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PURPOSE: There are different techniques for ultrasound-guided central venous catheter (CVC) insertion. When using the conventional syringe-on-needle technique, the syringe needs to be removed from the needle after venous puncture to pass the guidewire through the needle into the vein. When, alternatively, using the wire-in-needle technique, the needle is preloaded with the guidewire, and the guidewire-after venous puncture-is advanced into the vein under real-time ultrasound guidance. We tested the hypothesis that the wire-in-needle technique reduces the time to successful guidewire insertion in the internal jugular vein compared with the syringe-on-needle technique in adults. METHODS: We randomized 250 patients to the wire-in-needle or syringe-on-needle technique. Our primary endpoint was the time to successful guidewire insertion in the internal jugular vein. RESULTS: Two hundred and thirty eight patients were analyzed. The median (25th percentile, 75th percentile) time to successful guidewire insertion was 22 (16, 38) s in patients assigned to the wire-in-needle technique and 25 (19, 34) s in patients assigned to the syringe-on-needle technique (estimated location shift: 2 s; 95%-confidence-interval: - 1 to 5 s, p = 0.165). CVC insertion was successful on the first attempt in 103/116 patients (89%) assigned to the wire-in-needle technique and in 113/122 patients (93%) assigned to the syringe-on-needle technique. CVC insertion-related complications occurred in 8/116 patients (7%) assigned to the wire-in-needle technique and 19/122 patients (16%) assigned to the syringe-on-needle technique. CONCLUSION: The wire-in-needle technique-compared with the syringe-on-needle technique-did not reduce the time to successful guidewire insertion in the internal jugular vein. Clinicians can consider either technique for ultrasound-guided CVC insertion in adults.
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OBJECTIVE: Microcirculatory disturbances can contribute to organ dysfunction in patients undergoing major surgeries and critical illness. Incident dark field imaging (CytoCam, Braedius Medical BV, Huizen, Netherlands) provides direct visualization of the microcirculation. To utilize this method in daily clinical practice, automated image analysis is essential. This study aims to compare the automated analysis of recorded microcirculation video sequences using CytoCamTools V2 Analysis Manager (Braedius Medical BV) with established manual analysis using Capillary Mapper (Version 1.4.5, University Hospital Münster, Germany) as reference method. METHODS: Sublingual microcirculation video sequences were recorded in patients undergoing laparotomy at four time points (before surgery, 2 and 6 h after surgery, and on the first postoperative day) using incident dark field imaging. Agreement between automated and manual analysis of total vessel density (TVD), perfused vessel density (PVD), and proportion of perfused vessels (PPV) was compared using intraclass correlation (ICC) and Bland-Altman method. RESULTS: A total of 336 videos from 30 patients were analyzed. The ICC between the two measurement methods was 0.13 for TVD, 0.14 for PVD, and 0.16 for PPV. Bland-Altman analysis showed mean differences (95% limits of agreement) of 10.46 mm/mm2 (-1.73-22.65 mm/mm2) for TVD, 8.25 mm/mm2 (-9.88-26.39 mm/mm2) for PVD, and - 3.96% (-59.58%-51.65%) for PPV. DISCUSSION: Automated microcirculatory analysis using the Analysis Manager did not show clinically acceptable agreement with manual analysis using Capillary Mapper. Consequently, automated video analysis using the Analysis Manager does not appear to be a suitable approach. TRIAL REGISTRATION: ClinicalTrials.gov identifier: DRKS00020264.
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BACKGROUND: Implementation of goal-directed fluid therapy (GDFT) protocols remains low. Protocol compliance among anesthesiologists tends to be suboptimal owing to the high workload and the attention required for implementation. The assisted fluid management (AFM) system is a novel decision support tool designed to help clinicians apply GDFT protocols. This system predicts fluid responsiveness better than anesthesia practitioners do and achieves higher stroke volume (SV) and cardiac index values during surgery. We tested the hypothesis that an AFM-guided GDFT strategy would also be associated with better sublingual microvascular flow compared to a standard GDFT strategy. METHODS: This bicenter, parallel, 2-arm, prospective, randomized controlled, patient and assessor-blinded, superiority study considered for inclusion all consecutive patients undergoing high-risk abdominal surgery who required an arterial catheter and uncalibrated SV monitoring. Patients having standard GDFT received manual titration of fluid challenges to optimize SV while patients having an AFM-guided GDFT strategy received fluid challenges based on recommendations from the AFM software. In all patients, fluid challenges were standardized and titrated per 250 mL and vasopressors were administered to maintain a mean arterial pressure >70 mm Hg. The primary outcome (average of each patient's intraoperative microvascular flow index (MFI) across 4 intraoperative time points) was analyzed using a Mann-Whitney U test and the treatment effect was estimated with a median difference between groups with a 95% confidence interval estimated using the bootstrap percentile method (with 1000 replications). Secondary outcomes included SV, cardiac index, total amount of fluid, other microcirculatory variables, and postoperative lactate. RESULTS: A total of 86 patients were enrolled over a 7-month period. The primary outcome was significantly higher in patients with AFM (median [Q1-Q3]: 2.89 [2.84-2.94]) versus those having standard GDFT (2.59 [2.38-2.78] points, median difference 0.30; 95% confidence interval [CI], 0.19-0.49; P < .001). Cardiac index and SVI were higher (3.2 ± 0.5 vs 2.7 ± 0.7 l.min-1.m-2; P = .001 and 42 [35-47] vs 36 [32-43] mL.m-2; P = .018) and arterial lactate concentration was lower at the end of the surgery in patients having AFM-guided GDFT (2.1 [1.5-3.1] vs 2.9 [2.1-3.9] mmol.L-1; P = .026) than patients having standard GDFT strategy. Patients having AFM received a higher fluid volume but 3 times less norepinephrine than those receiving standard GDFT (P < .001). CONCLUSIONS: Use of an AFM-guided GDFT strategy resulted in higher sublingual microvascular flow during surgery compared to use of a standard GDFT strategy. Future trials are necessary to make conclusive recommendations that will change clinical practice.
