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Since 2019 when a cluster of cases with acute respiratory distress syndrome (ARDS) associated with e-cigarettes in the United States was reported, there have been increasing numbers of reports. Electronic-cigarette or Vaping Use-associated Lung Injury (EVALI) represents a recent entity of respiratory clinical syndromes, primarily in young adults. We report a previously healthy 16-year-old boy who developed severe ARDS following a brief nonspecific prodromal phase after excessive consumption of e-cigarettes. Despite maximum intensive care therapy, including several weeks of venovenous extracorporeal membrane oxygenation, plasmapheresis and repeated administration of immunoglobulins seemed the only way to achieve therapeutic success. Although many case reports have been published, to our knowledge, there are none to date on the therapeutic use of plasmaphoresis in severe EVALI. This case highlights the clinical features of EVALI and the diagnostic dilemma that can arise with EVALI occurring against the background of an expired SARS-CoV-2 infection, with a paediatric inflammatory syndrome (PIMS) as differential diagnosis. EVALI is a diagnosis of exclusion, and the medical history of vaping and e-cigarette use can provide valuable clues. Ethical approval for this case report (protocol number 23-145 RS) was provided by the Ethical Committee of the Department of Medicine, Philipps-Universität Marburg, Germany on 13 th of June 2023. Written informed consent to publish this case and the associated images was obtained from the patient and his mother.
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Plasmaferese , Vaping , Humanos , Masculino , Adolescente , Plasmaferese/métodos , Vaping/efeitos adversos , Síndrome do Desconforto Respiratório/terapia , Síndrome do Desconforto Respiratório/etiologia , Síndrome do Desconforto Respiratório/diagnóstico , COVID-19/terapia , COVID-19/diagnóstico , Oxigenação por Membrana Extracorpórea , Sistemas Eletrônicos de Liberação de Nicotina , Resultado do TratamentoRESUMO
Thoracic surgery is often associated with severe postoperative pain levels. Even though these are less pronounced in thoracoscopic approaches, mechanical irritation, compression or injury of intercostal nerves and placement of chest tubes can cause pain levels, which must be treated. An adequate pain therapy in thoracic surgery is essential as insufficient inspiration due to inadequate analgesia may result in postoperative complications. Epidural anesthesia was considered the gold standard in thoracotomy for a long time. For video-assisted thoracoscopy, however, it is sometimes no longer recommended due to its benefit-risk ratio. Alternative thoracic blocks are the paravertebral block, the erector spinae plane block and the serratus anterior block, for which research has found heterogeneous results.This article summarizes the current recommendations for perioperative management of thoracoscopic surgery and gives an overview of the PROSPECT recommendations as well as the current Association of the Scientific Medical Societies in Germany (AWMF) guidelines for perioperative and postoperative pain therapy. In particular, individual regional anesthesia techniques and their current evidence are reviewed.
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BACKGROUND: Regional anaesthesia has the benefit of reducing the need for systemic analgesia and therefore, potentially reducing undesired side effects. With the end of the sensory nerve block however, many patients report severe pain that requires therapy with opioids and often compromise the initial opioid sparing effect. This study aimed to characterise the postoperative pain profile and the phenomenon of rebound pain after axillary brachial plexus anaesthesia (RA) compared to general anaesthesia (GA). DESIGN: Single-centre observational, stratified cohort study. SETTING: The study was conducted at University Hospital Marburg from May 2020 until September 2022. PARTICIPANTS: One hundred thirty-two patients receiving elective hand and forearm surgery were enrolled in this study. INTERVENTIONS: Group RA received ultrasound-guided brachial plexus anaesthesia via the axillary approach with 30 mL of prilocaine 1% and 10 mL ropivacaine 0.2%. Group GA received balanced or total intravenous general anaesthesia. MAIN OUTCOME MEASURES: Primary endpoint were integrated pain scores (IPS) within 24 h postoperatively. Secondary endpoints were pain scores (NRS 0-10), morphine equivalents, patient satisfaction, quality of recovery and opioid-related side effects. RESULTS: One hundred thirty-two patients were analysed of which 66 patients received brachial plexus block and 66 patients received general anaesthesia. Following RA significantly lower IPS were seen directly after surgery (p < .001) and during the post-anaesthesia care unit interval (p < .001) but equalised after 3 h at the ward. No overshoot in pain scores or increased opioid consumption could be detected. Patient satisfaction and postoperative recovery were comparable between both groups. CONCLUSION: The IPS and NRS was initially lower in the RA group, increased with fading of the block until equal to the GA group and equal thereafter. Although various definitions of rebound pain were met during this phase, the opioid sparing effect of regional anaesthesia was not counteracted by it. The incidence of episodes with uncontrolled, severe pain did not differ between groups. We found no clinical implications of rebound pain in this setting, since the RA group did not show higher pain scores than the GA group at any time point. TRIAL REGISTRATION: German Clinical Trials Register (DRKS00021764).
