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Brazilian version of the Critical Care Functional Rehabilitation Outcome Measure: translation, cross-cultural adaptation and evaluation of clinimetric properties 巴西版重症监护功能康复结果测量:翻译、跨文化适应和临床特性评估
Q2 Medicine Pub Date : 2022-01-01 DOI: 10.5935/0103-507X.20220025-en
L. A. Forgiarini Júnior, Brenda Lilja da Fontoura, D. Kobylinski, Soraia Genebra Ibrahim Forgiarini, V. Maldaner
Objective To translate, crossculturally adapt and evaluate the clinimetric properties of the Critical Care Functional Rehabilitation Outcome Measure for evaluating the functionality of patients admitted to intensive care units in Brazil. Methods The process of translation and cross-cultural adaptation involved the following steps: initial translation, synthesis, back-translation, expert committee review and pretesting. The intra- and interrater reliability and agreement were analyzed between two physical therapists who evaluated the same group of patients (n = 35). The evaluations were performed by each therapist independently and blinded to the score assigned by the other professional. The qualitative analysis was performed by the review committee, and the experts adapted and synthesized the Portuguese translation of the Critical Care Functional Rehabilitation Outcome Measure. Results There was agreement between the initial Brazilian translations of the Critical Care Functional Rehabilitation Outcome Measure scale. The conceptual, idiomatic, semantic and experimental equivalences between the original and translated versions were assessed, resulting in the final Brazilian version of the scale, called the Medida de Resultado da Reabilitação Funcional em Cuidados Intensivos. The evaluation of the clinimetric properties showed evidence of a high degree of agreement and reliability, as all had an intraclass correlation coefficient above 0.75. The overall intraclass correlation coefficient was 0.89. Conclusion The translated version of the Critical Care Functional Rehabilitation Outcome Measure scale for assessing the functionality of patients admitted to an intensive care unit can be used reliably in Brazil following translation and cross-cultural adaptation to Brazilian Portuguese and presents evidence of excellent interrater reliability.
目的翻译、跨文化适应和评估巴西重症监护功能康复结局指标的临床特性,以评估入住重症监护病房的患者的功能。方法翻译与跨文化适应的过程包括:初译、综合、反译、专家委员会评审和预测。分析两名物理治疗师评估同一组患者(n = 35)的内部和内部信度和一致性。评估由每位治疗师独立完成,对其他专业人员分配的分数不知情。由审查委员会进行定性分析,专家们改编并综合了葡萄牙语翻译的重症监护功能康复结果测量。结果重症监护功能康复结果测量量表的最初巴西译本之间存在一致。对原始版本和翻译版本之间的概念、习语、语义和实验等效性进行了评估,产生了最终的巴西版本,称为Medida de Resultado da reabilita o functional em Cuidados intenvos。临床特性的评估显示了高度的一致性和可靠性,因为所有的类内相关系数都在0.75以上。总体类内相关系数为0.89。结论用于评估重症监护病房入院患者功能的重症监护功能康复结果测量量表的翻译版本可以在巴西可靠地使用,经过对巴西葡萄牙语的翻译和跨文化适应,并提供了出色的翻译可信度的证据。
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引用次数: 0
To: First Brazilian recommendation on physiotherapy with sensory motor stimulation in newborns and infants in the intensive care unit 致:巴西首个关于新生儿和重症监护病房婴儿用感觉运动刺激进行物理治疗的建议
Q2 Medicine Pub Date : 2022-01-01 DOI: 10.5935/0103-507X.20220032-en
S. T. Almeida, D. S. Levy, Carla Lucchi Pagliaro, C. Silvério
The special article presented by Johnston et al., entitled “First Brazilian recommendation of physical therapy for sensorimotor stimulation of newborns and infants in an intensive care unit”,(1) aimed to provide guidelines for sensorimotor stimulation. However, caution should be used when analyzing and interpreting the results of the included studies and developing guidelines for the recommendations. To recommend the modalities of therapeutic massage, i.e., tactile-kinesthetic stimulation and multisensory stimulation to improve sucking, the results were aggregated for two different outcomes: weight and sucking. For a better interpretation of the results of the studies, it should be noted in tables 5S, 6S and 8S of the commented article that only in the latter, there is a a single publication that evaluated suction.(2) According to the analysis of the authors of this recommendation, the study has a moderate level of evidence, which we agree with. However, the results and conclusions should be interpreted with caution due to the limitations of the study, as noted by the authors themselves: the small sample size; the heterogeneous sample of infants with and without medical complications; and the lack of daily collection of data on sucking, which hinders the understanding of the variability of daily behaviors. All these findings limit the ability to generalize a recommendation. When analyzing the multisensory approach, this study did not control for confounding factors, thus leading to a risk of measurement bias. Therefore, there is no way to isolate the effect of multisensory stimulation as the only factor favoring the sucking performance of newborns subjected to auditory, tactile, visual and vestibular stimulation.