ABSTRACT
BACKGROUND: Unfractionated heparin is administered in patients undergoing veno-arterial extracorporeal membrane oxygenation (VA-ECMO). Anticoagulation monitoring is recommended, with an anti-activated factor X (anti-Xa) targeting 0.3 to 0.7 IU/mL. Owing to heparin's heterogeneous pharmacokinetic properties, anti-Xa is unpredictable, generating a challenge in anticoagulation practices. The aim of this study was to build a pharmacokinetic model of heparin accounting for potential confounders, and derive an optimized dosing regimen for a given anti-Xa target. METHODS: Adult patients undergoing VA-ECMO were included between January 2020 and June 2021. Anticoagulation was managed with an initial 100 IU/kg heparin loading dose followed by a continuous infusion targeting 0.2 to 0.7 IU/mL anti-Xa. The data were split into model development and model validation cohorts. Statistical analysis was performed using a nonlinear mixed effects modeling population approach. Model-based simulations were performed to develop an optimized dosing regimen targeting the desired anti-Xa. RESULTS: A total of 74 patients were included, with 1703 anti-Xa observations. A single-compartment model best fitted the data. Interpatient variability for distribution volume was best explained by body weight, C-reactive protein and ECMO indication (post-cardiotomy shock or medical cardiogenic shock), and interpatient variability for elimination clearance was best explained by serum creatinine and C-reactive protein. Simulations using the optimized regimen according to these covariates showed accurate anti-Xa target attainment. CONCLUSION: In adult patients on VA-ECMO, heparin's effect increased with serum creatinine and medical indication, whereas it decreased with body weight and systemic inflammation. We propose an optimized dosing regimen accounting for key covariates, capable of accurately predicting a given anti-Xa target.
ABSTRACT
BACKGROUND: Preventive anesthetic impact on the high rates of postoperative neurocognitive disorders in elderly patients is debated. The Prevention of postOperative Cognitive dysfunction by Ketamine (POCK) study aimed to assess the effect of ketamine on this condition. METHODS: This is a multicenter, randomized, double-blind, interventional study. Patients ≥60 years undergoing major orthopedic surgery were randomly assigned in a 1:1 ratio to receive preoperative ketamine 0.5 mg/kg as an intravenous bolus (n = 152) or placebo (n = 149) in random blocks stratified according to the study site, preoperative cognitive status and age. The primary outcome was the proportion of objective delayed neurocognitive recovery (dNR) defined as a decline of one or more neuropsychological assessment standard deviations on postoperative day 7. Secondary outcomes included a three-month incidence of objective postoperative neurocognitive disorder (POND), as well as delirium, anxiety, and symptoms of depression seven days and three months after surgery. RESULTS: Among 301 patients included, 292 (97%) completed the trial. Objective dNR occurred in 50 (38.8%) patients in the ketamine group and 54 (40.9%) patients in the placebo group (OR [95% CI] 0.92 [0.56; 1.51], p = 0.73) on postoperative day 7. Incidence of objective POND three months after surgery did not differ significantly between the two groups nor did incidence of delirium, anxiety, apathy, and fatigue. Symptoms of depression were less frequent in the ketamine group three months after surgery (OR [95% CI] 0.34 [0.13-0.86]). CONCLUSIONS: A single preoperative bolus of intravenous ketamine does not prevent the occurrence of dNR or POND in elderly patients scheduled for major orthopedic surgery. (Clinicaltrials.gov NCT02892916).