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Background: It remains unknown whether there is a causal relationship between intraoperative hypotension and postoperative neurocognitive disorders. We tested the hypothesis that personalised-compared to routine-intraoperative blood pressure management reduces the incidence of postoperative neurocognitive disorders in patients having major noncardiac surgery. Methods: In this single-centre trial, 328 elective major noncardiac surgery patients were randomly allocated to receive personalised blood pressure management (i.e. maintaining intraoperative mean arterial pressure [MAP] above preoperative baseline MAP from automated 24-h blood pressure monitoring) or routine blood pressure management (i.e. maintaining MAP above 65 mm Hg). The primary outcome was the incidence of neurocognitive disorders (composite of delayed neurocognitive recovery and delirium) between postoperative days 3 and 7. Results: The primary outcome, neurocognitive disorders, occurred in 18 of 147 patients (12%) assigned to personalised and 21 of 148 patients (14%) assigned to routine blood pressure management (odds ratio [OR]=0.84, 95% confidence interval [CI]: 0.40-1.75, P=0.622). Delayed neurocognitive recovery occurred in 17 of 146 patients (12%) assigned to personalised and 17 of 145 patients (12%) assigned to routine blood pressure management (OR=0.99, 95% CI: 0.45-2.17, P=0.983). Delirium occurred in 2 of 157 patients (1%) assigned to personalised and 4 of 158 patients (3%) assigned to routine blood pressure management (OR=0.50, 95% CI: 0.04-3.53, P=0.684). Conclusions: Personalised intraoperative blood pressure management maintaining preoperative baseline MAP neither reduced the incidence of the composite primary outcome neurocognitive disorders between postoperative days 3 and 7 nor the incidences of the components of the composite primary outcome-delayed neurocognitive recovery and delirium-compared to routine blood pressure management in patients having major noncardiac surgery. Clinical trial registration: ClinicalTrials.gov (NCT03442907).
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Intraoperative hypotension is common and associated with organ injury. Hypotension can not only occur during surgery, but also thereafter. After surgery, most patients are treated in post-anesthesia care units (PACU). The incidence of PACU hypotension is largely unknown - presumably in part because arterial pressure is usually monitored intermittently in PACU patients. We therefore aimed to evaluate the incidence, duration, and severity of PACU hypotension in low-risk patients recovering from non-cardiac surgery. In this observational study, we performed blinded continuous non-invasive arterial pressure monitoring with finger-cuffs (ClearSight system; Edwards Lifesciences, Irvine, CA, USA) in 100 patients recovering from non-cardiac surgery in the PACU. We defined PACU hypotension as a mean arterial pressure (MAP) < 65 mmHg. Patients had continuous finger-cuff monitoring for a median (25th percentile, 75th percentile) of 64 (44 to 91) minutes. Only three patients (3%) had PACU hypotension for at least one consecutive minute. These three patients had 4, 4, and 2 cumulative minutes of PACU hypotension; areas under a MAP of 65 mmHg of 17, 9, and 9 mmHg x minute; and time-weighted averages MAP less than 65 mmHg of 0.5, 0.3, and 0.2 mmHg. The median volume of crystalloid fluid patients were given during PACU treatment was 200 (100 to 400) ml. None was given colloids or a vasopressor during PACU treatment. In low-risk patients recovering from non-cardiac surgery, the incidence of PACU hypotension was very low and the few episodes of PACU hypotension were short and of modest severity.
