Introduction of a Post-Anaesthesia Care Unit in a Teaching Hospital Is Associated with a Reduced Length of Hospital Stay in Noncardiac Surgery: A Single-Centre Interrupted Time Series Analysis.

BACKGROUND: A post-anaesthesia care unit (PACU) may improve postoperative care compared with intermediate care units (IMCU) due to its dedication to operative care and an individualized duration of postoperative stay. The effects of transition from IMCU to PACU for postoperative care following intermediate to high-risk noncardiac surgery on length of hospital stay, intensive care unit (ICU) utilization, and postoperative complications were investigated. METHODS: This single-centre interrupted time series analysis included patients undergoing eleven different noncardiac surgical procedures associated with frequent postoperative admissions to an IMCU or PACU between January 2018 and March 2019 (IMCU episode) and between October 2019 and December 2020 (PACU episode). Primary outcome was hospital length of stay, secondary outcomes included postoperative complications and ICU admissions. RESULTS: In total, 3300 patients were included. The hospital length of stay was lower following PACU admission compared to IMCU admission (IMCU 7.2 days [4.2-12.0] vs. PACU 6.0 days [3.6-9.1]; p < 0.001). Segmented regression analysis demonstrated that the introduction of the PACU was associated with a decrease in hospital length of stay (GMR 0.77 [95% CI 0.66-0.91]; p = 0.002). No differences between episodes were detected in the number of postoperative complications or postoperative ICU admissions. CONCLUSIONS: The introduction of a PACU for postoperative care of patients undergoing intermediate to high-risk noncardiac surgery was associated with a reduction in the length of stay at the hospital, without increasing postoperative complications.

Impact of wearable wireless continuous vital sign monitoring in abdominal surgical patients: before-after study.

BACKGROUND: Technological advances have enabled continuous monitoring of vital signs (CMVS) by wearable, wireless devices on general hospital wards to facilitate early detection of clinical deterioration, which could potentially improve clinical outcomes. However, evidence on the impact of these CMVS systems on patient outcomes is limited. This research aimed to explore the effect of CMVS on the clinical outcomes in major abdominal surgery patients in a general surgery ward. METHODS: A single-centre before-after study was conducted from October 2019 to June 2022. Patients in the intervention group received CMVS in addition to conventional intermittent vital sign monitoring (standard care for control group). With CMVS, heart rate and respiratory rate were measured every 5 min by a patch sensor. Proactive vital signs trends assessments and, when necessary, subsequent nursing activities were performed every nursing shift. The primary outcome of interest was the length of hospital stay (LOS); also, 12 patient-related outcomes were analysed. In the CMVS group, follow-up nursing activities of deviating vital signs trends were described and patient acceptability was measured. Post-hoc subgroup analysis was performed for colorectal and hepatopancreatobiliary surgery. RESULTS: A total of 908 patients were included (colorectal: n = 650; hepatopancreatobiliary: n = 257). Overall, median LOS was lower in the CMVS group (5.0 versus 5.5 days; P = 0.012), respectively. Post-hoc subgroup analysis showed this reduction in LOS was mostly observed in the colorectal group and not in the hepatopancreatobiliary group. Apart from a decrease in nurse-to-house-officer calls (from 15.3% to 7.7%; P = 0.007), all secondary clinical outcomes were similar in CMVS and control groups. However, a non-significant trend towards less-severe complications and reduced ICU LOS was observed in the CMVS group. In CMVS patients, 109 additional nursing activities were performed and 83% of patients indicated CMVS was acceptable. CONCLUSION: CMVS was associated with a significant reduction in LOS, while other clinical outcomes were unchanged. CMVS triggered additional nursing activities such as extra patient assessments and therapeutic interventions.

Is a preoperative multidisciplinary team meeting (cost)effective to improve outcome for high-risk adult patients undergoing noncardiac surgery: the PREPARATION study-a multicenter stepped-wedge cluster randomized trial.

