Effect of goal-directed haemodynamic therapy on postoperative complications in low-moderate risk surgical patients: a multicentre randomised controlled trial (FEDORA trial).

BACKGROUND: The aim of this study was to evaluate postoperative complications in patients having major elective surgery using oesophageal Doppler monitor-guided goal-directed haemodynamic therapy (GDHT), in which administration of fluids, inotropes, and vasopressors was guided by stroke volume, mean arterial pressure, and cardiac index. METHODS: The FEDORA trial was a prospective, multicentre, randomised, parallel-group, controlled patient- and observer-blind trial conducted in adults scheduled for major elective surgery. Randomization and allocation were carried out by a central computer system. In the control group, intraoperative fluids were given based on traditional principles. In the GDHT group, the intraoperative goals were to maintain a maximal stroke volume, with mean arterial pressure >70 mm Hg, and cardiac index ≥2.5 litres min-1 m-2. The primary outcome was percentage of patients with moderate or severe postoperative complications during the first 180 days after surgery. RESULTS: In total, 450 patients were randomized to the GDHT group (n=224) or control group (n=226). Data from 420 subjects were analysed. There were significantly fewer with complications in the GDHT group (8.6% vs 16.6%, P=0.018). There were also fewer complications (acute kidney disease, pulmonary oedema, respiratory distress syndrome, wound infections, etc.), and length of hospital stay was shorter in the GDHT group. There was no significant difference in mortality between groups. CONCLUSIONS: Oesophageal Doppler monitor-guided GDHT reduced postoperative complications and hospital length of stay in low-moderate risk patients undergoing intermediate risk surgery, with no difference in mortality at 180 days. CLINICAL TRIAL REGISTRATION: ISRCTN93543537.

A systematic review of sugammadex vs neostigmine for reversal of neuromuscular blockade.

We reviewed systematically sugammadex vs neostigmine for reversing neuromuscular blockade. We included 17 randomised controlled trials with 1553 participants. Sugammadex reduced all signs of residual postoperative paralysis, relative risk (95% CI) 0.46 (0.29-0.71), p = 0.0004 and minor respiratory events, relative risk (95% CI) 0.51 (0.32-0.80), p = 0.0034. There was no difference in critical respiratory events, relative risk (95% CI) 0.13 (0.02-1.06), p = 0.06. Sugammadex reduced drug-related side-effects, relative risk (95% CI) 0.72 (0.54-0.95), p = 0.02. There was no difference in the rate of postoperative nausea or the rate of postoperative vomiting, relative risk (95% CI) 0.94 (0.79-1.13), p = 0.53, and 0.87 (0.65-1.17), p = 0.36 respectively.

Management of peri-surgical anemia in elective surgery. Conclusions and recommendations according to Delphi-UCLA methodology.

