ABSTRACT
OBJECTIVE: To prospectively assess the construct and criterion validity of ClassIntra version 1.0, a newly developed classification for assessing intraoperative adverse events. DESIGN: International, multicentre cohort study. SETTING: 18 secondary and tertiary centres from 12 countries in Europe, Oceania, and North America. PARTICIPANTS: The cohort study included a representative sample of 2520 patients in hospital having any type of surgery, followed up until discharge. A follow-up to assess mortality at 30 days was performed in 2372 patients (94%). A survey was sent to a representative sample of 163 surgeons and anaesthetists from participating centres. MAIN OUTCOME MEASURES: Intraoperative complications were assessed according to ClassIntra. Postoperative complications were assessed daily until discharge from hospital with the Clavien-Dindo classification. The primary endpoint was construct validity by investigating the risk adjusted association between the most severe intraoperative and postoperative complications, measured in a multivariable hierarchical proportional odds model. For criterion validity, inter-rater reliability was evaluated in a survey of 10 fictitious case scenarios describing intraoperative complications. RESULTS: Of 2520 patients enrolled, 610 (24%) experienced at least one intraoperative adverse event and 838 (33%) at least one postoperative complication. Multivariable analysis showed a gradual increase in risk for a more severe postoperative complication with increasing grade of ClassIntra: ClassIntra grade I versus grade 0, odds ratio 0.99 (95% confidence interval 0.69 to 1.42); grade II versus grade 0, 1.39 (0.97 to 2.00); grade III versus grade 0, 2.62 (1.31 to 5.26); and grade IV versus grade 0, 3.81 (1.19 to 12.2). ClassIntra showed high criterion validity with an intraclass correlation coefficient of 0.76 (95% confidence interval 0.59 to 0.91) in the survey (response rate 83%). CONCLUSIONS: ClassIntra is the first prospectively validated classification for assessing intraoperative adverse events in a standardised way, linking them to postoperative complications with the well established Clavien-Dindo classification. ClassIntra can be incorporated into routine practice in perioperative surgical safety checklists, or used as a monitoring and outcome reporting tool for different surgical disciplines. Future studies should investigate whether the tool is useful to stratify patients to the appropriate postoperative care, to enhance the quality of surgical interventions, and to improve long term outcomes of surgical patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT03009929.
Subject(s)
Intraoperative Complications/classification , Postoperative Complications/classification , Surgical Procedures, Operative/adverse effects , Adolescent , Adult , Aged , Aged, 80 and over , Case-Control Studies , Child , Child, Preschool , Female , Humans , Intraoperative Complications/epidemiology , Male , Middle Aged , Postoperative Complications/epidemiology , Prospective Studies , Reproducibility of Results , Surgical Procedures, Operative/statistics & numerical data , Surveys and Questionnaires , Young AdultABSTRACT
BACKGROUND: Recent research has questioned restrictive transfusion policies in vulnerable elderly populations. Our audit assesses the prevalence and postoperative outcomes of extremely elderly patients undergoing the stress of surgery with perioperative hemoglobin (Hb) less than 9 g/dL. STUDY DESIGN AND METHODS: This retrospective analysis of prospectively collected data addressed patients aged 85+ undergoing elective surgery. Demographic data and baseline characteristics were recorded, as well as Hb and transfused red blood cell (RBC) units. The main endpoint was the prevalence of perioperative Hb less than 9 g/dL, that is, patients with baseline Hb <9 g/dL without preoperative transfusions (defined as Group A). Patients with perioperative Hb of 9 g/dL or greater (with or without transfusion) were designated as Group B. Secondary outcomes included morbidity, length of hospital stay, and mortality 30 days and 6 months after surgery. A bivariate analysis was performed followed by logistic regression to determine whether undergoing the stress of surgery with perioperative Hb less than 9 g/dL was an independent risk factor for postoperative outcomes. RESULTS: A total of 148 patients were included. The prevalence of perioperative Hb less than 9 g/dL was 25%. It was associated with increased morbidity and mortality -both 30 days and 6 months after surgery- and a prolonged length of hospital stay. Anemia-associated complications were higher among patients from Group A, whereas transfusion-associated ones were evenly distributed. In all the regression models, perioperative Hb less than 9 g/dL was an independent risk factor for worse postoperative outcomes. CONCLUSION: Perioperative Hb less than 9 g/dL was common among patients aged 85+, and it was associated with increased risk of adverse postoperative outcomes. The tolerance to anemia might decrease perioperatively when Hb is less than 9 g/dL. Thus, less restrictive thresholds deserve further evaluation.