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Bloqueio do Plexo Braquial , Humanos , Bloqueio do Plexo Braquial/efeitos adversos , Analgésicos Opioides/uso terapêutico , Estudos de Coortes , Dor Pós-Operatória/tratamento farmacológico , Dor Pós-Operatória/etiologia , Anestesia Geral/efeitos adversos , Anestésicos LocaisRESUMO
INTRODUCTION: Shivering is a common side effect after general anesthesia. Risk factors are hypothermia, young age and postoperative pain. Severe complications of shivering are rare but can occur due to increased oxygen consumption. Previous systematic reviews are outdated and have summarized the evidence on the topic using only pairwise comparisons. The objective of this manuscript was a quantitative synthesis of evidence on pharmacological interventions to treat postanesthetic shivering. EVIDENCE ACQUSITION: Systematic review and frequentist network meta-analysis using the R package netmeta. Endpoints were the risk ratio (RR) of persistent shivering at one, five and 10 minutes after treatment with saline/placebo as the comparator. Data were retrieved from Medline, Embase, Central and Web of Science up to January 2022. Eligibility criteria were: randomized, controlled, and blinded trials comparing pharmacological interventions to treat shivering after general anesthesia. Studies on shivering during or after any type of regional anesthesia were excluded as well as sedated patients after cardiac surgery. EVIDENCE SYNTHESIS: Thirty-two trials were eligible for data synthesis, including 28 pharmacological interventions. The largest network included 1431 patients. The network geometry was two-centered with most comparisons linked to saline/placebo or pethidine. The best interventions were after one minute: doxapram 2 mg/kg, tramadol 2 mg/kg and nefopam 10 mg, after 5 minutes: tramadol 2 mg/kg, nefopam 10 mg and clonidine 150 µg and after 10 minutes: nefopam 10 mg, methylphenidate 20 mg and tramadol 1 mg/kg, all reaching statistical significance. Pethidine 25 mg and clonidine 75 µg also performed well and with statistical significance in all networks. CONCLUSIONS: Nefopam, tramadol, pethidine and clonidine are the most effective treatments to stop postanesthetic shivering. The efficacy of doxapram is uncertain since different doses showed contradictory effects and the evidence for methylphenidate is based on a single comparison in only one network. Furthermore, both lack data on side effects. Further studies are needed to clarify the efficacy of dexmedetomidine to treat postanesthetic shivering.
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Metilfenidato , Nefopam , Tramadol , Humanos , Adulto , Estremecimento , Clonidina/farmacologia , Clonidina/uso terapêutico , Tramadol/uso terapêutico , Metanálise em Rede , Doxapram/farmacologia , Meperidina , Metilfenidato/farmacologiaRESUMO
BACKGROUND: Peripheral regional anaesthesia is frequently used for upper extremity surgery. To prolong the duration of analgesia, adjuvants can be added to single-injection local anaesthetics. Despite attempts to compare several adjuvants in pairwise meta-analyses, a comprehensive comparison is still missing. OBJECTIVE: The objective of this network meta-analysis was to determine the effectiveness of adjuvants in upper extremity peripheral nerve blocks. DESIGN: A systematic review of randomised controlled trials with network meta-analyses. DATA SOURCES: A literature search in Embase, CENTRAL, MEDLINE and Web of Science was performed up to March 2023. ELIGIBILITY CRITERIA: Randomised trials comparing different adjuvants injected perineurally in peripheral upper extremity nerve blocks were eligible. Frequentist network meta-analysis was conducted using a random effects model with physiological saline as the comparator. The primary endpoint was the ratio of means (ROM) of the duration of analgesia. RESULTS: The review included 242 randomised controlled trials with a total of 17â391 patients. Twenty-eight adjuvants were compared in the largest networks. Most network estimations consisted of a high proportion of direct evidence. Fourteen adjuvants increased the duration of analgesia significantly by the following factors, ROM [95% confidence interval (CI)]: dexamethasone 1.95 (1.79 to 2.13), buprenorphine 1.83 (1.51 to 2.24), butorphanol 1.84 (1.41 to 2.39), potassium chloride 1.89 (1.15 to 3.11), dexmedetomidine 1.70 (1.59 to 1.81), sufentanil 1.70 (1.27 to 2.29), ketorolac 1.68 (1.24 to 2.27), midazolam 1.55 (1.24 to 1.94), tramadol 1.52 (1.32 to 1.75), nalbuphine 1.50 (1.30 to 1.72), morphine 1.43 (1.09 to 1.88), magnesium sulfate 1.42 (1.20 to 1.67), clonidine 1.36 (1.24 to 1.50) and fentanyl 1.23 (1.08 to 1.40). Inconsistency in network meta-analysis was substantial. Overall side effect rates were low with all adjuvants. CONCLUSION: The best interventions to prolong the duration of analgesia were dexamethasone, followed by dexmedetomidine, opioids, electrolytes, ketorolac and midazolam. There are general concerns about the quality of underlying studies and the risk of publication bias. TRIAL REGISTRATION: PROSPERO 2018 CRD42018115722.