(2) The authors of this document, which integrates and represents the 20202022 management of the Department of Dysphagia of the Sociedade Brasileira de Fonoaudiologia (SBFa), also highlight the role of the speech therapist as responsible and qualified for prevention, evaluation, diagnosis, functional/functional rehabilitation and management of sucking and swallowing disorders, acting in units of low, medium and high complexity, hospitals (including neonatal intensive care units), rehabilitation centers, among others.(3) Thus, specialized literature in this area may provide more robust evidence focused on the functions of sucking, swallowing and feeding. For example, a double-blinded randomized clinical trial using an oral stimulation program (applied by speech therapists) before the first attempt at oral assessment showed promising results. The intervention group reached level 4 of oral feeding ability 8 days before the control group, and 75.7% of participants reached level 4in the first oral attempt. The control group had a lower probability of reaching 100% of the diet when compared to the intervention in the same Sheila Tamanini de Almeida1 , Deborah Salle Levy2 , Carla Lucchi Pagliaro3 , Carolina Castelli Silvério4
Johnston等人发表的特别文章题为“巴西首次推荐新生儿和重症监护病房婴儿的感觉运动刺激物理疗法”,(1)旨在提供感觉运动刺激的指导方针。然而,在分析和解释纳入研究的结果以及为建议制定指导方针时,应谨慎行事。为了推荐治疗按摩的方式,即触觉-动觉刺激和多感官刺激来改善吮吸,结果汇总为两个不同的结果:体重和吮吸。为了更好的解释研究的结果,在评论文章的表5S, 6S和8S中需要注意的是,只有在评论文章中,只有一篇出版物评估了吸力。(2)根据本推荐作者的分析,该研究具有中等水平的证据,我们同意。然而,由于研究的局限性,结果和结论应谨慎解释,正如作者自己所指出的:样本量小;有和没有医学并发症的婴儿的异质样本;而且缺乏关于吸吮的日常数据收集,这阻碍了对日常行为可变性的理解。所有这些发现限制了推广建议的能力。在分析多感官方法时,本研究没有控制混杂因素,从而导致测量偏倚的风险。因此,没有办法将多感觉刺激的影响作为影响新生儿在听觉、触觉、视觉和前庭刺激下吮吸表现的唯一因素。(2)本文件的作者整合并代表了巴西听觉学会(SBFa)吞咽困难科的20202022年管理,也强调了语言治疗师在预防、评估、诊断方面的责任和资格。吮吸和吞咽障碍的功能/功能康复和管理,适用于低、中、高复杂性的单位,医院(包括新生儿重症监护病房),康复中心等。(3)因此,该领域的专业文献可能会提供更有力的证据,关注吮吸、吞咽和喂养的功能。例如,一项双盲随机临床试验在第一次尝试进行口腔评估之前使用了口腔刺激计划(由语言治疗师应用),结果显示出很好的效果。干预组比对照组早8天达到4级口服喂养能力,75.7%的参与者在第一次口腔尝试中达到4级。对照组达到100%饮食目标的可能性低于同样的实验组:希拉·塔马尼尼·德·阿尔梅达、黛博拉·萨勒·莱维、卡拉·卢奇·帕格里亚罗、卡罗莱纳·卡斯泰利·西尔维萨里
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引用次数: 0
Extracorporeal mechanical support and aspiration thrombectomy in treatment of massive pulmonary embolism: a case report 体外机械支持和吸入性取栓治疗大面积肺栓塞1例
Q2 Medicine Pub Date : 2022-01-01 DOI: 10.5935/0103-507X.20220342-en
João Valente Jorge, C. Barreiros, Doroteia R Silva, R. Calé, J. Ribeiro
Acute massive pulmonary embolism is the most serious presentation of venous thromboembolism that can ultimately cause obstructive shock, leading to cardiac arrest and death. In this case report, the authors present a case of a 49-year-old female who successfully recovered from a massive pulmonary embolism with the combined use of venoarterial extracorporeal membrane oxygenation and pulmonary aspiration thrombectomy, with no complications from these procedures. Although evidence of benefit from mechanical support has not been established for patients with massive pulmonary embolism, the implementation of extracorporeal cardiocirculatory support during resuscitation may allow improvement of systemic organ perfusion and better chance of survival. Recent guidelines from the European Society of Cardiology state that venoarterial extracorporeal membrane oxygenation in combination with catheter-directed treatment may be considered for patients presenting with massive pulmonary embolism and refractory cardiac arrest. The use of extracorporeal membrane oxygenation as a stand-alone technique with anticoagulation remains controversial, and additional therapies, such as surgical or percutaneous embolectomy, must be considered. Since this intervention is not supported by high-quality studies, we believe it is important to report real-world successful cases. With this case report, we illustrate the benefit derived from resuscitation assisted by extracorporeal mechanical support and early aspiration thrombectomy in patients with massive pulmonary embolism. Additionally, it emphasizes the synergy that derives from integrated multidisciplinary systems for providing complex interventions, of which extracorporeal membrane oxygenation and Interventional Cardiology are clear examples.