BACKGROUND: As a result of increased life expectancy and improved care for patients suffering from chronic disease, the number of patients with multimorbidity requiring surgical intervention is increasing. For complex surgical patients, it is essential to balance the potential benefits of surgical treatment against the risk of permanent loss of functional capacity and quality of life due to complications. European and US guidelines on perioperative care recommend preoperative multidisciplinary team (MDT) discussions for high-risk noncardiac surgical patients. However, the evidence underlying benefits from preoperative MDT meetings with all relevant perioperative specialties present is limited. The current study aims to investigate the effect of implementation of preoperative MDT discussions for high-risk patients undergoing noncardiac surgery on serious adverse events. METHODS/DESIGN: PREPARATION is a stepped-wedge cluster randomized trial in 14 Dutch hospitals without currently established preoperative MDT meeting. The intervention, preoperative MDT meetings, will be implemented sequentially with seven blocks of 2 hospitals switching from control (preoperative screening as usual) to the intervention every 3 months. Each hospital will be randomized to one of seven blocks. We aim to include 1200 patients. The primary outcome is the incidence of serious adverse events at 6 months. Secondary outcomes include (cost)effectiveness, functional outcome, and quality of life for up to 12 months. DISCUSSION: PREPARATION is the first study to assess the effectiveness of a preoperative MDT meeting for high-risk noncardiac surgical patients in the presence of an anesthesiologist. If the results suggest that preoperative MDT discussions for high-risk patients are (cost)-effective, the current study facilitates implementation of preoperative MDT meetings in clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov NCT05703230. Registered on 11/09/2022.

Process Evaluation of a Wireless Wearable Continuous Vital Signs Monitoring Intervention in 2 General Hospital Wards: Mixed Methods Study.

BACKGROUND: Continuous monitoring of vital signs (CMVS) using wearable wireless sensors is increasingly available to patients in general wards and can improve outcomes and reduce nurse workload. To assess the potential impact of such systems, successful implementation is important. We developed a CMVS intervention and implementation strategy and evaluated its success in 2 general wards. OBJECTIVE: We aimed to assess and compare intervention fidelity in 2 wards (internal medicine and general surgery) of a large teaching hospital. METHODS: A mixed methods sequential explanatory design was used. After thorough training and preparation, CMVS was implemented-in parallel with the standard intermittent manual measurements-and executed for 6 months in each ward. Heart rate and respiratory rate were measured using a chest-worn wearable sensor, and vital sign trends were visualized on a digital platform. Trends were routinely assessed and reported each nursing shift without automated alarms. The primary outcome was intervention fidelity, defined as the proportion of written reports and related nurse activities in case of deviating trends comparing early (months 1-2), mid- (months 3-4), and late (months 5-6) implementation periods. Explanatory interviews with nurses were conducted. RESULTS: The implementation strategy was executed as planned. A total of 358 patients were included, resulting in 45,113 monitored hours during 6142 nurse shifts. In total, 10.3% (37/358) of the sensors were replaced prematurely because of technical failure. Mean intervention fidelity was 70.7% (SD 20.4%) and higher in the surgical ward (73.6%, SD 18.1% vs 64.1%, SD 23.7%; P<.001). Fidelity decreased over the implementation period in the internal medicine ward (76%, 57%, and 48% at early, mid-, and late implementation, respectively; P<.001) but not significantly in the surgical ward (76% at early implementation vs 74% at midimplementation [P=.56] vs 70.7% at late implementation [P=.07]). No nursing activities were needed based on vital sign trends for 68.7% (246/358) of the patients. In 174 reports of 31.3% (112/358) of the patients, observed deviating trends led to 101 additional bedside assessments of patients and 73 consultations by physicians. The main themes that emerged during interviews (n=21) included the relative priority of CMVS in nurse work, the importance of nursing assessment, the relatively limited perceived benefits for patient care, and experienced mediocre usability of the technology. CONCLUSIONS: We successfully implemented a system for CMVS at scale in 2 hospital wards, but our results show that intervention fidelity decreased over time, more in the internal medicine ward than in the surgical ward. This decrease appeared to depend on multiple ward-specific factors. Nurses' perceptions regarding the value and benefits of the intervention varied. Implications for optimal implementation of CMVS include engaging nurses early, seamless integration into electronic health records, and sophisticated decision support tools for vital sign trend interpretation.

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.

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.

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.

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).

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.

Patient reported postoperative pain with a smartphone application: A proof of concept.

