prevent alarm-fatigue. The current study explored the performance of classical and various adaptive threshold-based alarm strategies to warn for vital sign abnormalities observed during development of an adverse event. A classical threshold-based alarm strategy used for continuous vital signs monitoring in surgical ward patients was evaluated retrospectively. Next, (combinations of) six methods to adapt alarm thresholds to personal or situational factors were simulated in the same dataset. Alarm performance was assessed using the overall alarm rate and sensitivity to detect adverse events. Using a wireless patch-based monitoring system, 3999 h of vital signs data was obtained in 39 patients. The clinically used classical alarm system produced 0.49 alarms/patient/day, and alarms were generated for 11 out of 18 observed adverse events. Each of the tested adaptive strategies either increased sensitivity to detect adverse events or reduced overall alarm rate. Combining specific strategies improved overall performance most and resulted in earlier presentation of alarms in case of adverse events. Strategies that adapt vital sign alarm thresholds to personal or situational factors may improve early detection of adverse events or reduce alarm rates as compared to classical alarm strategies. Accordingly, further investigation of the potential of adaptive alarms for continuous vital signs monitoring in ward patients is warranted.

Risk of perioperative thyroid storm in hyperthyroid patients: a systematic review.

BACKGROUND: Thyroid storm is a feared complication in patients with hyperthyroidism undergoing surgery. We assessed the risk of thyroid storm for different preoperative treatment options for patients with primary hyperthyroidism undergoing surgery. METHODS: Pubmed, EMBASE, and The Cochrane Library were searched systematically for all studies reporting on adult hyperthyroid patients undergoing elective surgery under general anaesthesia. Selected studies were categorised based on preoperative treatment: no treatment, antithyroid medication (thionamides), iodine, ß-blocking medication, or a combination thereof. Treatment effect, that is restoring euthyroidism, was extracted from the publications if available. Risk of bias was assessed using the Risk of Bias in Non-randomised Studies of Interventions (ROBINS-I) or the Cochrane Risk of Bias tool for randomised studies. RESULTS: The search yielded 7009 articles, of which 26 studies published between 1975 and 2020 were selected for critical appraisal. All studies had moderate to critical risk of bias, mainly attributable to risk of confounding, classification of intervention status, and definition of the outcome. All studies reported on thyroidectomy patients. We found no randomised studies comparing the risk of thyroid storm between treated and untreated patients. Cases of thyroid storm were reported in all treatment groups with incidences described ranging from 0% to 14%. CONCLUSION: Evidence assessing the risk of perioperative thyroid storm is of insufficient quality. Given the seriousness of this complication and the impossibility of identifying patients at increased risk, preoperative treatment of these patients remains warranted.

Preoperative multidisciplinary team decisions for high-risk patients scheduled for noncardiac surgery-a retrospective observational study.

PURPOSE: Preoperative multidisciplinary team (MDT) meetings are recommended for patients at high risk for perioperative complications and mortality, although the underlying evidence is scarce. We aimed to investigate the effect of MDT decisions on patient management and patient outcome. METHODS: We conducted a single-centre retrospective cohort study including all noncardiac surgical patients selected for discussion at preoperative MDT meetings from January 2017 to December 2019 (N = 120). We abstracted preoperative data, MDT decisions, and patient outcomes from the electronic health records for analysis. RESULTS: Of the 120 patients registered for an MDT meeting, 43% did not undergo their initially planned surgery. Only 27% of patients received perioperative management as planned before the MDT meeting. Most surgery cancellations were the MDT's decision (22%) or the patient's decision before or after the MDT discussion (10%). Postoperative complications occurred in 28% of operated patients, and postoperative mortality was 4% at 30 days and 10% at three months, most of which was attributable to postoperative complications. Non-operated patients had a 7% mortality rate at 30 days and 9% at three months. Alterations of perioperative management following MDT discussion were associated with fewer cases of extended length of hospital stay (> ten days). CONCLUSION: This study shows that preoperative MDT meetings for high-risk noncardiac surgical patients altered the management of most patients. Management alterations were associated with fewer hospital admissions of long duration. These results should be interpreted with appropriate caution given the methodological limitations inherent to this small study.