急性大面积肺栓塞是静脉血栓栓塞最严重的表现,最终可引起阻塞性休克,导致心脏骤停和死亡。在这个病例报告中,作者报告了一个49岁的女性病例,她成功地从一个巨大的肺栓塞中恢复,联合使用静脉动脉体外膜氧合和肺吸入性血栓切除术,这些手术没有并发症。虽然没有证据表明机械支持对大面积肺栓塞患者有益,但在复苏期间实施体外心肺支持可能会改善全身器官灌注,提高生存机会。欧洲心脏病学会最近的指南指出,对于出现大面积肺栓塞和难治性心脏骤停的患者,可以考虑静脉体外膜氧合联合导管指导治疗。体外膜氧合作为抗凝的独立技术仍然存在争议,必须考虑其他治疗方法,如手术或经皮栓塞切除术。由于这种干预没有高质量的研究支持,我们认为报告现实世界的成功案例是很重要的。在这个病例报告中,我们阐述了在体外机械支持和早期吸入性血栓切除术的辅助下对大面积肺栓塞患者进行复苏的益处。此外,它强调了提供复杂干预的综合多学科系统的协同作用,其中体外膜氧合和介入心脏病学是明显的例子。
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引用次数: 0
The Respiratory Rate-Oxygenation Index predicts failure of post-extubation high-flow nasal cannula therapy in intensive care unit patients: a retrospective cohort study. 呼吸速率-氧合指数预测重症监护室患者拔管后高流量鼻插管治疗失败:一项回顾性队列研究。
Q2 Medicine Pub Date : 2022-01-01 DOI: 10.5935/0103-507X.20220477-pt
Yuli V Fuentes, Katherine Carvajal, Santiago Cardona, Gina Sofia Montaño, Elsa D Ibáñez-Prada, Alirio Bastidas, Eder Caceres, Ricardo Buitrago, Marcela Poveda, Luis Felipe Reyes

Objective: To investigate the applicability of the Respiratory Rate-Oxygenation Index to identify the risk of high-flow nasal cannula failure in post-extubation pneumonia patients.

Methods: This was a 2-year retrospective observational study conducted in a reference hospital in Bogotá, Colombia. All patients in whom post-extubation high-flow nasal cannula therapy was used as a bridge to extubation were included in the study. The Respiratory Rate-Oxygenation Index was calculated to assess the risk of post-extubation high-flow nasal cannula failure.

Results: A total of 162 patients were included in the study. Of these, 23.5% developed high-flow nasal cannula failure. The Respiratory Rate-Oxygenation Index was significantly lower in patients who had high-flow nasal cannula failure [median (IQR): 10.0 (7.7 - 14.4) versus 12.6 (10.1 - 15.6); p = 0.006]. Respiratory Rate-Oxygenation Index > 4.88 showed a crude OR of 0.23 (95%CI 0.17 - 0.30) and an adjusted OR of 0.89 (95%CI 0.81 - 0.98) stratified by severity and comorbidity. After logistic regression analysis, the Respiratory Rate-Oxygenation Index had an adjusted OR of 0.90 (95%CI 0.82 - 0.98; p = 0.026). The area under the Receiver Operating Characteristic curve for extubation failure was 0.64 (95%CI 0.53 - 0.75; p = 0.06). The Respiratory Rate-Oxygenation Index did not show differences between patients who survived and those who died during the intensive care unit stay.

Conclusion: The Respiratory Rate-Oxygenation Index is an accessible tool to identify patients at risk of failing high-flow nasal cannula post-extubation treatment. Prospective studies are needed to broaden the utility in this scenario.

目的:探讨呼吸速率-氧合指数在诊断拔管后肺炎患者高流量鼻插管失败风险中的适用性。方法:这是一项在哥伦比亚波哥大一家参考医院进行的为期2年的回顾性观察研究。所有拔管后使用高流量鼻插管治疗作为拔管桥梁的患者均纳入研究。计算呼吸速率-氧合指数以评估拔管后高流量鼻插管失败的风险。结果:共纳入162例患者。其中,23.5%出现高流量鼻插管失败。高流量鼻插管失败患者的呼吸速率-氧合指数显著降低[中位数(IQR): 10.0 (7.7 - 14.4) vs 12.6 (10.1 - 15.6);P = 0.006]。呼吸速率-氧合指数> 4.88,按严重程度和合并症分层,粗OR为0.23 (95%CI 0.17 ~ 0.30),调整OR为0.89 (95%CI 0.81 ~ 0.98)。经logistic回归分析,呼吸速率-氧合指数调整OR为0.90 (95%CI 0.82 ~ 0.98;P = 0.026)。拔管失败的受试者工作特征曲线下面积为0.64 (95%CI 0.53 ~ 0.75;P = 0.06)。呼吸速率-氧合指数在重症监护期间存活和死亡的患者之间没有显示差异。结论:呼吸速率-氧合指数是一种可识别高流量鼻插管拔管后治疗失败风险患者的工具。需要前瞻性研究来扩大在这种情况下的效用。
{"title":"The Respiratory Rate-Oxygenation Index predicts failure of post-extubation high-flow nasal cannula therapy in intensive care unit patients: a retrospective cohort study.","authors":"Yuli V Fuentes,&nbsp;Katherine Carvajal,&nbsp;Santiago Cardona,&nbsp;Gina Sofia Montaño,&nbsp;Elsa D Ibáñez-Prada,&nbsp;Alirio Bastidas,&nbsp;Eder Caceres,&nbsp;Ricardo Buitrago,&nbsp;Marcela Poveda,&nbsp;Luis Felipe Reyes","doi":"10.5935/0103-507X.20220477-pt","DOIUrl":"https://doi.org/10.5935/0103-507X.20220477-pt","url":null,"abstract":"<p><strong>Objective: </strong>To investigate the applicability of the Respiratory Rate-Oxygenation Index to identify the risk of high-flow nasal cannula failure in post-extubation pneumonia patients.</p><p><strong>Methods: </strong>This was a 2-year retrospective observational study conducted in a reference hospital in Bogotá, Colombia. All patients in whom post-extubation high-flow nasal cannula therapy was used as a bridge to extubation were included in the study. The Respiratory Rate-Oxygenation Index was calculated to assess the risk of post-extubation high-flow nasal cannula failure.</p><p><strong>Results: </strong>A total of 162 patients were included in the study. Of these, 23.5% developed high-flow nasal cannula failure. The Respiratory Rate-Oxygenation Index was significantly lower in patients who had high-flow nasal cannula failure [median (IQR): 10.0 (7.7 - 14.4) versus 12.6 (10.1 - 15.6); p = 0.006]. Respiratory Rate-Oxygenation Index > 4.88 showed a crude OR of 0.23 (95%CI 0.17 - 0.30) and an adjusted OR of 0.89 (95%CI 0.81 - 0.98) stratified by severity and comorbidity. After logistic regression analysis, the Respiratory Rate-Oxygenation Index had an adjusted OR of 0.90 (95%CI 0.82 - 0.98; p = 0.026). The area under the Receiver Operating Characteristic curve for extubation failure was 0.64 (95%CI 0.53 - 0.75; p = 0.06). The Respiratory Rate-Oxygenation Index did not show differences between patients who survived and those who died during the intensive care unit stay.