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Daily Chlorhexidine Bath for Health Care Associated Infection Prevention (CLEAN-IT): protocol for a multicenter cluster randomized crossover open-label trial. 预防医护人员相关感染的每日洗必泰浴(CLEAN-IT):多中心群组随机交叉开放标签试验方案。
Critical care science Pub Date : 2024-09-27 eCollection Date: 2024-01-01 DOI: 10.62675/2965-2774.20240053-en
Bruno Martins Tomazini, Thabata Silva Veiga, Renato Hideo Nakagawa Santos, Viviane Bezerra Campos, Samira Martins Tokunaga, Elton Sousa Santos, Leticia Galvão Barbante, Renato da Costa Maia, Karina Leal Negrelli, Nanci Valeis, Eliana Vieira Santucci, Ligia Nasi Laranjeira, Fernando Azevedo Medrado, Thiago Costa Lisboa, Bruno Adler Maccagnan Pinheiro Besen, Antônio Paulo Nassar Junior, Viviane Cordeiro Veiga, Adriano José Pereira, Alexandre Biasi Cavalcanti
{"title":"Daily Chlorhexidine Bath for Health Care Associated Infection Prevention (CLEAN-IT): protocol for a multicenter cluster randomized crossover open-label trial.","authors":"Bruno Martins Tomazini, Thabata Silva Veiga, Renato Hideo Nakagawa Santos, Viviane Bezerra Campos, Samira Martins Tokunaga, Elton Sousa Santos, Leticia Galvão Barbante, Renato da Costa Maia, Karina Leal Negrelli, Nanci Valeis, Eliana Vieira Santucci, Ligia Nasi Laranjeira, Fernando Azevedo Medrado, Thiago Costa Lisboa, Bruno Adler Maccagnan Pinheiro Besen, Antônio Paulo Nassar Junior, Viviane Cordeiro Veiga, Adriano José Pereira, Alexandre Biasi Cavalcanti","doi":"10.62675/2965-2774.20240053-en","DOIUrl":"10.62675/2965-2774.20240053-en","url":null,"abstract":"<p><strong>Background: </strong>Critically ill patients are at increased risk of health care-associated infections due to various devices (central line-associated bloodstream infection, catheter-associated urinary tract infection, and ventilator-associated pneumonia), which pose a significant threat to this population. Among several strategies, daily bathing with chlorhexidine digluconate, a water-soluble antiseptic, has been studied as an intervention to decrease the incidence of health care-associated infections in the intensive care unit; however, its ability to reduce all health care-associated infections due to various devices is unclear. We designed the Daily Chlorhexidine Bath for Health Care Associated Infection Prevention (CLEAN-IT) trial to assess whether daily chlorhexidine digluconate bathing reduces the incidence of health care-associated infections in critically ill patients compared with soap and water bathing.</p><p><strong>Methods: </strong>The CLEAN-IT trial is a multicenter, open-label, cluster randomized crossover clinical trial. All adult patients admitted to the participating intensive care units will be included in the trial. Each cluster (intensive care unit) will be randomized to perform either initial chlorhexidine digluconate bathing or soap and water bathing with crossover for a period of 3 to 6 months, depending on the time of each center's entrance to the study, with a 1-month washout period between chlorhexidine digluconate bathing and soap and water bathing transitions. The primary outcome is the incidence of health care-associated infections due to devices. The secondary outcomes are the incidence of each specific health care-associated infection, rates of microbiological cultures positive for multidrug-resistant pathogens, antibiotic use, intensive care unit and hospital length of stay, and intensive care unit and hospital mortality.</p><p><strong>Conclusion: </strong>The CLEAN-IT trial will be used to study feasible and affordable interventions that might reduce the health care-associated infection burden in critically ill patients.</p>","PeriodicalId":72721,"journal":{"name":"Critical care science","volume":"36 ","pages":"e20240053en"},"PeriodicalIF":0.0,"publicationDate":"2024-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11463980/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142367681","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
Reply to: Neurocritical care management supported by multimodal brain monitoring after acute brain injury. 回复:急性脑损伤后多模式脑监测支持的神经重症监护管理。
Critical care science Pub Date : 2024-09-27 eCollection Date: 2024-01-01 DOI: 10.62675/2965-2774.20240187-en
Elisabete Monteiro, Sofia Rocha E Silva, Marek Czosnyka, José Artur Paiva, Celeste Dias