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Anestesia por Condução , Dexmedetomidina , Humanos , Anestésicos Locais/efeitos adversos , Metanálise em Rede , Midazolam , Dexmedetomidina/efeitos adversos , Cetorolaco , Dor , Extremidade Superior/cirurgia , Dexametasona , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
Spinal anesthesia is a safe alternative to general anesthesia but remains underrepresented in the ambulatory setting. Most concerns relate to low flexibility of spinal anesthesia duration and the management of urinary retention in the outpatient setting. This review focuses on the characterization and safety of the local anesthetics that are available to adapt spinal anesthesia very flexibly to the needs of ambulatory surgery. Furthermore, recent studies on the management of postoperative urinary retention provide evidence for safe, but report wider discharge criteria and much lower hospital admission rates. With the local anesthetics that have current approval for usage in spinal anesthesia, most requirements for ambulatory surgeries can be met. The reported evidence on local anesthetics without approval supports clinically established off-label use and can improve the results even further.
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Raquianestesia , Retenção Urinária , Humanos , Anestésicos Locais , Raquianestesia/métodos , Procedimentos Cirúrgicos Ambulatórios/métodos , Complicações Pós-OperatóriasRESUMO
OBJECTIVES: Surgical fear is one of the most important psychological risk factors for postoperative pain, but less is known about the contribution of protective factors. This study investigated somatic and psychological risk and resilience factors of postoperative pain and validated the German version of the Surgical Fear Questionnaire (SFQ). SETTING: University Hospital of Marburg, Germany. DESIGN: Single-centre observational study and cross-sectional validation study. PARTICIPANTS: Data for validating the SFQ were obtained from a cross-sectional observational study (N=198, mean age 43.6 years, 58.8% female) with persons undergoing different kinds of elective surgery. A sample of N=196 (mean age 43.0 years, 45.4% female) undergoing elective (orthopaedic) surgery was analysed to investigate somatic and psychological predictors of relevant acute postsurgical pain (APSP). OUTCOME MEASURES: Participants completed preoperative and postoperative assessments at postoperative days 1, 2 and 7. Presurgical pain, age, gender, pain expectation, surgical setting, physical status, anaesthesia, surgical fear, pain catastrophising, depression, optimism and self-efficacy were examined as predictors. RESULTS: Confirmatory factor analysis confirmed the original two-factor structure of the SFQ. Correlation analyses indicated good convergent and divergent validity. Internal consistency (Cronbach's α) was between 0.85 and 0.89. Blockwise logistic regression analyses for the risk of APSP revealed outpatient setting, higher preoperative pain, younger age, more surgical fear and low dispositional optimism as significant predictors. CONCLUSIONS: The German SFQ is a valid, reliable and economical instrument with which the important psychological predictor surgical fear can be assessed. Modifiable factors that increase the risk of postoperative pain were higher pain intensity before surgery and being fearful about negative consequences of the surgery whereas positive expectations seem to buffer against postsurgical pain. TRIAL REGISTRATION NUMBERS: DRKS00021764 and DRKS00021766.