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STUDY OBJECTIVE: Processed electroencephalography (pEEG) may help clinicians optimize depth of general anesthesia. Avoiding excessive depth of anesthesia may reduce intraoperative hypotension and the need for vasopressors. We tested the hypothesis that pEEG-guided - compared to non-pEEG-guided - general anesthesia reduces the amount of norepinephrine needed to keep intraoperative mean arterial pressure above 65 mmHg in patients having vascular surgery. DESIGN: Randomized controlled clinical trial. SETTING: University Medical Center Hamburg-Eppendorf, Hamburg, Germany. PATIENTS: 110 patients having vascular surgery. INTERVENTIONS: pEEG-guided general anesthesia. MEASUREMENTS: Our primary endpoint was the average norepinephrine infusion rate from the beginning of induction of anesthesia until the end of surgery. MAIN RESULT: 96 patients were analyzed. The mean ± standard deviation average norepinephrine infusion rate was 0.08 ± 0.04 µg kg-1 min-1 in patients assigned to pEEG-guided and 0.12 ± 0.09 µg kg-1 min-1 in patients assigned to non-pEEG-guided general anesthesia (mean difference 0.04 µg kg-1 min-1, 95% confidence interval 0.01 to 0.07 µg kg-1 min-1, p = 0.004). Patients assigned to pEEG-guided versus non-pEEG-guided general anesthesia, had a median time-weighted minimum alveolar concentration of 0.7 (0.6, 0.8) versus 0.8 (0.7, 0.8) (p = 0.006) and a median percentage of time Patient State Index was <25 of 12 (1, 41) % versus 23 (3, 49) % (p = 0.279). CONCLUSION: pEEG-guided - compared to non-pEEG-guided - general anesthesia reduced the amount of norepinephrine needed to keep mean arterial pressure above 65 mmHg by about a third in patients having vascular surgery. Whether reduced intraoperative norepinephrine requirements resulting from pEEG-guided general anesthesia translate into improved patient-centered outcomes remains to be determined in larger trials.
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Anestesia Geral , Eletroencefalografia , Norepinefrina , Procedimentos Cirúrgicos Vasculares , Vasoconstritores , Humanos , Anestesia Geral/métodos , Norepinefrina/administração & dosagem , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Eletroencefalografia/efeitos dos fármacos , Procedimentos Cirúrgicos Vasculares/efeitos adversos , Vasoconstritores/administração & dosagem , Hipotensão/prevenção & controle , Pressão Arterial/efeitos dos fármacos , Monitorização Intraoperatória/métodosRESUMO
Haemodynamic monitoring and management are cornerstones of perioperative care. The goal of haemodynamic management is to maintain organ function by ensuring adequate perfusion pressure, blood flow, and oxygen delivery. We here present guidelines on "Intraoperative haemodynamic monitoring and management of adults having non-cardiac surgery" that were prepared by 18 experts on behalf of the German Society of Anaesthesiology and Intensive Care Medicine (Deutsche Gesellschaft für Anästhesiologie und lntensivmedizin; DGAI).
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Anestesiologia , Cuidados Críticos , Monitorização Hemodinâmica , Hemodinâmica , Monitorização Intraoperatória , Sociedades Médicas , Adulto , Humanos , Anestesiologia/métodos , Anestesiologia/normas , Cuidados Críticos/métodos , Cuidados Críticos/normas , Alemanha , Monitorização Hemodinâmica/métodos , Monitorização Intraoperatória/métodos , Monitorização Intraoperatória/normas , Assistência Perioperatória/métodos , Assistência Perioperatória/normas , Sociedades Científicas , Procedimentos Cirúrgicos Operatórios , Literatura de Revisão como AssuntoRESUMO
The microcirculation describes the network of the smallest vessels in our cardiovascular system. On a microcirculatory level, oxygen delivery is determined by the flow of oxygen-carrying red blood cells in a given single capillary (capillary red blood cell flow) and the density of the capillary network in a given tissue volume (capillary vessel density). Handheld vital videomicroscopy enables visualisation of the capillary bed on the surface of organs and tissues but currently is only used for research. Measurements are generally possible on all organ surfaces but are most often performed in the sublingual area. In patients presenting for elective surgery, the sublingual microcirculation is usually intact and functional. Induction of general anaesthesia slightly decreases capillary red blood cell flow and increases capillary vessel density. During elective, even major, noncardiac surgery, the sublingual microcirculation is preserved and remains functional, presumably because elective noncardiac surgery is scheduled trauma and haemodynamic alterations are immediately treated by anaesthesiologists, usually restoring the macrocirculation before the microcirculation is substantially impaired. Additionally, surgery is regional trauma and thus likely causes regional, rather than systemic, impairment of the microcirculation. Whether or not the sublingual microcirculation is impaired after noncardiac surgery remains a subject of ongoing research. Similarly, it remains unclear if cardiac surgery, especially with cardiopulmonary bypass, impairs the sublingual microcirculation. The effects of therapeutic interventions specifically targeting the microcirculation remain to be elucidated and tested. Future research should focus on further improving microcirculation monitoring methods and investigating how regional microcirculation monitoring can inform clinical decision-making and treatment.