</p><p><strong>Conclusion: </strong>The Respiratory Rate-Oxygenation Index is an accessible tool to identify patients at risk of failing high-flow nasal cannula post-extubation treatment. Prospective studies are needed to broaden the utility in this scenario.</p>","PeriodicalId":53519,"journal":{"name":"Revista Brasileira de Terapia Intensiva","volume":"34 3","pages":"360-366"},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9749095/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10717267","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Patient safety culture and incidents recorded during nursing shift changes in intensive care units. 重症监护室护理班次变化期间记录的患者安全文化和事故。
Q2 Medicine Pub Date : 2022-01-01 DOI: 10.5935/0103-507X.20220446-pt
Elaine Machado Oliveira, Rafaela Andolhe, Kátia Grillo Padilha

Objective: To analyze the association of patient safety culture perceived by nursing professionals with incidents recorded during nursing shifts in intensive care units.

Methods: This was a cross-sectional study that investigated patient safety culture measured by the Hospital Survey on Patient Safety Culture instrument. Descriptive statistics, chi-square tests, Student's t-test and multiple linear regression models were analyzed considering a significance level of 5%.

Results: The study reported a mean of 3.1 (standard deviation of 0.4) for the culture of patient safety in the perception of nursing professionals and 480 incidents with and without damage recorded during the nursing shifts. The variables patient safety culture with a difference between means of 0.543 (95%CI 0.022 - 1.065; p < 0.05) and nursing assistants with a difference between means of -0.133 (95%CI -0.192 - -0.074; p < 0.05) were associated with the incidents recorded during the nursing shifts. Further, nursing assistants had a lower tendency to record incidents than did the nurses.

Conclusion: The strengthening of the patient safety culture and the aspects tangential to the nursing professionals represent a possible target for interventions to encourage the recording of incidents during the nursing shift shifts and improve patient safety.

目的:分析护理专业人员感知的患者安全文化与重症监护室轮班期间记录的事故之间的关系。方法:本研究为横断面研究,以医院病患安全文化调查仪器测量病患安全文化。采用描述性统计、卡方检验、Student’st检验和多元线性回归模型,显著性水平为5%。结果:该研究报告了护理专业人员感知患者安全文化的平均值为3.1(标准差为0.4),在护理班次期间记录了480起有或无损害事件。各变量患者安全培养差异均值为0.543 (95%CI 0.022 ~ 1.065;p < 0.05)和护理员之间的均值差异为-0.133 (95%CI -0.192 ~ -0.074;P < 0.05)与值班期间记录的事件相关。此外,护理助理记录事件的倾向低于护士。结论:加强患者安全文化和护理专业人员的相关方面可能是干预的目标,以鼓励记录护理轮班期间的事件,提高患者安全。
{"title":"Patient safety culture and incidents recorded during nursing shift changes in intensive care units.","authors":"Elaine Machado Oliveira,&nbsp;Rafaela Andolhe,&nbsp;Kátia Grillo Padilha","doi":"10.5935/0103-507X.20220446-pt","DOIUrl":"https://doi.org/10.5935/0103-507X.20220446-pt","url":null,"abstract":"<p><strong>Objective: </strong>To analyze the association of patient safety culture perceived by nursing professionals with incidents recorded during nursing shifts in intensive care units.</p><p><strong>Methods: </strong>This was a cross-sectional study that investigated patient safety culture measured by the Hospital Survey on Patient Safety Culture instrument. Descriptive statistics, chi-square tests, Student's t-test and multiple linear regression models were analyzed considering a significance level of 5%.</p><p><strong>Results: </strong>The study reported a mean of 3.1 (standard deviation of 0.4) for the culture of patient safety in the perception of nursing professionals and 480 incidents with and without damage recorded during the nursing shifts. The variables patient safety culture with a difference between means of 0.543 (95%CI 0.022 - 1.065; p < 0.05) and nursing assistants with a difference between means of -0.133 (95%CI -0.192 - -0.074; p < 0.05) were associated with the incidents recorded during the nursing shifts. Further, nursing assistants had a lower tendency to record incidents than did the nurses.</p><p><strong>Conclusion: </strong>The strengthening of the patient safety culture and the aspects tangential to the nursing professionals represent a possible target for interventions to encourage the recording of incidents during the nursing shift shifts and improve patient safety.</p>","PeriodicalId":53519,"journal":{"name":"Revista Brasileira de Terapia Intensiva","volume":"34 3","pages":"386-392"},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9749089/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10351911","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Antivirals for adult patients hospitalized with SARS-CoV-2 infection: A randomized, Phase II/III, multicenter, placebo-controlled, adaptive study, with multiple arms and stages. COALITION COVID-19 BRAZIL IX – REVOLUTIOn: protocol and statistical analysis plan 成年SARS-CoV-2感染住院患者的抗病毒药物:一项随机、II/III期、多中心、安慰剂对照、适应性研究,包括多组和分期。联盟COVID-19巴西IX -革命:协议和统计分析计划