Subject(s)
Ketamine , Orthopedic Procedures , Postoperative Cognitive Complications , Preoperative Care , Humans , Ketamine/administration & dosage , Ketamine/therapeutic use , Double-Blind Method , Aged , Male , Female , Orthopedic Procedures/adverse effects , Postoperative Cognitive Complications/prevention & control , Preoperative Care/methods , Middle Aged , Aged, 80 and over , Postoperative Complications/prevention & control , Postoperative Complications/epidemiology , Neurocognitive Disorders/prevention & control , Neuropsychological Tests , Delirium/prevention & controlABSTRACT
BACKGROUND: Postoperative pulmonary complications is a major issue that affects outcomes of surgical patients. The hypothesis was that the intraoperative ventilation parameters are associated with occurrence of postoperative pulmonary complications. METHODS: A single-center retrospective cohort study was conducted at the Lille University Hospital, France. The study included 33,701 adults undergoing noncardiac, nonthoracic elective surgery requiring general anesthesia with tracheal intubation between January 2010 and December 2019. Intraoperative ventilation parameters were compared between patients with and without one or more postoperative pulmonary complications (respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, and aspiration pneumonitis) within 7 days of surgery. RESULTS: Among 33,701 patients, 2,033 (6.0%) had one or more postoperative pulmonary complications. The lower tidal volume to predicted body weight ratio (odds ratio per -1 ml·kgPBW-1, 1.08; 95% CI, 1.02 to 1.14; P < 0.001), higher mechanical power (odds ratio per 4 J·min-1, 1.37; 95% CI, 1.26 to 1.49; P < 0.001), dynamic respiratory system compliance less than 30 ml·cm H2O (1.30; 95% CI, 1.15 to 1.46; P < 0.001), oxygen saturation measured by pulse oximetry less than 96% (odds ratio, 2.42; 95% CI, 1.97 to 2.96; P < 0.001), and lower end-tidal carbon dioxide (odds ratio per -3 mmHg, 1.06; 95% CI, 1.00 to 1.13; P = 0.023) were independently associated with postoperative pulmonary complications. Patients with postoperative pulmonary complications were more likely to be admitted to the intensive care unit (odds ratio, 12.5; 95% CI, 6.6 to 10.1; P < 0.001), had longer hospital length of stay (subhazard ratio, 0.43; 95% CI, 0.40 to 0.45), and higher in-hospital (subhazard ratio, 6.0; 95% CI, 4.1 to 9.0; P < 0.001) and 1-yr mortality (subhazard ratio, 2.65; 95% CI, 2.33 to 3.02; P < 0.001). CONCLUSIONS: In the study's population, decreased rather than increased tidal volume, decreased compliance, increased mechanical power, and decreased end-tidal carbon dioxide were independently associated with postoperative pulmonary complications.
Subject(s)
Carbon Dioxide , Pulmonary Atelectasis , Adult , Humans , Retrospective Studies , Lung , Pulmonary Atelectasis/epidemiology , Pulmonary Atelectasis/etiology , Postoperative Complications/diagnosis , Postoperative Complications/epidemiologySubject(s)
Analgesia , Nociception , Humans , Blood Pressure , Autonomic Nervous System , Baroreflex , Heart RateABSTRACT
Importance: Delayed admission of patients with surgical emergencies to the operating room occurs frequently and is associated with poor outcomes. In France, where 3 distinct organizational pathways in hospitals exist (a dedicated emergency operating room and team [DET], a dedicated operating room in a central operating theater [DOR], and no dedicated structure or team [NOR]), neither the incidence nor the influence of delayed urgent surgery is known, and no guidelines are available to date. Objective: To examine the overall frequency of delayed admission of patients with surgical emergencies to the operating room across the 3 organizational pathways in hospitals in France. Design, Setting, and Participants: This prospective multicenter cohort study was conducted in 10 French tertiary hospitals. All consecutive adult patients admitted for emergency surgery from October 5 to 16, 2020, were included and prospectively monitored. Patients requiring pediatric surgery, obstetrics, interventional radiology, or endoscopic procedures were excluded. Exposures: Emergency surgery. Main Outcomes and Measures: The main outcome was the global incidence of delayed emergency surgery across 3 predefined organizational pathways: DET, DOR, and NOR. The ratio between the actual time to surgery (observed duration between surgical indication and incision) and the ideal time to surgery (predefined optimal duration between surgical indication and incision according to the Non-Elective Surgery Triage classification) was calculated for each patient. Surgery was considered delayed when this ratio was greater than 1. Results: A total of 1149 patients were included (mean [SD] age, 55 [21] years; 685 [59.9%] males): 649 in the DET group, 320 in the DOR group, and 171 in the NOR group (missing data: n = 5). The global frequency of surgical delay was 32.5% (95% CI, 29.8%-35.3%) and varied across the 3 organizational pathways: DET, 28.4% (95% CI, 24.8%-31.9%); DOR, 32.2% (95% CI, 27.0%-37.4%); and NOR, 49.1% (95% CI, 41.6%-56.7%) (P < .001). The adjusted odds ratio for delay was 1.80 (95% CI, 1.17-2.78) when comparing NOR with DET. Conclusions and Relevance: In this cohort study, the frequency of delayed emergency surgery in France was 32.5%. Reduced delays were found in organizational pathways that included dedicated theaters and teams. These preliminary results may pave the way for comprehensive large-scale studies, from which results may potentially inform new guidelines for quicker and safer access to emergency surgery.