MAIN OUTCOME: Thirty patients (60%) found it satisfying or very satisfying to communicate their pain with the app. Pain experienced after surgery was scored by patients as 'no': 3 (6%), 'little': 5 (10%), 'bearable': 25 (50%), 'considerable': 13 (26%) and 'severe': 1 (2%). Forty-five patients (90%) were positive about the ease of recording. Forty-five patients (90%) could correctly record their pain with the app. Thirty-eight patients (76%) agreed that in-app notifications to record pain were useful. Two patients (4%) were too ill to use the application. Based on usability feedback, we will redesign the pain intensity wheel and the in-app pain chart to improve clarity for patients to understand the course of their pain. SECONDARY OUTCOMES: The median patient recorded pain app score 4.0 (range 0 to 10) and nurse recorded numerical rating scale (NRS) for pain NRS 4.0 (range 0 to 9) were not statistically different (p = 0.06). Forty-two percent from a total of 307 patient pain app scores were ≥ 5 (on a scale from 0 no pain at all to 10 worst imaginable pain). Of these, 83% were recorded as 'bearable' while only in 18% of the recordings patients asked for additional analgesia. The results suggest that self-recording the severity of postoperative pain by patients with a smartphone application could be useful for postoperative pain management. The application was perceived as user-friendly and had high satisfaction rates from both patients and stakeholders. Further research is needed to validate the 11-point numeric and faces pain scale with the current gold standards visual analogue scale (VAS) and NRS for pain.

Wireless Remote Home Monitoring of Vital Signs in Patients Discharged Early After Esophagectomy: Observational Feasibility Study.

BACKGROUND: Hospital stays after major surgery are shorter than ever before. Although enhanced recovery and early discharge have many benefits, some complications will now first manifest themselves in home settings. Remote patient monitoring with wearable sensors in the first days after hospital discharge may capture clinical deterioration earlier but is largely uncharted territory. OBJECTIVE: This study aimed to assess the technical feasibility of patients, discharged after esophagectomy, being remotely monitored at home with a wireless patch sensor and the experiences of these patients. In addition, we determined whether observing vital signs with a wireless patch sensor influences clinical decision making. METHODS: In an observational feasibility study, vital signs of patients were monitored with a wearable patch sensor (VitalPatch, VitalConnect Inc) during the first 7 days at home after esophagectomy and discharge from hospital. Vital signs trends were shared with the surgical team once a day, and they were asked to check the patient's condition by phone each morning. Patient experiences were evaluated with a questionnaire, and technical feasibility was analyzed on a daily basis as the percentage of data loss and gap durations. In addition, the number of patients for whom a change in clinical decision was made based on the results of remote vital signs monitoring at home was assessed. RESULTS: Patients (N=20) completed 7 days each of home monitoring with the wearable patch sensor. Each of the patients had good recovery at home, and remotely observed vital signs trends did not alter clinical decision making. Patients appreciated that surgeons checked their vital signs daily (mean 4.4/5) and were happy to be called by the surgical team each day (mean 4.5/5). Wearability of the patch was high (mean 4.4/5), and no reports of skin irritation were mentioned. Overall data loss of vital signs measurements at home was 25%; both data loss and gap duration varied considerably among patients. CONCLUSIONS: Remote monitoring of vital signs combined with telephone support from the surgical team was feasible and well perceived by all patients. Future studies need to evaluate the impact of home monitoring on patient outcome as well as the cost-effectiveness of this new approach.

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.

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.

Are current wireless monitoring systems capable of detecting adverse events in high-risk surgical patients? A descriptive study.