Q2 Medicine Pub Date : 2022-01-01 DOI: 10.5935/0103-507X.20220002-en
I. Maia, A. Marcadenti, F. Zampieri, L. Damiani, R. H. Santos, K. Negrelli, S. P. Gomes, Jaqueline Oliveira Gomes, Mariana Barbosa Dos Santos Carollo, T. A. Miranda, E. Santucci, Nanci Valeis, L. Laranjeira, G. Westphal, J. G. Horta, U. Flato, C. Fernandes, W. C. Barros, Renata S Bolan, O. Gebara, M. S. A. Alencar Filho, V. A. Hamamoto, M. Hernandes, N. Golin, Ronald Torres de Olinda, F. Machado, R. Rosa, V. Veiga, L. Azevedo, Á. Avezum, R. Lopes, Tiago Moreno L Souza, O. Berwanger, A. Cavalcanti
Repurposed drugs are important in resource-limited settings because the interventions are more rapidly available, have already been tested safely in other populations and are inexpensive. Repurposed drugs are an effective solution, especially for emerging diseases such as COVID-19. The REVOLUTIOn trial has the objective of evaluating three repurposed antiviral drugs, atazanavir, daclatasvir and sofosbuvir, already used for HIV- and hepatitis C virus-infected patients in a randomized, placebo-controlled, adaptive, multiarm, multistage study. The drugs will be tested simultaneously in a Phase II trial to first identify whether any of these drugs alone or in combination reduce the viral load. If they do, a Phase III trial will be initiated to investigate if these medications are capable of increasing the number of days free respiratory support. Participants must be hospitalized adults aged ≥ 18 years with initiation of symptoms ≤ 9 days and SpO2 ≤ 94% in room air or a need for supplemental oxygen to maintain an SpO2 > 94%. The expected total sample size ranges from 252 to 1,005 participants, depending on the number of stages that will be completed in the study. Hence, the protocol is described here in detail together with the statistical analysis plan. In conclusion, the REVOLUTIOn trial is designed to provide evidence on whether atazanavir, daclatasvir or sofosbuvir decrease the SARS-CoV-2 load in patients with COVID-19 and increase the number of days patients are free of respiratory support. In this protocol paper, we describe the rationale, design, and status of the trial. ClinicalTrials.gov identifier: NCT04468087
重新利用的药物在资源有限的情况下很重要,因为干预措施可以更快地获得,已经在其他人群中进行了安全试验,而且价格低廉。重新利用药物是一种有效的解决方案,特别是对于COVID-19等新出现的疾病。REVOLUTIOn试验的目的是在一项随机、安慰剂对照、适应性、多组、多阶段研究中评估三种重新用途的抗病毒药物阿扎那韦、daclatasvir和sofosbuvir,这三种药物已经用于HIV和丙型肝炎病毒感染患者。这些药物将同时在二期试验中进行测试,首先确定这些药物单独使用或联合使用是否能降低病毒载量。如果确实如此,将启动三期试验,以调查这些药物是否能够增加免费呼吸支持的天数。参与者必须是年龄≥18岁、开始出现症状≤9天、室内空气中SpO2≤94%或需要补充氧气维持SpO2 bb0 94%的住院成年人。预计总样本量在252至1005名参与者之间,具体取决于研究将完成的阶段数量。因此,这里将详细描述该方案以及统计分析计划。总之,REVOLUTIOn试验旨在提供证据,证明阿扎那韦、daclatasvir或索非布韦是否能降低COVID-19患者的SARS-CoV-2载量,并增加患者无需呼吸支持的天数。在这篇协议文件中,我们描述了试验的基本原理、设计和现状。ClinicalTrials.gov识别码:NCT04468087
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引用次数: 2
Current stage of the intensive care unit structure in Argentina: results from the Sociedad Argentina de Terapia Intensiva self-assessment survey of intensive care units 阿根廷重症监护病房结构的当前阶段:来自阿根廷重症监护病房协会自我评估调查的结果
Q2 Medicine Pub Date : 2022-01-01 DOI: 10.5935/0103-507X.20220021-en
R. Gilardino, A. Gallesio, M. Arias-López, N. Boada, V. Mandich, J. Sagardia, M. E. Ratto, A. Fernández
Objective To describe and compare the structure of Argentinean intensive care units that completed the “self-assessment survey of intensive care units” developed by the Sociedad Argentina de Terapia Intensiva. Methods An observational crosssectional study was conducted using an online voluntary survey through the Sociedad Argentina de Terapia Intensiva member database and other social media postings. Answers received between December 2018 and July 2020 were analyzed. Descriptive statistics and nonparametric tests were used. Results A total of 392 surveys were received, and 244 were considered for the analysis. Seventy-seven percent (187/244) belonged to adult intensive care units, and 23% (57/244) belonged to pediatric intensive care units. The overall completion rate was 76%. The sample included 2,567 ICU beds (adult: 1,981; pediatric: 586). We observed a clear concentration of intensive care units in the Central and Buenos Aires regions of Argentina. The median number of beds was 10 (interquartile range 7 - 15). The median numbers of multiparameter monitors, mechanical ventilators, and pulse oximeters were 1 per bed with no regional or intensive care unit type differences (adult versus pediatric). Although our sample showed that the pediatric intensive care units had a higher mechanical ventilation/bed ratio than the adult intensive care units, this finding was not linearly correlated. Conclusion Argentina has a notable concentration of critical care beds and better structural complexity in the Buenos Aires and Centro regions for both adult and pediatric intensive care units. In addition, a lack of accurate data reported from the intensive care unit structure and resources was observed. Further improvement opportunities are required to allocate intensive care unit resources at the institutional and regional levels.
