Prediction of fluid responsiveness in mechanically ventilated cardiac surgical patients: the performance of seven different functional hemodynamic parameters.

BACKGROUND: Functional hemodynamic parameters such as stroke volume and pulse pressure variation (SVV and PPV) have been shown to be reliable predictors of fluid responsiveness in mechanically ventilated patients. Today, different minimally- and non-invasive hemodynamic monitoring systems measure functional hemodynamic parameters. Although some of these parameters are described by the same name, they differ in their measurement technique and thus may provide different results. We aimed to test the performance of seven functional hemodynamic parameters simultaneously in the same clinical setting. METHODS: Hemodynamic measurements were done in 30 cardiac surgery patients that were mechanically ventilated. Before and after a standardized intravenous fluid bolus, hemodynamics were measured by the following monitoring systems: PiCCOplus (SVVPiCCO, PPVPiCCO), LiDCOrapid (SVVLiDCO, PPVLiDCO), FloTrac (SVVFloTrac), Philips Intellivue (PPVPhilips) and Masimo pulse oximeter (pleth variability index, PVI). Prediction of fluid responsiveness was tested by calculation of receiver operating characteristic (ROC) curves including a gray zone approach and compared using Fisher's Z-Test. RESULTS: Fluid administration resulted in an increase in cardiac output, while all functional hemodynamic parameters decreased. A wide range of areas under the ROC-curve (AUC's) was observed: AUC-SVVPiCCO = 0.91, AUC-PPVPiCCO = 0.88, AUC-SVVLiDCO = 0.78, AUC-PPVLiDCO = 0.89, AUC-SVVFloTrac = 0.87, AUC-PPVPhilips = 0.92 and AUC-PVI = 0.68. Optimal threshold values for prediction of fluid responsiveness ranged between 9.5 and 17.5%. Lowest threshold values were observed for SVVLiDCO, highest for PVI. CONCLUSION: All functional hemodynamic parameters tested except for PVI showed that their use allows a reliable identification of potential fluid responders. PVI however, may not be suitable after cardiac surgery to predict fluid responsiveness. TRIAL REGISTRATION: NCT02571465 , registered on October 7th, 2015 (retrospectively registered).

Accuracy, Precision, and Trending of 4 Pulse Wave Analysis Techniques in the Postoperative Period.

OBJECTIVE: The aim of this study was to analyze the accuracy, precision, and trending ability of the following 4 pulse wave analysis devices to measure continuous cardiac output: PiCCO2 ([PCCO]; Pulsion Medical System, Munich, Germany); LiDCORapid ([LCCO]; LiDCO Ltd, London, UK); FloTrac/Vigileo ([FCCO]; Edwards Lifesciences, Irvine, CA); and Nexfin ([NCCO]; BMEYE, Amsterdam, The Netherlands). DESIGN: Prospective, observational clinical study. SETTING: Intensive care unit of a single-center, teaching hospital. PARTICIPANTS: The study comprised 22 adult patients after elective coronary artery bypass surgery. INTERVENTIONS: Three measurement cycles were performed in all patient durings their immediate postoperative intensive care stay before and after fluid loading. Hemodynamic measurements were performed 5 minutes before and immediately after the administration of 500 mL colloidal fluid over 20 minutes. MEASUREMENTS AND MAIN RESULTS: PCCO, LCCO, FCCO, and NCCO were assessed and compared with cardiac output derived from intermittent transpulmonary thermodilution (ICO). One hundred thirty-two matched sets of data were available for analysis. Bland-Altman analysis using linear mixed effects models with random effects for patient and trial revealed a mean bias ±2 standard deviation (%error) of -0.86 ± 1.41 L/min (34.9%) for PCCO-ICO, -0.26 ± 2.81 L/min (46.3%) for LCCO-ICO, -0.28 ± 2.39 L/min (43.7%) for FCCO-ICO, and -0.93 ± 2.25 L/min (34.6%) for NCCO-ICO. Bland-Altman plots without adjustment for repeated measurements and replicates yielded considerably larger limits of agreement. Trend analysis for all techniques did not meet criteria for acceptable performance. CONCLUSIONS: All 4 tested devices using pulse wave analysis for measuring cardiac output failed to meet current criteria for meaningful and adequate accuracy, precision, and trending ability in cardiac output monitoring.