BACKGROUND: Adverse events are common in high-risk surgical patients, but early detection is difficult. Recent innovations have resulted in wireless and 'wearable' sensors, which may capture patient deterioration at an early stage, but little is known regarding their ability to timely detect events. The objective of this study is to describe the ability of currently available wireless sensors to detect adverse events in high-risk patients. METHODS: A descriptive analysis was performed of all vital signs trend data obtained during an observational comparison study of wearable sensors for vital signs monitoring in high-risk surgical patients during the initial days of recovery at a surgical step-down unit (SDU) and subsequent traumatology or surgical oncology ward. Heart rate (HR), respiratory rate (RR) and oxygen saturation (SpO2) were continuously recorded. Vital sign trend patterns of patients that developed adverse events were described and compared to vital sign recordings of patients without occurrence of adverse events. Two wearable patch sensors were used (SensiumVitals and HealthPatch), a bed-based mattress sensor (EarlySense) and a patient-worn monitor (Masimo Radius-7). RESULTS: Twenty adverse events occurred in 11 of the 31 patients included. Atrial fibrillation (AF) was most common (20%). The onset of AF was recognizable as a sudden increase in HR in all recordings, and all patients with new-onset AF after esophagectomy developed other postoperative complications. Patients who developed respiratory insufficiency showed an increase in RR and a decrease in SpO2, but an increase in HR was not always visible. In patients without adverse events, temporary periods of high HR and RR are observed as well, but these were transient and less frequent. CONCLUSIONS: Current systems for remote wireless patient monitoring on the ward are capable of detecting abnormalities in vital sign patterns in patients who develop adverse events. Remote patient monitoring may have potential to improve patient safety by generating early warnings for deterioration to nursing staff.

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.

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.

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.

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.

Postoperative patients' perspectives on rating pain: A qualitative study.

BACKGROUND: In postoperative pain treatment patients are asked to rate their pain experience on a single uni-dimensional pain scale. Such pain scores are also used as indicator to assess the quality of pain treatment. However, patients may differ in how they interpret the Numeric Rating Scale (NRS) score. OBJECTIVES: This study examines how patients assign a number to their currently experienced postoperative pain and which considerations influence this process. METHODS: A qualitative approach according to grounded theory was used. Twenty-seven patients were interviewed one day after surgery. RESULTS: Three main themes emerged that influenced the Numeric Rating Scale scores (0-10) that patients actually reported to professionals: score-related factors, intrapersonal factors, and the anticipated consequences of a given pain score. Anticipated consequences were analgesic administration-which could be desired or undesired-and possible judgements by professionals. We also propose a conceptual model for the relationship between factors that influence the pain rating process. Based on patients' score-related and intrapersonal factors, a preliminary pain score was "internally" set. Before reporting the pain score to the healthcare professional, patients considered the anticipated consequences (i.e., expected judgements by professionals and anticipation of analgesic administration) of current Numeric Rating Scale scores. CONCLUSIONS: This study provides insight into the process of how patients translate their current postoperative pain into a numeric rating score. The proposed model may help professionals to understand the factors that influence a given Numeric Rating Scale score and suggest the most appropriate questions for clarification. In this way, patients and professionals may arrive at a shared understanding of the pain score, resulting in a tailored decision regarding the most appropriate treatment of current postoperative pain, particularly the dosing and timing of opioid administration.

Postoperative bladder catheterization based on individual bladder capacity: a randomized trial.

BACKGROUND: Untreated postoperative urinary retention can result in permanent lower urinary tract dysfunction and can be prevented by timely bladder catheterization. The author hypothesized that the incidence of postoperative bladder catheterization can be decreased by using the patient's own maximum bladder capacity (MBC) instead of a fixed bladder volume of 500 ml as a threshold for catheterization. METHODS: Randomized parallel-arm and single-blinded comparative effectiveness trial conducted in 1,840 surgical patients, operated under general or spinal anesthesia without an indwelling urinary catheter. Patients were randomized to either use their individual MBC (index) or a fixed bladder volume of 500 ml (control) as a threshold for postoperative bladder catheterization. Preoperatively, the MBC was determined at home by voiding in a calibrated bowl. All other bladder volumes were measured by ultrasound. Postoperatively, bladder catheterization was performed when spontaneous voiding was impossible, and the ultrasound measurement exceeded the threshold for the group in which the patient was randomized (500 or MBC). The primary outcome was the incidence of bladder catheterization. RESULTS: The average MBC in the control group was 582 ml (±199 ml) and in the index group 611 ml (±209 ml). The incidence of catheterization decreased from 11.8% (107 of 909 patients) in the control group to 8.6% (80 of 931) in the index group (relative risk 0.73, 95% CI 0.55 to 0.96, P = 0.025). There were no adverse events in either group. CONCLUSIONS: In patients undergoing surgery under general or spinal anesthesia using the MBC rather than a fixed 500 ml threshold for bladder catheterization is a safe approach that significantly reduces the incidence of postoperative bladder catheterizations.