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565 result(s) for "Monitoring, Intraoperative - statistics "
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Clinical experience with contact-force and flexible-tip ablation catheter designs
Purpose Lesion formation is a critical determinant of technical and clinical success of pulmonary vein isolation. Different catheter designs aim to enhance tissue contact during ablation to enable optimized lesion formation. We analyzed procedural characteristics and predictors of clinical success in patients ablated with three different contemporary ablation catheters. Methods Two hundred sixty-eight sequentially included patients receiving pulmonary vein isolation (PVI) with conventional ( n  = 122), contact-force ( n  = 96) and flexible-tip ( n  = 60) catheters were followed for a median of 14.1 months with 7d-Holter-monitoring and TTE at 3, 6, 12, and 24 months. Baseline characteristics and follow-up times were homogeneous across all groups. Results Multivariable Cox proportional hazard regression for arrhythmia recurrence demonstrated a favorable hazard ratio for contact-force and flexible-tip catheters vs. conventional open irrigation catheters. Procedure time and fluoroscopy time were shorter for contact-force and flexible-tip catheters versus conventional catheters, but equal between. Linear lesions were applied in 58 % of contact-force and 66 % of flexible-tip cases, and CFAEs were targeted in 26 % of either. Conclusions Our non-randomized prospectively collected data do not show a difference in observed procedure characteristics and in clinical outcome for flexible-tip versus contact-force catheter designs, while both display improved performance against conventional open irrigated-tip catheters. Linear lesions and CFAEs ablation were not associated with improved arrhythmia-free survival.
The relationship between the Bispectral Index (BIS) and the Observer Alertness of Sedation Scale (OASS) scores during propofol sedation with and without ketamine: a randomized, double blinded, placebo controlled clinical trial
Prior studies have examined the static effect of intravenous ketamine on the BIS Index for sedation but it remains unknown if the BIS Index is a reliable method to track sedation levels in the presence of ketamine. The major objective of the current investigation was to compare the BIS Vista Index ability to track varying depths of sedation as determined by OASS scores in a standardized anesthetic regimen with and without ketamine. The study was a randomized, double blinded clinical trial. Patients undergoing breast surgery under sedation with propofol were randomized to receive ketamine (1.5 μg kg min −1 ) or saline. Infusion data was used to estimate propofol plasma concentrations (Cp). The main outcome of interest was the correlation between the BIS Vista Index with the OASS score. Twenty subjects were recruited and fifteen completed the study. Four hundred fifty-five paired data points were included in the analysis. Model performance (Nagelkerke R 2 ) of the multinomial logistic regression model was 0.57 with the c-statistic of 0.87 (95 % CI 0.82–0.91). Compared to awake the odds ratio for BIS values predicting moderate sedation in the saline/propofol group 1.19 (95 % CI 1.12–1.25) but only 1.06 (95 % CI 1.02–1.1) in the ketamine/propofol group ( P  = 0.001). There was no difference in the odds for BIS values to predict deep sedation between groups ( P  = 0.14). The BIS monitor can be used to monitor sedation level even when ketamine is used with propofol as part of the sedation regimen. However, ketamine reduces the value of the BIS in predicting moderate sedation levels.
The Entropy Module® and Bispectral Index® as Guidance for Propofol-Remifentanil Anaesthesia in Combination with Regional Anaesthesia Compared with a Standard Clinical Practice Group
This study was designed to investigate the impact of the Entropy Module® and Bispectral Index® (BIS) monitoring on drug consumption and recovery times compared with standard anaesthetic practice in patients undergoing orthopaedic surgery using a combination of regional and general anaesthesia as performed by an experienced anaesthesiologist. We hypothesised that electroencephalogram monitoring would lead to a lower drug consumption as well as shorter recovery times. With institutional review board approval and written informed consent, 90 adult patients undergoing surgery to the upper or lower extremity received regional anaesthesia for post- and intraoperative pain control and were randomised to receive general anaesthesia by propofol/remifentanil infusion controlled either solely by clinical parameters or by targeting Entropy or BIS values of 50. Recovery times and drug consumption were recorded. Data from 79 patients were analysed. Compared with standard practice, patients with Entropy or BIS monitoring showed a similar propofol consumption (standard practice 101±22 μg/kg/minute, Entropy 106±24 μg/kg/minute, BIS 104±20 μg/kg/minute) and showed similar Aldrete scores (10/10) one minute after extubation: 9.1∓0.3, 9.2±0.6 and 9.3±0.5, respectively. Time points of extubation were 7.3±2.9 minutes, 9.2∓3.9 minutes and 6.8±2.9 minutes, respectively, demonstrating a significant difference between Entropy and BIS (P=0.023). Compared with standard practice, targeting an Entropy or BIS value of 50 did not result in a reduction of propofol consumption during general anaesthesia combined with regional anaesthesia as performed by an experienced anaesthesiologist in orthopaedic patients.