INTRODUCTION: Preoperative anemia affects approximately one third of surgical patients. It increases the risk of blood transfusion and influences short- and medium-term functional outcomes, increases comorbidities, complications and costs. The "Patient Blood Management" (PBM) programs, for integrated and multidisciplinary management of patients, are considered as paradigms of quality care and have as one of the fundamental objectives to correct perioperative anemia. PBM has been incorporated into the schemes for intensified recovery of surgical patients: the recent Enhanced Recovery After Surgery 2021 pathway (in Spanish RICA 2021) includes almost 30 indirect recommendations for PBM. OBJECTIVE: To make a consensus document with RAND/UCLA Delphi methodology to increase the penetration and priority of the RICA 2021 recommendations on PBM in daily clinical practice. MATERIAL AND METHODS: A coordinating group composed of 6 specialists from Hematology-Hemotherapy, Anesthesiology and Internal Medicine with expertise in anemia and PBM was formed. A survey was elaborated using Delphi RAND/UCLA methodology to reach a consensus on the key areas and priority professional actions to be developed at the present time to improve the management of perioperative anemia. The survey questions were extracted from the PBM recommendations contained in the RICA 2021 pathway. The development of the electronic survey (Google Platform) and the management of the responses was the responsibility of an expert in quality of care and clinical safety. Participants were selected by invitation from speakers at AWGE-GIEMSA scientific meetings and national representatives of PBM-related working groups (Seville Document, SEDAR HTF section and RICA 2021 pathway participants). In the first round of the survey, the anonymized online questionnaire had 28 questions: 20 of them were about PBM concepts included in ERAS guidelines (2 about general PBM organization, 10 on diagnosis and treatment of preoperative anemia, 3 on management of postoperative anemia, 5 on transfusion criteria) and 8 on pending aspects of research. Responses were organized according to a 10-point Likter scale (0: strongly disagree to 10: strongly agree). Any additional contributions that the participants considered appropriate were allowed. They were considered consensual because all the questions obtained an average score of more than 9 points, except one (question 14). The second round of the survey consisted of 37 questions, resulting from the reformulation of the questions of the first round and the incorporation of the participants' comments. It consisted of 2 questions about general organization of PBM programme, 15 questions on the diagnosis and treatment of preoperative anemia; 3 on the management of postoperative anemia, 6 on transfusional criteria and finally 11 questions on aspects pending od future investigations. Statistical treatment: tabulation of mean, median and interquartiles 25-75 of the value of each survey question (Tables 1, 2 and 3). RESULTS: Except for one, all the recommendations were accepted. Except for three, all above 8, and most with an average score of 9 or higher. They are grouped into: 1.- "It is important and necessary to detect and etiologically diagnose any preoperative anemia state in ALL patients who are candidates for surgical procedures with potential bleeding risk, including pregnant patients". 2.- "The preoperative treatment of anemia should be initiated sufficiently in advance and with all the necessary hematinic contributions to correct this condition". 3.- "There is NO justification for transfusing any unit of packed red blood cells preoperatively in stable patients with moderate anemia Hb 8-10g/dL who are candidates for potentially bleeding surgery that cannot be delayed." 4.- "It is recommended to universalize restrictive criteria for red blood cell transfusion in surgical and obstetric patients." 5.- "Postoperative anemia should be treated to improve postoperative results and accelerate postoperative recovery in the short and medium term". CONCLUSIONS: There was a large consensus, with maximum acceptance,strong level of evidence and high recommendation in most of the questions asked. Our work helps to identify initiatives and performances who can be suitables for the implementation of PBM programs at each hospital and for all patients.

Perioperative colloids: From theory to practice.

INTRODUCTION: Fluid administration is the cornerstone in hypovolemic patient's reanimation. Clinical guidelines restrict colloid administration favouring crystalloids. Currently, we don't know exactly which is the daily clinical practice during the perioperative period. The objective of this study is to describe perioperative use of colloids analysing possible reasons aiming to use them. MATERIAL AND METHODS: Prospective, cross-section, national, multicentre observational study. Fluid Day sub-study. We enrolled all patient's older than 18 years old who underwent surgery during the 24 h of the 2-days study (February, 2019, 18th and 20th). We registered demographic data, comorbidities, anaesthetic and surgical procedure data, fluids administered, perioperative bleeding and monitoring type used during the perioperative period. RESULTS: A total of 5928 cases were analysed and 542 patients (9.1%) received any type of colloids, being hydroxiethyl-starch the most frequently used (5.1%). Patients receiving colloids suffered more longing surgery (150 [90-255] vs. 75 [45-120] min), were urgently operated (13.7 vs. 7.5%) and were more frequent classified as high risk (22 vs. 4.8%). Their recovery was mostly in critical care units (45.1 vs.15.8%). Patients with bleeding less than 500 ml received colloids in a percentage of 5.9 versus 45.9% when this figure was overcome. Patients who received colloids were anaemic more frequently: 29.4 vs. 16.3%. Colloids administration had a higher risk for transfusion (OR 15.7). Advanced monitoring also increased the risk for receiving colloids (OR 9.43). CONCLUSIONS: In our environment with routine clinical practice, colloids administration is limited and close linked to perioperative bleeding.

Postoperative arterial hypotension: the unnoticed enemy.

Postoperative hypotension is a frequently underestimated health problem associated with high morbidity and mortality and increased use of health care resources. It also poses significant clinical, technological, and human challenges for healthcare. As it is a modifiable and avoidable risk factor, this document aims to increase its visibility, defining its clinical impact and the technological challenges involved in optimizing its management, taking clinical-technological, humanistic, and economic aspects into account.