RéSUMé: OBJECTIF: Les réunions préopératoires d'une équipe multidisciplinaire (EMD) sont recommandées pour les patients présentant un risque élevé de complications périopératoires et mortalité, bien que les données probantes sous-jacentes soient rares. Notre objectif était d'étudier l'effet des décisions d'une EMD sur la prise en charge et les issues des patients. MéTHODE: Nous avons mené une étude de cohorte rétrospective monocentrique incluant tous les patients chirurgicaux non cardiaques retenus pour discussion lors des réunions préopératoires de l'EMD de janvier 2017 à décembre 2019 (N = 120). Pour notre analyse, nous avons extrait les données préopératoires, les décisions de l'EMD et les issues des patients des dossiers de santé électroniques. RéSULTATS: Sur les 120 patients inscrits pour discussion dans une réunion de l'EMD, 43 % n'ont pas subi la chirurgie initialement prévue. Seulement 27 % des patients ont bénéficié de la prise en charge périopératoire prévue avant la réunion de l'EMD. La plupart des annulations de chirurgie étaient dues à la décision de l'EMD (22 %) ou à la décision du patient avant ou après la discussion de l'EMD (10 %). Des complications postopératoires sont survenues chez 28 % des patients opérés, et la mortalité postopératoire était de 4 % à 30 jours et de 10 % à trois mois, en majorité attribuable à des complications postopératoires. Les patients non opérés avaient un taux de mortalité de 7 % à 30 jours et de 9 % à trois mois. Les modifications de prise en charge périopératoire à la suite des discussions de l'EMD ont été associées à une réduction des cas de prolongation du séjour à l'hôpital (> dix jours). CONCLUSION: Cette étude montre que les réunions préopératoires de l'EMD pour les patients chirurgicaux non cardiaques à haut risque ont modifié la prise en charge de la plupart des patients. Les modifications apportées à la prise en charge ont été associées à une diminution du nombre d'admissions à l'hôpital pour une longue durée. Ces résultats doivent toutefois être interprétés avec prudence compte tenu des limites méthodologiques inhérentes à cette petite étude.

Vital Signs Monitoring with Wearable Sensors in High-risk Surgical Patients: A Clinical Validation Study.

BACKGROUND: Vital signs are usually recorded once every 8 h in patients at the hospital ward. Early signs of deterioration may therefore be missed. Wireless sensors have been developed that may capture patient deterioration earlier. The objective of this study was to determine whether two wearable patch sensors (SensiumVitals [Sensium Healthcare Ltd., United Kingdom] and HealthPatch [VitalConnect, USA]), a bed-based system (EarlySense [EarlySense Ltd., Israel]), and a patient-worn monitor (Masimo Radius-7 [Masimo Corporation, USA]) can reliably measure heart rate (HR) and respiratory rate (RR) continuously in patients recovering from major surgery. METHODS: In an observational method comparison study, HR and RR of high-risk surgical patients admitted to a step-down unit were simultaneously recorded with the devices under test and compared with an intensive care unit-grade monitoring system (XPREZZON [Spacelabs Healthcare, USA]) until transition to the ward. Outcome measures were 95% limits of agreement and bias. Clarke Error Grid analysis was performed to assess the ability to assist with correct treatment decisions. In addition, data loss and duration of data gaps were analyzed. RESULTS: Twenty-five high-risk surgical patients were included. More than 700 h of data were available for analysis. For HR, bias and limits of agreement were 1.0 (-6.3, 8.4), 1.3 (-0.5, 3.3), -1.4 (-5.1, 2.3), and -0.4 (-4.0, 3.1) for SensiumVitals, HealthPatch, EarlySense, and Masimo, respectively. For RR, these values were -0.8 (-7.4, 5.6), 0.4 (-3.9, 4.7), and 0.2 (-4.7, 4.4) respectively. HealthPatch overestimated RR, with a bias of 4.4 (limits: -4.4 to 13.3) breaths/minute. Data loss from wireless transmission varied from 13% (83 of 633 h) to 34% (122 of 360 h) for RR and 6% (47 of 727 h) to 27% (182 of 664 h) for HR. CONCLUSIONS: All sensors were highly accurate for HR. For RR, the EarlySense, SensiumVitals sensor, and Masimo Radius-7 were reasonably accurate for RR. The accuracy for RR of the HealthPatch sensor was outside acceptable limits. Trend monitoring with wearable sensors could be valuable to timely detect patient deterioration.