Subject(s)
Emergencies , Operating Rooms , Male , Adult , Child , Humans , Middle Aged , Female , Cohort Studies , Prospective Studies , Tertiary Care CentersABSTRACT
Importance: General anesthesia and procedural sedation are common practice for mechanical thrombectomy in acute ischemic stroke. However, risks and benefits of each strategy are unclear. Objective: To determine whether general anesthesia or procedural sedation for anterior circulation large-vessel occlusion acute ischemic stroke thrombectomy are associated with a difference in periprocedural complications and 3-month functional outcome. Design, Setting, and Participants: This open-label, blinded end point randomized clinical trial was conducted between August 2017 and February 2020, with final follow-up in May 2020, at 10 centers in France. Adults with occlusion of the intracranial internal carotid artery and/or the proximal middle cerebral artery treated with thrombectomy were enrolled. Interventions: Patients were assigned to receive general anesthesia with tracheal intubation (n = 135) or procedural sedation (n = 138). Main Outcomes and Measures: The prespecified primary composite outcome was functional independence (a score of 0 to 2 on the modified Rankin Scale, which ranges from 0 [no neurologic disability] to 6 [death]) at 90 days and absence of major periprocedural complications (procedure-related serious adverse events, pneumonia, myocardial infarction, cardiogenic acute pulmonary edema, or malignant stroke) at 7 days. Results: Among 273 patients evaluable for the primary outcome in the modified intention-to-treat population, 142 (52.0%) were women, and the mean (SD) age was 71.6 (13.8) years. The primary outcome occurred in 38 of 135 patients (28.2%) assigned to general anesthesia and in 50 of 138 patients (36.2%) assigned to procedural sedation (absolute difference, 8.1 percentage points; 95% CI, -2.3 to 19.1; P = .15). At 90 days, the rate of patients achieving functional independence was 33.3% (45 of 135) with general anesthesia and 39.1% (54 of 138) with procedural sedation (relative risk, 1.18; 95% CI, 0.86-1.61; P = .32). The rate of patients without major periprocedural complications at 7 days was 65.9% (89 of 135) with general anesthesia and 67.4% (93 of 138) with procedural sedation (relative risk, 1.02; 95% CI, 0.86-1.21; P = .80). Conclusions and Relevance: In patients treated with mechanical thrombectomy for anterior circulation acute ischemic stroke, general anesthesia and procedural sedation were associated with similar rates of functional independence and major periprocedural complications. Trial Registration: ClinicalTrials.gov Identifier: NCT03229148.
Subject(s)
Brain Ischemia , Endovascular Procedures , Ischemic Stroke , Stroke , Adult , Humans , Female , Aged , Male , Ischemic Stroke/etiology , Brain Ischemia/complications , Conscious Sedation , Stroke/drug therapy , Anesthesia, General , Thrombectomy/adverse effects , Endovascular Procedures/adverse effects , Treatment OutcomeABSTRACT
INTRODUCTION: Intraoperative monitoring of nociception has made great progress in adult anesthesia. However, pediatric data are scarce. The Nociception Level (NOL) is one of the most recent indexes of nociception. Its originality is that it provides a multiparametric assessment of nociception. In adults, NOL monitoring allowed lower perioperative opioid requirements, hemodynamic stability, and qualitative postoperative analgesia. So far, the NOL has never been used in children. Our objective was to validate the ability of NOL to provide a quantitative assessment of nociception in anesthetized children. METHODS: In 5-12 years old children anesthetized with sevoflurane and alfentanil (10 µg kg-1), before surgical incision, we performed three standardized tetanic stimulations (5 s, 100 Hz) of different intensities (10-30-60 mA) in a randomized order. NOL, heart rate, blood pressure and Analgesia-Nociception Index variations were assessed after each stimulation. RESULTS: Thirty children were included. Data were analyzed with a covariance pattern linear mixed regression model. NOL increased after the stimulations (p < 0.05 at each intensity). NOL response was influenced by stimulation intensity (p < 0.001). Heart rate and blood pressure were barely modified by the stimulations. Analgesia-Nociception Index decreased after the stimulations (p < 0.001 at each intensity). Analgesia-Nociception index response was not influenced by stimulation intensity (p = 0.064). NOL and Analgesia-Nociception Index responses were significantly correlated (Pearson r = 0.47; p < 0.001). CONCLUSIONS: NOL allows a quantitative assessment of nociception under anesthesia in 5-12 years-old children. This study provides a solid basis for all future investigations on NOL monitoring in pediatric anesthesia. REGISTRATION: NCT05233449.
Subject(s)
Anesthesia , Nociception , Adult , Child , Child, Preschool , Humans , Analgesics, Opioid , Heart Rate , Monitoring, Intraoperative , Nociception/physiology , PainABSTRACT
This paper describes the development and implementation of an anesthesia data warehouse in the Lille University Hospital. We share the lessons learned from a ten-year project and provide guidance for the implementation of such a project. Our clinical data warehouse is mainly fed with data collected by the anesthesia information management system and hospital discharge reports. The data warehouse stores historical and accurate data with an accuracy level of the day for administrative data, and of the second for monitoring data. Datamarts complete the architecture and provide secondary computed data and indicators, in order to execute queries faster and easily. Between 2010 and 2021, 636 784 anesthesia records were integrated for 353 152 patients. We reported the main concerns and barriers during the development of this project and we provided 8 tips to handle them. We have implemented our data warehouse into the OMOP common data model as a complementary downstream data model. The next step of the project will be to disseminate the use of the OMOP data model for anesthesia and critical care, and drive the trend towards federated learning to enhance collaborations and multicenter studies.