目的对完成阿根廷重症监护病房自我评估调查的阿根廷重症监护病房的结构进行描述和比较。方法通过阿根廷社会协会会员数据库和其他社交媒体帖子进行在线自愿调查,进行观察性横断面研究。对2018年12月至2020年7月收到的答案进行了分析。采用描述性统计和非参数检验。结果共收到调查问卷392份,其中244份纳入分析。成人重症监护病房占77%(187/244),儿科重症监护病房占23%(57/244)。总体完成率为76%。样本包括2567张ICU床位(成人:1981张;儿科:586)。我们观察到重症监护病房明显集中在阿根廷中部和布宜诺斯艾利斯地区。床位数中位数为10张(四分位数间距7 - 15)。多参数监护仪、机械呼吸机和脉搏血氧仪的中位数为每张病床1台,没有地区或重症监护病房类型差异(成人与儿科)。虽然我们的样本显示儿科重症监护病房的机械通气/床位比高于成人重症监护病房,但这一发现并不是线性相关的。结论阿根廷的成人和儿童重症监护病房在布宜诺斯艾利斯和Centro地区的床位集中度和结构复杂性均较好。此外,观察到缺乏来自重症监护病房结构和资源的准确数据。需要有进一步改进的机会,以便在机构和区域两级分配重症监护病房资源。
{"title":"Current stage of the intensive care unit structure in Argentina: results from the Sociedad Argentina de Terapia Intensiva self-assessment survey of intensive care units","authors":"R. Gilardino, A. Gallesio, M. Arias-López, N. Boada, V. Mandich, J. Sagardia, M. E. Ratto, A. Fernández","doi":"10.5935/0103-507X.20220021-en","DOIUrl":"https://doi.org/10.5935/0103-507X.20220021-en","url":null,"abstract":"Objective To describe and compare the structure of Argentinean intensive care units that completed the “self-assessment survey of intensive care units” developed by the Sociedad Argentina de Terapia Intensiva. Methods An observational crosssectional study was conducted using an online voluntary survey through the Sociedad Argentina de Terapia Intensiva member database and other social media postings. Answers received between December 2018 and July 2020 were analyzed. Descriptive statistics and nonparametric tests were used. Results A total of 392 surveys were received, and 244 were considered for the analysis. Seventy-seven percent (187/244) belonged to adult intensive care units, and 23% (57/244) belonged to pediatric intensive care units. The overall completion rate was 76%. The sample included 2,567 ICU beds (adult: 1,981; pediatric: 586). We observed a clear concentration of intensive care units in the Central and Buenos Aires regions of Argentina. The median number of beds was 10 (interquartile range 7 - 15). The median numbers of multiparameter monitors, mechanical ventilators, and pulse oximeters were 1 per bed with no regional or intensive care unit type differences (adult versus pediatric). Although our sample showed that the pediatric intensive care units had a higher mechanical ventilation/bed ratio than the adult intensive care units, this finding was not linearly correlated. Conclusion Argentina has a notable concentration of critical care beds and better structural complexity in the Buenos Aires and Centro regions for both adult and pediatric intensive care units. In addition, a lack of accurate data reported from the intensive care unit structure and resources was observed. Further improvement opportunities are required to allocate intensive care unit resources at the institutional and regional levels.","PeriodicalId":53519,"journal":{"name":"Revista Brasileira de Terapia Intensiva","volume":"34 1","pages":"237 - 246"},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71065505","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
A nationwide survey on health resources and clinical practices during the early COVID-19 pandemic in Brazil 巴西COVID-19大流行早期卫生资源和临床实践的全国性调查
Q2 Medicine Pub Date : 2022-01-01 DOI: 10.5935/0103-507X.20220005-en
Pedro Paulo Zanella do Amaral Campos, Guilherme Martins de Souza, T. Midega, H. Guimarães, T. Corrêa, R. Cordioli
Objective: To evaluate clinical practices and hospital resource organization during the early COVID-19 pandemic in Brazil. Methods: This was a multicenter, cross-sectional survey. An electronic questionnaire was provided to emergency department and intensive care unit physicians attending COVID-19 patients. The survey comprised four domains: characteristics of the participants, clinical practices, COVID-19 treatment protocols and hospital resource organization. Results: Between May and June 2020, 284 participants [median (interquartile ranges) age 39 (33 - 47) years, 56.3% men] responded to the survey; 33% were intensivists, and 9% were emergency medicine specialists. Half of the respondents worked in public hospitals. Noninvasive ventilation (89% versus 73%; p = 0.001) and highflow nasal