Continuous cardiac output measurement by un-calibrated pulse wave analysis and pulmonary artery catheter in patients with septic shock.

Septic shock is a serious medical condition. With increased concerns about invasive techniques, a number of non-invasive and semi-invasive devices measuring cardiac output (CO) have become commercially available. The aim of the present study was to determine the accuracy, precision and trending abilities of the FloTrac and the continuous pulmonary artery catheter thermodilution technique determining CO in septic shock patients. Consecutive septic shock patients were included in two centres and CO was measured every 4 h up to 48 h by FloTrac (APCO) and by pulmonary artery catheter (PAC) using the continuous (CCO) and intermittent (ICO) technique. Forty-seven septic shock patients with 326 matched sets of APCO, CCO and ICO data were available for analysis. Bland and Altman analysis revealed a mean bias ±2 SD of 0.0 ± 2.14 L min(-1) for APCO-ICO (%error = 34.5 %) and 0.23 ± 2.55 L min(-1) for CCO-ICO (%error = 40.4 %). Trend analysis showed a concordance of 85 and 81 % for APCO and CCO, respectively. In contrast to CCO, APCO was influenced by systemic vascular resistance and by mean arterial pressure. In septic shock patients, APCO measurements assessed by FloTrac but also the established CCO measurements using the PAC did not meet the currently accepted statistical criteria indicating acceptable clinical performance.

The influence of acute pulmonary hypertension on cardiac output measurements: calibrated pulse contour analysis, transpulmonary and pulmonary artery thermodilution against a modified Fick method in an animal model.

BACKGROUND: In critically ill patients with significant pulmonary hypertension (PH), close perioperative cardiovascular monitoring is mandatory, considering the increased morbidity and mortality in this patient group. Although the pulmonary artery catheter is still the standard for the diagnosis of PH, its use to monitor cardiac output (CO) in patients with PH is decreasing as a result of increased morbidity and possible influence of tricuspid regurgitation on the measurements. However, continuous CO measurement methods have never been evaluated under PH regarding their agreement and trending ability. In this study, we evaluated the influence of acute PH and different CO states on transpulmonary thermodilution (TPTD) and calibrated pulse contour analysis (PiCCO; both assessed with PiCCO plus™), intermittent pulmonary artery thermodilution (PATD), and continuous thermodilution (CCO) compared with a modified Fick method (FICK) in an animal model. METHODS: Nine healthy pigs were studied under anesthesia. PH of 25 and 40 mm Hg (by administration of the thromboxane analog U46619), CO decreases, and CO increases were induced to test the different CO measurement techniques over a broad range of hemodynamic situations. Before each step, a new baseline data set was collected. CO values were compared using Bland-Altman analysis; trending abilities were assessed via concordance and polar plot analysis. The influence of pulmonary pressure on CO measurements was analyzed using linear mixed models. RESULTS: A mean bias of -0.26 L/min with prediction intervals of -0.88 to 1.4 L/min was measured between TPTD and FICK. Their concordance rate was 100% (94%-100% confidence interval), and the mean polar angle -3° with radial limits of agreement of ±28° indicated good trending abilities. PATD compared with FICK also showed good trending ability. Comparisons of PiCCO and CCO versus FICK revealed low agreement and poor trending results with concordance rates of 84% (71%-93%) and 88% (74%-95%), mean polar angles from -17° and -19°, and radial limits of agreement of ±45° and 40°. Pulmonary pressures influenced only the difference between FICK and PiCCO, as assessed by linear mixed models. CONCLUSIONS: TPTD compared with FICK was able to track all changes induced during the study period, including those by PH. It yielded better agreement than PATD both compared with FICK. PiCCO and CCO were not mapping all changes correctly, and when used clinically in unstable patients, regular controls with intermittent techniques are required. Acute pharmacologically induced PH did influence the difference between FICK and PiCCO.

Viscoelastic blood coagulation measurement with Sonoclot predicts postoperative bleeding in cardiac surgery after heparin reversal.

