Efficacy of a pre-operative anaemia clinic in patients undergoing elective abdominal cancer surgery.

BACKGROUND: Pre-operative iron deficiency anaemia (IDA) is common in patients undergoing elective major abdominal surgery and is associated with increased risk of perioperative complications. However, widespread implementation of pre-operative anaemia management is lacking. Guidelines recommend investigation of anaemia preferably 4-6 weeks before surgery to allow time for correction. However, this is not always feasible in abdominal cancer surgery with short time to surgery and may be influenced by concomitant chemotherapy. The objective of this study was to assess the efficacy of implementing a pre-operative screening and treatment programme for IDA in elective abdominal cancer surgery patients, with short duration to surgery and concomitant use of chemotherapy. METHODS: All patients scheduled for elective abdominal cancer surgery with IDA were included. Anaemia was defined according to the World Health Organization-criteria and iron deficiency as a transferrin saturation <0.20. The primary outcome was change in haemoglobin (Hb) between iron infusion and surgery in patients receiving pre-operative intravenous iron infusion. RESULTS: Of 178 diagnosed IDA patients 134 (75%) received intravenous iron, 103 pre-operatively (58%) at median day 17 (interquartile range: 9-27) before surgery while 31 (17%) received post-operative intravenous iron treatment. The pre-operative Hb increased 0.89 g/dL (95% CI: 0.64-1.13, p < .001) compared to a decrease of 0.4 g/dL (95% CI: 0.19-0.58, p < .001) in 75 patients not treated pre-operatively. Patients diagnosed with severe anaemia had the largest pre-operative Hb increase. Iron infusion >2 weeks pre-operatively resulted in a greater Hb increment of 1.13 g/dL (95% CI: 0.81-1.45) compared to iron infusion ≤2 weeks before surgery 0.48 g/dL (95% CI: 0.16-0.81). Hb increased by 0.64 g/dL (95% CI 0.19-1.21) in patients receiving chemotherapy ≤31 days prior to surgery. CONCLUSION: In patients scheduled for abdominal cancer surgery, including in patients with concomitant chemotherapy, pre-operative IDA management is feasible and results in a significant pre-operative Hb increase compared to patients not treated. On the day of surgery 25% patients treated pre-operatively were no longer anaemic.

Genome-wide association studies with experimental validation identify a protective role for B lymphocytes against chronic post-surgical pain.

BACKGROUND: Chronic post-surgical pain (CPSP) significantly impacts patients' recovery and quality of life. Although environmental risk factors are well-established, genetic risk remains less understood. METHODS: A meta-analysis of genome-wide association studies followed by partitioned heritability was performed on 1350 individuals across five surgery types: hysterectomy, mastectomy, abdominal, hernia, and knee. In subsequent animal studies, withdrawal thresholds to evoked mechanical stimulation were measured in Rag1 null mutant and wild-type mice after plantar incision and laparotomy. Cell sorting by flow cytometry tracked recruitment of immune cell types. RESULTS: We discovered 77 genome-wide significant single-nucleotide polymorphism (SNP) hits, distributed among 24 loci and 244 genes. Meta-analysis of all cohorts estimated a SNP-based narrow-sense heritability for CPSP at ∼39%, indicating a substantial genetic contribution. Partitioned heritability analysis across a wide variety of tissues revealed enrichment of heritability in immune system-related genes, particularly those associated with B and T cells. Rag1 null mutant mice lacking both T and B cells exhibited exacerbated and prolonged allodynia up to 42 days after surgery, which was rescued by B-cell transfer. Recruitment patterns of B cells but not T cells differed significantly during the first 7 days after injury in the footpad, lymph nodes, and dorsal root ganglia. CONCLUSIONS: These findings suggest a key protective role for the adaptive immune system in the development of chronic post-surgical pain.

Wireless continuous single-lead ST-segment monitoring to detect new-onset myocardial injury at the general ward-An exploratory subanalysis.