Effects of dobutamine and phenylephrine on cerebral perfusion in patients undergoing cerebral bypass surgery: a randomised crossover trial.

BACKGROUND: Patients undergoing cerebral bypass surgery are prone to cerebral hypoperfusion. Currently, arterial blood pressure is often increased with vasopressors to prevent cerebral ischaemia. However, this might cause vasoconstriction of the graft and cerebral vasculature and decrease perfusion. We hypothesised that cardiac output, rather than arterial blood pressure, is essential for adequate perfusion and aimed to determine whether dobutamine administration resulted in greater graft perfusion than phenylephrine administration. METHODS: This randomised crossover study included 10 adult patients undergoing cerebral bypass surgery. Intraoperatively, patients randomly and sequentially received dobutamine to increase cardiac index or phenylephrine to increase mean arterial pressure (MAP). An increase of >10% in cardiac index or >10% in MAP was targeted, respectively. Before both interventions, a reference phase was implemented. The primary outcome was the absolute difference in graft flow between the reference and intervention phase. We compared the absolute flow difference between each intervention and constructed a random-effect linear regression model to explore treatment and carry-over effects. RESULTS: Graft flow increased with a median of 4.1 (inter-quartile range [IQR], 1.7-12.0] ml min-1) after dobutamine administration and 3.6 [IQR, 1.3-7.8] ml min-1 after phenylephrine administration (difference -0.6 ml min-1; 95% confidence interval [CI], -14.5 to 5.3; P=0.441). There was no treatment effect (0.9 ml min-1; 95% CI, 0.0-20.1; P=0.944) and no carry-over effect. CONCLUSIONS: Both dobutamine and phenylephrine increased graft flow during cerebral bypass surgery, without a preference for one method over the other. CLINICAL TRIAL REGISTRATION: Netherlands Trial Register, NL7077 (https://www.trialregister.nl/trial/7077).

The Effect of Steroids in Patients Undergoing Cardiopulmonary Bypass: An Individual Patient Meta-Analysis of Two Randomized Trials.

OBJECTIVE: Steroids suppress the inflammatory response to cardiopulmonary bypass, but the impact on death at 30 days, myocardial infarction or injury, stroke, renal failure, respiratory failure, new atrial fibrillation, transfusion requirement, infection, and length of intensive care unit (ICU) and hospital stays are uncertain. DESIGN: Patient-level data meta-analysis of 2 randomized trials. SETTING: Eighty-eight cardiac surgical centers in 19 countries. PARTICIPANTS: A total of 11,989 participants, from the Steroids in Cardiac Surgery trial and the Dexamethasone in Cardiac Surgery study, undergoing cardiac surgery with the use of cardiopulmonary bypass. INTERVENTIONS: Participants were randomly assigned to steroid or placebo. MEASURES AND MAIN RESULTS: Outcomes assessed were mortality at 30 days, myocardial infarction or injury, stroke, renal failure, respiratory failure, new atrial fibrillation, transfusion requirement, infection, and length of ICU and hospital stays. There was no significant difference in death at 30 days between the steroid and placebo groups (odds ratio [OR], 0.87; 95% confidence interval [CI], 0.72-1.07). Myocardial infarction did not differ significantly (OR, 1.17; 95% CI, 0.93-1.47); however, myocardial injury was higher in the steroid group (OR, 1.25; 95% CI, 1.12-1.40). There were no significant differences for the outcomes of stroke, renal failure, new atrial fibrillation, or transfusion. Steroids significantly reduced respiratory failure (OR, 0.83; 95% CI, 0.75-0.99), infection (OR, 0.80; 95% CI, 0.72-0.89), and length of ICU (p < 0.001) and hospital stays (p = 0.006). CONCLUSIONS: This patient-level meta-analysis does not support the routine use of steroids in cardiac surgery. Steroid administration did not decrease the risk of death, myocardial infarction, stroke, renal failure, new atrial fibrillation, or transfusion. Steroids increased the risk of myocardial injury in both the Steroids in Cardiac Surgery and Dexamethasone in Cardiac Surgery trials. Finally, steroids lowered the risk of respiratory failure and infection, and reduced length of ICU and hospital stay.