{"title":"Reply to: Neurocritical care management supported by multimodal brain monitoring after acute brain injury.","authors":"Elisabete Monteiro, Sofia Rocha E Silva, Marek Czosnyka, José Artur Paiva, Celeste Dias","doi":"10.62675/2965-2774.20240187-en","DOIUrl":"10.62675/2965-2774.20240187-en","url":null,"abstract":"","PeriodicalId":72721,"journal":{"name":"Critical care science","volume":"36 ","pages":"e20240187en"},"PeriodicalIF":0.0,"publicationDate":"2024-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11463983/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142367682","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
Clinical practices related to liberation from mechanical ventilation in Latin American pediatric intensive care units: survey of the Sociedad Latino-Americana de Cuidados Intensivos Pediátricos Mechanical Ventilation Liberation Group. 拉丁美洲儿科重症监护病房机械通气解放相关临床实践:拉丁美洲儿科重症监护协会机械通气解放小组调查。
Critical care science Pub Date : 2024-09-23 eCollection Date: 2024-01-01 DOI: 10.62675/2965-2774.20240066-en
Alejandra Retta, Analía Fernández, Ezequiel Monteverde, Cintia Johnston, Andrés Castillo-Moya, Silvio Torres, Jesus Dominguez-Rojas, Matias G Herrera, Vlademir Aguilera-Avendaño, Yúrika López-Alarcón, Davi Pascual Rojas Flores, Manuel Eduardo Munaico-Abanto, Júlia Acuña, Rosa León, Carla Ferreira, Gabriela Sequeira, Cristina Camilo, Mauricio Yunge, Yolanda López Fernández
{"title":"Clinical practices related to liberation from mechanical ventilation in Latin American pediatric intensive care units: survey of the Sociedad Latino-Americana de Cuidados Intensivos Pediátricos Mechanical Ventilation Liberation Group.","authors":"Alejandra Retta, Analía Fernández, Ezequiel Monteverde, Cintia Johnston, Andrés Castillo-Moya, Silvio Torres, Jesus Dominguez-Rojas, Matias G Herrera, Vlademir Aguilera-Avendaño, Yúrika López-Alarcón, Davi Pascual Rojas Flores, Manuel Eduardo Munaico-Abanto, Júlia Acuña, Rosa León, Carla Ferreira, Gabriela Sequeira, Cristina Camilo, Mauricio Yunge, Yolanda López Fernández","doi":"10.62675/2965-2774.20240066-en","DOIUrl":"10.62675/2965-2774.20240066-en","url":null,"abstract":"<p><strong>Objective: </strong>To address the current practice of liberating patients from invasive mechanical ventilation in pediatric intensive care units, with a focus on the use of standardized protocols, criteria, parameters, and indications for noninvasive respiratory support postextubation.</p><p><strong>Methods: </strong>Electronic research was carried out from November 2021 to May 2022 in Ibero-American pediatric intensive care units. Physicians and respiratory therapists participated, with a single representative for each pediatric intensive care unit included. There were no interventions.</p><p><strong>Results: </strong>The response rate was 48.9% (138/282), representing 10 Ibero-American countries. Written invasive mechanical ventilation liberation protocols were available in only 34.1% (47/138) of the pediatric intensive care units, and their use was associated with the presence of respiratory therapists (OR 3.85; 95%CI 1.79 - 8.33; p = 0.0008). The most common method of liberation involved a gradual reduction in ventilatory support plus a spontaneous breathing trial (47.1%). The mean spontaneous breathing trial duration was 60 - 120 minutes in 64.8% of the responses. The presence of a respiratory therapist in the pediatric intensive care unit was the only variable associated with the use of a spontaneous breathing trial as the primary method of liberation from invasive mechanical ventilation (OR 5.1; 95%CI 2.1 - 12.5). Noninvasive respiratory support protocols were not frequently used postextubation (40.4%). Nearly half of the respondents (43.5%) reported a preference for using bilevel positive airway pressure as the mode of noninvasive ventilation postextubation.</p><p><strong>Conclusion: </strong>A high proportion of Ibero-American pediatric intensive care units lack liberation protocols. Our study highlights substantial variability in extubation readiness practices, underscoring the need for standardization in this process. However, the presence of a respiratory therapist was associated with increased adherence to guidelines.</p>","PeriodicalId":72721,"journal":{"name":"Critical care science","volume":"36 ","pages":"e20240066en"},"PeriodicalIF":0.0,"publicationDate":"2024-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11463992/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142333678","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