Subject(s)
Anesthesia , Data Warehousing , HumansABSTRACT
PURPOSE: Individuals in late pregnancy are at risk of significant hemodynamic variations, especially during Cesarean delivery. Although non-invasive monitoring might enable the early detection of variations in cardiac output (CO), clinical validation is lacking. METHODS: In a prospective, single-center study, we measured CO simultaneously with finger plethysmography and transthoracic echocardiography in 100 third-trimester pregnant individuals in the supine and left lateral decubitus (LLD) positions. RESULTS: A Bland-Altman analysis revealed a mean (standard deviation) bias of 1.36 (1.04) L·min-1 in the supine position (95% limits of agreement, -0.68 to 3.4 L·min-1; percent error, 26.6%), indicating overestimation by finger plethysmography. The intra-class correlation coefficient was 0.43 (95% confidence interval [CI], 0.33 to 0.51). Regarding the changes in CO induced by the supine-to-LLD transition, the concordance rate in a four-quadrant plot was 98.3% (95% CI, 91.1 to 99.9%). CONCLUSION: Our study showed a poor reliability of finger plethysmography for static measurement of CO. Nevertheless, finger plethysmography had a reasonably high concordance rate for the detection of CO changes secondary to positional changes in late-pregnant individuals. STUDY REGISTRATION DATE: www. CLINICALTRIALS: gov (NCT03735043); registered 8 November 2018.
RéSUMé: OBJECTIF: Les personnes en fin de grossesse sont à risque de variations hémodynamiques importantes, en particulier pendant un accouchement par césarienne. Bien que le monitorage non invasif puisse permettre la détection précoce des variations du débit cardiaque (DC), la validation clinique de ce type de monitorage fait défaut. MéTHODE: Dans une étude prospective monocentrique, nous avons mesuré le DC simultanément avec la pléthysmographie au doigt et l'échocardiographie transthoracique chez 100 femmes au troisième trimestre de leur grossesse en décubitus dorsal et en décubitus latéral gauche (DLG). RéSULTATS: Une analyse de Bland-Altman a révélé un biais moyen (écart type) de 1,36 (1,04) L·min1 en décubitus dorsal (limites d'agrément à 95 %, -0,68 à 3,4 L·min1; pourcentage d'erreur, 26,6 %), indiquant une surestimation lorsque mesuré par pléthysmographie au doigt. Le coefficient de corrélation intraclasse était de 0,43 (intervalle de confiance [IC] à 95 %, 0,33 à 0,51). En ce qui concerne les changements de DC induits par la transition du décubitus dorsal au décubitus latéral gauche, le taux de concordance dans un diagramme à quatre quadrants était de 98,3 % (IC 95 %, 91,1 à 99,9 %). CONCLUSION: Notre étude a montré une faible fiabilité de la pléthysmographie au doigt pour la mesure statique du DC. Néanmoins, la pléthysmographie au doigt avait un taux de concordance raisonnablement élevé pour la détection des changements de DC secondaires aux changements de position chez les patientes en fin de grossesse. www.clinicaltrials.gov (NCT03735043); enregistrée le 8 novembre 2018.
Subject(s)
Plethysmography , Thermodilution , Female , Pregnancy , Humans , Prospective Studies , Reproducibility of Results , Cardiac Output , Monitoring, PhysiologicABSTRACT
BACKGROUND: Hypotension and blood pressure (BP) variability during endovascular therapy (EVT) for acute ischemic stroke (AIS) due to an anterior large vessel occlusion (LVO) is associated with worse outcomes. However, the optimal BP threshold during EVT is still unknown given the lack of randomized controlled evidence. We designed the DETERMINE trial to assess whether an individualized BP management during EVT could achieve better functional outcomes compared to a standard BP management. METHODS: The DETERMINE trial is a multicenter, prospective, randomized, controlled, open-label, blinded endpoint clinical trial (PROBE design). AIS patients with a proximal anterior LVO are randomly assigned, in a 1:1 ratio, to an experimental arm in which mean arterial pressure (MAP) is maintained within 10% of the first MAP measured before EVT, or a control arm in which systolic BP (SBP) is maintained within 140-180 mm Hg until reperfusion is achieved or artery closure in case of EVT failure. The primary outcome is the rate of favorable functional outcomes, defined by a modified Rankin Scale (mRS) between 0 and 2 at 90 days. Secondary outcomes include excellent outcome and ordinal analysis of the mRS at 90 days, early neurological improvement at 24 h (National Institutes of Health Stroke Scale), final infarct volume, symptomatic intracranial hemorrhage rates, and all-cause mortality at 90 days. Overall, 432 patients will be included. DISCUSSION: DETERMINE will assess the clinical relevance of an individualized BP management before reperfusion compared to the one size fits all approach currently recommended by international guidelines. TRIAL REGISTRATION: ClinicalTrials.gov , NCT04352296. Registered on 20th April 2020.