Fluid challenges in operating room: A planned sub study of the Fluid Day observational study.

BACKGROUND: Intraoperative fluid administration is a ubiquitous intervention in surgical patients. But inadequate fluid administration may lead to poor postoperative outcomes. Fluid challenges (FCs), in or outside the so-called goal-directed fluid therapy, allows testing the cardiovascular system and the need for further fluid administration. Our primary aim was to evaluate how anesthesiologists conduct FCs in the operating room in terms of type, volume, variables used to trigger a FC and to compare the proportion of patients receiving further fluid administration based on the response to the FC. METHODS: This was a planned substudy of an observational study conducted in 131 centres in Spain in patients undergoing surgery. RESULTS: A total of 396 patients were enrolled and analysed in the study. The median [interquartile range] amount of fluid given during a FC was 250ml (200-400). The main indication for FC was a decrease in systolic arterial pressure in 246 cases (62.2%). The second was a decrease in mean arterial pressure (54.4%). Cardiac output was used in 30 patients (7.58%), while stroke volume variation in 29 of 385 cases (7.32%). The response to the initial FC did not have an impact when prescribing further fluid administration. CONCLUSIONS: The current indication and evaluation of FC in surgical patients is highly variable. Prediction of fluid responsiveness is not routinely used, and inappropriate variables are frequently evaluated for assessing the hemodynamic response to FC, which may result in deleterious effects.

A critical review of the perioperative fluid therapy and hemodynamic monitoring recommendations of the Enhanced Recovery of the Adult Pathway (RICA): A position statement of the fluid therapy and hemodynamic monitoring Subcommittee of the Hemostasis, Transfusion Medicine and Fluid Therapy Section (SHTF) of the Spanish Society of Anesthesiology and Critical Care (SEDAR).

In an effort to standardize perioperative management and improve postoperative outcomes of adult patients undergoing surgery, the Ministry of Health, through the Spanish Multimodal Rehabilitation Group (GERM), and the Aragonese Institute of Health Sciences, in collaboration with multiple Spanish scientific societies and based on the available evidence, published in 2021 the Spanish Intensified Adult Recovery (RICA) guideline. This document includes 12 perioperative measures related to fluid therapy and hemodynamic monitoring. Fluid administration and hemodynamic monitoring are not straightforward but are directly related to postoperative patient outcomes. The Fluid Therapy and Hemodynamic Monitoring Subcommittee of the Hemostasis, Transfusion Medicine and Fluid Therapy Section (SHTF) of the Spanish Society of Anesthesiology and Critical Care (SEDAR) has reviewed these recommendations and concluded that they should be revised as they do not follow an adequate methodology.

Research priorities in perioperative fluid therapy and hemodynamic monitoring: A Delphi Consensus Survey from the Fluid Therapy and Hemodynamic Monitoring Subcommittee of the Hemostasis, Transfusion Medicine and Fluid Therapy Section (SHTF) of the Spanish Society of Anesthesiology and Critical Care (SEDAR).

BACKGROUND: Research in fluid therapy and perioperative hemodynamic monitoring is difficult and expensive. The objectives of this study were to summarize these topics and to prioritize these topics in order of research importance. METHODS: Electronic structured Delphi questionnaire over three rounds among 30 experts in fluid therapy and hemodynamic monitoring identified through the Fluid Therapy and Hemodynamic Monitoring Subcommittee of the Hemostasis, Transfusion Medicine and Fluid Therapy Section of the Spanish Society of Anesthesiology and Critical Care. RESULTS: 77 topics were identified and ranked in order of prioritization. Topics were categorized into themes of crystalloids, colloids, hemodynamic monitoring and others. 31 topics were ranked as essential research priority. To determine whether intraoperative hemodynamic optimization algorithms based on the invasive or noninvasive Hypotension Prediction Index versus other management strategies could decrease the incidence of postoperative complications. As well as whether the use of renal stress biomarkers together with a goal-directed fluid therapy protocol could reduce hospital stay and the incidence of acute kidney injury in adult patients undergoing non-cardiac surgery, reached the highest consensus. CONCLUSIONS: The Fluid Therapy and Hemodynamic Monitoring Subcommittee of the Hemostasis, Transfusion Medicine and Fluid Therapy Section of the Spanish Society of Anesthesiology and Critical Care will use these results to carry out the research.