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Pacientes Internados , Dor Pós-Operatória , Humanos , Feminino , Adulto , Masculino , Fatores de Proteção , Estudos Transversais , Dor Pós-Operatória/etiologia , Fatores de Risco , Inquéritos e Questionários , Hospitais Universitários , Reprodutibilidade dos TestesRESUMO
In the palliative phase of disease, patients often suffer from a variety of distressing symptoms. Often, treatment is difficult because several problems exist at the same time and the necessary medications can cause side effects that require treatment. This article addresses important symptoms - other than pain - and provides treatment recommendations based on current literature.
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Cuidados Paliativos , Assistência Terminal , Humanos , Manejo da Dor , Dor/tratamento farmacológicoRESUMO
BACKGROUND: Guidelines endorse self-reported functional capacity for preoperative cardiovascular assessment, although evidence for its predictive value is inconsistent. We hypothesised that self-reported effort tolerance improves prediction of major adverse cardiovascular events (MACEs) after noncardiac surgery. METHODS: This is an international prospective cohort study (June 2017 to April 2020) in patients undergoing elective noncardiac surgery at elevated cardiovascular risk. Exposures were (i) questionnaire-estimated effort tolerance in metabolic equivalents (METs), (ii) number of floors climbed without resting, (iii) self-perceived cardiopulmonary fitness compared with peers, and (iv) level of regularly performed physical activity. The primary endpoint was in-hospital MACE consisting of cardiovascular mortality, non-fatal cardiac arrest, acute myocardial infarction, stroke, and congestive heart failure requiring transfer to a higher unit of care or resulting in a prolongation of stay on ICU/intermediate care (≥24 h). Mixed-effects logistic regression models were calculated. RESULTS: In this study, 274 (1.8%) of 15 406 patients experienced MACE. Loss of follow-up was 2%. All self-reported functional capacity measures were independently associated with MACE but did not improve discrimination (area under the curve of receiver operating characteristic [ROC AUC]) over an internal clinical risk model (ROC AUCbaseline 0.74 [0.71-0.77], ROC AUCbaseline+4METs 0.74 [0.71-0.77], ROC AUCbaseline+floors climbed 0.75 [0.71-0.78], AUCbaseline+fitnessvspeers 0.74 [0.71-0.77], and AUCbaseline+physical activity 0.75 [0.72-0.78]). CONCLUSIONS: Assessment of self-reported functional capacity expressed in METs or using the other measures assessed here did not improve prognostic accuracy compared with clinical risk factors. Caution is needed in the use of self-reported functional capacity to guide clinical decisions resulting from risk assessment in patients undergoing noncardiac surgery. CLINICAL TRIAL REGISTRATION: NCT03016936.
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Infarto do Miocárdio , Complicações Pós-Operatórias , Humanos , Estudos Prospectivos , Autorrelato , Complicações Pós-Operatórias/etiologia , Infarto do Miocárdio/etiologia , Medição de Risco , Fatores de RiscoRESUMO
INTRODUCTION: Previous studies demonstrated that the implementation of the Kidney Disease Improving Global Outcomes (KDIGO) guideline-based bundle, consisting of different supportive measures in patients at high risk for acute kidney injury (AKI), might reduce rate and severity of AKI after surgery. However, the effects of the care bundle in broader population of patients undergoing surgery require confirmation. METHODS AND ANALYSIS: The BigpAK-2 trial is an international, randomised, controlled, multicentre trial. The trial aims to enrol 1302 patients undergoing major surgery who are subsequently admitted to the intensive care or high dependency unit and are at high-risk for postoperative AKI as identified by urinary biomarkers (tissue inhibitor of metalloproteinases 2*insulin like growth factor binding protein 7 (TIMP-2)*IGFBP7)). Eligible patients will be randomised to receive either standard of care (control) or a KDIGO-based AKI care bundle (intervention). The primary endpoint is the incidence of moderate or severe AKI (stage 2 or 3) within 72 hours after surgery, according to the KDIGO 2012 criteria. Secondary endpoints include adherence to the KDIGO care bundle, occurrence and severity of any stage of AKI, change in biomarker values during 12 hours after initial measurement of (TIMP-2)*(IGFBP7), number of free days of mechanical ventilation and vasopressors, need for renal replacement therapy (RRT), duration of RRT, renal recovery, 30-day and 60-day mortality, intensive care unit length-of-stay and hospital length-of-stay and major adverse kidney events. An add-on study will investigate blood and urine samples from recruited patients for immunological functions and kidney damage. ETHICS AND DISSEMINATION: The BigpAK-2 trial was approved by the Ethics Committee of the Medical Faculty of the University of Münster and subsequently by the corresponding Ethics Committee of the participating sites. A study amendment was approved subsequently. In the UK, the trial was adopted as an NIHR portfolio study. Results will be disseminated widely and published in peer-reviewed journals, presented at conferences and will guide patient care and further research. TRIAL REGISTRATION NUMBER: NCT04647396.