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Procedimentos Cirúrgicos Cardíacos , Medicina Perioperatória , Humanos , Microcirculação , Soalho Bucal/irrigação sanguínea , Oxigênio/farmacologiaRESUMO
OBJECTIVES: The IKORUS system (Vygon, Écouen, France) allows continuous monitoring of the urethral perfusion index (uPI) using a photoplethysmographic sensor mounted near the base of the balloon of a dedicated urinary catheter. We aimed to test the hypothesis that the uPI decreases during off-pump coronary artery bypass (OPCAB) surgery and to investigate the relationship between the uPI and macrocirculatory variables. DESIGN: Prospective observational study. SETTING: University Medical Center Hamburg-Eppendorf, Hamburg, Germany. PARTICIPANTS: Twenty patients having OPCAB surgery. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The primary endpoint was changes in the uPI during OPCAB surgery. We additionally investigated associations between the uPI and cardiac output, mean arterial pressure, heart rate, and point-of-care variables. Twenty patients with 24,137 uPI measurements were included. Overall, there was a high interindividual variability in the uPI. Compared with the preparation phase (during which the median [interquartile range] uPI was 7.7 [5.6-12.0]), the uPI decreased by 14% (95% CI 13%-15%) during the bypass grafting phase, by 35% (95% CI 34%-36%) during the cardiac positioning phase, and by 7% (95% CI 6%-9%) during hemostasis. There was no clinically important association between uPI and either cardiac output, mean arterial pressure, or heart rate. CONCLUSIONS: The uPI decreases during OPCAB surgery, specifically during the cardiac positioning phase. There was no clinically important association between uPI and either cardiac output, mean arterial pressure, or heart rate. It, therefore, remains to be determined whether intraoperative uPI decreases are clinically important, reflect alterations in intra-abdominal tissue perfusion that are not reflected by systemic macrohemodynamics, and can help clinicians guide therapeutic interventions.
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Ponte de Artéria Coronária sem Circulação Extracorpórea , Humanos , Pressão Arterial , Débito Cardíaco/fisiologia , Frequência Cardíaca/fisiologia , Índice de Perfusão , Estudos ProspectivosRESUMO
BACKGROUND: Finger-cuff methods allow noninvasive continuous arterial pressure monitoring. This study aimed to determine whether continuous finger-cuff arterial pressure monitoring helps clinicians reduce hypotension within 15 min after starting induction of anesthesia and during noncardiac surgery. Specifically, this study tested the hypotheses that continuous finger-cuff-compared to intermittent oscillometric-arterial pressure monitoring helps clinicians reduce the area under a mean arterial pressure of 65 mmHg within 15 min after starting induction of anesthesia and the time-weighted average mean arterial pressure less than 65 mmHg during noncardiac surgery. METHODS: In this single-center trial, 242 noncardiac surgery patients were randomized to unblinded continuous finger-cuff arterial pressure monitoring or to intermittent oscillometric arterial pressure monitoring (with blinded continuous finger-cuff arterial pressure monitoring). The first of two hierarchical primary endpoints was the area under a mean arterial pressure of 65 mmHg within 15 min after starting induction of anesthesia; the second primary endpoint was the time-weighted average mean arterial pressure less than 65 mmHg during surgery. RESULTS: Within 15 min after starting induction of anesthesia, the median (interquartile range) area under a mean arterial pressure of 65 mmHg was 7 (0, 24) mmHg × min in 109 patients assigned to continuous finger-cuff monitoring versus 19 (0.3, 60) mmHg × min in 113 patients assigned to intermittent oscillometric monitoring (P = 0.004; estimated location shift: -6 [95% CI: -15 to -0.3] mmHg × min). During surgery, the median (interquartile range) time-weighted average mean arterial pressure less than 65 mmHg was 0.04 (0, 0.27) mmHg in 112 patients assigned to continuous finger-cuff monitoring and 0.40 (0.03, 1.74) mmHg in 115 patients assigned to intermittent oscillometric monitoring (P < 0.001; estimated location shift: -0.17 [95% CI: -0.41 to -0.05] mmHg). CONCLUSIONS: Continuous finger-cuff arterial pressure monitoring helps clinicians reduce hypotension within 15 min after starting induction of anesthesia and during noncardiac surgery compared to intermittent oscillometric arterial pressure monitoring.
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Anestesia , Hipotensão , Humanos , Pressão Arterial , Hipotensão/diagnóstico , Determinação da Pressão Arterial/métodos , Procedimentos Cirúrgicos Vasculares , Pressão SanguíneaRESUMO
PURPOSE: Shock is a life-threatening condition characterized by substantial alterations in the microcirculation. This study tests the hypothesis that considering sublingual microcirculatory perfusion variables in the therapeutic management reduces 30-day mortality in patients admitted to the intensive care unit (ICU) with shock. METHODS: This randomized, prospective clinical multicenter trial-recruited patients with an arterial lactate value above two mmol/L, requiring vasopressors despite adequate fluid resuscitation, regardless of the cause of shock. All patients received sequential sublingual measurements using a sidestream-dark field (SDF) video microscope at admission to the intensive care unit (± 4 h) and 24 (± 4) hours later that was performed blindly to the treatment team. Patients were randomized to usual routine or to integrating sublingual microcirculatory perfusion variables in the therapy plan. The primary endpoint was 30-day mortality, secondary endpoints were length of stay on the ICU and the hospital, and 6-months mortality. RESULTS: Overall, we included 141 patients with cardiogenic (n = 77), post cardiac surgery (n = 27), or septic shock (n = 22). 69 patients were randomized to the intervention and 72 to routine care. No serious adverse events (SAEs) occurred. In the interventional group, significantly more patients received an adjustment (increase or decrease) in vasoactive drugs or fluids (66.7% vs. 41.8%, p = 0.009) within the next hour. Microcirculatory values 24 h after admission and 30-day mortality did not differ [crude: 32 (47.1%) patients versus 25 (34.7%), relative risk (RR) 1.39 (0.91-1.97); Cox-regression: hazard ratio (HR) 1.54 (95% confidence interval (CI) 0.90-2.66, p = 0.118)]. CONCLUSION: Integrating sublingual microcirculatory perfusion variables in the therapy plan resulted in treatment changes that do not improve survival at all.