Association between preoperative baseline pulse pressure and estimated pulse wave velocity and acute renal failure and mortality following colorectal surgery. A single-centre observational study. / Asociación entre la presión de pulso y la velocidad onda pulso estimada basal preoperatoria con las complicaciones postoperatorias, insuficiencia renal aguda y mortalidad tras cirugía colorrectal. Estudio unicéntrico observacional.

BACKGROUND: Elevated pulse wave velocity is a haemodynamic parameter considered to be a risk factor for the development of cardiovascular alterations, while pulse pressure is a predictor of cardiovascular complications and development of acute renal failure after both cardiac and non-cardiac surgery. Our objective was to determine whether baseline pulse pressure and estimated pulse wave velocity are associated with renal failure and 30-day mortality following colorectal surgery. METHODS: Retrospective observational study. A total of 816 adult patients undergoing elective colorectal surgery were evaluated by performing multivariable logistic regression analysis to determine whether baseline pulse pressure and estimated pulse wave velocity were independently associated with complications, specifically renal failure and 30-day postoperative mortality, and whether pulse pressure and estimated pulse wave velocity thresholds correlated with outcomes. RESULTS: Baseline pulse pressure was 56.00mmHg (45.00;68.00) and estimated pulse wave velocity was 13.16m/s (10.76;14.85). Baseline pulse pressure was not associated with acute renal failure or mortality in the univariate model. Baseline estimated pulse wave velocity was not associated with complications, acute renal failure, or mortality. An estimated pulse wave velocity of 13.78m/s significantly predicted acute renal failure (AUC 0.654 [0.588-0.720]) and mortality (AUC 0.698 [0.600-0.796]). CONCLUSIONS: Neither pulse pressure nor preoperative baseline estimated pulse wave velocity were associated with acute renal failure or postoperative mortality. The preoperative estimated pulse wave velocity threshold of 13.78m/s predicted an increased risk of acute renal failure and postoperative mortality.

Association between preoperative baseline pulse pressure and estimated pulse wave velocity and acute renal failure and mortality following colorectal surgery. A single-centre observational study.

BACKGROUND: Elevated pulse wave velocity is a haemodynamic parameter considered to be a risk factor for the development of cardiovascular alterations, while pulse pressure is a predictor of cardiovascular complications and development of acute renal failure after both cardiac and non-cardiac surgery. Our objective was to determine whether baseline pulse pressure and estimated pulse wave velocity are associated with renal failure and 30-day mortality following colorectal surgery. METHODS: Retrospective observational study. A total of 816 adult patients undergoing elective colorectal surgery were evaluated by performing multivariable logistic regression analysis to determine whether baseline pulse pressure and estimated pulse wave velocity were independently associated with complications, specifically renal failure and 30-day postoperative mortality, and whether pulse pressure and estimated pulse wave velocity thresholds correlated with outcomes. RESULTS: Baseline pulse pressure was 56.00 mmHg (45.00;68.00) and estimated pulse wave velocity was 13.16 m/s (10.76;14.85). Baseline pulse pressure was not associated with acute renal failure or mortality in the univariate model. Baseline estimated pulse wave velocity was not associated with complications, acute renal failure, or mortality. An estimated pulse wave velocity of 13.78 m/s significantly predicted acute renal failure (AUC 0.654 [0.588-0.720]) and mortality (AUC 0.698 [0.600-0.796]). CONCLUSIONS: Neither pulse pressure nor preoperative baseline estimated pulse wave velocity were associated with acute renal failure or postoperative mortality. The preoperative estimated pulse wave velocity threshold of 13.78 m/s predicted an increased risk of acute renal failure and postoperative mortality.

Intraoperative crystalloid utilization variability and association with postoperative outcomes: A post hoc analysis of two multicenter prospective cohort studies.