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Injúria Renal Aguda , Inibidor Tecidual de Metaloproteinase-2 , Humanos , Inibidor Tecidual de Metaloproteinase-2/urina , Estudos Prospectivos , Biomarcadores , Injúria Renal Aguda/etiologia , Injúria Renal Aguda/prevenção & controle , Terapia de Substituição Renal , Estudos Multicêntricos como AssuntoRESUMO
Patients in the palliative phase of a disease often suffer from pain, which leads to a significant reduction in quality of life. Since in most cases there is a progression rather than an improvement of the disease over time, pain therapy must also be dynamically adapted. Due to accompanying symptoms and the physical burden of the disease, treatment of pain is often difficult. In the palliative situation, pain should not only be understood as an excitation of nociceptors but is rather also an expression of mental stress. In this article, we would like to give an overview of the available drugs, application methods and alternative treatment options. Specifically, the article is divided into the following subsections: non-opioid analgesics, opioids, co-analgesics, patient-controlled analgesia procedures, neuraxial and peripheral regional anesthesia procedures, neurolysis, supportive therapies and palliative sedation. Thus, when treating palliative patients, the focus should not only be on the one symptom of pain, but, in the sense of the bio-psycho-social model, a multimodal oriented treatment of the patient with all his symptoms, also including his relatives, must be carried out.
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Manejo da Dor , Cuidados Paliativos , Humanos , Cuidados Paliativos/métodos , Manejo da Dor/métodos , Qualidade de Vida , Dor , Analgésicos , Analgésicos Opioides/uso terapêuticoRESUMO
BACKGROUND: Volatile propofol can be measured in exhaled air and correlates to plasma concentrations with a time delay. However, the effect of single-lung ventilation on exhaled propofol is unclear. Therefore, our goal was to evaluate exhaled propofol concentrations during single-lung compared to double-lung ventilation using double-lumen tubes. METHODS: In a first step, we quantified adhesion of volatile propofol to the inner surface of double-lumen tubes during double- and single-lumen ventilation in vitro. In a second step, we enrolled 30 patients scheduled for lung surgery in two study centers. Anesthesia was provided with propofol and remifentanil. We utilized left-sided double-lumen tubes to separately ventilate each lung. Exhaled propofol concentrations were measured at 1-min intervals and plasma for propofol analyses was sampled every 20 min. To eliminate the influence of dosing on volatile propofol concentration, exhalation rate was normalized to plasma concentration. RESULTS: In-vitro ventilation of double-lumen tubes resulted in increasing propofol concentrations at the distal end of the tube over time. In vitro clamping the bronchial lumen led to an even more pronounced increase (Δ AUC +62%) in propofol gas concentration over time. Normalized propofol exhalation during lung surgery was 31% higher during single-lung compared to double-lung ventilation. CONCLUSION: During single-lung ventilation, propofol concentration in exhaled air, in contrast to our expectations, increased by approximately one third. However, this observation might not be affected by change in perfusion-ventilation during single-lung ventilation but rather arises from reduced propofol absorption on the inner surface area of the double-lumen tube. Thus, it is only possible to utilize exhaled propofol concentration to a limited extent during single-lung ventilation. REGISTRATION OF CLINICAL TRIAL: DRKS-ID DRKS00014788 (www.drks.de).