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Choque Séptico , Humanos , Microcirculação , Estudos Prospectivos , Choque Séptico/tratamento farmacológico , Ressuscitação/métodos , Unidades de Terapia IntensivaRESUMO
BACKGROUND: Perioperative hemodynamic management aims to optimize organ perfusion pressure and blood flow-assuming this ensures that oxygen delivery meets cellular metabolic needs. Cellular metabolic needs are reflected by energy expenditure. A better understanding of energy expenditure under general anesthesia could help tailor perioperative hemodynamic management to actual demands. We thus sought to assess energy expenditure under general anesthesia. Our primary hypothesis was that energy expenditure under general anesthesia is lower than preoperative awake resting energy expenditure. METHODS: We conducted an observational study on patients having elective noncardiac surgery at the University Medical Center Hamburg-Eppendorf (Germany) between September 2019 and March 2020. We assessed preoperative awake resting energy expenditure, energy expenditure under general anesthesia, and energy expenditure after surgery using indirect calorimetry. We compared energy expenditure under general anesthesia at incision to preoperative awake resting energy expenditure using a Wilcoxon signed-rank test for paired measurements. RESULTS: We analyzed 60 patients. Median (95% confidence interval [CI]) preoperative awake resting energy expenditure was 953 (95% CI, 906-962) kcal d -1 m -2 . Median energy expenditure under general anesthesia was 680 (95% CI, 642-711) kcal d -1 m -2 -and thus 263 (95% CI, 223-307) kcal d -1 m -2 or 27% (95% CI, 23%-30%) lower than preoperative awake resting energy expenditure ( P < .001). CONCLUSIONS: Median energy expenditure under general anesthesia is about one-quarter lower than preoperative awake resting energy expenditure in patients having noncardiac surgery.
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Metabolismo Basal , Metabolismo Energético , Humanos , Calorimetria Indireta , Anestesia Geral , AlemanhaRESUMO
BACKGROUND: Intraoperative hypotension is associated with myocardial injury, acute kidney injury, and death. In routine practice, specific causes of intraoperative hypotension are often unclear. A more detailed understanding of underlying haemodynamic alterations of intraoperative hypotension may identify specific treatments. We thus aimed to use machine learning - specifically, hierarchical clustering - to identify underlying haemodynamic alterations causing intraoperative hypotension in major abdominal surgery patients. Specifically, we tested the hypothesis that there are distinct endotypes of intraoperative hypotension, which may help refine therapeutic interventions. METHODS: We conducted a secondary analysis of intraoperative haemodynamic measurements from a prospective observational study in 100 patients who had major abdominal surgery under general anaesthesia. We used stroke volume index, heart rate, cardiac index, systemic vascular resistance index, and pulse pressure variation measurements. Intraoperative hypotension was defined as any mean arterial pressure ≤65 mm Hg or a mean arterial pressure between 66 and 75 mm Hg requiring a norepinephrine infusion rate exceeding 0.1 µg kg-1 min-1. To identify endotypes of intraoperative hypotension, we used hierarchical clustering (Ward's method). RESULTS: A total of 615 episodes of intraoperative hypotension occurred in 82 patients (46 [56%] female; median age: 64 [57, 73] yr) who had surgery of a median duration of 270 (195, 335) min. Hierarchical clustering revealed six distinct intraoperative hypotension endotypes. Based on their clinical characteristics, we labelled these endotypes as (1) myocardial depression, (2) bradycardia, (3) vasodilation with cardiac index increase, (4) vasodilation without cardiac index increase, (5) hypovolaemia, and (6) mixed type. CONCLUSION: Hierarchical clustering identified six endotypes of intraoperative hypotension. If validated, considering these intraoperative hypotension endotypes may enable causal treatment of intraoperative hypotension.