Patients admitted for acute medical conditions and major noncardiac surgery are at risk of myocardial injury. This is frequently asymptomatic, especially in the context of concomitant pain and analgesics, and detection thus relies on cardiac biomarkers. Continuous single-lead ST-segment monitoring from wireless electrocardiogram (ECG) may enable more timely intervention, but criteria for alerts need to be defined to reduce false alerts. This study aimed to determine optimal ST-deviation thresholds from wireless single-lead ECG for detection of myocardial injury following major abdominal cancer surgery and during acute exacerbation of chronic obstructive pulmonary disease. Patients were monitored with a wireless single-lead ECG patch for up to 4 days and had daily troponin measurements. Single-lead ST-segment deviations of <0.255 mV and/or >0.245 mV (based on previous study comparison with 0.1 mV 12-lead ECG and variation in single-lead ECG) were analyzed for relation to myocardial injury defined as hsTnT elevation of 20-64 ng/L with an absolute change of ≥5 ng/L, or a hsTnT level ≥ 65 ng/L. In total, 528 patients were included for analysis, of which 15.5% had myocardial injury. For corrected ST-thresholds lasting ≥10 and ≥ 20 min, we found specificities of 91% and 94% and sensitivities of 17% and 13% with odds ratios of 2.0 (95% CI: 1.1; 3.9) and 2.4 (95% CI: 1.1; 5.1) for myocardial injury. In conclusion, wireless single-lead ECG monitoring with corrected ST thresholds detected patients developing myocardial injury with specificities >90% and sensitivities <20%, suggesting increased focus on sensitivity improvement.

Excessive Oxygen Administration in High-Risk Patients Admitted to Medical and Surgical Wards Monitored by Wireless Pulse Oximeter.

The monitoring of oxygen therapy when patients are admitted to medical and surgical wards could be important because exposure to excessive oxygen administration (EOA) may have fatal consequences. We aimed to investigate the association between EOA, monitored by wireless pulse oximeter, and nonfatal serious adverse events (SAEs) and mortality within 30 days. We included patients in the Capital Region of Copenhagen between 2017 and 2018. Patients were hospitalized due to acute exacerbation of chronic obstructive pulmonary disease (AECOPD) or after major elective abdominal cancer surgery, and all were treated with oxygen supply. Patients were divided into groups by their exposure to EOA: no exposure, exposure for 1-59 min or exposure over 60 min. The primary outcome was SAEs or mortality within 30 days. We retrieved data from 567 patients for a total of 43,833 h, of whom, 63% were not exposed to EOA, 26% had EOA for 1-59 min and 11% had EOA for ≥60 min. Nonfatal SAEs or mortality within 30 days developed in 24%, 12% and 22%, respectively, and the adjusted odds ratio for this was 0.98 (95% CI, 0.96-1.01) for every 10 min. increase in EOA, without any subgroup effects. In conclusion, we did not observe higher frequencies of nonfatal SAEs or mortality within 30 days in patients exposed to excessive oxygen administration.

Workload associated with manual assessment of vital signs as compared with continuous wireless monitoring.

BACKGROUND: Vital sign monitoring is considered an essential aspect of clinical care in hospitals. In general wards, this relies on intermittent manual assessments performed by clinical staff at intervals of up to 12 h. In recent years, continuous monitoring of vital signs has been introduced to the clinic, with improved patient outcomes being one of several potential benefits. The aim of this study was to determine the workload difference between continuous monitoring and manual monitoring of vital signs as part of the National Early Warning Score (NEWS). METHODS: Three wireless sensors continuously monitored blood pressure, heart rate, respiratory rate, and peripheral oxygen saturation in 20 patients admitted to the general hospital ward. The duration needed for equipment set-up and maintenance for continuous monitoring in a 24-h period was recorded and compared with the time spent on manual assessments and documentation of vital signs performed by clinical staff according to the NEWS. RESULTS: The time used for continuous monitoring was 6.0 (IQR 3.2; 7.2) min per patient per day vs. 14 (9.7; 32) min per patient per day for the NEWS. Median difference in duration for monitoring of vital signs was 9.9 (95% CI 5.6; 21) min per patient per day between NEWS and continuous monitoring (p < .001). Time used for continuous monitoring in isolated patients was 6.6 (4.6; 12) min per patient per day as compared with 22 (9.7; 94) min per patient per day for NEWS. CONCLUSION: The use of continuous monitoring was associated with a significant reduction in workload in terms of time for monitoring as compared with manual assessment of vital signs.

The effect of technical filtering and clinical criteria on alert rates from continuous vital sign monitoring in the general ward.