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Anestesia , Ventilação Monopulmonar , Propofol , Humanos , Ventilação Monopulmonar/métodos , Expiração , Remifentanil , Intubação Intratraqueal/métodosRESUMO
BACKGROUND: Patients suffering from severe trauma experience substantial immunological stress. Lung injury is a known risk factor for the development of posttraumatic complications, but information on the long-term course of the pulmonary inflammatory response and treatment with mild hypothermia are scarce. AIM: To investigate the pulmonary inflammatory response to multiple trauma and hemorrhagic shock in a porcine model of combined trauma and to assess the immunomodulatory properties of mild hypothermia. METHODS: Following induction of trauma (blunt chest trauma, liver laceration, tibia fracture), two degrees of hemorrhagic shock (45 and 50%) over 90 (n = 30) and 120 min. (n = 20) were induced. Animals were randomized to hypothermia (33°C) or normothermia (38°C). We evaluated bronchoalveolar lavage (BAL) fluid and tissue levels of cytokines and investigated changes in microRNA- and gene-expression as well as tissue apoptosis. RESULTS: We observed a significant induction of Interleukin (IL) 1ß, IL-6, IL-8, and Cyclooxygenase-2 mRNA in lung tissue. Likewise, an increased IL-6 protein concentration could be detected in BAL-fluid, with a slight decrease of IL-6 protein in animals treated with hypothermia. Lower IL-10 protein levels in normothermia and higher IL-10 protein concentrations in hypothermia accompanied this trend. Tissue apoptosis increased after trauma. However, intervention with hypothermia did not result in a meaningful reduction of pro-inflammatory biomarkers or tissue apoptosis. CONCLUSION: We observed signs of a time-dependent pulmonary inflammation and apoptosis at the site of severe trauma, and to a lower extent in the trauma-distant lung. Intervention with mild hypothermia had no considerable effect during 48 hours following trauma.
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Traumatismo Múltiplo , Choque Hemorrágico , Traumatismos Torácicos , Ferimentos não Penetrantes , Animais , Interleucina-10 , Interleucina-6 , Pulmão , Traumatismo Múltiplo/complicações , Traumatismo Múltiplo/terapia , Choque Hemorrágico/terapia , Suínos , Traumatismos Torácicos/complicações , Traumatismos Torácicos/terapiaRESUMO
BACKGROUND: Purpose of the present study is an evaluation of postoperative incidence for delirium after coronary artery bypass surgery (CABG). Study addressed whether application of Histidine-Tryptophan-Ketoglutarate (HTK) solution (Bretschneider) or blood cardioplegia (Calafiore) is associated with increased of postoperative delirium cases. MATERIALS AND METHODS: In a retrospective, single center evaluation a total number of 273 patients were enrolled in the study from January 2017 to October 2021. There were 124 patients assigned to the Calafiore group blood cardioplegic solution (BCC) and 149 patients were included in the Bretschneider group (HTK). The primary endpoint was the postoperative delirium rate in its frequency of occurrence. Definition of the dilirium status was performed using the Confusion Assessment Method in the Intensive Care Unit (CAM-ICU) score during the first three postoperative days. Secondary endpoints were the time intervals of intensive care duration of stay, mechanical ventilation, total extracorporeal circulation, ischemia and reperfusion. Serum levels of the electrolytes Sodium, Potassium, ionized Calcium, and Chloride were monitored. RESULTS: Although no significant difference in delirium status between the groups were noticed, on third postoperative day, delirium rate dependent on cardioplegia solution used (HTK 12.0%; BCC 3.0%; p = .024) and duration of intensive care stay differed (HTK 4.5 vs. BCC 3.0 days; p = .001). Although Ischemic time (HTK 73.0 vs. BCC 83.0 min; p < .001) and reperfusion time (HTK 35.0 vs. Calafiore 24.0 min; p < .001) were extended in the BCC group less cases of delirium were diagnosed. Serum sodium levels after HTK cardioplegic infusion were decreased (HTK 129.68 vs. BCC 138.96 mmol/l; p < .001). The significant difference persists up to the hundredth extracorporeal circulation circuit min (p = .005). CONCLUSION: The present data suggest an impact of the cardioplegic solution used upon postoperative delirium rates. Optimization of cardiac arrest protocols is needed. Present data encourage further prospective studies regarding the impact of cardioplegic solutions on electrolyte imbalance for postoperative delirium rates in CABG surgery.