Intraoperative sRAGE kinetics
Background Glycated proteins (advanced glycation endproducts, AGE) in tissue are associated with degenerative diseases. This study evaluated the role of sRAGE (soluble receptor for advanced glycation endproducts), a decoy receptor of AGEs in blood, for the outcome of patients after coronary artery bypass grafting (CABG). Methods A total of 90 patients undergoing CABG were analysed in two centres. Perioperative blood samples were collected before surgery up to 1 week postoperatively. sRAGE was measured by ELISA. Patients were subdivided regarding age (< 64 versus > 70 years, 14 % versus 35 % female), euroSCORE (< 3 versus > 4, 14 % versus 29 % female) and sRAGE changes between sternotomy and end of the operation (< 30 % versus > 45 %, 33 % versus 33 % female) and subsequently analysed with respect of postoperative outcome parameters. Results Preoperative sRAGE values did not correlate with the outcome of the patients. sRAGE levels increase within 10 min from 1,539 ± 96 to 5,311 ± 187 pg/ml after sternotomy, then returning to baseline levels within 2 days after surgery. Comparing the analysed possible risk factors age, euroSCORE and sRAGE changes, no difference was observed regarding 30-day mortality. Age and the euroSCORE are superior with respect of tachyarrythmia, whereas sRAGE kinetics seems to be superior with respect of prolonged postoperative respiration time/stay in the intensive care unit or catecholamine support. Conclusion A prolonged, increased intraoperative sRAGE level is a new outcome predictor for patients undergoing CABG surgery, mutually complementary to the euroSCORE.
Predictive Value and Safety of Intraoperative Neurophysiological Monitoring With Motor Evoked Potentials in Glioma Surgery
Abstract BACKGROUND: Resection of gliomas in or adjacent to the motor system is widely performed with intraoperative neuromonitoring (IOM). Despite the fact that data on the safety of IOM are available, the significance and predictive value of the procedure are still under discussion. Moreover, cases of false-negative monitoring affect the surgeon's confidence in IOM. OBJECTIVE: To examine cases of false-negative IOM to reveal structural explanations. METHODS: Between 2007 and 2010, we resected 115 consecutive supratentorial gliomas in or close to eloquent motor areas using direct cortical stimulation for monitoring of motor evoked potentials (MEPs). The monitoring data were reviewed and related to new postoperative motor deficit and postoperative imaging. Clinical outcomes were assessed during follow-up. RESULTS: Monitoring of MEPs was successful in 112 cases (97.4%). Postoperatively, 30.3% of patients had a new motor deficit, which remained permanent in 12.5%. Progression-free follow-up was 9.7 months (range, 2 weeks-40.6 months). In 65.2% of all cases, MEPs were stable throughout the operation, but 8.9% showed a new temporary motor deficit, whereas 4.5% (5 patients) presented with permanently deteriorated motor function representing false-negative monitoring at first glance. However, these cases were caused by secondary hemorrhage, ischemia, or resection of the supplementary motor area. CONCLUSION: Continuous MEP monitoring provides reliable monitoring of the motor system, influences the course of operation in some cases, and has to be regarded as the standard for IOM of the motor system. In our series, we found no false-negative MEP results.