cannula (49% versus 32%; p = 0.005) were reported to be more commonly available in private hospitals than in public hospitals. Mechanical ventilation was more commonly used in public hospitals than private hospitals (70% versus 50%; p = 0,024). In the Emergency Departments, positive endexpiratory pressure was most commonly adjusted according to SpO2, while in the intensive care units, positive end-expiratory pressure was adjusted according to the best lung compliance. In the Emergency Departments, 25% of the respondents did not know how to set positive end-expiratory pressure. Compared to private hospitals, public hospitals had a lower availability of protocols for personal protection equipment during tracheal intubation (82% versus 94%; p = 0.005), managing mechanical ventilation [64% versus 75%; p = 0.006] and weaning patients from mechanical ventilation [34% versus 54%; p = 0.002]. Finally, patients spent less time in the emergency department before being transferred to the intensive care unit in private hospitals than in public hospitals [2 (1 - 3) versus 5 (2 - 24) hours; p < 0.001]. Conclusion: This survey revealed significant heterogeneity in the organization of hospital resources, clinical practices and treatments among physicians during the early COVID-19 pandemic in Brazil.
目的:评价巴西COVID-19大流行早期的临床实践和医院资源组织。方法:采用多中心横断面调查。向急诊和重症监护病房的医生提供了一份电子问卷。调查包括四个领域:参与者特征、临床实践、COVID-19治疗方案和医院资源组织。结果:在2020年5月至6月期间,284名参与者[中位数(四分位数间距)为39岁(33 - 47岁),男性56.3%]回应了调查;33%是重症医师,9%是急诊医学专家。半数受访者在公立医院工作。无创通气(89%对73%;P = 0.001)和高流量鼻插管(49%对32%;P = 0.005),在私立医院比在公立医院更常见。公立医院比私立医院更常使用机械通气(70%比50%;P = 0.024)。在急诊科,呼气末正压最常根据SpO2调整,而在重症监护病房,呼气末正压根据最佳肺顺应性调整。在急诊科,25%的受访者不知道如何设定呼气末正压。与私立医院相比,公立医院在气管插管期间个人防护设备协议的可得性较低(82%对94%;P = 0.005),管理机械通气[64%对75%;P = 0.006]和脱离机械通气的患者[34%对54%;P = 0.002]。最后,与公立医院相比,私立医院的患者在转到重症监护室之前在急诊科待的时间更短[2(1 - 3)小时比5(2 - 24)小时];P < 0.001]。结论:本调查揭示了巴西早期COVID-19大流行期间医院资源组织、临床实践和医生治疗的显著异质性。
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引用次数: 1
Effects of balanced solution on short-term outcomes in traumatic brain injury patients: a secondary analysis of the BaSICS randomized trial 平衡溶液对创伤性脑损伤患者短期预后的影响:对BaSICS随机试验的二次分析
Q2 Medicine Pub Date : 2022-01-01 DOI: 10.5935/0103-507X.20220261-en
F. Zampieri, L. Damiani, R. Biondi, F. Freitas, V. Veiga, R. Figueiredo, A. Serpa-Neto, A. L. O. Manoel, T. A. Miranda, T. Corrêa, L. Azevedo, N. B. Silva, F. Machado, A. Cavalcanti
Objective To describe the effects of balanced solution use on the short-term outcomes of patients with traumatic brain injury enrolled in BaSICS trial. Methods Patients were randomized to receive either 0.9% saline or balanced solution during their intensive care unit stay. The primary endpoint was 90-day mortality, and the secondary outcomes were days alive and free of intensive care unit stay at 28 days. The primary endpoint was assessed using Bayesian logistic regression. The secondary endpoint was assessed using a Bayesian zero-inflated beta binomial regression. Results We included 483 patients (236 in the 0.9% saline arm and 247 in the balanced solution arm). A total of 338 patients (70%) with a Glasgow coma scale score ≤ 12 were enrolled. The overall probability that balanced solutions were associated with higher 90-day mortality was 0.98 (OR 1.48; 95%CrI 1.04 - 2.09); this mortality increment was particularly noticeable in patients with a Glasgow coma scale score below 6 at enrollment (probability of harm of 0.99). Balanced solutions were associated with -1.64 days alive and free of intensive care unit at 28 days (95%CrI -3.32 - 0.00) with a probability of harm of 0.97. Conclusion There was a high probability that balanced solutions were associated with high 90-day mortality and fewer days alive and free of intensive care units at 28 days. ClinicalTrials.gov: NCT02875873
目的探讨平衡液的使用对BaSICS试验中创伤性脑损伤患者短期预后的影响。方法患者在重症监护室住院期间随机接受0.9%生理盐水或平衡溶液。主要终点是90天死亡率,次要终点是存活天数和28天无重症监护病房。主要终点采用贝叶斯逻辑回归进行评估。次要终点采用贝叶斯零膨胀β二项回归进行评估。结果纳入483例患者(0.9%生理盐水组236例,平衡溶液组247例)。格拉斯哥昏迷评分≤12分的患者共338例(70%)入组。平衡溶液与较高90天死亡率相关的总体概率为0.98 (OR 1.48;95%CrI (1.04 - 2.09);在入组时格拉斯哥昏迷评分低于6分的患者中,这种死亡率增加尤为明显(危害概率为0.99)。平衡溶液与-1.64天存活和28天无重症监护病房相关(95%CrI -3.32 - 0.00),危害概率为0.97。结论平衡溶液与高90天死亡率、28天存活和离开重症监护病房天数相关的可能性较大。ClinicalTrials.gov: NCT02875873