Haematoma, abscess or meningitis after neuraxial anaesthesia in the USA and the Netherlands: A closed claims analysis.

BACKGROUND: Severe complications after neuraxial anaesthesia are rare but potentially devastating. OBJECTIVE: We aimed to identify characteristics and preventable causes of haematoma, abscess or meningitis after neuraxial anaesthesia. DESIGN: Observational study, closed claims analysis. SETTING: Closed anaesthesia malpractice claims from the USA and the Netherlands were examined from 2007 until 2017. PATIENTS: Claims of patients with haematoma (n = 41), abscess (n = 18) or meningitis (n = 14) associated with neuraxial anaesthesia for labour, acute and chronic pain that initiated and closed between 2007 and 2017 were included. There were no exclusions. MAIN OUTCOME MEASURES: We analysed potential preventable causes in patient-related, neuraxial procedure-related, treatment-related and legal characteristics of these complications. RESULTS: Patients experiencing spinal haematoma were predominantly above 60 years of age and using antihaemostatic medication, whereas patients with abscess or meningitis were middle-aged, relatively healthy and more often involved in emergency interventions. Potential preventable causes of unfavourable sequelae constituted errors in timing/prescription of antihaemostatic medication (10 claims, 14%), unsterile procedures (n = 10, 14%) and delay in diagnosis/treatment of the complication (n = 18, 25%). The number of claims resulting in payment was similar between countries (USA n = 15, 38% vs. the Netherlands n = 17, 52%; P = 0.25). The median indemnity payment, which the patient received varied widely between the USA (&OV0556;285 488, n = 14) and the Netherlands (&OV0556;31 031, n = 17) (P = 0.004). However, the considerable differences in legal systems and administration of expenses between countries may make meaningful comparison of indemnity payments inappropriate. CONCLUSIONS: Claims of spinal haematoma were often related to errors in antihaemostatic medication and delay in diagnosis and/or treatment. Spinal abscess claims were related to emergency interventions and lack of sterility. We wish to highlight these potential preventable causes, both when performing the neuraxial procedure and during postprocedural care of patients.

Ten years of the Helsinki Declaration on patient safety in anaesthesiology: An expert opinion on peri-operative safety aspects.

: Patient safety is an activity to mitigate preventable patient harm that may occur during the delivery of medical care. The European Board of Anaesthesiology (EBA)/European Union of Medical Specialists had previously published safety recommendations on minimal monitoring and postanaesthesia care, but with the growing public and professional interest it was decided to produce a much more encompassing document. The EBA and the European Society of Anaesthesiology (ESA) published a consensus on what needs to be done/achieved for improvement of peri-operative patient safety. During the Euroanaesthesia meeting in Helsinki/Finland in 2010, this vision was presented to anaesthesiologists, patients, industry and others involved in health care as the 'Helsinki Declaration on Patient Safety in Anaesthesiology'. In May/June 2020, ESA and EBA are celebrating the 10th anniversary of the Helsinki Declaration on Patient Safety in Anaesthesiology; a good opportunity to look back and forward evaluating what was achieved in the recent 10 years, and what needs to be done in the upcoming years. The Patient Safety and Quality Committee (PSQC) of ESA invited experts in their fields to contribute, and these experts addressed their topic in different ways; there are classical, narrative reviews, more systematic reviews, political statements, personal opinions and also original data presentation. With this publication we hope to further stimulate implementation of the Helsinki Declaration on Patient Safety in Anaesthesiology, as well as initiating relevant research in the future.

Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine (StEP) initiative: infection and sepsis.

BACKGROUND: Perioperative infection and sepsis are of fundamental concern to perioperative clinicians. However, standardised endpoints are either poorly defined or not routinely implemented. The Standardised Endpoints in Perioperative Medicine (StEP) initiative was established to derive a set of standardised endpoints for use in perioperative clinical trials. METHODS: We undertook a systematic review to identify measures of infection and sepsis used in the perioperative literature. A multi-round Delphi consensus process that included more than 60 clinician researchers was then used to refine a recommended list of outcome measures. RESULTS: A literature search yielded 1857 titles of which 255 met inclusion criteria for endpoint extraction. A long list of endpoints, with definitions and timescales, was generated and those potentially relevant to infection and sepsis circulated to the theme subgroup and then the wider StEP-COMPAC working group, undergoing a three-stage Delphi process. The response rates for Delphi rounds 1, 3, and 3 were 89% (n=8), 67% (n=62), and 80% (n=8), respectively. A set of 13 endpoints including fever, surgical site, and organ-specific infections as defined by the US Centres for Disease Control and Sepsis-3 are proposed for future use. CONCLUSIONS: We defined a consensus list of standardised endpoints related to infection and sepsis for perioperative trials using an established and rigorous approach. Each endpoint was evaluated with respect to validity, reliability, feasibility, and patient centredness. One or more of these should be considered for inclusion in future perioperative clinical trials assessing infection, sepsis, or both, thereby permitting synthesis and comparison of future results.

Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine (StEP) initiative: patient comfort.

BACKGROUND: Maximising patient comfort during and after surgery is a primary concern of anaesthetists and other perioperative clinicians, but objective measures of what constitutes patient comfort in the perioperative period remain poorly defined. The Standardised Endpoints in Perioperative Medicine initiative was established to derive a set of standardised endpoints for use in perioperative clinical trials. METHODS: We undertook a systematic review to identify measures of patient comfort used in the anaesthetic, surgical, and other perioperative literature. A multi-round Delphi consensus process that included up to 89 clinician researchers was then used to refine a recommended list of outcome measures. RESULTS: We identified 122 studies in a literature search, which were the basis for a preliminary list of 24 outcome measures and their definitions. The response rates for Delphi Rounds 1, 2, and 3 were 100% (n=22), 90% (n=79), and 100% (n=13), respectively. A final list of six defined endpoints was identified: pain intensity (at rest and during movement) at 24 h postoperatively, nausea and vomiting (0-6 h, 6-24 h, and overall), one of two quality-of-recovery (QoR) scales (QoR score or QoR-15), time to gastrointestinal recovery, time to mobilisation, and sleep quality. CONCLUSIONS: As standardised outcomes will support benchmarking and pooling (meta-analysis) of trials, one or more of these recommended endpoints should be considered for inclusion in clinical trials assessing patient comfort and pain after surgery.

Trends in practice and safety measures of epidural analgesia: Report of a national survey.

BACKGROUND: The clinical use of epidural analgesia has changed over past decades. Minimally invasive surgery and emergence of alternative analgesic techniques have led to an overall decline in its use. In addition, there is increasing awareness of the patient-specific risks for complications such as spinal haematoma and abscess. Local guidelines for management of severe neurological complications during or after epidural analgesia, ie, "epidural alert systems", have been introduced in hospitals to coordinate and potentially streamline early diagnosis and treatment. How widely such protocols have been implemented in daily practice is unknown. METHODS: We conducted a survey to analyse trends in practice, key indications, safety measures, safety reporting, and management of complications of epidural analgesia in the Netherlands. Data were gathered using a web-based questionnaire and analysed using descriptive statistics. RESULTS: Questionnaires from 85 of all 94 Dutch hospitals performing epidural analgesia were collected and analysed, a 90% response rate. Fifty-five percent reported a trend towards decreased use of perioperative epidural analgesia, while 68% reported increasing use of epidural analgesia for labour. Reported key indications for epidural analgesia were thoracotomy, upper abdominal laparotomy, and abdominal cancer debulking. An epidural alert system for neurological complications of epidural analgesia was available in 45% of hospitals. CONCLUSIONS: This national audit concerning use and safety of epidural analgesia demonstrates that a minority of Dutch hospitals have procedures to manage suspected neurological complications of epidural analgesia, whereas in the remaining hospitals responsibilities and timelines for management of epidural emergencies are determined on an ad hoc basis.