OBJECTIVES: Continuous vital sign monitoring at the general hospital ward has major potential advantages over intermittent monitoring but generates many alerts with risk of alert fatigue. We hypothesized that the number of alerts would decrease using different filters. METHODS: This study was an exploratory analysis of the alert reducing effect from adding two different filters to continuously collected vital sign data (peripheral oxygen saturation, blood pressure, heart rate, and respiratory rate) in patients admitted after major surgery or severe medical disease. Filtered data were compared to data without artifact removal. Filter one consists of artifact removal, filter two consists of artifact removal plus duration criteria adjusted for severity of vital sign deviation. Alert thresholds were based on the National Early Warning Score (NEWS) threshold. RESULTS: A population of 716 patients admitted for severe medical disease or major surgery with continuous wireless vital sign monitoring at the general ward with a mean monitoring time of 75.8 h, were included for the analysis. Without artifact removal, we found a median of 137 [IQR: 87-188] alerts per patient/day, artifact removal resulted in a median of 101 [IQR: 56-160] alerts per patient/day and with artifact removal combined with a duration-severity criterion, we found a median of 19 [IQR: 9-34] alerts per patient/day. Reduction of alerts was 86.4% (p < 0.001) for values without artifact removal (137 alerts) vs. the duration criteria and a reduction (19 alerts) of 81.5% (p < 0.001) for the criteria with artifact removal (101 alerts) vs. the duration criteria (19 alerts). CONCLUSION: We conclude that a combination of artifact removal and duration-severity criteria approach substantially reduces alerts generated by continuous vital sign monitoring.

Update of the international HerniaSurge guidelines for groin hernia management.

BACKGROUND: Groin hernia repair is one of the most common operations performed globally, with more than 20 million procedures per year. The last guidelines on groin hernia management were published in 2018 by the HerniaSurge Group. The aim of this project was to assess new evidence and update the guidelines. The guideline is intended for general and abdominal wall surgeons treating adult patients with groin hernias. METHOD: A working group of 30 international groin hernia experts and all involved stakeholders was formed and examined all new literature on groin hernia management, available until April 2022. Articles were screened for eligibility and assessed according to GRADE methodologies. New evidence was included, and chapters were rewritten. Statements and recommendations were updated or newly formulated as necessary. RESULTS: Ten chapters of the original HerniaSurge inguinal hernia guidelines were updated. In total, 39 new statements and 32 recommendations were formulated (16 strong recommendations). A modified Delphi method was used to reach consensus on all statements and recommendations among the groin hernia experts and at the European Hernia Society meeting in Manchester on October 21, 2022. CONCLUSION: The HerniaSurge Collaboration has updated the international guidelines for groin hernia management. The updated guidelines provide an overview of the best available evidence on groin hernia management and include evidence-based statements and recommendations for daily practice. Future guideline development will change according to emerging guideline methodology.

The future of postoperative vital sign monitoring in general wards: improving patient safety through continuous artificial intelligence-enabled alert formation and reduction.

PURPOSE: Monitoring of vital signs at the general ward with continuous assessments aided by artificial intelligence (AI) is increasingly being explored in the clinical setting. This review aims to describe current evidence for continuous vital sign monitoring (CVSM) with AI-based alerts - from sensor technology, through alert reduction, impact on complications, and to user-experience during implementation. RECENT FINDINGS: CVSM identifies significantly more vital sign deviations than manual intermittent monitoring. This results in high alert generation without AI-evaluation, both in patients with and without complications. Current AI is at the rule-based level, and this potentially reduces irrelevant alerts and identifies patients at need. AI-aided CVSM identifies complications earlier with reduced staff workload and a potential reduction of severe complications. SUMMARY: The current evidence for AI-aided CSVM suggest a significant role for the technology in reducing the constant 10-30% in-hospital risk of severe postoperative complications. However, large, randomized trials documenting the benefit for patient improvements are still sparse. And the clinical uptake of explainable AI to improve implementation needs investigation.

Deviating vital signs in continuous monitoring prior to discharge and risk of readmission: an observational study.

Premature discharge may result in readmission while longer hospitalization may increase risk of complications such as immobilization and reduce hospital capacity. Continuous monitoring detects more deviating vital signs than intermittent measurements and may help identify patients at risk of deterioration after discharge. We aimed to investigate the association between deviating vital signs detected by continuous monitoring prior to discharge and risk of readmission within 30 days. Patients undergoing elective major abdominal surgery or admitted with acute exacerbation of chronic obstructive pulmonary disease were included in this study. Eligible patients had vital signs monitored continuously within the last 24 h prior to discharge. The association between sustained deviated vital signs and readmission risk was analyzed by using Mann-Whitney's U test and Chi-square test. A total of 51 out of 265 patients (19%) were readmitted within 30 days. Deviated respiratory vital signs occurred frequently in both groups: desaturation < 88% for at least ten minutes was seen in 66% of patients who were readmitted and in 62% of those who were not (p = 0.62) while desaturation < 85% for at least five minutes was seen in 58% of readmitted and 52% of non-readmitted patients (p = 0.5). At least one sustained deviated vital sign was detected in 90% and 85% of readmitted patients and non-readmitted patients, respectively (p = 0.2). Deviating vital signs prior to hospital discharge were frequent but not associated with increased risk of readmission within 30 days. Further exploration of deviating vital signs using continuous monitoring is needed.