Subject(s)
Brain Ischemia , Endovascular Procedures , Ischemic Stroke , Stroke , Blood Pressure , Brain Ischemia/diagnosis , Brain Ischemia/etiology , Brain Ischemia/therapy , Endovascular Procedures/adverse effects , Humans , Prospective Studies , Stroke/diagnosis , Stroke/etiology , Stroke/therapy , Thrombectomy/adverse effects , Treatment OutcomeABSTRACT
INTRODUCTION: Intraoperative monitoring of nociception has recently made substantial progress in adult anesthesia. In contrast, pediatric data are scarce. Newborn-Infant Parasympathetic Evaluation (NIPE index, Mdoloris Medical Systems, Loos, France) is the first nociception index specifically designed for young children. It is a dimensionless index comprised between 0 and 100. Two previous studies suggested that NIPE could indeed 'detect' nociception in anesthetized children. The objective of our study was to investigate if NIPE allowed to detect and to provide a quantitative assessment of nociception in children. METHODS: Children were anesthetized with sevoflurane, and received a bolus of alfentanil (10 µg/kg before intubation). Before surgical incision, each participant received three tetanic stimulations (5 s, 100 Hertz) with a 5 min interval, in a randomized order: 10, 30 and 60 milliamps. NIPE and heart rate variations were assessed after each stimulation. RESULTS: Thirty children (2.4±1.6 years) were included. Mean delay between alfentanil and the first stimulation was 19±4 min. Mean baseline NIPE was 75±10. NIPE variation after the stimulations was significant at 10, 30 and 60 mA (linear mixed regression model, p<0.001). The intensity of stimulation significantly influenced the amplitude of NIPE variation (linear mixed regression model p<0.001), but had no statistically significant effect on heart rate variation (p=0.52). DISCUSSION: NIPE might allow a quantitative assessment of nociception in young children in these anesthetic conditions. This study provides a basis for future research investigating the potential benefits of NIPE-guided intraoperative analgesia in pediatric anesthesia. TRIAL REGISTRATION NUMBER: NCT04381637.
ABSTRACT
BACKGROUND: Perioperative hypersensitivity reactions may be difficult to diagnose during general anesthesia. Postinduction hypotension is the most common sign but is not specific. It was recently suggested that low end-tidal carbon dioxide (ETco2) might be a marker of anaphylaxis (Ring and Messmer grades III to IV immediate hypersensitivity reactions) in hypotensive patients under mechanical ventilation. To test this hypothesis, the authors compared ETco2 in patients with a diagnosis of anaphylaxis and in patients with severe hypotension from any other cause after the induction of anesthesia. METHODS: This was a retrospective single-center case-control study in which two groups were formed from an anesthesia data warehouse. The anaphylaxis group was formed on the basis of tryptase/histamine assay data and allergy workup data recorded over the period 2010 to 2018. The control (hypotension) group consisted of all patients having experienced severe hypotension (mean arterial pressure less than 50 mmHg for 5 min or longer) with a cause other than anaphylaxis after anesthesia induction in 2017. RESULTS: The anaphylaxis and hypotension groups comprised 49 patients (grade III: n = 38; grade IV: n = 11) and 555 patients, respectively. The minimum ETco2 value was significantly lower in the anaphylaxis group (median [interquartile range]: 17 [12 to 23] mmHg) than in the hypotension group (32 [29 to 34] mmHg; P < 0.001). The area under the receiver operating characteristic curve (95% CI) for ETco2 was 0.95 (0.91 to 0.99). The sensitivity and specificity (95% CI) for the optimal cutoff value were 0.92 (0.82 to 0.98) and 0.94 (0.92 to 0.99), respectively. In multivariable analysis, minimum ETco2 was associated with anaphylaxis after adjusting for confounders and competing predictors, including arterial pressure, heart rate, and peak airway pressure (odds ratio [95% CI] for ETco2: 0.51 [0.38 to 0.68]; P < 0.001). CONCLUSIONS: In case of severe hypotension after anesthesia induction, a low ETco2 contributes to the diagnosis of anaphylaxis, in addition to the classical signs of perioperative immediate hypersensitivity.