Accuracy of remote continuous respiratory rate monitoring technologies intended for low care clinical settings: a prospective observational study.

PURPOSE: Altered respiratory rate (RR) has been identified as an important predictor of serious adverse events during hospitalization. Introduction of a well-tolerated continuous RR monitor could potentially reduce serious adverse events such as opioid-induced respiratory depression. The purpose of this study was to investigate the ability of different monitor devices to detect RR in low care clinical settings. METHODS: This was a prospective method-comparison study with a cross-sectional design. Thoracic impedance pneumography (IPG), frequency modulated continuous wave radar, and an acoustic breath sounds monitor were compared with the gold standard of capnography for their ability to detect RR in breaths per minute (breaths·min-1) in awake postoperative patients in the postanesthesia care unit. The Bland and Altman method for repeated measurements and mixed effect modelling was used to obtain bias and limits of agreement (LoA). Furthermore, the ability of the three devices to assist with correct treatment decisions was evaluated in Clarke Error Grids. RESULTS: Twenty patients were monitored for 1,203 min, with a median [interquartile range] of 61 [60-63] min per patient. The bias (98.9% LoA) were 0.1 (-7.9 to 7.9) breaths·min-1 for the acoustic monitor, -1.6 (-10.8 to 7.6) for the radar, and -1.9 (-13.1 to 9.2) for the IPG. The extent to which the monitors guided adequate or led to inadequate treatment decisions (determined by Clarke Error Grid analysis) differed significantly between the monitors (P = 0.011). Decisions were correct 96% of the time for acoustic, 95% of the time for radar, and 94% of the time for IPG monitoring devices. CONCLUSIONS: None of the studied devices (acoustic, IPG, and radar monitor) had LoA that were within our predefined (based on clinical judgement) limits of ± 2 breaths·min-1. The acoustic breath sound monitor predicted the correct treatment more often than the IPG and the radar device.

Non-invasive bladder volume measurement for the prevention of postoperative urinary retention: validation of two ultrasound devices in a clinical setting.

Ultrasound scanning of bladder volume is used for prevention of postoperative urinary retention (POUR). Accurate assessment of bladder volume is needed to allow clinical decision-making regarding the need for postoperative catheterization. Two commonly used ultrasound devices, the BladderScan® BVI 9400 and the newly released Prime® (Verathon Medical®, Bothell, WA, USA), with or without the 'pre-scan' option, have not been validated in clinical practice. The aim of this study was to assess the performance of these devices in daily clinical practice. Between June and September 2016 a prospective observational study was conducted in 318 surgical patients (18 years or older) who needed a urinary catheter perioperatively for clinical reasons. For acceptable performance, we required that the volume as estimated by the BladderScan® differs by no more than 5% from the actual urine volume after catheterization. The Schuirmann's two one-sided test was performed to assess equivalence between the BladderScan® estimate and catheterization. The BVI 9400® overestimated the actual bladder volume by + 17.5% (95% CI + 8.8 to + 26.3%). The Prime® without pre-scan underestimated by - 4.1% (95% CI - 8.8 to + 0.5%) and the Prime® with pre-scan underestimated by - 6.3% (95% CI - 11.6 to - 1.1%). This study shows that while both ultrasound devices were able to approximate current bladder volume, both BVI 9400® and Prime®-with and without pre-scan-were not able to measure the actual bladder volume within our predefined limit of ± 5%. Using the pre-scan feature of the Prime® did not further improve accuracy.