Quantifying physiological stability in the general ward using continuous vital signs monitoring: the circadian kernel density estimator.

Technological advances seen in recent years have introduced the possibility of changing the way hospitalized patients are monitored by abolishing the traditional track-and-trigger systems and implementing continuous monitoring using wearable biosensors. However, this new monitoring paradigm raise demand for novel ways of analyzing the data streams in real time. The aim of this study was to design a stability index using kernel density estimation (KDE) fitted to observations of physiological stability incorporating the patients' circadian rhythm. Continuous vital sign data was obtained from two observational studies with 491 postoperative patients and 200 patients with acute exacerbation of chronic obstructive pulmonary disease. We defined physiological stability as the last 24 h prior to discharge. We evaluated the model against periods of eight hours prior to events defined either as severe adverse events (SAE) or as a total score in the early warning score (EWS) protocol of ≥ 6, ≥ 8, or ≥ 10. The results found good discriminative properties between stable physiology and EWS-events (area under the receiver operating characteristics curve (AUROC): 0.772-0.993), but lower for the SAEs (AUROC: 0.594-0.611). The time of early warning for the EWS events were 2.8-5.5 h and 2.5 h for the SAEs. The results showed that for severe deviations in the vital signs, the circadian KDE model can alert multiple hours prior to deviations being noticed by the staff. Furthermore, the model shows good generalizability to another cohort and could be a simple way of continuously assessing patient deterioration in the general ward.

Deviations in continuously monitored electrodermal activity before severe clinical complications: a clinical prospective observational explorative cohort study.

Monitoring of high-risk patients in hospital wards is crucial in identifying and preventing clinical deterioration. Sympathetic nervous system activity measured continuously and non-invasively by Electrodermal activity (EDA) may relate to complications, but the clinical use remains untested. The aim of this study was to explore associations between deviations of EDA and subsequent serious adverse events (SAE). Patients admitted to general wards after major abdominal cancer surgery or with acute exacerbation of chronic obstructive pulmonary disease were continuously EDA-monitored for up to 5 days. We used time-perspectives consisting of 1, 3, 6, and 12 h of data prior to first SAE or from start of monitoring. We constructed 648 different EDA-derived features to assess EDA. The primary outcome was any SAE and secondary outcomes were respiratory, infectious, and cardiovascular SAEs. Associations were evaluated using logistic regressions with adjustment for relevant confounders. We included 714 patients and found a total of 192 statistically significant associations between EDA-derived features and clinical outcomes. 79% of these associations were EDA-derived features of absolute and relative increases in EDA and 14% were EDA-derived features with normalized EDA above a threshold. The highest F1-scores for primary outcome with the four time-perspectives were 20.7-32.8%, with precision ranging 34.9-38.6%, recall 14.7-29.4%, and specificity 83.1-91.4%. We identified statistically significant associations between specific deviations of EDA and subsequent SAE, and patterns of EDA may be developed to be considered indicators of upcoming clinical deterioration in high-risk patients.

Genome-wide association study suggests a critical contribution of the adaptive immune system to chronic post-surgical pain.

Chronic post-surgical pain affects a large proportion of people undergoing surgery, delaying recovery time and worsening quality of life. Although many environmental variables have been established as risk factors, less is known about genetic risk. To uncover genetic risk factors we performed genome-wide association studies in post-surgical cohorts of five surgery types- hysterectomy, mastectomy, abdominal, hernia, and knee- totaling 1350 individuals. Genetic associations between post-surgical chronic pain levels on a numeric rating scale (NRS) and additive genetic effects at common SNPs were evaluated. We observed genome-wide significant hits in almost all cohorts that displayed significance at the SNP, gene, and pathway levels. The cohorts were then combined via a GWAS meta-analysis framework for further analyses. Using partitioned heritability, we found that loci at genes specifically expressed in the immune system carried enriched heritability, especially genes related to B and T cells. The relevance of B cells in particular was then demonstrated in mouse postoperative pain assays. Taken altogether, our results suggest a role for the adaptive immune system in chronic post-surgical pain.