Subject(s)
Anaphylaxis/etiology , Anaphylaxis/metabolism , Anesthesia, General/methods , Carbon Dioxide/metabolism , Hypotension/etiology , Hypotension/metabolism , Case-Control Studies , Female , Humans , Male , Middle Aged , Retrospective Studies , Tidal VolumeABSTRACT
The ANI is a nociception monitor based on the high frequency parts of heart rate variability. Tracheal intubation may induce potentially deleterious hemodynamic disturbances or motor reactions if analgesia is inadequate. We investigated whether ANI modification generated by a standardized moderate short tetanic stimulation performed before laryngoscopy could predict hemodynamic or somatic reactions to subsequent intubation. We designed a prospective, interventional, monocentric, pilot study. Regional ethics board approved the study, written informed consent was obtained from each participant. Before laryngoscopy, under steady-state total intravenous anaesthesia with propofol and remifentanil, the ulnar nerve was stimulated with a 5 s tetanus (70 mA, 50 Hz). After another steady-state period, orotracheal intubation was performed. ANI variation, hemodynamic parameters and somatic reactions associated with tetanus and intubation were collected. To assess the predictability of hemodynamic or somatic reaction during laryngoscopy by tetanus-induced ANI variation, we calculated the area under the corresponding Receiver Operating Characteristic curve (AUCROC) and the 95% confidence intervals. Thirty-five patients were analyzed. ANI decreased by 21 ± 17 after tetanus. Regarding the ability of tetanus-induced ANI variation to predict hemodynamic or somatic reactions during subsequent intubation, the AUCROCs [95% CI] were 0.61 [0.41-0.81] and 0.52 [0.31-0.72] respectively. ANI varied after a short moderate tetanic stimulation performed before laryngoscopy but this variation was not predictive of a hemodynamic or somatic reaction during intubation.Trial registration NCT04354311, April 20th 2020, retrospectively registered.
Subject(s)
Laryngoscopy , Tetanus , Anesthetics, Intravenous/pharmacology , Heart Rate/physiology , Humans , Intubation, Intratracheal , Pain Measurement , Pilot Projects , Prospective StudiesABSTRACT
BACKGROUND: Electronic health records (EHRs, such as those created by an anesthesia management system) generate a large amount of data that can notably be reused for clinical audits and scientific research. The sharing of these data and tools is generally affected by the lack of system interoperability. To overcome these issues, Observational Health Data Sciences and Informatics (OHDSI) developed the Observational Medical Outcomes Partnership (OMOP) common data model (CDM) to standardize EHR data and promote large-scale observational and longitudinal research. Anesthesia data have not previously been mapped into the OMOP CDM. OBJECTIVE: The primary objective was to transform anesthesia data into the OMOP CDM. The secondary objective was to provide vocabularies, queries, and dashboards that might promote the exploitation and sharing of anesthesia data through the CDM. METHODS: Using our local anesthesia data warehouse, a group of 5 experts from 5 different medical centers identified local concepts related to anesthesia. The concepts were then matched with standard concepts in the OHDSI vocabularies. We performed structural mapping between the design of our local anesthesia data warehouse and the OMOP CDM tables and fields. To validate the implementation of anesthesia data into the OMOP CDM, we developed a set of queries and dashboards. RESULTS: We identified 522 concepts related to anesthesia care. They were classified as demographics, units, measurements, operating room steps, drugs, periods of interest, and features. After semantic mapping, 353 (67.7%) of these anesthesia concepts were mapped to OHDSI concepts. Further, 169 (32.3%) concepts related to periods and features were added to the OHDSI vocabularies. Then, 8 OMOP CDM tables were implemented with anesthesia data and 2 new tables (EPISODE and FEATURE) were added to store secondarily computed data. We integrated data from 5,72,609 operations and provided the code for a set of 8 queries and 4 dashboards related to anesthesia care. CONCLUSIONS: Generic data concerning demographics, drugs, units, measurements, and operating room steps were already available in OHDSI vocabularies. However, most of the intraoperative concepts (the duration of specific steps, an episode of hypotension, etc) were not present in OHDSI vocabularies. The OMOP mapping provided here enables anesthesia data reuse.