OBJECTIVES: The aim of the study was to determine if Sonoclot with its sensitive glass bead-activated, viscoelastic test can predict postoperative bleeding in patients undergoing cardiac surgery at predefined time points. DESIGN: A prospective, observational clinical study. SETTING: A teaching hospital, single center. PARTICIPANTS: Consecutive patients undergoing cardiac surgery (N = 300). INTERVENTIONS: Besides routine laboratory coagulation studies and heparin management with standard (kaolin) activated clotting time, additional native blood samples were analyzed on a Sonoclot using glass bead-activated tests. Glass bead-activated clotting time, clot rate, and platelet function were recorded immediately before anesthesia induction and at the end of surgery after heparin reversal but before chest closure. MEASUREMENTS AND MAIN RESULTS: Primary outcome was postoperative blood loss (chest tube drainage at 4, 8, and 12 hours postoperatively). Secondary outcome parameters were transfusion requirements, need for surgical re-exploration, time of mechanical ventilation, length of intensive care unit and hospital stay, and hospital morbidity and mortality. Patients were categorized into "bleeders" and "nonbleeders." Patient characteristics, operations, preoperative standard laboratory parameters, and procedural times were comparable between bleeders and nonbleeders except for sex and age. Bleeders had higher rates of transfusions, surgical re-explorations, and complications. Only glass bead measurements by Sonoclot after heparin reversal before chest closure but not preoperatively were predictive for increased postoperative bleeding. CONCLUSIONS: Sonoclot with its glass bead-activated tests may predict the risk for postoperative bleeding in patients undergoing cardiac surgery at the end of surgery after heparin reversal but before chest closure.

Trending ability and limitations of transpulmonary thermodilution and pulse contour cardiac output measurement in cats as a model for pediatric patients.

The present study evaluated transpulmonary thermodilution (TPTD) and pulse contour cardiac output (PCCO) both measured by the PiCCO Plus™ monitor (Pulsion Medical Systems, Munich, Germany) against pulmonary artery thermodilution (PATD) in cats as a hemodynamic model for small children. A wide range of cardiac outputs (CO) was simultaneously measured. Accuracy and trending abilities were critically evaluated. Three cats were studied under isoflurane anesthesia and 160 CO measurements were performed with 3 mL ice-cold 5 % dextrose with PATD and TPTD. The results were compared with the PCCO measurement before the bolus measurement. Cardiac output was manipulated from 32 to 224 mL/kg/min by dobutamine, dopamine, phenylephrine, medetomidine and increased concentrations of isoflurane. Bland-Altman analysis, concordance and polar plot analysis were performed to assess accuracy and trending ability. TPTD was measuring constantly higher than PATD with a mean bias of 73 mL/kg/min and limits of agreement of 34-112 mL/kg/min, a concordance rate of 94 % and a mean polar angle of -5° with radial limits of agreement (RLOA) of 33°. Concordance rate of the PCCO versus PATD was 82 % with a mean polar angle of -10° and RLOA of 46° and versus TPTD 90 % with a mean polar angle of -6° and RLOA of 46°. Both tested methods constantly overestimated simultaneous PATD measurements. The small size, low flows and the relative short catheter not reaching the abdominal aorta may explain that. However TPTD tracked changes accurately opposed to a poor trending ability of the PCCO measurement.

Update on minimally invasive hemodynamic monitoring in thoracic anesthesia.

PURPOSE OF REVIEW: Advanced hemodynamic monitoring is indispensable for adequate management of patients undergoing major surgery. This article will summarize minimally invasive hemodynamic monitoring technologies and their potential use in thoracic anesthesia. RECENT FINDINGS: According to their inherent principle, currently available technologies can be classified into four groups: bioimpedance and bioreactance, applied Fick's principle, pulse wave analysis and Doppler. All devices measure stroke volume and cardiac output. Functional hemodynamic variables and volumetric parameters have been integrated in some devices. Two major indications can be identified: the 'hemodynamically unstable' patient and the patient 'at risk' for hemodynamic instability. Although there is evidence for the first indication, pre-emptive hemodynamic therapy or perioperative hemodynamic optimization for the patient 'at risk' is still an issue of ongoing debate. There is a growing body of evidence that this approach can positively influence patients' outcome with less postoperative complications in selected patient groups. SUMMARY: Many different minimally invasive hemodynamic monitoring devices have been developed and clinically introduced in the last years. They offer the advantage of being less invasive and easier to use. However, these techniques have several limitations and data are scarce in patients undergoing thoracic anesthesia, preventing their widespread use so far.

Can changes in arterial pressure be used to detect changes in cardiac output during volume expansion in the perioperative period?