Wireless Single-Lead versus Standard 12-Lead ECG, for ST-Segment Deviation during Adenosine Cardiac Stress Scintigraphy.

Wearable wireless electrocardiographic (ECG) monitoring is well-proven for arrythmia detection, but ischemia detection accuracy is not well-described. We aimed to assess the agreement of ST-segment deviation from single- versus 12-lead ECG and their accuracy for the detection of reversible ischemia. Bias and limits of agreement (LoA) were calculated between maximum deviations in ST segments from single- and 12-lead ECG during 82Rb PET-myocardial cardiac stress scintigraphy. Sensitivity and specificity for reversible anterior-lateral myocardial ischemia detection were assessed for both ECG methods, using perfusion imaging results as a reference. Out of 110 patients included, 93 were analyzed. The maximum difference between single- and 12-lead ECG was seen in II (-0.019 mV). The widest LoA was seen in V5, with an upper LoA of 0.145 mV (0.118 to 0.172) and a lower LoA of -0.155 mV (-0.182 to -0.128). Ischemia was seen in 24 patients. Single-lead and 12-lead ECG both had poor accuracy for the detection of reversible anterolateral ischemia during the test: single-lead ECG had a sensitivity of 8.3% (1.0-27.0%) and specificity of 89.9% (80.2-95.8%), and 12-lead ECG a sensitivity of 12.5% (3.0-34.4%) and a specificity of 91.3% (82.0-96.7%). In conclusion, agreement was within predefined acceptable criteria for ST deviations, and both methods had high specificity but poor sensitivity for the detection of anterolateral reversible ischemia. Additional studies must confirm these results and their clinical relevance, especially in the light of the poor sensitivity for detecting reversible anterolateral cardiac ischemia.

Continuous monitoring is superior to manual measurements in detecting vital sign deviations in patients with COVID-19.

BACKGROUND: Patients admitted to the emergency care setting with COVID-19-infection can suffer from sudden clinical deterioration, but the extent of deviating vital signs in this group is still unclear. Wireless technology monitors patient vital signs continuously and might detect deviations earlier than intermittent measurements. The aim of this study was to determine frequency and duration of vital sign deviations using continuous monitoring compared to manual measurements. A secondary analysis was to compare deviations in patients admitted to ICU or having fatal outcome vs. those that were not. METHODS: Two wireless sensors continuously monitored (CM) respiratory rate (RR), heart rate (HR), and peripheral arterial oxygen saturation (SpO2 ). Frequency and duration of vital sign deviations were compared with point measurements performed by clinical staff according to regional guidelines, the National Early Warning Score (NEWS). RESULTS: SpO2 < 92% for more than 60 min was detected in 92% of the patients with CM vs. 40% with NEWS (p < .00001). RR > 24 breaths per minute for more than 5 min were detected in 70% with CM vs. 33% using NEWS (p = .0001). HR ≥ 111 for more than 60 min was seen in 51% with CM and 22% with NEWS (p = .0002). Patients admitted to ICU or having fatal outcome had longer durations of RR > 24 brpm (p = .01), RR > 21 brpm (p = .01), SpO2 < 80% (p = .01), and SpO2 < 85% (p = .02) compared to patients that were not. CONCLUSION: Episodes of desaturation and tachypnea in hospitalized patients with COVID-19 infection are common and often not detected by routine measurements.

Associations between clinical interventions and transcutaneous blood gas values in postoperative patients.