Multimodal Intraoperative Spinal Cord Monitoring during Spinal Deformity Surgery: Efficacy, Diagnostic Characteristics, and Algorithm Development
Objective: This study aims to present the diagnostic characteristics of multimodal intraoperative monitoring (IOM) in spinal deformity surgery and to define and categorise the neuromonitoring events, as well as propose an algorithm of action. Materials and Methods: We reviewed 1,155 consecutive patients (807 female, 348 male) who underwent deformity correction using standardised perioperative care, cortical/cervical somatosensory evoked potentials (SSEPs), and upper/lower limb transcranial electrical motor evoked potential (MEPs) by a single surgeon. The mean age at surgery was 13.8 years (range 10–23.3). We categorised IOM events as true, transient true, and false positive or negative. Diagnostic performance criteria were calculated. Results: The most common diagnosis was adolescent idiopathic scoliosis in 717 (62%) patients. We identified 3 true positive monitoring events occurring in 2 patients (0.17%), 8 transient true positive (0.69%), and 8 transient false positive events (0.69%). There were no false negative events and no patient had postoperative neurological complications. The multimodal IOM technique had a sensitivity of 100%, specificity of 99.3%, positive predictive value of 55.6%, and negative predictive value of 100%. Sensitivity was 100% for MEPs and multimodal monitoring compared to 20% for cortical or cervical SSEPs. The frequency of true or transient true positive events was higher (p = 0.07) in Scheuermann’s kyphosis (3/91 patients, 3.3%) compared to adolescent idiopathic scoliosis (6/717 patients, 0.84%). Conclusion: Multimodal IOM is highly sensitive and specific for spinal cord injury. This technique is reliable for the assessment of the condition of the spinal cord during major deformity surgery. We propose an algorithm of intraoperative action to allow close cooperation between the surgical, anaesthetic, and neurophysiology teams and to prevent neurological deficits.
Impact of continuous non-invasive blood pressure monitoring on hemodynamic fluctuation during general anesthesia: a randomized controlled study
This study assessed the ability of a continuous non-invasive blood pressure (BP) monitoring system to reduce intra-anesthetic hemodynamic fluctuation compared with intermittent BP cuff measurement. Forty patients undergoing total knee arthroplasty under general anesthesia were enrolled and randomly divided into two groups (Control and CS group). BP management was performed using the same protocol with BP measured by intermittent BP cuff in the Control and that by continuous non-invasive BP monitoring in the CS group. We assessed the accuracy and precision of the continuous non-invasive BP monitoring compared with BP cuff measurement using Bland–Altman, four-quadrant plot, and polar-plot analyses. Additionally, the occurrence of hypotension and hypertention during general anesthesia was compared between the two groups. The continuous non-invasive BP monitoring showed excellent accuracy of − 1.1 ± 8.1 mmHg during surgery and an acceptable trending ability with a concordance rate of 95.1% according to the four-quadrant plot analysis and an angular concordance rate of 86.7% by polar-plot analysis. Hypotension was less common in the CS group during induction of anesthesia (p = 0.002) and surgery (p = 0.008). Hypertension occurred more frequently in the Control group during emergence from anesthesia (p = 0.037). The duration of hemodynamic stability (systolic BP 80–110% of baseline) intraoperatively was longer in the CS group than in the Control group (87.7 vs. 61.9%; p < 0.001). Accuracy and trending ability of the continuous non-invasive BP monitoring was clinically acceptable, and lead to hemodynamic stability and reduction of intra-anesthetic hypotension and hypertension intraoperatively.
A survey of current practices, attitudes and demands of anaesthesiologists regarding the depth of anaesthesia monitoring in China
Background In this study, we aimed to analyse survey data to explore two different hypotheses; and for this purpose, we distributed an online survey to Chinese anaesthesiologists. The hypothetical questions in this survey include: (1) Chinese anaesthesiologists mainly use the depth of anaesthesia (DoA) monitors to prevent intraoperative awareness and (2) the accuracy of these monitors is the most crucial performance factor during the clinical daily practice of Chinese anaesthesiologists. Methods We collected and statistically analysed the response of a total of 12,750 anesthesiologists who were invited to participate in an anonymous online survey. The Chinese Society of Anaesthesiologists (CSA) trial group provided the email address of each anaesthesiologist, and the selection of respondents was random from the computerized system. Results The overall response rate was 32.0% (4037 respondents). Only 9.1% (95% confidence interval, 8.2-10.0%) of the respondents routinely used DoA monitors. Academic respondents (91.5, 90.3-92.7%) most frequently used DoA monitoring to prevent awareness, whereas nonacademic respondents (88.8, 87.4-90.2%) most frequently used DoA monitoring to guide the delivery of anaesthetic agents. In total, the number of respondents who did not use a DoA monitor and whose patients experienced awareness (61.7, 57.8-65.6%) was significantly greater than those who used one or several DoA monitors (51.5, 49.8-53.2%). Overall, the crucial performance factor during DoA monitoring was considered by 61.9% (60.4-63.4%) of the respondents to be accuracy. However, most respondents (95.7, 95.1-96.3%) demanded improvements in the accuracy of the monitors for DoA monitoring. In addition, broad application in patients of all ages (86.3, 85.2-87.4%), analgesia monitoring (80.4, 79.2-81.6%), and all types of anaesthetic agents (75.6, 74.3-76.9%) was reported. In total, 65.0% (63.6-66.5%) of the respondents believed that DoA monitors should be combined with EEG and vital sign monitoring, and 53.7% (52.1-55.2%) believed that advanced DoA monitors should include artificial intelligence. Conclusions Academic anaesthesiologists primarily use DoA monitoring to prevent awareness, whereas nonacademic anaesthesiologists use DoA monitoring to guide the delivery of anaesthetics. Anaesthesiologists demand high-accuracy DoA monitors incorporating EEG signals, multiple vital signs, and antinociceptive indicators. DoA monitors with artificial intelligence may represent a new direction for future research on DoA monitoring.