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Soluções Cardioplégicas , Delírio do Despertar , Humanos , Incidência , Delírio do Despertar/tratamento farmacológico , Estudos Retrospectivos , Estudos Prospectivos , Parada Cardíaca Induzida/métodos , Ponte de Artéria Coronária/efeitos adversos , Ponte de Artéria Coronária/métodos , SódioRESUMO
Objectives: To determine the profile of cytokines in patients with severe COVID-19 who were enrolled in a trial of COVID-19 convalescent plasma (CCP). Methods: Patients were randomized to receive standard treatment and 3 CCP units or standard treatment alone (CAPSID trial, ClinicalTrials.gov NCT04433910). The primary outcome was a dichotomous composite outcome (survival and no longer severe COVID-19 on day 21). Time to clinical improvement was a key secondary endpoint. The concentrations of 27 cytokines were measured (baseline, day 7). We analyzed the change and the correlation between serum cytokine levels over time in different subgroups and the prediction of outcome in receiver operating characteristics (ROC) analyses and in multivariate models. Results: The majority of cytokines showed significant changes from baseline to day 7. Some were strongly correlated amongst each other (at baseline the cluster IL-1ß, IL-2, IL-6, IL-8, G-CSF, MIP-1α, the cluster PDGF-BB, RANTES or the cluster IL-4, IL-17, Eotaxin, bFGF, TNF-α). The correlation matrix substantially changed from baseline to day 7. The heatmaps of the absolute values of the correlation matrix indicated an association of CCP treatment and clinical outcome with the cytokine pattern. Low levels of IP-10, IFN-γ, MCP-1 and IL-1ß on day 0 were predictive of treatment success in a ROC analysis. In multivariate models, low levels of IL-1ß, IFN-γ and MCP-1 on day 0 were significantly associated with both treatment success and shorter time to clinical improvement. Low levels of IP-10, IL-1RA, IL-6, MCP-1 and IFN-γ on day 7 and high levels of IL-9, PDGF and RANTES on day 7 were predictive of treatment success in ROC analyses. Low levels of IP-10, MCP-1 and high levels of RANTES, on day 7 were associated with both treatment success and shorter time to clinical improvement in multivariate models. Conclusion: This analysis demonstrates a considerable dynamic of cytokines over time, which is influenced by both treatment and clinical course of COVID-19. Levels of IL-1ß and MCP-1 at baseline and MCP-1, IP-10 and RANTES on day 7 were associated with a favorable outcome across several endpoints. These cytokines should be included in future trials for further evaluation as predictive factors.
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COVID-19 , Citocinas , Humanos , Proteína Antagonista do Receptor de Interleucina 1 , Interleucina-17 , Quimiocina CCL3 , Fator de Necrose Tumoral alfa , Interleucina-6 , Interleucina-4 , Capsídeo , COVID-19/terapia , Becaplermina , Quimiocina CXCL10 , Interleucina-2 , Interleucina-8 , Interleucina-9 , Fator Estimulador de Colônias de Granulócitos , Soroterapia para COVID-19RESUMO
Background: Intraoperative hypotension is common in patients having non-cardiac surgery and associated with postoperative acute myocardial injury, acute kidney injury, and mortality. Avoiding intraoperative hypotension is a complex task for anesthesiologists. Using artificial intelligence to predict hypotension from clinical and hemodynamic data is an innovative and intriguing approach. The AcumenTM Hypotension Prediction Index (HPI) software (Edwards Lifesciences; Irvine, CA, USA) was developed using artificial intelligencespecifically machine learningand predicts hypotension from blood pressure waveform features. We aimed to describe the incidence, duration, severity, and causes of intraoperative hypotension when using HPI monitoring in patients having elective major non-cardiac surgery. Methods: We built up a European, multicenter, prospective, observational registry including at least 700 evaluable patients from five European countries. The registry includes consenting adults (≥18 years) who were scheduled for elective major non-cardiac surgery under general anesthesia that was expected to last at least 120 min and in whom arterial catheter placement and HPI monitoring was planned. The major objectives are to quantify and characterize intraoperative hypotension (defined as a mean arterial pressure [MAP] < 65 mmHg) when using HPI monitoring. This includes the time-weighted average (TWA) MAP < 65 mmHg, area under a MAP of 65 mmHg, the number of episodes of a MAP < 65 mmHg, the proportion of patients with at least one episode (1 min or more) of a MAP < 65 mmHg, and the absolute maximum decrease below a MAP of 65 mmHg. In addition, we will assess causes of intraoperative hypotension and investigate associations between intraoperative hypotension and postoperative outcomes. Discussion: There are only sparse data on the effect of using HPI monitoring on intraoperative hypotension in patients having elective major non-cardiac surgery. Therefore, we built up a European, multicenter, prospective, observational registry to describe the incidence, duration, severity, and causes of intraoperative hypotension when using HPI monitoring in patients having elective major non-cardiac surgery.