BACKGROUND: Cardiac output (CO) is rarely monitored during surgery, and arterial pressure remains the only hemodynamic parameter for assessing the effects of volume expansion (VE). However, whether VE-induced changes in arterial pressure accurately reflect changes in CO has not been demonstrated. The authors studied the ability of VE-induced changes in arterial pressure and in pulse pressure variation to detect changes in CO induced by VE in the perioperative period. METHODS: The authors studied 402 patients in four centers. Hemodynamic variables were recorded before and after VE. Response to VE was defined as more than 15% increase in CO. The ability of VE-induced changes in arterial pressure to detect changes in CO was assessed using a gray zone approach. RESULTS: VE increased CO of more than 15% in 205 patients (51%). Areas under the receiver operating characteristic curves for VE-induced changes in systolic, diastolic, means, and pulse pressure ranged between 0.64 and 0.70, and sensitivity and specificity ranged between 52 and 79%. For these four arterial pressure-derived parameters, large gray zones were found, and more than 60% of the patients lay within this inconclusive zone. A VE-induced decrease in pulse pressure variation of 3% or more allowed detecting a fluid-induced increase in CO of more than 15% with a sensitivity of 90% and a specificity of 77% and a gray zone between 2.2 and 4.7% decrease in pulse pressure variation including 14% of the patients. CONCLUSION: Only changes in pulse pressure variation accurately detect VE-induced changes in CO and have a potential clinical applicability.

Obese trauma patients are at increased risk of early hypovolemic shock: a retrospective cohort analysis of 1,084 severely injured patients.

INTRODUCTION: Morbid obesity and its consequences are considered risk factors for adverse outcome in trauma, although the pathophysiologic mechanisms are incompletely understood. The aim of this study was to compare initial resuscitation, treatment, and short-term outcome of severely injured patients by body mass index (BMI). METHODS: A total of 1,084 severely injured patients with an injury severity score of 16 or greater were enrolled between 1996 and 2009 and grouped according to BMI. Their course of treatment and in-hospital outcome were analyzed by univariate and multivariate comparison. RESULTS: Of these patients, 603 (55.6%) were of normal weight with a BMI between 18.5 and 24.9, 361 (33.3%) had BMI values between 25 and 29.9, and 90 patients (8.3%) were obese (BMI ≥ 30). Thirty patients (2.8%) had BMI levels below 18.5. All groups were comparable with respect to injury severity, initial resuscitation, and time to ICU admission. There was a tendency towards higher mortality in obese patients (mortality 24.4%) and also overweight patients (mortality 18.8%) when compared with patients with a normal BMI (mortality 16.6%). Obese patients showed the highest mortality on day 0 (8.9% vs. 2.8% in the normal-weight group, P = 0.023), mostly due to persistent shock (6.7%). When corrected for BMI, obese patients are provided significantly lower volumes of intravenous fluids during the initial resuscitation period. CONCLUSION: In contrast to the mostly American literature, only a low percentage of trauma patients at a European trauma center are obese. These patients are at risk of higher mortality from persistent hemorrhagic shock in the initial phase after trauma, which may potentially be related to relative hypovolemia during the resuscitation period. In the later course of treatment, no significant differences exist with respect to specific complications, hospital stay, or in-hospital mortality.

Clinical validation of a new thermodilution system for the assessment of cardiac output and volumetric parameters.

INTRODUCTION: Transpulmonary thermodilution is used to measure cardiac output (CO), global end-diastolic volume (GEDV) and extravascular lung water (EVLW). A system has been introduced (VolumeView/EV1000™ system, Edwards Lifesciences, Irvine CA, USA) that employs a novel algorithm for the mathematical analysis of the thermodilution curve. Our aim was to evaluate the agreement of this method with the established PiCCO™ method (Pulsion Medical Systems SE, Munich, Germany, clinicaltrials.gov identifier: NCT01405040) METHODS: Seventy-two critically ill patients with clinical indication for advanced hemodynamic monitoring were included in this prospective, multicenter, observational study. During a 72-hour observation period, 443 sets of thermodilution measurements were performed with the new system. These measurements were electronically recorded, converted into an analog resistance signal and then re-analyzed by a PiCCO2™ device (Pulsion Medical Systems SE). RESULTS: For CO, GEDV, and EVLW, the systems showed a high correlation (r(2) = 0.981, 0.926 and 0.971, respectively), minimal bias (0.2 L/minute, 29.4 ml and 36.8 ml), and a low percentage error (9.7%, 11.5% and 12.2%). Changes in CO, GEDV and EVLW were tracked with a high concordance between the two systems, with a traditional concordance for CO, GEDV, and EVLW of 98.5%, 95.1%, and 97.7% and a polar plot concordance of 100%, 99.8% and 99.8% for CO, GEDV, and EVLW, respectively. Radial limits of agreement for CO, GEDV and EVLW were 0.31 ml/minute, 81 ml and 40 ml, respectively. The precision of GEDV measurements was significantly better using the VolumeView™ algorithm compared to the PiCCO™ algorithm (0.033 (0.03) versus 0.040 (0.03; median (interquartile range), P = 0.000049). CONCLUSIONS: For CO, GEDV, and EVLW, the agreement of both the individual measurements as well as measurements of change showed the interchangeability of the two methods. For the VolumeView method, the higher precision may indicate a more robust GEDV algorithm. TRIAL REGISTRATION: clinicaltrials.gov NCT01405040.