Comparison of cardiac output optimization with an automated closed-loop goal-directed fluid therapy versus non standardized manual fluid administration during elective abdominal surgery: first prospective randomized controlled trial
An intraoperative automated closed-loop system for goal-directed fluid therapy has been successfully tested in silico, in vivo and in a clinical case–control matching. This trial compared intraoperative cardiac output (CO) in patients managed with this closed-loop system versus usual practice in an academic medical center. The closed-loop system was connected to a CO monitoring system and delivered automated colloid fluid boluses. Moderate to high-risk abdominal surgical patients were randomized either to the closed-loop or the manual group. Intraoperative final CO was the primary endpoint. Secondary endpoints were intraoperative overall mean cardiac index (CI), increase from initial to final CI, intraoperative fluid volume and postoperative outcomes. From January 2014 to November 2015, 46 patients were randomized. There was a lower initial CI (2.06 vs. 2.51 l min−1 m−2, p = 0.042) in the closed-loop compared to the control group. No difference in final CO and in overall mean intraoperative CI was observed between groups. A significant relative increase from initial to final CI values was observed in the closed-loop but not the control group (+ 28.6%, p = 0.006 vs. + 1.2%, p = 0.843). No difference was found for intraoperative fluid management and postoperative outcomes between groups. There was no significant impact on the primary study endpoint, but this was found in a context of unexpected lower initial CI in the closed-loop group.Trial registry number ID-RCB/EudraCT: 2013-A00770-45. ClinicalTrials.gov Identifier NCT01950845, date of registration: 17 September 2013.
Validation of electrical velocimetry in resuscitation of patients undergoing liver transplantation. Observational study
Major hemodynamic changes are frequently noted during liver transplantation (LT). We evaluated the performance of electrical velocimetry (EV) as compared to that of TEE in SV optimization during liver transplantation. This was an observational study in 32 patients undergoing LT. We compared SV values measured simultaneously by EV (SVEV) and TEE (SVTEE) at baseline 30 min after induction, at the end of dissection phase, 30 min after anhepatic phase, 30 min after reperfusion. We also evaluated the reliability of EV to track changes In SV before and after 49 fluid challenges. Finally, the SV variation (SVV) and pulse pressure variation (PPV) were tested as predictors for volume responsiveness, defined as an increase in SV ≥ 10% after 250 ml of colloid. For 112 paired SV data, the overall correlation was 0.76 and bias (limits of agreement) 0.3 (− 29 to 29) ml percentage error 62%. The EV was able to track changes in SV with a concordance rate of 97%, and a sensitivity and specificity of 93% to detect a positive fluid challenge. The AUC values (with 95% confidence intervals) for SVV and PPV were 0.68 (0.52–0.83) and 0.72 (0.57–0.86), respectively, indicating low predictive capacity in these setting. The absolute values of SV derived from EV did not agree with SV derived from TEE. However, EV was able to track the direction of changes in SV during hemodynamic management of patients undergoing liver transplantation.Clinical trial registration: Clinicaltrials.gov Identifier: NCT03228329 prospectively Registered on 13-July-2017.