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Hipotensão , Monitorização Intraoperatória , Humanos , Feminino , Pessoa de Meia-Idade , Masculino , Estudos Retrospectivos , Monitorização Intraoperatória/métodos , Hipotensão/etiologia , Estudos de Coortes , Aprendizado de Máquina , Complicações Pós-OperatóriasRESUMO
BACKGROUND: Intraoperative hypotension is common in patients having non-cardiac surgery and is associated with serious complications and death. However, optimal intraoperative blood pressures for individual patients remain unknown. We therefore aim to test the hypothesis that personalized perioperative blood pressure management-based on preoperative automated blood pressure monitoring-reduces the incidence of a composite outcome of acute kidney injury, acute myocardial injury, non-fatal cardiac arrest, and death within 7 days after surgery compared to routine blood pressure management in high-risk patients having major abdominal surgery. METHODS: IMPROVE-multi is a multicenter randomized trial in 1272 high-risk patients having elective major abdominal surgery that we plan to conduct at 16 German university medical centers. Preoperative automated blood pressure monitoring using upper arm cuff oscillometry will be performed in all patients for one night to obtain the mean of the nighttime mean arterial pressures. Patients will then be randomized either to personalized blood pressure management or to routine blood pressure management. In patients assigned to personalized management, intraoperative mean arterial pressure will be maintained at least at the mean of the nighttime mean arterial pressures. In patients assigned to routine management, intraoperative blood pressure will be managed per routine. The primary outcome will be a composite of acute kidney injury, acute myocardial injury, non-fatal cardiac arrest, and death within 7 days after surgery. DISCUSSION: Our trial will determine whether personalized perioperative blood pressure management reduces the incidence of major postoperative complications and death within 7 days after surgery compared to routine blood pressure management in high-risk patients having major abdominal surgery. TRIAL REGISTRATION: ClinicalTrials.gov NCT05416944. Registered on June 14, 2022.
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Injúria Renal Aguda , Parada Cardíaca , Humanos , Pressão Sanguínea , Abdome/cirurgia , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/prevenção & controle , Complicações Pós-Operatórias/epidemiologia , Injúria Renal Aguda/complicações , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Multicêntricos como AssuntoRESUMO
BACKGROUND: The NICCI system (Getinge, Gothenburg, Sweden) is a new noninvasive haemodynamic monitoring system using a finger sensor. OBJECTIVES: We aimed to investigate the performance of the NICCI system to measure blood pressure and pulse pressure variation compared with intra-arterial measurements. DESIGN: A prospective method comparison study. SETTING: University Medical Center Hamburg-Eppendorf, Hamburg, Germany. PATIENTS: Forty-seven neurosurgery patients. MAIN OUTCOME MEASURES: We performed a method comparison study in 47 neurosurgery patients to compare NICCI blood pressure measurements (BP NICCI ) with intra-arterial blood pressure measurements (BP ART ) (Bland-Altman analysis, four-quadrant plot, error grid analysis) and NICCI pulse pressure variation measurements (PPV NICCI ) with pulse pressure variation calculated manually from the intra-arterial blood pressure waveform (PPV ART ) (Bland-Altman analysis, predictive agreement, Cohen's kappa). RESULTS: The mean of the differencesâ±âstandard deviation (95% limits of agreement) between BP NICCI and BP ART was 11â±â10âmmHg (-8 to 30âmmHg) for mean blood pressure (MBP), 3â±â12âmmHg (-21 to 26âmmHg) for systolic blood pressure (SBP) and 12â±â10âmmHg (-8 to 31âmmHg) for diastolic blood pressure (DBP). In error grid analysis, 54% of BP NICCI and BP ART MBP measurement pairs were classified as 'no risk', 43% as 'low risk', 3% as 'moderate risk' and 0% as 'significant risk' or 'dangerous risk'. The mean of the differences between PPV NICCI and PPV ART was 1â±â3% (-4 to 6%). The predictive agreement between PPV NICCI and PPV ART was 80% and Cohen's kappa was 0.55. CONCLUSIONS: The absolute agreement between BP NICCI and BP ART was not clinically acceptable. We recommend not using the current version of the NICCI system for blood pressure monitoring during surgery. The absolute agreement between PPV NICCI and PPV ART was clinically acceptable with moderate predictive agreement regarding pulse pressure variation categories. The NICCI system needs to be further developed and re-evaluated when an improved version is available. TRIAL REGISTRATION: The study was registered in the German Clinical Trials Register (DRKS00023188) on 2 October 2020.