Ventilation liberation in Ibero-American pediatric intensive care units. 伊比利亚-美洲儿科重症监护室的通气解放。
Critical care science Pub Date : 2024-09-23 eCollection Date: 2024-01-01 DOI: 10.62675/2965-2774.20240163-en
José Colleti Junior, Arnaldo Prata-Barbosa, Cristian Tedesco Tonial
{"title":"Ventilation liberation in Ibero-American pediatric intensive care units.","authors":"José Colleti Junior, Arnaldo Prata-Barbosa, Cristian Tedesco Tonial","doi":"10.62675/2965-2774.20240163-en","DOIUrl":"10.62675/2965-2774.20240163-en","url":null,"abstract":"","PeriodicalId":72721,"journal":{"name":"Critical care science","volume":"36 ","pages":"e20240163en"},"PeriodicalIF":0.0,"publicationDate":"2024-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11463984/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142333679","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
Position statement of the Brazilian Palliative Care Academy on withdrawing and withholding life-sustaining interventions in the context of palliative care. 巴西姑息治疗学院关于在姑息治疗中撤销和暂停维持生命干预措施的立场声明。
Critical care science Pub Date : 2024-09-09 eCollection Date: 2024-01-01 DOI: 10.62675/2965-2774.20240021-en
Edison Iglesias de Oliveira Vidal, Sabrina Correa da Costa Ribeiro, Maria Júlia Kovacs, Luciano Máximo da Silva, Daniele Pompei Sacardo, Simone Brasil de Oliveira Iglesias, Josimário João da Silva, Cinara Carneiro Neves, Diego Lima Ribeiro, Fernanda Gomes Lopes
{"title":"Position statement of the Brazilian Palliative Care Academy on withdrawing and withholding life-sustaining interventions in the context of palliative care.","authors":"Edison Iglesias de Oliveira Vidal, Sabrina Correa da Costa Ribeiro, Maria Júlia Kovacs, Luciano Máximo da Silva, Daniele Pompei Sacardo, Simone Brasil de Oliveira Iglesias, Josimário João da Silva, Cinara Carneiro Neves, Diego Lima Ribeiro, Fernanda Gomes Lopes","doi":"10.62675/2965-2774.20240021-en","DOIUrl":"10.62675/2965-2774.20240021-en","url":null,"abstract":"<p><p>The issue of withrawing and withholding life-sustaining interventions is an important source of controversy among healthcare professionals caring for patients with serious illnesses. Misguided decisions, both in terms of the introduction/maintenance and the withdrawal/withholding of these measures, represent a source of avoidable suffering for patients, their loved ones, and healthcare professionals. This document represents the position statement of the Bioethics Committee of the Brazilian Palliative Care Academy on this issue and establishes seven principles to guide, from a bioethical perspective, the approach to situations related to this topic in the context of palliative care in Brazil. The position statement establishes the equivalence between the withdrawal and withholding of life-sustaining interventions and the inadequacy related to initiating or maintaining such measures in contexts where they are in disagreement with the values and care goals defined together with patients and their families. Additionally, the position statement distinguishes strictly futile treatments from potentially inappropriate treatments and elucidates their critical implications for the appropriateness of the medical decision-making process in this context. Finally, we address the issue of conscientious objection and its limits, determine that the ethical commitment to the relief of suffering should not be influenced by the decision to employ or not employ life-sustaining interventions and warn against the use of language that causes patients/families to believe that only one of the available options related to the use or nonuse of these interventions will enable the relief of suffering.</p>","PeriodicalId":72721,"journal":{"name":"Critical care science","volume":"36 ","pages":"e20240021en"},"PeriodicalIF":0.0,"publicationDate":"2024-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11463991/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142302419","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