BACKGROUND: The optimal regimen for intravenous administration of intraoperative fluids remains unclear. Our goal was to analyze intraoperative crystalloid volume administration practices and their association with postoperative outcomes. METHODS: We extracted clinical data from two multicenter observational studies including adult patients undergoing colorectal surgery and total hip (THA) and knee arthroplasty (TKA). We analyzed the distribution of intraoperative fluid administration. Regression was performed using a general linear model to determine factors predictive of fluid administration. Patient outcomes and intraoperative crystalloid utilization were summarized for each surgical cohort. Regression models were developed to evaluate associations of high or low intraoperative crystalloid with the likelihood of increased postoperative complications, mainly acute kidney injury (AKI) and hospital length of stay (LOS). RESULTS: 7580 patients were included. The average adjusted intraoperative crystalloid infusion rate across all surgeries was to 7.9 (SD 4) mL/kg/h. The regression model strongly favored the type of surgery over other patient predictors. We found that high fluid volume was associated with 40% greater odds ratio (OR 1.40; 95% confidence interval 1.01-1.95, p = 0.044) of postoperative complications in patients undergoing THA, while we found no associations for the other types of surgeries, AKI and LOS CONCLUSIONS: A wide variability was observed in intraoperative crystalloid volume administration; however, this did not affect postoperative outcomes.

Patient Blood Management for primary hip and knee replacement. A survey among POWER.2 study researchers. / Patient Blood Management en artroplastia primaria de cadera y rodilla. Encuesta entre los investigadores del estudio POWER.2.

BACKGROUND: Implementation of Patient Blood Management programs remain variable in Europe, and even in centres with well-established PBM programs variability exists in transfusion practices. OBJECTIVES AND METHODS: We conducted a survey in order to assess current practice in perioperative Patient Blood Management in patients undergoing total hip and knee replacement among researchers involved in POWER.2 Study in Spain (an observational prospective study evaluating enhanced recovery pathways in orthopaedic surgery). RESULTS: A total of 322 responses were obtained (37.8%). Half of responders check Haemoglobin levels in patients at least 4 weeks before surgery; 35% treat all anaemic patients, although 99.7% consider detection and treatment of preoperative anaemia could influence the postoperative outcomes. Lack of infrastructure (76%) and lack of time (51%) are the main stated reasons not to treat anaemic patients. Iron status is routinely checked by 19% before surgery, and 36% evaluate it solely in the anaemic patient. Hb<9.9 g/dl is the threshold to delay surgery for 61% of clinicians, and 22% would consider transfusing preoperatively clinically stable patients without active bleeding. The threshold to transfuse patients without cardiovascular disease is 8 g/dl for 43%, and 7 g/dl for 34% of the responders; 75% of clinicians consider they use "restrictive thresholds", and 90% follow the single unit transfusion policy. CONCLUSIONS: The results of our survey show variability in clinical practice in Patient Blood Management in major orthopaedic surgery, despite being the surgery with the greatest tradition in these programs.

Postoperative Outcomes Within an Enhanced Recovery after surgery protocol in gastric surgery for cancer (POWER.4): Study protocol for a prospective, multicentre, observational cohort study. / Auditoría nacional de complicaciones después de la cirugía gástrica por cáncer dentro o no de un protocolo de recuperación intensificada (POWER.4): Protocolo de un estudio prospectivo, multicéntrico, observacional de cohortes.

BACKGROUND AND OBJECTIVE: Enhanced recovery pathways or ERAS have been applied in gastric cancer surgery extrapolated from colorectal surgery. The objective of the study is to assess postoperative complications 30 days after gastric surgery for cancer, with any level of compliance with the ERAS protocol. The secondary objectives are to assess 30-day mortality, the relationship between adherence to the ERAS protocol and complications, the impact of each of the items of the protocol on postoperative complications and hospital stay, and to describe the impact of complications on length of hospital stay. MATERIALS AND METHODS: Multicenter, observational, prospective study including all consecutive patients undergoing scheduled gastric cancer surgery, over a period of 3 months, with a 30-day follow-up at participating centers, with any level of compliance with the protocol. RESULTS: The approval of the Comité Autonómico de Ética de la Investigación de Aragón has been obtained (C.P. - C.I. PI19 / 106, 27 th March 2019). POWER.4 was registered at www.clinicaltrials.gov on March 7, 2019 (NCT03865810). CONCLUSIONS: The data as a whole will be published in peer-reviewed journals. The data will not be made public by identifying each participating center. It is expected that the results of this study will identify potential areas for improvement in which more targeted research is needed.