[New aspects of minimally invasive cardiac output monitoring]. / Hämodynamisches Monitoring - Neue Aspekte des minimalinvasiven Herzzeitvolumen-Monitorings.

The variety of minimally invasive cardiac output (CO) monitoring devices is growing rendering it difficult to keep track of new developments. In this article technical principles, limitations and validation procedures considering new aspects are reviewed. An integrated approach for their use is proposed since no single device can comply with all clinical needs. CO should be interpreted in combination with clinical information and other hemodynamic parameters. It's evident that not the monitor per se, but only the protocol / therapy based on the hemodynamic data can improve patients outcome.

Assessing the diagnostic accuracy of pulse pressure variations for the prediction of fluid responsiveness: a "gray zone" approach.

BACKGROUND: Respiratory arterial pulse pressure variations (PPV) are the best predictors of fluid responsiveness in mechanically ventilated patients during general anesthesia. However, previous studies were performed in a small number of patients and determined a single cutoff point to make clinical discrimination. The authors sought to test the predictive value of PPV in a large, multicenter study and to express it using a gray zone approach. METHODS: The authors studied 413 patients during general anesthesia and mechanical ventilation in four centers. PPV, central venous pressure, and cardiac output were recorded before and after volume expansion (VE). Response to VE was defined as more than 15% increase in cardiac output after VE. The following approaches were used to determine the gray zones: resampled and two-graph receiver operator characteristic curves. The impact of changes in the benefit-risk balance of VE on the gray zone was also evaluated. RESULTS: The authors observed 209 responders (51%) and 204 nonresponders (49%) to VE. The area under receiver operating characteristic curve was 0.89 (95% CI: 0.86-0.92) for PPV, compared with 0.57 (95% CI: 0.54-0.59) for central venous pressure (P < 10). The gray zone approach identified a range of PPV values (between 9% and 13%) for which fluid responsiveness could not be predicted reliably. These PPV values were seen in 98 (24%) patients. Changes in the cost ratio of VE moderately affected the gray zone limits. CONCLUSION: Despite a strong predictive value, PPV may be inconclusive (between 9% and 13%) in approximately 25% of patients during general anesthesia.

Clinical review: Update on hemodynamic monitoring--a consensus of 16.

Hemodynamic monitoring plays a fundamental role in the management of acutely ill patients. With increased concerns about the use of invasive techniques, notably the pulmonary artery catheter, to measure cardiac output, recent years have seen an influx of new, less-invasive means of measuring hemodynamic variables, leaving the clinician somewhat bewildered as to which technique, if any, is best and which he/she should use. In this consensus paper, we try to provide some clarification, offering an objective review of the available monitoring systems, including their specific advantages and limitations, and highlighting some key principles underlying hemodynamic monitoring in critically ill patients.

Pulse pressure variation: where are we today?

In the present review we will describe and discuss the physiological and technological background necessary in understanding the dynamic parameters of fluid responsiveness and how they relate to recent softwares and algorithms' applications. We will also discuss the potential clinical applications of these parameters in the management of patients under general anesthesia and mechanical ventilation along with the potential improvements in the computational algorithms.

Uncalibrated radial and femoral arterial pressure waveform analysis for continuous cardiac output measurement: an evaluation in cardiac surgery patients.