The suspension and nonimplementation of life support interventions in palliative care. 姑息关怀中生命支持干预的中止和不执行。
Critical care science Pub Date : 2024-09-09 eCollection Date: 2024-01-01 DOI: 10.62675/2965-2774.20240196Ed-en
Regis Goulart Rosa, Livia Biason, Lara Patricia Kretzer
{"title":"The suspension and nonimplementation of life support interventions in palliative care.","authors":"Regis Goulart Rosa, Livia Biason, Lara Patricia Kretzer","doi":"10.62675/2965-2774.20240196Ed-en","DOIUrl":"10.62675/2965-2774.20240196Ed-en","url":null,"abstract":"","PeriodicalId":72721,"journal":{"name":"Critical care science","volume":"36 ","pages":"e20240196Eden"},"PeriodicalIF":0.0,"publicationDate":"2024-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11463988/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142302420","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
Update on the Epimed Monitor Adult ICU Database: 15 years of its use in national registries, quality improvement initiatives and clinical research. Epimed Monitor 成人重症监护室数据库的最新情况:在国家登记、质量改进计划和临床研究中使用该数据库的 15 年历程。
Critical care science Pub Date : 2024-09-02 eCollection Date: 2024-01-01 DOI: 10.62675/2965-2774.20240150-en
Marcio Soares, Lunna Perdigão Borges, Leonardo Dos Santos Lourenco Bastos, Fernando Godinho Zampieri, Gabriel Alves Miranda, Pedro Kurtz, Suzana Margareth Lobo, Lucas Rodrigo Garcia de Mello, Gastón Burghi, Ederlon Rezende, Otávio Tavares Ranzani, Jorge Ibrain Figueira Salluh
{"title":"Update on the Epimed Monitor Adult ICU Database: 15 years of its use in national registries, quality improvement initiatives and clinical research.","authors":"Marcio Soares, Lunna Perdigão Borges, Leonardo Dos Santos Lourenco Bastos, Fernando Godinho Zampieri, Gabriel Alves Miranda, Pedro Kurtz, Suzana Margareth Lobo, Lucas Rodrigo Garcia de Mello, Gastón Burghi, Ederlon Rezende, Otávio Tavares Ranzani, Jorge Ibrain Figueira Salluh","doi":"10.62675/2965-2774.20240150-en","DOIUrl":"10.62675/2965-2774.20240150-en","url":null,"abstract":"<p><p>In recent decades, several databases of critically ill patients have become available in both low-, middle-, and high-income countries from all continents. These databases are also rich sources of data for the surveillance of emerging diseases, intensive care unit performance evaluation and benchmarking, quality improvement projects and clinical research. The Epimed Monitor database is turning 15 years old in 2024 and has become one of the largest of these databases. In recent years, there has been rapid geographical expansion, an increase in the number of participating intensive care units and hospitals, and the addition of several new variables and scores, allowing a more complete characterization of patients to facilitate multicenter clinical studies. As of December 2023, the database was being used regularly for 23,852 beds in 1,723 intensive care units and 763 hospitals from ten countries, totaling more than 5.6 million admissions. In addition, critical care societies have adopted the system and its database to establish national registries and international collaborations. In the present review, we provide an updated description of the database; report experiences of its use in critical care for quality improvement initiatives, national registries and clinical research; and explore other potential future perspectives and developments.</p>","PeriodicalId":72721,"journal":{"name":"Critical care science","volume":"36 ","pages":"e20240150en"},"PeriodicalIF":0.0,"publicationDate":"2024-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11463981/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142127550","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
Fluid management in sepsis: 5 reasons why less fluid might be more rational. 败血症的输液管理:少输液可能更合理的 5 个原因。
Critical care science Pub Date : 2024-08-30 eCollection Date: 2024-01-01 DOI: 10.62675/2965-2774.20240111-en
Thiago Masashi Taniguchi, Leandro Utino Taniguchi
{"title":"Fluid management in sepsis: 5 reasons why less fluid might be more rational.","authors":"Thiago Masashi Taniguchi, Leandro Utino Taniguchi","doi":"10.62675/2965-2774.20240111-en","DOIUrl":"10.62675/2965-2774.20240111-en","url":null,"abstract":"","PeriodicalId":72721,"journal":{"name":"Critical care science","volume":"36 ","pages":"e20240111en"},"PeriodicalIF":0.0,"publicationDate":"2024-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11463987/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142127548","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
