Initiatives to detect and prevent death from perioperative deterioration.

PURPOSE OF REVIEW: This study indicates that there are differences between hospitals in detection, as well as in adequate management of postsurgical complications, a phenomenon that is described as 'failure-to-rescue'.In this review, recent initiatives to reduce failure-to-rescue in the perioperative period are described. RECENT FINDINGS: Use of cognitive aids, emergency manuals, family participation as well as remote monitoring systems are measures to reduce failure-to-rescue situations. Postoperative visit of an anaesthesiologist on the ward was not shown to improve outcome, but there is still room for improvement of postoperative care. SUMMARY: Improving the complete emergency chain, including monitoring, recognition and response in the afferent limb, as well as diagnostic and treatment in the efferent limb, should lead to reduced failure-to-rescue situations in the perioperative period.

Surveillance of high-risk early postsurgical patients for real-time detection of complications using wireless monitoring (SHEPHERD study): results of a randomized multicenter stepped wedge cluster trial.

Background: Vital signs measurements on the ward are performed intermittently. This could lead to failure to rapidly detect patients with deteriorating vital signs and worsens long-term outcome. The aim of this study was to test the hypothesis that continuous wireless monitoring of vital signs on the postsurgical ward improves patient outcome. Methods: In this prospective, multicenter, stepped-wedge cluster randomized study, patients in the control group received standard monitoring. The intervention group received continuous wireless monitoring of heart rate, respiratory rate and temperature on top of standard care. Automated alerts indicating vital signs deviation from baseline were sent to ward nurses, triggering the calculation of a full early warning score followed. The primary outcome was the occurrence of new disability three months after surgery. Results: The study was terminated early (at 57% inclusion) due to COVID-19 restrictions. Therefore, only descriptive statistics are presented. A total of 747 patients were enrolled in this study and eligible for statistical analyses, 517 patients in the control group and 230 patients in the intervention group, the latter only from one hospital. New disability at three months after surgery occurred in 43.7% in the control group and in 39.1% in the intervention group (absolute difference 4.6%). Conclusion: This is the largest randomized controlled trial investigating continuous wireless monitoring in postoperative patients. While patients in the intervention group seemed to experience less (new) disability than patients in the control group, results remain inconclusive with regard to postoperative patient outcome due to premature study termination. Clinical trial registration: ClinicalTrials.gov, ID: NCT02957825.

Validation of the PreOperative Score to predict Post-Operative Mortality (POSPOM) in Dutch non-cardiac surgery patients.

BACKGROUND: Standardized risk assessment tools can be used to identify patients at higher risk for postoperative complications and death. In this study, we validate the PreOperative Score to predict Post-Operative Mortality (POSPOM) for in-hospital mortality in a large cohort of non-cardiac surgery patients. In addition, the performance of POSPOM to predict postoperative complications was studied. METHODS: Data from the control cohort of the TRACE (routine posTsuRgical Anesthesia visit to improve patient outComE) study was analysed. POSPOM scores for each patient were calculated post-hoc. Observed in-hospital mortality was compared with predicted mortality according to POSPOM. Discrimination was assessed by receiver operating characteristic curves with C-statistics for in-hospital mortality and postoperative complications. To describe the performance of POSPOM sensitivity, specificity, negative predictive values, and positive predictive values were calculated. For in-hospital mortality, calibration was assessed by a calibration plot. RESULTS: In 2490 patients, the observed in-hospital mortality was 0.5%, compared to 1.3% as predicted by POSPOM. 27.1% of patients had at least one postoperative complication of which 22.4% had a major complication. For in-hospital mortality, POSPOM showed strong discrimination with a C-statistic of 0.86 (95% CI, 0.78-0.93). For the prediction of complications, the discrimination was poor to fair depending on the severity of the complication. The calibration plot showed poor calibration of POSPOM with an overestimation of in-hospital mortality. CONCLUSION: Despite the strong discriminatory performance, POSPOM showed poor calibration with an overestimation of in-hospital mortality. Performance of POSPOM for the prediction of any postoperative complication was poor but improved according to severity.

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.

Enhanced PeriOperative Care and Health protection programme for the prevention of surgical site infections after elective abdominal surgery (EPOCH): study protocol of a randomised controlled, multicentre, superiority trial.

INTRODUCTION: Surgical site infections (SSI) are a common postoperative complication. During the development of the new WHO guidelines on SSI prevention, also in the Netherlands was concluded that perioperative care could be optimised beyond the current standard practice. We selected a limited set of readily available, cheap and evidence-based interventions from these new guidelines that are not part of standard practice in the Netherlands and formulated an Enhanced PeriOperative Care and Health bundle (EPOCH). Here, we describe the protocol for an open-label, randomised controlled, parallel-group, superiority trial to test the effect of the EPOCH bundle added to (national) standard care in comparison to standard care alone on the incidence of SSI. METHODS AND ANALYSIS: EPOCH consists of intraoperative high fractional inspired oxygen (0.80); goal-directed fluid therapy; active preoperative, intraoperative and postoperative warming; perioperative glucose control and treatment of severe hyperglycaemia (>10 mmoll-1) and standardised surgical site handling. Patients scheduled for elective abdominal surgery with an incision larger than 5 cm are eligible for inclusion. Participants are randomised daily, 1:1 according to variable block sizes, and stratified per participating centre to either EPOCH added to standard care or standard care only. The primary endpoint will be SSI incidence according to the Centers for Disease Control and Prevention (CDC) definition within 30 days as part of routine clinical follow-up. Four additional questionnaires will be sent out over the course of 90 days to capture disability and costs. Other secondary endpoints include anastomotic leakage, incidence of incisional hernia, serious adverse events, hospital readmissions, length of stay and cost effectiveness. Analysis of the primary endpoint will be on an intention-to-treat basis. ETHICS AND DISSEMINATION: Ethics approval is granted by the Amsterdam UMC Medical Ethics Committee (reference 2015_121). Results will be disseminated through peer-reviewed journals and summaries shared with stakeholders. This protocol is published before analysis of the results. TRIAL REGISTRATION NUMBER: Registered in the Dutch Trial Register: NL5572.