Clinical practice guideline. Unintentional perioperative hypothermia. / Guía de práctica clínica de hipotermia perioperatoria no intencionada.

The importance of the safety of our patients in the surgical theatre, has driven many projects. The majority of them aimed at better control and clinical performance; mainly of the variables that intervene or modulate the results of surgical procedures, and have a direct relationship with them. The Spanish Society of Anesthesiology, Critical Care and Therapeutic Pain (SEDAR), maintains a constant concern for a variable that clearly determines the outcomes of our clinical processes, "unintentional hypothermia" that develops in all patients undergoing an anesthetic or surgical procedure. SEDAR has promoted, in collaboration with other scientific Societies and patient Associations, the elaboration of this clinical practice guideline, which aims to answer clinical questions not yet resolved and for which, up to now, there are no documents based in the best scientific evidence available. With GRADE methodology and technical assistance from the Ibero-American Cochrane Collaboration office, this clinical practice guideline presents three recommendations (weak in favor) for active heating methods for the prevention of hypothermia (skin, fluid or gas); three for the prioritization of strategies for the prevention of hypothermia (too weak in favor and one strongly in favor); two of preheating strategies prior to anesthetic induction (both weak in favor); and two for research.

Monitoring of nociception, reality or fiction? / Monitorización de la nocicepción, ¿realidad o ficción?

There are currently various projects underway that attempt to monitor the nociceptive responses caused by surgical stress and ensure patients the best analgesic conditions. The systemic response to surgical stress has repercussions in the postoperative period, such as worse pain control, delayed recovery, greater complications, longer stay in resuscitation and hospital units, and increased healthcare costs. However, treatment with higher doses of opioids than necessary may lead to slower awakening, increased drowsiness and adverse effects, as well as situations of postoperative opioid-induced hyperalgesia. There are 2 large groups of nociceptive monitoring according to the origin of the theoretical objective of monitoring response to the stimulus, that may derive from changes in the electroencephalogram or the response of the autonomic nervous system.

Goal directed hemodynamic therapy based in esophageal Doppler flow parameters: A systematic review, meta-analysis and trial sequential analysis. / Terapia hemodinámica guiada por objetivos basada en parámetros de flujo con Doppler esofágico: revisión sistemática, metaanálisis y análisis secuencial de ensayos.

BACKGROUND: Numerous studies have compared perioperative esophageal doppler monitoring (EDM) guided intravascular volume replacement strategies with conventional clinical volume replacement in surgical patients. The use of the EDM within hemodynamic algorithms is called 'goal directed hemodynamic therapy' (GDHT). METHODS: Meta-analysis of the effects of EDM guided GDHT in adult non-cardiac surgery on postoperative complications and mortality using PRISMA methodology. A systematic search was performed in Medline, PubMed, EMBASE, and the Cochrane Library (last update, March 2015). INCLUSION CRITERIA: Randomized clinical trials (RCTs) in which perioperative GDHT was compared to other fluid management. PRIMARY OUTCOMES: Overall complications. SECONDARY OUTCOMES: Mortality; number of patients with complications; cardiac, renal and infectious complications; incidence of ileus. Studies were subjected to quantifiable analysis, pre-defined subgroup analysis (stratified by surgery, type of comparator and risk); pre-defined sensitivity analysis and trial sequential analysis (TSA). RESULTS: Fifty six RCTs were initially identified, 15 fulfilling the inclusion criteria, including 1,368 patients. A significant reduction was observed in overall complications associated with GDHT compared to other fluid therapy (RR=0.75; 95%CI: 0.63-0.89; P=0.0009) in colorectal, urological and high-risk surgery compared to conventional fluid therapy. No differences were found in secondary outcomes, neither in other subgroups. The impact on preventing the development of complications in patients using EDM is high, causing a relative risk reduction (RRR) of 50% for a number needed to treat (NNT)=6. CONCLUSIONS: GDHT guided by EDM decreases postoperative complications, especially in patients undergoing colorectal surgery and high-risk surgery. However, no differences versus restrictive fluid therapy and in intermediate-risk patients were found.