{"title":"Effects of balanced solution on short-term outcomes in traumatic brain injury patients: a secondary analysis of the BaSICS randomized trial","authors":"F. Zampieri, L. Damiani, R. Biondi, F. Freitas, V. Veiga, R. Figueiredo, A. Serpa-Neto, A. L. O. Manoel, T. A. Miranda, T. Corrêa, L. Azevedo, N. B. Silva, F. Machado, A. Cavalcanti","doi":"10.5935/0103-507X.20220261-en","DOIUrl":"https://doi.org/10.5935/0103-507X.20220261-en","url":null,"abstract":"Objective To describe the effects of balanced solution use on the short-term outcomes of patients with traumatic brain injury enrolled in BaSICS trial. Methods Patients were randomized to receive either 0.9% saline or balanced solution during their intensive care unit stay. The primary endpoint was 90-day mortality, and the secondary outcomes were days alive and free of intensive care unit stay at 28 days. The primary endpoint was assessed using Bayesian logistic regression. The secondary endpoint was assessed using a Bayesian zero-inflated beta binomial regression. Results We included 483 patients (236 in the 0.9% saline arm and 247 in the balanced solution arm). A total of 338 patients (70%) with a Glasgow coma scale score ≤ 12 were enrolled. The overall probability that balanced solutions were associated with higher 90-day mortality was 0.98 (OR 1.48; 95%CrI 1.04 - 2.09); this mortality increment was particularly noticeable in patients with a Glasgow coma scale score below 6 at enrollment (probability of harm of 0.99). Balanced solutions were associated with -1.64 days alive and free of intensive care unit at 28 days (95%CrI -3.32 - 0.00) with a probability of harm of 0.97. Conclusion There was a high probability that balanced solutions were associated with high 90-day mortality and fewer days alive and free of intensive care units at 28 days. ClinicalTrials.gov: NCT02875873","PeriodicalId":53519,"journal":{"name":"Revista Brasileira de Terapia Intensiva","volume":"34 1","pages":"410 - 417"},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71065661","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 2
The prognostic value of peripheral ischemic microvascular reserve in sepsis is not related to calcitonin gene-related peptide or substance P 脓毒症患者外周血缺血微血管储备的预后价值与降钙素基因相关肽或P物质无关
Q2 Medicine Pub Date : 2022-01-01 DOI: 10.5935/0103-507X.20220102-en
Ana Carolina de Miranda, Fernanda do Carmo De Stefani, H. Carraro Júnior, Alain Márcio Luy, L. Ferreira, L. G. Morello, I. A. C. Menezes
Objective To evaluate the mechanisms attributed to the prognostic value of peripheral ischemic microvascular reserve in patients with sepsis. Methods This observational cohort study enrolled 46 consecutive septic patients in the intensive care unit between November 2020 and October 2021. After fluid resuscitation, the peripheral ischemic microvascular reserve was evaluated using the association of postocclusion reactive hyperemia with the peripheral perfusion index. Additionally, peripheral venous blood samples were used to evaluate the neuropeptide calcitonin gene-related peptide and substance P levels in the upper limb before and immediately after postocclusion reactive hyperemia Results There was no statistically significant correlation (p > 0.05) between basal values (pg/mL) or variations from neuropeptide levels (%) and the peripheral ischemic microvascular reserve (%). Conclusion Although calcitonin gene-related peptide and substance P may have a prognostic role in sepsis, these neuropeptides do not appear to contribute to peripheral ischemic microvascular reserve.
目的探讨脓毒症患者外周血缺血微血管储备对预后的影响机制。方法:本观察性队列研究纳入了2020年11月至2021年10月期间重症监护病房连续收治的46例脓毒症患者。液体复苏后,外周血缺血微血管储备的评价采用闭合后反应性充血与外周血灌注指数的关联。结果基础值(pg/mL)或神经肽水平变化(%)与外周血缺血微血管储备(%)之间无统计学意义(P > 0.05)。结论虽然降钙素基因相关肽和P物质在脓毒症中可能具有预后作用,但这些神经肽似乎对周围缺血性微血管储备没有贡献。
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引用次数: 1
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Revista Brasileira de Terapia Intensiva
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