Subject(s)
Aging/physiology , Blood Transfusion/standards , Age Factors , Aged, 80 and over , Aging/blood , Blood Transfusion/methods , Blood Transfusion/statistics & numerical data , Calibration , Clinical Audit , Elective Surgical Procedures/methods , Elective Surgical Procedures/mortality , Elective Surgical Procedures/standards , Elective Surgical Procedures/statistics & numerical data , Erythrocyte Transfusion/adverse effects , Female , Humans , Length of Stay , Male , Morbidity , Postoperative Hemorrhage/epidemiology , Postoperative Hemorrhage/mortality , Postoperative Hemorrhage/therapy , Retrospective Studies , Risk Factors , Survival Analysis , Transfusion Reaction/epidemiology , Transfusion Reaction/mortality , Transfusion Reaction/prevention & control , Vulnerable PopulationsABSTRACT
BACKGROUND: Preoperative risk and postoperative outcomes among the elderly are the subject of extensive debate. However, the eldest old, that is, the fastest-growing and most vulnerable group, are insufficiently studied; even their mortality rate is unclear. This prospective observational study was performed with the aim of determining the mortality rate of this population and establishing which preoperative conditions were predictors of which postoperative outcomes. The study was undertaken between 2011 and 2015 in a major tertiary care university hospital. METHODS: All patients aged ≥85 years undergoing any elective procedure during the study period were included. Patients were followed up for 30 days postoperatively.The preoperative conditions studied were demographic data, grade of surgical complexity (1-3), preoperative comorbidities, and some characteristically geriatric conditions (functional reserve, nutrition, cognitive status, polypharmacy, dependency, and frailty). The outcome measures were 30-day all-cause mortality (primary end point), morbidity, prolonged length of stay, and escalation of care in living conditions. RESULTS: Of 139 eligible patients, 127 completed follow-up. The 30-day mortality was 7.9%; 95% confidence interval (CI), 3.2-12.6. It had 3 predictors: malnutrition (odds ratio [OR], 15; 95% CI, 3-89), complexity 3 (OR, 9.1; CI, 2-52), and osteoporosis/osteoporotic fractures (OR, 14.7; CI, 2-126). Significant predictors for morbidity (40%) were ischemic heart disease (OR, 3.9; CI, 1-11) and complexity 3 (OR, 3.6; CI, 2-9), while a nonfrail phenotype (OR, 0.3; CI, 0.1-0.8) was found to be protective. Only 2 factors were found to be predictive of longer admissions, namely complexity 3 (OR, 4.4; CI, 2-10) and frailty (OR, 2.7; CI, 2-7). Finally, risk factors for escalation of care in living conditions were slow gait (a surrogate for frailty, OR, 2.5; CI, 1-6), complexity 3 (OR, 3.2; CI, 1-7), and hypertension (OR, 2.9; CI, 1-9). CONCLUSIONS: The eldest old is a distinct group with a considerable mortality rate and their own particular risk factors. Surgical complexity and certain geriatric variables (malnutrition and frailty), which are overlooked in American Society of Anesthesiologists and most other usual scores, are particularly relevant in this population. Inclusion of these factors along with appropriate comorbidities for risk stratification should guide better decision making for families and doctors alike and encourage preoperative optimization of patients.
Subject(s)
Elective Surgical Procedures/mortality , Elective Surgical Procedures/trends , Frail Elderly , Geriatric Assessment/methods , Preoperative Care/mortality , Preoperative Care/trends , Aged, 80 and over , Elective Surgical Procedures/adverse effects , Female , Humans , Male , Mortality/trends , Preoperative Care/methods , Prospective Studies , Risk FactorsABSTRACT
Se comparará la cardiotoxicidad de tres anestésicos locales: dos altamente difundidos, Bupivacaína y Lidocaína, y un nuevo anestésico local por aparecer en el mercado argentino: Ropivacaína. Esta es una aminoamida cuyo perfil anestésico es similar a la Bupivacaína, en su pKa, unión a proteínas, pero con una liposubilidad intermedia entre Bupivacaína y Lidocaína (es 2 a 3 veces menos liposoluble que la Bupivacaína). Para su uso correcto es necesario conocer la influencia de las variables Farmacocinéticas y Farmacodinámicas en el desarrollo de toxicidad.
Subject(s)
Humans , Male , Female , Pregnancy , Infant, Newborn , Adult , Aged , Anesthetics, Local/pharmacokinetics , Anesthetics, Local/pharmacology , Anesthetics, Local/toxicity , Bupivacaine/administration & dosage , Bupivacaine/toxicity , Heart Conduction System/drug effects , Lidocaine/administration & dosage , Lidocaine/toxicity , Clonidine/therapeutic use , Hypotension , Phenylephrine/therapeutic use , Homeopathic Dosage , Risk FactorsABSTRACT
Se comparará la cardiotoxicidad de tres anestésicos locales: dos altamente difundidos, Bupivacaína y Lidocaína, y un nuevo anestésico local por aparecer en el mercado argentino: Ropivacaína. Esta es una aminoamida cuyo perfil anestésico es similar a la Bupivacaína, en su pKa, unión a proteínas, pero con una liposubilidad intermedia entre Bupivacaína y Lidocaína (es 2 a 3 veces menos liposoluble que la Bupivacaína). Para su uso correcto es necesario conocer la influencia de las variables Farmacocinéticas y Farmacodinámicas en el desarrollo de toxicidad.(AU)