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Neurocirurgia , Pressão Arterial/fisiologia , Pressão Sanguínea/fisiologia , Determinação da Pressão Arterial/métodos , Humanos , Monitorização Intraoperatória/métodosRESUMO
BACKGROUND: Hypotension during induction of anaesthesia is associated with organ injury. Continuous arterial pressure monitoring might help reduce hypotension. We tested the hypothesis that continuous intra-arterial compared with intermittent oscillometric arterial pressure monitoring reduces hypotension during induction of anaesthesia in noncardiac surgery patients. METHODS: In this single-centre randomised trial, 242 noncardiac surgery patients in whom intra-arterial arterial pressure monitoring was planned were randomised to unblinded continuous intra-arterial or to intermittent oscillometric arterial pressure monitoring (with blinded intra-arterial arterial pressure monitoring) during induction of anaesthesia. The primary endpoint was the area under a mean arterial pressure (MAP) of 65 mm Hg within the first 15 min of induction of anaesthesia. Secondary endpoints included areas under MAP values of 60, 50, and 40 mm Hg and durations of MAP values <65, <60, <50, and <40 mm Hg. RESULTS: There were 224 subjects available for analysis. The median (25th-75th percentile) area under a MAP of 65 mm Hg was 15 (2-36) mm Hg ⢠min in subjects assigned to continuous intra-arterial monitoring and 46 (7-111) mm Hg ⢠min in subjects assigned to intermittent oscillometric monitoring (P<0.001). Subjects assigned to continuous intra-arterial monitoring had smaller areas under MAP values of 60, 50, and 40 mm Hg and shorter durations of MAP values <65, <60, <50, and <40 mm Hg than subjects assigned to intermittent oscillometric monitoring. CONCLUSION: Continuous intra-arterial arterial pressure monitoring reduces hypotension during induction of anaesthesia compared with intermittent oscillometric arterial pressure monitoring in noncardiac surgery patients. In patients for whom an arterial catheter is planned, clinicians might therefore consider inserting the arterial catheter before rather than after induction of anaesthesia. CLINICAL TRIALS REGISTRATION: NCT04894019.
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Determinação da Pressão Arterial , Hipotensão , Anestesia Geral/efeitos adversos , Pressão Arterial , Humanos , Hipotensão/diagnóstico , Hipotensão/etiologia , Hipotensão/prevenção & controle , VigíliaRESUMO
BACKGROUND: The new noninvasive finger sensor system NICCI (Getinge; Gothenburg, Sweden) allows continuous cardiac output monitoring. We aimed to investigate its cardiac output measurement performance. OBJECTIVES: To investigate the NICCI system's cardiac output measurement performance. DESIGN: Prospective method comparison study. SETTING: University Medical Center Hamburg-Eppendorf, Hamburg, Germany. PATIENTS: Fifty-one patients after cardiac surgery. MAIN OUTCOME MEASURES: We performed a method comparison study in 51 patients after cardiac surgery to compare NICCI cardiac output (CO NICCI ) and NICCI cardiac output calibrated to pulmonary artery thermodilution cardiac output measurement (CO NICCI-CAL ) with pulmonary artery thermodilution cardiac output (CO PAT ). As a secondary analysis we also compared CNAP cardiac output (CO CNAP ) and externally calibrated CNAP cardiac output (CO CNAP-CAL ) with CO PAT . RESULTS: We analysed 299 cardiac output measurement pairs. The mean of the differences (95% limits of agreement) between CO NICCI and CO PAT was 0.6 (-1.8 to 3.1) l min -1 with a percentage error of 48%. The mean of the differences between CO NICCI-CAL and CO PAT was -0.4 (-1.9 to 1.1) l min -1 with a percentage error of 29%. The mean of the differences between CO CNAP and CO PAT was 1.0 (-1.8 to 3.8) l min -1 with a percentage error of 53%. The mean of the differences between CO CNAP-CAL and CO PAT was -0.2 (-2.0 to 1.6) l min -1 with a percentage error of 35%. CONCLUSION: The agreement between CO NICCI and CO PAT is not clinically acceptable. TRIAL REGISTRATION: The study was registered in the German Clinical Trial Register (DRKS00023189) after inclusion of the first patient on October 2, 2020.
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Procedimentos Cirúrgicos Cardíacos , Termodiluição , Débito Cardíaco , Procedimentos Cirúrgicos Cardíacos/métodos , Humanos , Monitorização Fisiológica/métodos , Reprodutibilidade dos Testes , Termodiluição/métodosRESUMO
It remains unknown whether chronic systemic inflammation is associated with impaired microvascular perfusion during surgery. We evaluated the association between the preoperative basal inflammatory state, measured by plasma soluble urokinase-type plasminogen activator receptor (suPAR) levels, and intraoperative sublingual microcirculatory variables in patients undergoing major non-cardiac surgery. Plasma suPAR levels were determined in 100 non-cardiac surgery patients using the suPARnostic® quick triage lateral flow assay. We assessed sublingual microcirculation before surgical incision and every 30 min during surgery using Sidestream Darkfield (SDF+) imaging and determined the De Backer score, the Consensus Proportion of Perfused Vessels (Consensus PPV), and the Consensus PPV (small). Elevated suPAR levels were associated with lower intraoperative De Backer score, Consensus PPV, and Consensus PPV (small). For each ng mL−1 increase in suPAR, De Backer score, Consensus PPV, and Consensus PPV (small) decreased by 0.7 mm−1, 2.5%, and 2.8%, respectively, compared to baseline. In contrast, CRP was not significantly correlated with De Backer score (r = −0.034, p = 0.36), Consensus PPV (r = −0.014, p = 0.72) or Consensus PPV Small (r = −0.037, p = 0.32). Postoperative De Backer score did not change significantly from baseline (5.95 ± 3.21 vs. 5.89 ± 3.36, p = 0.404), while postoperative Consensus PPV (83.49 ± 11.5 vs. 81.15 ± 11.8, p < 0.001) and Consensus PPV (small) (80.87 ± 13.4 vs. 78.72 ± 13, p < 0.001) decreased significantly from baseline. In conclusion, elevated preoperative suPAR levels were associated with intraoperative impairment of sublingual microvascular perfusion in patients undergoing elective major non-cardiac surgery.