Insights into postoperative respiration by using continuous wireless monitoring of respiratory rate on the postoperative ward: a cohort study.

Change of respiratory rate (RespR) is the most powerful predictor of clinical deterioration. Brady- (RespR ≤ 8) and tachypnea (RespR ≥ 31) are associated with serious adverse events. Simultaneously, RespR is the least accurately measured vital parameter. We investigated the feasibility of continuously measuring RespR on the ward using wireless monitoring equipment, without impeding mobilization. Continuous monitoring of vital parameters using a wireless SensiumVitals® patch was installed and RespR was measured every 2 mins. We defined feasibility of adequate RespR monitoring if the system reports valid RespR measurements in at least 50% of time-points in more than 80% of patients during day- and night-time, respectively. Data from 119 patients were analysed. The patch detected in 171,151 of 227,587 measurements valid data for RespR (75.2%). During postoperative day and night four, the system still registered 68% and 78% valid measurements, respectively. 88% of the patients had more than 67% of valid RespR measurements. The RespR's most frequently measured were 13-15; median RespR was 15 (mean 16, 25th- and 75th percentile 13 and 19). No serious complications or side effects were observed. We successfully measured electronically RespR on a surgical ward in postoperative patients continuously for up to 4 days post-operatively using a wireless monitoring system. While previous studies mentioned a digit preference of 18-22 for RespR, the most frequently measured RespR were 13-16. However, in the present study we did not validate the measurements against a reference method. Rather, we attempted to demonstrate the feasibility of achieving continuous wireless measurement in patients on surgical postoperative wards. As the technology used is based on impedance pneumography, obstructive apnoea might have been missed, namely in those patients receiving opioids post-operatively.

TRACE (Routine posTsuRgical Anesthesia visit to improve patient outComE): a prospective, multicenter, stepped-wedge, cluster-randomized interventional study.

BACKGROUND: Perioperative complications occur in 30-40% of non-cardiac surgical patients and are the leading cause of early postoperative morbidity and mortality. Regular visits by trained health professionals may decrease the incidence of complications and mortality through earlier detection and adequate treatment of complications. Until now, no studies have been performed on the impact of routine postsurgical anesthesia visits on the incidence of postoperative complications and mortality. METHODS: TRACE is a prospective, multicenter, stepped-wedge cluster randomized interventional study in academic and peripheral hospitals in the Netherlands. All hospitals start simultaneously with a control phase in which standard care is provided. Sequentially, in a randomized order, hospitals cross over to the intervention phase in which patients at risk are routinely followed up by an anesthesia professional at postoperative days 1 and 3, aiming to detect and prevent or treat postoperative complications. We aim to include 5600 adult patients who are at high risk of developing complications. The primary outcome variable is 30-day postoperative mortality. Secondary outcomes include incidence of postoperative complications and postoperative quality of life up to one year following surgery. Statistical analyses will be performed to compare the control and intervention cohorts with multilevel linear and logistic regression models, adjusted for temporal trends and for clusters (hospitals). The time horizon of the economic (cost-effectiveness) evaluation will be 30 days and one year following surgery. DISCUSSION: TRACE is the first to study the effects of a routine postoperative visit by an anesthesia healthcare professional on mortality and cost-effectiveness of surgical patients. If the intervention proves to be beneficial for the patient and cost-effective, the stepped-wedge design ensures direct implementation in the participating hospitals. TRIAL REGISTRATION: Nederlands Trial Register/Netherlands Trial Registration, NTR5506 . Registered on 02 December 2015.

Haemostatic and cranial computed tomography characteristics in patients with acute and delayed coagulopathy after isolated traumatic brain injury.

PRIMARY OBJECTIVE: To investigate whether the development of coagulopathy at different stages after isolated traumatic brain injury (TBI) is associated with distinct cranial computed tomography characteristics. RESEARCH DESIGN: Retrospective cohort study in 226 patients with moderate-to-severe isolated TBI who were categorized as subjects without coagulopathy or with acute temporary, acute sustained or delayed coagulopathy. METHODS AND PROCEDURES: Coagulopathy was defined as an activated partial thromboplastin time >40 seconds and/or prothrombin time (PT) >1.2 and/or platelet count <120*10(9)l(-1). Cranial CT scans were assigned to the six-point Traumatic Coma Data Bank (TCDB) CT-classification. MAIN OUTCOMES AND RESULTS: Coagulopathy occurred in 44% of patients in the first 24-hours post-trauma. Patients with acute, sustained coagulopathy showed a prolonged PT (1.64 ± 0.89) when compared to patients without (1.03 ± 0.07), acute temporary (1.27 ± 0.22) or delayed coagulopathy (1.08 ± 0.06; p < 0.05). Patients with acute temporary or delayed coagulopathy had the worst TCDB CT classification scores, while mortality rates were the highest in patients with sustained or delayed coagulopathy. CONCLUSIONS: Not only the mere presence of coagulopathy, but also the course of haemostatic alterations following neurotrauma may hold predictive value for patient outcome, irrespective of the severity level of cerebral injury.