OBJECTIVES: Arterial pressure waveform analysis is a less invasive alternative to the pulmonary artery catheter for continuous cardiac output (CO) measurement. Uncalibrated and calibrated systems are actually available (ie, the FloTrac/Vigileo system [Edwards Lifesciences, Irvine, CA] and the PiCCOplus system [Pulsion Medical Systems, Munich, Germany]). According to the FloTrac/Vigileo manufacturer, reliable measurements can be performed using any existing arterial catheter. The aim of this study was to evaluate CO determined by the FloTrac/Vigileo system using a radial (FCO(radial)) and femoral arterial catheter (FCO(femoral)) as well as the PiCCOplus system (PCO). Intermittent pulmonary artery thermodilution (ICO) was used as primary reference technique. DESIGN: A prospective clinical study. SETTING: A teaching hospital, single center. PARTICIPANTS: Twenty-six cardiac surgery patients. INTERVENTIONS: Perioperative CO measurements. MEASUREMENTS AND MAIN RESULTS: CO was assessed at predefined measurement points. FCO(radial), FCO(femoral), and PCO were recorded after the induction of anesthesia, after sternotomy, at skin closure, after intensive care unit transfer, and during intensive care unit stay 12 and 24 hours after study initiation. ICO was determined as the mean of 3 bolus injections. Bland-Altman analysis revealed comparable mean bias and limits of agreement for FCO(radial), FCO(femoral), and PCO when compared with ICO. There was a decreased agreement for all devices in the postoperative period. However, a consistently close agreement was observed for the direct comparison between FCO(radial) and FCO(femoral). CONCLUSIONS: Performance of the FloTrac/Vigileo system via radial as well as femoral access and the PiCCOplus monitoring for cardiac output measurement were comparable when tested against intermittent thermodilution in cardiac surgery patients.

Minimally invasive monitoring of cardiac output in the cardiac surgery intensive care unit.

Cardiac output monitoring in the cardiac surgery patient is standard practice that is traditionally performed using the pulmonary artery catheter. However, over the past 20 years, the value of pulmonary artery catheters has been challenged, with some authors suggesting that its use might be not only unnecessary but also harmful. New minimally invasive devices that measure cardiac output have become available. In this paper, we review their operative principles, limitations, and utility in an integrated approach that could potentially change patients' outcome. However, it is now clear that it is how the monitor is used (ie, the protocol or therapy associated with its use, or its lack thereof), and not the monitor per se, that should be questioned when a patient's outcome is being evaluated.

Interchangeability of cardiac output measurements between non-invasive photoplethysmography and bolus thermodilution: A systematic review and individual patient data meta-analysis.

BACKGROUND: Continuous non-invasive cardiac output devices using digital photoplethysmography (PPG) are widely available for bedside use, but their interchangeability with reference methods has not yet been evaluated in a systematic review and patient data meta-analysis. METHODS: A systematic review and meta-analysis of studies comparing non-invasive cardiac output monitoring using PPG with the invasive bolus thermodilution method was performed. With ethical approval, all published studies from the PUBMED, Embase, Scopus, Web of Science, and Google Scholar databases from January 1, 2010 to January 1, 2018 were included. From these analysed studies, individual patient data were interpreted using the interchangeability methods for both absolute values and changes in cardiac output measurements. RESULTS: Ten studies comparing PPG and bolus thermodilution in the operating room and intensive care settings were included. The interchangeability rate (95% CI) was 37% (24-48) (n=1350 pairs of measurements). The interchangeability rate was poorer with the CNAP device (CNSystems, Graz, Austria) [18% (17-20)] than with the Clearsight (Edwards Lifesciences, Irvine, CA) device [33% (31-34), P<0.0001], for patients receiving norepinephrine [19% (17-20) vs. 33% (32-34), P<0.0001], and for patients with low mean arterial pressure (<65mmHg) [26% (23-29) vs. 30% (29-31), P<0.0001]. Among the 1009 comparisons of the changes in cardiac output between both methods, 561 (56%) were interpretable with a trend interchangeability rate at 24% (12-36). CONCLUSIONS: Cardiac output measurements using PPG were not interchangeable with bolus thermodilution in regard to both absolute values and changes in cardiac output measurements, and should be used with caution in clinical practice. TRIAL REGISTRATION: PROSPERO ID CRD42018089513.

Assessment of cardiac output changes using a modified FloTrac/Vigileo algorithm in cardiac surgery patients.