PURPOSE: Postoperative monitoring of circulation and respiration is pivotal to guide intervention strategies and ensure patient outcomes. Transcutaneous blood gas monitoring (TCM) may allow for noninvasive assessment of changes in cardiopulmonary function after surgery, including a more direct assessment of local micro-perfusion and metabolism. To form the basis for studies assessing the clinical impact of TCM complication detection and goal-directed-therapy, we examined the association between clinical interventions in the postoperative period and changes in transcutaneous blood gasses. METHODS: Two-hundred adult patients who have had major surgery were enrolled prospectively and monitored with transcutaneous blood gas measurements (oxygen (TcPO2) and carbon dioxide (TcPCO2)) for 2 h in the post anaesthesia care unit, with recording of all clinical interventions. The primary outcome was changes in TcPO2, secondarily TcPCO2, from 5 min before a clinical intervention versus 5 min after, analysed with paired t-test. RESULTS: Data from 190 patients with 686 interventions were analysed. During clinical interventions, a mean change in TcPO2 of 0.99 mmHg (95% CI-1.79-0.2, p = 0.015) and TcPCO2 of-0.67 mmHg (95% CI 0.36-0.98, p < 0.001) was detected. CONCLUSION: Clinical interventions resulted in significant changes in transcutaneous oxygen and carbon dioxide. These findings suggest future studies to assess the clinical value of changes in transcutaneous PO2 and PCO2 in a postoperative setting. TRIAL REGISTRY: Clinical trial number: NCT04735380. CLINICAL TRIAL REGISTRY: https://clinicaltrials.gov/ct2/show/NCT04735380.

Laser Speckle Contrast Imaging-based diagnosis of severe mesenteric traction syndrome: Hemodynamics and prostacyclin - A prospective cohort study.

BRIEF ABSTRACT: Today, the diagnosis and grading of mesenteric traction syndrome relies on a subjective assessment of facial flushing. However, this method has several limitations. In this study, Laser Speckle Contrast Imaging and a predefined cut-off value are assessed and validated for the objective identification of severe mesenteric traction syndrome. BACKGROUND: Severe mesenteric traction syndrome (MTS) is associated with increased postoperative morbidity. The diagnosis is based on an assessment of the developed facial flushing. Today this is performed subjectively, as no objective method exists. One possible objective method is Laser Speckle Contrast Imaging (LSCI), which has been used to show significantly higher facial skin blood flow in patients developing severe MTS. Using these data, a cut-off value has been identified. This study aimed to validate our predefined LSCI cut-off value for identifying severe MTS. METHODS: A prospective cohort study was performed on patients planned for open esophagectomy or pancreatic surgery from March 2021 to April 2022. All patients underwent continuous measurement of forehead skin blood flow using LSCI during the first hour of surgery. Using the predefined cut-off value, the severity of MTS was graded. In addition, blood samples for prostacyclin (PGI2) analysis and hemodynamics were collected at predefined time points to validate the cut-off value. MAIN RESULTS: Sixty patients were included in the study. Using our predefined LSCI cut-off value, 21 (35 %) patients were identified as developing severe MTS. These patients were found to have higher concentrations of 6-Keto-PGFaα (p = 0.002), lower SVR (p < 0.001), lower MAP (p = 0.004), and higher CO (p < 0.001) 15 min into surgery, as compared with patients not developing severe MTS. CONCLUSION: This study validated our LSCI cut-off value for the objective identification of severe MTS patients as this group developed increased concentrations of PGI2 and more pronounced hemodynamic alterations compared with patients not developing severe MTS.

Robot-assisted laparoscopic radical cystectomy with intracorporeal ileal conduit diversion versus open radical cystectomy with ileal conduit for bladder cancer in an ERAS setup (BORARC): protocol for a single-centre, double-blinded, randomised feasibility study.

BACKGROUND: Radical cystectomy (RC) with urinary diversion is the recommended treatment for selected cases of non-metastatic high-risk non-muscle-invasive and muscle-invasive bladder cancer. It remains unknown whether robot-assisted laparoscopic cystectomy (RARC) offers any advantage in terms of safety compared to open cystectomy (ORC) in an Enhanced Recovery After Surgery (ERAS) setup. Blinded randomised controlled trials (RCTs) between RARC versus ORC have never been conducted in cystectomy patients. We will investigate the feasibility of conducting a double-blinded RCT comparing ORC with RARC with intra-corporal ileal conduit (iRARC) in an ERAS setup. METHODS: This is a single-centre, double-blinded, randomised (1:1) clinical feasibility study for patients with non-metastatic high-risk non-muscle-invasive or muscle-invasive bladder cancer scheduled for cystectomy. All participants are recruited from Rigshospitalet, Denmark. The planned sample size is 50 participants to investigate whether blinding of the surgical technique is feasible. Participants and postoperative caring physicians and nurses are blinded using a pre-study designed abdominal dressing and blinding of the patient's electronic health record. Study endpoints are assessed 90 days postoperatively. The primary aim is to study the frequency and pattern of unplanned unblinding after surgery and the number of participants who cannot guess the surgical technique at the day of discharge. Eleven secondary endpoints are assessed: length of stay, days alive and out of hospital, in-hospital complication rate, 30-day complication rate, 90-day complication rate, readmission rate, quality of life, blood loss, pain, rate of moderate/severe post-anaesthesia care unit (PACU) complications, and delirium. Participants are managed in an ERAS setup in both arms of the trial. DISCUSSION: We report on the design and objectives of a novel experimental feasibility study investigating whether blinding of the surgical technique in cystectomy patients is possible. This information is essential for the design of future blinded trials comparing ORC to RARC. There is a continued need to compare RARC and ORC in terms of both efficacy, safety, and oncological outcomes. Estimated end of study is March 2021. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT03977831. Registered on the 6th of June 2019.