Subject(s)
Anesthesia , Medical Informatics , Data Science , Databases, Factual , Electronic Health Records , Hospitals , HumansABSTRACT
BACKGROUND: The Pupillary Pain Index is a recent pupillometric index designed to assess the level of analgesia under general anesthesia in children and adults. If analgesia is inadequate, acute nociceptive stimuli such as skin incision may induce significant hemodynamic disturbances. AIMS: Our aim was to investigate the potential relationship between pre-incision Pupillary Pain Index and heart rate increase following skin incision in children. METHODS: This was a prospective, non-randomized, registered pilot study. We included children undergoing surgery under general anesthesia. Pupillary Pain Index was assessed 2 min before skin incision. Then, heart rate maximal variation (ΔHR ) and pupillary diameter maximal variation (ΔPD ) in the minute following incision were recorded. Spearman coefficient was calculated to characterize the relationship between Pupillary Pain Index and ΔHR or ΔPD . Using receiver operating characteristic curve analysis, we also studied the predictive value of pre-incision Pupillary Pain Index for heart rate and pupillary diameter reactivity. RESULTS: 53 patients were included (10 ± 4 years, 40 ± 19 kg). There was a modest correlation between pre-incision Pupillary Pain Index and ΔHR (Spearman rs = 0.35 [0.05-0.57], p = .011), and between pre-incision Pupillary Pain Index and ΔPD (Spearman rs = 0.54 [0.33-0.71], p < .001). Regarding the predictive value of Pupillary Pain Index for heart rate or pupillary diameter reactivity, the corresponding areas under the receiver operating characteristic curves were 0.90 [0.82-0.99] and 0.78 [0.65-0.93], respectively. A threshold of Pupillary Pain Index <3 predicted the absence of heart rate reactivity at incision with a good performance (negative predictive value = 1). CONCLUSIONS: In children, pre-incision Pupillary Pain Index was moderately correlated with post-incision nociception. Pre-incision Pupillary Pain Index had good predictive performances for heart rate or pupillary diameter reactivity to skin incision. Pre-incision Pupillary Pain Index <3 might predict the absence of heart rate reaction to incision.
Subject(s)
Anesthesia, General , Pupil , Adult , Child , Heart Rate , Humans , Pain , Pilot Projects , Prospective Studies , Reflex, PupillaryABSTRACT
Despite a large body of evidence, the implementation of guidelines on hemodynamic optimization and goal-directed therapy remains limited in daily routine practice. To facilitate/accelerate this implementation, a panel of experts in the field proposes an approach based on six relevant questions/answers that are frequently mentioned by clinicians, using a critical appraisal of the literature and a modified Delphi process. The mean arterial pressure is a major determinant of organ perfusion, so that the authors unanimously recommend not to tolerate absolute values below 65 mmHg during surgery to reduce the risk of postoperative organ dysfunction. Despite well-identified limitations, the authors unanimously propose the use of dynamic indices to rationalize fluid therapy in a large number of patients undergoing non-cardiac surgery, pending the implementation of a "validity criteria checklist" before applying volume expansion. The authors recommend with a good agreement mini- or non-invasive stroke volume/cardiac output monitoring in moderate to high-risk surgical patients to optimize fluid therapy on an individual basis and avoid volume overload. The authors propose to use fluids and vasoconstrictors in combination to achieve optimal blood flow and maintain perfusion pressure above the thresholds considered at risk. Although purchase of disposable sensors and stand-alone monitors will result in additional costs, the authors unanimously acknowledge that there are data strongly suggesting this may be counterbalanced by a sustained reduction in postoperative morbidity and hospital lengths of stay. Beside existing guidelines, knowledge and explicit clinical reasoning tools followed by decision algorithms are mandatory to implement individualized hemodynamic optimization strategies and reduce postoperative morbidity and duration of hospital stay in high-risk surgical patients.
ABSTRACT
BACKGROUND: Postoperative pain in spine surgery is an issue. Erector spinae plane block (ESPB) may reduce such postoperative pain, but its usefulness has never been evaluated in the specific context of trauma surgery. We thus studied the effect of bilateral ultrasound-guided ESPB on postoperative pain and opioid requirement after percutaneous lumbar arthrodesis for trauma. METHODS: All patients who underwent percutaneous lumbar arthrodesis for spine trauma between December 2019 and March 2020 were retrospectively studied. Some patients received preoperative bilateral ESPB (30 mL of 0.375% ropivacaine on each side; ESPB group), others received the standard of care (i.e., postoperative muscular infiltration with 30 mL of 0.75% of ropivacaine; control group), according to the preference of the anesthesiologist in charge of the patient. The rest of the management was identical in all patients. The primary outcome was the cumulative morphine consumption at 24 hours postoperatively. Secondary outcomes included pain score at various time points until 24 hours. RESULTS: Fifty-five patients were included, of whom 24 received an EPSB and 31 received the standard of care. The cumulative morphine consumption (mean [standard deviation]) at 24 hours was 13 (12) mg in the ESPB group, and 35 (17) mg in the control group (P < 0.001). Pain scores were significantly lower in the ESPB group compared with the control group up to 9 hours after surgery (P < 0.01). CONCLUSIONS: In this pilot study, compared with standard analgesia, ESPB reduced opioid requirement and postoperative pain after percutaneous lumbar arthrodesis for trauma. A randomized controlled trial is required to prove this effectiveness.