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STUDY OBJECTIVE: We explored the feasibility of a Clinical Decision Support System (CDSS) to guide evidence-based perioperative anticoagulation. DESIGN: Prospective randomised clinical management simulation multicentre study. SETTING: Five University and 11 general hospitals in Germany. PARTICIPANTS: We enrolled physicians (anaesthesiologist (n = 73), trauma surgeons (n = 2), unknown (n = 1)) with different professional experience. INTERVENTIONS: A CDSS based on a multiple-choice test was developed and validated at the University Hospital of Frankfurt (phase-I). The CDSS comprised European guidelines for the management of anticoagulation in cardiology, cardio-thoracic, non-cardio-thoracic surgery and anaesthesiology. Phase-II compared the efficiency of physicians in identifying evidence-based approach of managing perioperative anticoagulation. In total 168 physicians were randomised to CDSS (PERI-KOAG) or CONTROL. MEASUREMENTS: Overall mean score and association of processing time and professional experience were analysed. The multiple-choice test consists of 11 cases and two correct answers per question were required to gain 100% success rate (=22 points). MAIN RESULTS: In total 76 physicians completed the questionnaire (n = 42 PERI-KOAG; n = 34 CONTROL; attrition rate 54%). Overall mean score (max. 100% = 22 points) was significantly higher in PERI-KOAG compared to CONTROL (82 ± 15% vs. 70 ± 10%; 18 ± 3 vs. 15 ± 2 points; P = 0.0003). A longer processing time is associated with significantly increased overall mean scores in PERI-KOAG (≥33 min. 89 ± 10% (20 ± 2 points) vs. <33 min. 73 ± 15% (16 ± 3 points), P = 0.0005) but not in CONTROL (≥33 min. 74 ± 13% (16 ± 3 points) vs. <33 min. 69 ± 9% (15 ± 2 points), P = 0.11). Within PERI-KOAG, there is a tendency towards higher results within the more experienced group (>5 years), but no significant difference to less (≤5 years) experienced colleagues (87 ± 10% (19 ± 2 points) vs. 78 ± 17% (17 ± 4 points), P = 0.08). However, an association between professional experience and success rate in CONTROL has not been shown (71 ± 8% vs. 70 ± 13%, 16 ± 2 vs. 15 ± 3 points; P = 0.66). CONCLUSIONS: CDSS significantly improved the identification of evidence-based treatment approaches. A precise usage of CDSS is mandatory to maximise efficiency.
Assuntos
Sistemas de Apoio a Decisões Clínicas , Médicos , Anticoagulantes/efeitos adversos , Hospitais Universitários , Humanos , Estudos ProspectivosRESUMO
BACKGROUND: Double lumen tube (DLT) intubation is the most commonly used technique for one lung ventilation. Bronchial blockers (BB) are an alternative, especially for difficult airways. The EZ-bronchial blocker (EZB) is an innovative y-shaped and double-ended device of the BB family. METHODS: A randomised, controlled trial was conducted in 80 patients undergoing elective thoracic surgery using DLT or EZB for one lung ventilation (German Clinical Trial Register DRKS00014816). The objective of the study was to compare the clinical performance of EZB with DLT. Primary endpoint was total time to obtain successful one lung ventilation. Secondary endpoints were time subsections, quality of lung collapse, difficulty of intubation, any complications during the procedure, incidence of objective trauma of the oropharynx and supraglottic space and intubation-related subjective symptoms. RESULTS: 74 patients were included, DLT group (n = 38), EZB group (n = 36). Median total time to obtain one lung ventilation [IQR] in the DLT group was 234 s [207 to 294] versus 298 s [243 to 369] in the EZB group (P = 0.007). Median total time was relevantly influenced by different preparation times. Quality of lung collapse was equal in both groups, DLT group 89.5% were excellent vs. 83.3% in the EZB group (P = 0.444). Inadequate lung collapse in five patients of the EZB group resulted in unsuccessful repositioning attempts and secondary DLT placement. Endoscopic examinations revealed significantly more carina trauma (P = 0.047) and subglottic haemorrhage (P = 0.047) in the DLT group. Postoperative subjective symptoms (sore throat, hoarseness) were more common in the DLT group, as were speech problems. CONCLUSIONS: Using EZB prima facie results in prolonged time to obtain one lung ventilation with equal quality of lung collapse for the thoracic surgeon. If preparation times are omitted in the analysis, the time difference is statistically and clinically not relevant. Our data showed only little evidence for reducing objective airway trauma as well as subjective complaints. In summary both procedures were comparable in terms of times and clinical applicability. Therefore decisions for DLT or EZB should depend more on individual experience, in-house equipment and the individual patient, than on any times that are neither clinically significant nor relevant. TRIAL REGISTRATION: German Clinical Trial Register DRKS00014816 , prospectively registered on 07.06.2018.