Continuous Glucose Monitoring Reveals Perioperative Hypoglycemia in Most Patients With Diabetes Undergoing Major Surgery: A Prospective Cohort Study.

OBJECTIVE: To investigate the frequency and duration of hypo- and hyperglycemia, assessed by continuous glucose monitoring (CGM) during and after major surgery, in departments with implemented diabetes care protocols. SUMMARY BACKGROUND DATA: Inadequate glycemic control in the perioperative period is associated with serious adverse events, but monitoring currently relies on point blood glucose measurements, which may underreport glucose excursions. METHODS: Adult patients without (A) or with diabetes [non-insulin-treated type 2 (B), insulin-treated type 2 (C) or type 1 (D)] undergoing major surgery were monitored using CGM (Dexcom G6), with an electrochemical sensor in the interstitial fluid, during surgery and for up to 10 days postoperatively. Patients and health care staff were blinded to CGM values, and glucose management adhered to the standard diabetes care protocol. Thirty-day postoperative serious adverse events were recorded. The primary outcome was duration of hypoglycemia (glucose <70 mg/dL). Clinicaltrials.gov: NCT04473001. RESULTS: Seventy patients were included, with a median observation time of 4.0 days. CGM was recorded in median 96% of the observation time. The median daily duration of hypoglycemia was 2.5 minutes without significant difference between the 4 groups (A-D). Hypoglycemic events lasting ≥15 minutes occurred in 43% of all patients and 70% of patients with type 1 diabetes. Patients with type 1 diabetes spent a median of 40% of the monitoring time in the normoglycemic range 70 to 180 mg/dL and 27% in the hyperglycemic range >250 mg/dL. Duration of preceding hypo- and hyperglycemia tended to be longer in patients with serious adverse events, compared with patients without events, but these were exploratory analyses. CONCLUSIONS: Significant duration of both hypo- and hyperglycemia was detected in high proportions of patients, particularly in patients with diabetes, despite protocolized perioperative diabetes management.

Continuous wireless pre- and postoperative vital sign monitoring reveal new, severe desaturations after vascular surgery.

OBJECTIVES: Postoperative deviating physiologic values (vital signs) may represent postoperative stress or emerging complications. But they can also reflect chronic preoperative values. Distinguishing between the two circumstances may influence the utility of using vital signs in patient monitoring. Thus, we aimed to describe the occurrence of vital sign deviations before and after major vascular surgery, hypothesising that preoperative vital sign deviations were longer in duration postoperatively. METHODS: In this prospective observational study, arterial vascular patients were continuously monitored wirelessly - from the day before until 5 days after surgery. Recorded values were: heart rate, respiration rate, peripheral arterial oxygen saturation (SpO2 ) and blood pressure. The outcomes were 1. cumulative duration of SpO2 < 85% / 24 h, and 2. cumulative duration per 24 h of vital sign deviations. RESULTS: Forty patients were included with a median monitoring time of 21 h preoperatively and 42 h postoperatively. The median duration of SpO2 < 85% preoperatively was 14.4 min/24 h whereas it was 28.0 min/24 h during day 0 in the ward (p = .09), and 16.8 min/24 h on day 1 in the ward (p = 0.61). Cumulative duration of SpO2 < 80% was significantly longer on day 0 in the ward 2.4 min/24 h (IQR 0.0-4.6) versus 6.7 min/24 h (IQR 1.8-16.2) p = 0.01. CONCLUSION: Deviating physiology is common in patients before and after vascular surgery. A longer duration of severe desaturation was found on the first postoperative day in the ward compared to preoperatively, whereas moderate desaturations were reflected in postoperative desaturations. Cumulative duration outside thresholds is, in some cases, exacerbated after surgery.