Subject(s)
Nerve Block/methods , Pain Management/methods , Pain, Postoperative/prevention & control , Spinal Fusion/adverse effects , Ultrasonography, Interventional/methods , Adult , Anesthetics, Local/therapeutic use , Female , Humans , Lumbar Vertebrae/surgery , Male , Middle Aged , Paraspinal Muscles/drug effects , Pilot Projects , Retrospective Studies , Ropivacaine/therapeutic useABSTRACT
Clinical dashboards summarize indicators of high-volume patient data in a concise, user-friendly visual format. There are few studies of the use of dashboards to improve professional practice in anesthesiology. The objective of the present study was to describe the user-centered development, implementation and preliminary evaluation of clinical dashboards dealing with anesthesia unit management and quality assessment in a French university medical center. User needs and technical requirements were identified in end user interviews and then synthesized. Several representations were then developed (according to good visualization practice) and submitted to end users for appraisal. Lastly, dashboards were implemented and made accessible for everyday use via the medical center's network. After a period of use, end user feedback on the dashboard platform was collected as a system usability score (range 0 to 100). Seventeen themes (corresponding to 29 questions and 42 indicators) were identified. After prioritization and feasibility assessment, 10 dashboards were ultimately implemented and deployed. The dashboards variously addressed the unit's overall activity, compliance with guidelines on intraoperative hemodynamics, ventilation and monitoring, and documentation of the anesthesia procedure. The mean (standard deviation) system usability score was 82.6 (11.5), which corresponded to excellent usability. We developed clinical dashboards for a university medical center's anesthesia units. The dashboards' deployment was well received by the center's anesthesiologists. The dashboards' impact on activity and practice after several months of use will now have to be assessed.
Subject(s)
Anesthesia , Anesthesiology , Feedback , HumansABSTRACT
BACKGROUND/OBJECTIVES: The present study aimed at evaluating the impact on the early outcome of patients with ruptured intracranial aneurysms. METHODS: Our study prospectively included 26 consecutive patients with ruptured intracranial aneurysm managed at our institution in context of COVID-19 pandemic between March 1st, 2020 and April, 26th, 2020 (2020 group). A group control included other 28 consecutive patients managed at the same institution for the same disease in 2019, during the same time frame (2019 group). On admission, poor neurological status was defined as WFNS score >3. Severe radiological status was defined by the presence of intracerebral hematoma, or/and acute hydrocephalus requiring further EVD or/and the presence of vasospasm on presentation. Statistical analysis was performed to compare the 2 distinct groups. RESULTS: Rates of poor neurological presentation and severe radiological presentation on hospital admission were higher in the 2020 group (p = 0.01 and p = 0.02, respectively). The delayed hospital admission was 2.7 days in 2020 group and 0.75 days in 2019 group (p = 0.005). Therefore, vasospasm's rate on presentation was also higher in the 2020 group (p = 0.04). CONCLUSION: To our knowledge, this is one of the first studies demonstrating influence of the COVID-19 pandemic on patients with urgent and severe intracranial aneurysmal disease. In case of recurrent COVID-19 pandemic, educating the population concerning specific symptoms such as sudden headache, neurological deficit or even sudden chest pain should be emphasized.
Subject(s)
Aneurysm, Ruptured/diagnostic imaging , Aneurysm, Ruptured/epidemiology , COVID-19/diagnostic imaging , COVID-19/epidemiology , Intracranial Aneurysm/diagnostic imaging , Intracranial Aneurysm/epidemiology , Adult , Aged , Aged, 80 and over , Cohort Studies , Female , France/epidemiology , Humans , Male , Middle Aged , Pandemics , Prospective StudiesABSTRACT
OBJECTIVES: The world is currently facing an unprecedented healthcare crisis caused by the COVID-19 pandemic. The objective of these guidelines is to produce a framework to facilitate the partial and gradual resumption of intervention activity in the context of the COVID-19 pandemic. METHODS: The group has endeavoured to produce a minimum number of recommendations to highlight the strengths to be retained in the 7 predefined areas: (1) protection of staff and patients; (2) benefit/risk and patient information; (3) preoperative assessment and decision on intervention; (4) modalities of the preanaesthesia consultation; (5) specificity of anaesthesia and analgesia; (6) dedicated circuits and (7) containment exit type of interventions. RESULTS: The SFAR Guideline panel provides 51 statements on anaesthesia management in the context of COVID-19 pandemic. After one round of discussion and various amendments, a strong agreement was reached for 100% of the recommendations and algorithms. CONCLUSION: We present suggestions for how the risk of transmission by and to anaesthetists can be minimised and how personal protective equipment policies relate to COVID-19 pandemic context.