INTRODUCTION: The FloTrac/Vigileo (Edwards Lifesciences, Irvine, CA, USA) allows pulse pressure-derived cardiac output measurement without external calibration. Software modifications were performed in order to eliminate initially observed deficits. The aim of this study was to assess changes in cardiac output determined by the FloTrac/Vigileo system (FCO) with an initially released (FCOA) and a modified (FCOB) software version, as well as changes in cardiac output from the PiCCOplus system (PCO; Pulsion Medical Systems, Munich, Germany). Both devices were compared with cardiac output measured by intermittent thermodilution (ICO). METHODS: Cardiac output measurements were performed in patients after elective cardiac surgery. Two sets of data (A and B) were obtained using FCOA and FCOB in 50 patients. After calibration of the PiCCOplus system, triplicate FCO and PCO values were recorded and ICO was determined in the supine position and cardiac output changes due to body positioning were recorded 15 minutes later (30 degrees head-up, 30 degrees head-down, supine). Student's t test, analysis of variance and Bland-Altman analysis were calculated. RESULTS: Significant changes of FCO, PCO and ICO induced by body positioning were observed in both data sets. For set A, DeltaFCOA was significantly larger than DeltaICO induced by positioning the head down. For set B, there were no significant differences between DeltaFCOB and DeltaICO. For set A, increased limits of agreement were found for FCOA-ICO when compared with PCO-ICO. For set B, mean bias and limits of agreement were comparable for FCOB-ICO and PCO-ICO. CONCLUSIONS: The modification of the FloTrac/Vigileo system resulted in an improved performance in order to reliably assess cardiac output and track the related changes in patients after cardiac surgery.

Minimally invasive haemodynamic monitoring.

Different minimally invasive haemodynamic monitoring techniques are commercially available today and in the recent years they have proved adequate in replacing the pulmonary artery catheter under certain clinical conditions.Moreover, several of these techniques provide additional new parameters primarily related to preload assessment.Therefore, in order to be used in daily clinical practice, the diversity of minimally invasive haemodynamic monitoring requires knowledge of the different techniques, the different parameters provided by the devices and their clinical validity. The aim of the present article is to review the most widely used minimally invasive cardiac output monitoring techniques; emphasize the new parameters available for preload assessment;and propose a modular stepwise monitoring concept.

Optimisation of Perioperative Cardiovascular Management to Improve Surgical Outcome II (OPTIMISE II) trial: study protocol for a multicentre international trial of cardiac output-guided fluid therapy with low-dose inotrope infusion compared with usual care in patients undergoing major elective gastrointestinal surgery.

INTRODUCTION: Postoperative morbidity and mortality in older patients with comorbidities undergoing gastrointestinal surgery are a major burden on healthcare systems. Infections after surgery are common in such patients, prolonging hospitalisation and reducing postoperative short-term and long-term survival. Optimal management of perioperative intravenous fluids and inotropic drugs may reduce infection rates and improve outcomes from surgery. Previous small trials of cardiac-output-guided haemodynamic therapy algorithms suggested a modest reduction in postoperative morbidity. A large definitive trial is needed to confirm or refute this and inform widespread clinical practice. METHODS: The Optimisation of Perioperative Cardiovascular Management to Improve Surgical Outcome II (OPTIMISE II) trial is a multicentre, international, parallel group, open, randomised controlled trial. 2502 high-risk patients undergoing major elective gastrointestinal surgery will be randomly allocated in a 1:1 ratio using minimisation to minimally invasive cardiac output monitoring to guide protocolised administration of intravenous fluid combined with low-dose inotrope infusion, or usual care. The trial intervention will be carried out during and for 4 hours after surgery. The primary outcome is postoperative infection of Clavien-Dindo grade II or higher within 30 days of randomisation. Participants and those delivering the intervention will not be blinded to treatment allocation; however, outcome assessors will be blinded when feasible. Participant recruitment started in January 2017 and is scheduled to last 3 years, within 50 hospitals worldwide. ETHICS/DISSEMINATION: The OPTIMISE II trial has been approved by the UK National Research Ethics Service and has been approved by responsible ethics committees in all participating countries. The findings will be disseminated through publication in a widely accessible peer-reviewed scientific journal. TRIAL REGISTRATION NUMBER: ISRCTN39653756.