Relationship Between Preoperative Evaluation Blood Pressure and Preinduction Blood Pressure: A Cohort Study in Patients Undergoing General Anesthesia.

BACKGROUND: For outcomes research where changes in intraoperative blood pressure are a possible causative factor, it is important to determine an appropriate source for a reference value. We studied to what extent preinduction blood pressure values in the operating room differ from those obtained during preoperative evaluation outside the operating room. METHODS: Cohort study including 4408 patients aged 60 years or older undergoing noncardiac surgery. The outcome was the difference between the preinduction mean blood pressure (MBP) and the MBP obtained during preoperative evaluation. A difference of ≥10 mm Hg was considered clinically relevant. A paired samples t test was used to estimate the difference. Linear regression was used to obtain estimates adjusted for patient characteristics, comorbidity, medications, type of surgery, and preoperative blood pressure. RESULTS: Complete data were available for 3660 (83%) patients. There were 2228 (61%) patients with a difference of ≥10 mm Hg between the preinduction and preoperative MBP. The overall mean difference between both MBPs was 11 mm Hg (95% confidence interval, 10-11) with important variability among individuals. Patients with higher preoperative MBP values had smaller differences. After adjusting for patient characteristics, comorbidity, medications, type of surgery, and preoperative blood pressure, the difference decreased an estimated 5.0 mm Hg (95% confidence interval, 4.7-5.4) for every increase of 10 mm Hg in preoperative MBP. Patient characteristics, comorbidity, type of surgery, or medication were not strongly associated with the difference. CONCLUSIONS: The average preinduction blood pressure was higher than the preoperative blood pressure. This difference between the measurements can be explained by stress-induced effects and regression to the mean. To define an optimal reference value for research purposes or to arrive at a clinical perioperative blood pressure target, one should consider that there is important variability both within and between patients.

Comparative effectiveness of a serious game and an e-module to support patient safety knowledge and awareness.

BACKGROUND: Serious games have the potential to teach complex cognitive skills in an engaging way, at relatively low costs. Their flexibility in use and scalability makes them an attractive learning tool, but more research is needed on the effectiveness of serious games compared to more traditional formats such e-modules. We investigated whether undergraduate medical students developed better knowledge and awareness and were more motivated after learning about patient-safety through a serious game than peers who studied the same topics using an e-module. METHODS: Fourth-year medical students were randomly assigned to either a serious game that included video-lectures, biofeedback exercises and patient missions (n = 32) or an e-module, that included text-based lectures on the same topics (n = 34). A third group acted as a historical control-group without extra education (n = 37). After the intervention, which took place during the clinical introduction course, before the start of the first rotation, all students completed a knowledge test, a self-efficacy test and a motivation questionnaire. During the following 10-week clinical rotation they filled out weekly questionnaires on patient-safety awareness and stress. RESULTS: The results showed patient safety knowledge had equally improved in the game group and e-module group compared to controls, who received no extra education. Average learning-time was 3 h for the game and 1 h for the e-module-group. The serious game was evaluated as more engaging; the e-module as more easy to use. During rotations, students in the three groups reported low and similar levels of patient-safety awareness and stress. Students who had treated patients successfully during game missions experienced higher self-efficacy and less stress during their rotation than students who treated patients unsuccessfully. CONCLUSIONS: Video-lectures (in a game) and text-based lectures (in an e-module) can be equally effective in developing knowledge on specific topics. Although serious games are strongly engaging for students and stimulate them to study longer, they do not necessarily result in better performance in patient safety issues.

Postoperative pain: knowledge and beliefs of patients and nurses.