RESUMO
BACKGROUND: Handheld vital microscopy allows direct observation of red blood cells within the sublingual microcirculation. Automated analysis allows quantifying microcirculatory tissue perfusion variables - including tissue red blood cell perfusion (tRBCp), a functional variable integrating microcirculatory convection and diffusion capacities. OBJECTIVE: We aimed to describe baseline microcirculatory tissue perfusion in patients presenting for elective noncardiac surgery and test that microcirculatory tissue perfusion is preserved during elective general anaesthesia for noncardiac surgery. DESIGN: Prospective observational study. SETTING: University Medical Center Hamburg-Eppendorf, Hamburg, Germany. PATIENTS: 120 elective noncardiac surgery patients (major abdominal, orthopaedic or trauma and minor urologic surgery) and 40 young healthy volunteers. MAIN OUTCOME MEASURES: We measured sublingual microcirculation using incident dark field imaging with automated analysis at baseline before induction of general anaesthesia, under general anaesthesia before surgical incision and every 30âmin during surgery. We used incident the dark field imaging technology with a validated automated analysis software. RESULTS: A total of 3687 microcirculation video sequences were analysed. Microcirculatory tissue perfusion variables varied substantially between individuals - but ranges were similar between patients and volunteers. Under general anaesthesia before surgical incision, there were no important changes in tRBCp, functional capillary density and capillary haematocrit compared with preinduction baseline. However, total vessel density was higher and red blood cell velocity and the proportion of perfused vessels were lower under general anaesthesia. There were no important changes in any microcirculatory tissue perfusion variables during surgery. CONCLUSION: In patients presenting for elective noncardiac surgery, baseline microcirculatory tissue perfusion variables vary substantially between individuals - but ranges are similar to those in young healthy volunteers. Microcirculatory tissue perfusion is preserved during general anaesthesia and noncardiac surgery - when macrocirculatory haemodynamics are maintained.
Assuntos
Ferida Cirúrgica , Anestesia Geral , Hemodinâmica/fisiologia , Humanos , Microcirculação/fisiologia , PerfusãoRESUMO
STUDY OBJECTIVE: Postinduction and intraoperative hypotension are associated with organ injury in non-cardiac surgery patients. Automated ambulatory blood pressure monitoring can identify chronic arterial hypertension and nocturnal blood pressure non-dipping. We tested the hypotheses that: a) chronic arterial hypertension and nocturnal non-dipping are independent risk factors for postinduction and intraoperative hypotension; and b) adding information on chronic arterial hypertension and nocturnal non-dipping improves hypotension prediction models based on readily available preoperative clinical information. DESIGN: Prediction model development based on a secondary analysis of a prospective observational study. SETTING: German university medical center. PATIENTS: 366 non-cardiac surgery patients who had preoperative automated ambulatory blood pressure monitoring. MEASUREMENTS: Multivariable analyses to identify risk factors for postinduction and intraoperative hypotension. Area under receiver operating characteristics curves (AUROC) and likelihood-ratio tests to test whether adding information on chronic arterial hypertension and nocturnal non-dipping improves hypotension prediction models based on readily available preoperative clinical information. MAIN RESULTS: Risk factors for postinduction hypotension were age in years (odds ratio: 1.06 (95% confidence interval: 1.03 to 1.10), P = 0.001), American Society of Anesthesiologists physical status class (1.85 (1.02 to 3.35), P = 0.043), preoperative use of angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers (15.19 (1.76 to 131.46), P = 0.013), chronic arterial hypertension (2.54 (1.49 to 4.34), P = 0.001), and nocturnal non-dipping (3.61 (2.09 to 6.23), P < 0.001). The model's AUROC was 0.76 (95% confidence interval: 0.71 to 0.81) with and 0.67 (0.62 to 0.73) without information on chronic arterial hypertension and nocturnal non-dipping (P < 0.001). Risk factors for intraoperative hypotension were male sex (1.73 (1.07 to 2.80), P = 0.025), chronic arterial hypertension (4.35 (2.33 to 8.14), P < 0.001), and nocturnal non-dipping (3.56 (2.07 to 6.11), P < 0.001). The model's AUROC was 0.76 (0.70 to 0.81) with and 0.63 (0.57 to 0.69) without information on chronic arterial hypertension and nocturnal non-dipping (P < 0.001). CONCLUSIONS: Chronic arterial hypertension and nocturnal non-dipping are independent risk factors for postinduction and intraoperative hypotension in non-cardiac surgery patients. Adding information on chronic arterial hypertension and nocturnal non-dipping moderately improved hypotension prediction models based on preoperative clinical information.