AIMS AND OBJECTIVES: To describe patients' and nurses' knowledge and beliefs regarding pain management. Moreover, to explore the effect of information and education on patients' and nurses' knowledge and beliefs regarding pain management. BACKGROUND: In the treatment of postoperative pain, patients' and nurses' inadequate knowledge and erroneous beliefs may hamper the appropriate use of analgesics. DESIGN: A randomised controlled trial and a cross-sectional study. METHODS: In 2013, half of 760 preoperative patients were allocated to the intervention group and received written information about the complications of postoperative pain. The knowledge and beliefs of 1184 nurses were studied in 2014 in a cross-sectional study. All data were collected with the same questionnaires. RESULTS: In the intervention group, patients' knowledge level was significant higher than in the control group, while no differences were found in beliefs. Nurses had higher knowledge and more positive beliefs towards pain management compared with both patient groups. Nurses with additional pain education scored better than nurses without additional pain education. Nurses were also asked what percentage of pain scores matched their impression of the patient's pain, and the mean was found to be 63%. CONCLUSIONS: Written information was effective for increasing patients' knowledge. However, it was not effective for changing beliefs about analgesics and patients and nurses had erroneous beliefs about analgesics. RELEVANCE TO CLINICAL PRACTICE: It is necessary to continue to inform patients and nurses about the need for analgesics after surgery. Such education could also emphasise that a discrepancy between a patient's reported pain score and the nurse's own assessment of the patient's pain should prompt a discussion with the patient about his/her pain.

Effect of Fibrinogen Concentrate on Intraoperative Blood Loss Among Patients With Intraoperative Bleeding During High-Risk Cardiac Surgery: A Randomized Clinical Trial.

Importance: Fibrinogen concentrate might partly restore coagulation defects and reduce intraoperative bleeding. Objective: To determine whether fibrinogen concentrate infusion dosed to achieve a plasma fibrinogen level of 2.5 g/L in high-risk cardiac surgery patients with intraoperative bleeding reduces intraoperative blood loss. Design, Setting, and Participants: A randomized, placebo-controlled, double-blind clinical trial conducted in Isala Zwolle, the Netherlands (February 2011-January 2015), involving patients undergoing elective, high-risk cardiac surgery (ie, combined coronary artery bypass graft [CABG] surgery and valve repair or replacement surgery, the replacement of multiple valves, aortic root reconstruction, or reconstruction of the ascending aorta or aortic arch) with intraoperative bleeding (blood volume between 60 and 250 mL suctioned from the thoracic cavity in a period of 5 minutes) were randomized to receive either fibrinogen concentrate or placebo. Interventions: Intravenous, single-dose administration of fibrinogen concentrate (n = 60) or placebo (n = 60), targeted to achieve a postinfusion plasma fibrinogen level of 2.5 g/L. Main Outcomes and Measures: The primary outcome was blood loss in milliliters between intervention (ie, after removal of cardiopulmonary bypass) and closure of chest. Safety variables (within 30 days) included: in-hospital mortality, myocardial infarction, cerebrovascular accident or transient ischemic attack, renal insufficiency or failure, venous thromboembolism, pulmonary embolism, and operative complications. Results: Among 120 patients (mean age; 71 [SD, 10] years, 37 women [31%]) included in the study, combined CABG and valve repair or replacement surgery comprised 72% of procedures and had a mean (SD) cardiopulmonary bypass time of 200 minutes (83) minutes. For the primary outcome, median blood loss in the fibrinogen group was 50 mL (interquartile range [IQR], 29-100 mL) compared with 70 mL (IQR, 33-145 mL) in the control group (P = .19), the absolute difference 20 mL (95% CI, -13 to 35 mL). There were 6 cases of stroke or transient ischemic attack (4 in the fibrinogen group); 4 myocardial infarctions (3 in the fibrinogen group); 2 deaths (both in the fibrinogen group); 5 cases with renal insufficiency or failure (3 in the fibrinogen group); and 9 cases with reoperative thoracotomy (4 in the fibrinogen group). Conclusions and Relevance: Among patients with intraoperative bleeding during high-risk cardiac surgery, administration of fibrinogen concentrate, compared with placebo, resulted in no significant difference in the amount of intraoperative blood loss. Trial Registration: clinicaltrials.gov Identifier: NCT01124981 and EudraCT No: 2009-018086-12.