Respiratory mechanics characteristics at the time of barotrauma presentation in patients with critical COVID-19 infection. COVID-19 重症感染患者出现气压创伤时的呼吸力学特征。
Critical care science Pub Date : 2024-08-30 eCollection Date: 2024-01-01 DOI: 10.62675/2965-2774.20240248-en
Gabriela Vieira Steckert, Sophia Andreola Borba, Gabriela Meirelles Marchese, Fabrício Schultz Medeiros, Tiago Severo Garcia, Marcio Manozzo Boniatti, Iuri Christmann Wawrzeniak
{"title":"Respiratory mechanics characteristics at the time of barotrauma presentation in patients with critical COVID-19 infection.","authors":"Gabriela Vieira Steckert, Sophia Andreola Borba, Gabriela Meirelles Marchese, Fabrício Schultz Medeiros, Tiago Severo Garcia, Marcio Manozzo Boniatti, Iuri Christmann Wawrzeniak","doi":"10.62675/2965-2774.20240248-en","DOIUrl":"10.62675/2965-2774.20240248-en","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate how ventilatory support, the duration of invasive ventilatory support use and lung mechanics are related to barotrauma development in patients who are severely infected with COVID-19 and who are admitted to the intensive care unit and develop pulmonary barotrauma.</p><p><strong>Methods: </strong>Retrospective cohort study of patients who were severely infected with COVID-19 and who developed pulmonary barotrauma secondary to mechanical ventilation.</p><p><strong>Results: </strong>This study included 60 patients with lung barotrauma who were divided into two groups: 37 with early barotrauma and 23 with late barotrauma. The early barotrauma group included more individuals who needed noninvasive ventilation (62.2% versus 26.1%, p = 0.01). The tidal volume/kg of predicted body weight on the day of barotrauma was measured, and 24 hours later, it was significantly greater in the late barotrauma group than in the early barotrauma group. During the day, barotrauma was accompanied by plateau pressure and driving pressure accompanied by tidal volume, which significantly increased in the late barotrauma group. According to the SAPS 3, patients in the early barotrauma group had more pulmonary thromboembolism and more severe illness. However, the intensive care unit mortality rates did not significantly differ between the two groups (66.7% for early barotrauma versus 76.9% for late barotrauma).</p><p><strong>Conclusion: </strong>We investigated the effect of respiratory mechanics on barotrauma in patients with severe COVID-19 and found that 25% of patients were on nonprotective ventilation parameters when they developed barotrauma. However, 50% of patients were on protective ventilation parameters, suggesting that other nonventilatory factors may contribute to barotrauma.</p>","PeriodicalId":72721,"journal":{"name":"Critical care science","volume":"36 ","pages":"e20240248en"},"PeriodicalIF":0.0,"publicationDate":"2024-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11463995/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142127549","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
VATICAN (Ventilator-Associated Tracheobronchitis Initiative to Conduct Antibiotic Evaluation): protocol for a multicenter randomized open-label trial of watchful waiting versus antimicrobial therapy for ventilator-associated tracheobronchitis. VATICAN(呼吸机相关气管支气管炎抗生素评估倡议):针对呼吸机相关气管支气管炎的观察等待与抗菌治疗的多中心随机开放标签试验方案。
Critical care science Pub Date : 2024-08-26 eCollection Date: 2024-01-01 DOI: 10.62675/2965-2774.20240029-en
Bruno Martins Tomazini, Bruno Adler Maccagnan Pinheiro Besen, Camila Dietrich, Ana Paula Rossi Gandara, Debora Patrícia Silva, Carla Cristina Gomes Pinheiro, Mariane Nascimento Luz, Renata Rodrigues de Mattos, Luiz Fernando Lima Reis, Roberta Muriel Longo Roepke, Carlos Sérgio Luna Gomes Duarte, Antônio Paulo Nassar Júnior, Viviane Cordeiro Veiga, Beatriz Arns, Giovanna Marssola Nascimento, Adriano José Pereira, Alexandre Biasi Cavalcanti, Flávia Ribeiro Machado, Luciano Cesar Pontes Azevedo
{"title":"VATICAN (Ventilator-Associated Tracheobronchitis Initiative to Conduct Antibiotic Evaluation): protocol for a multicenter randomized open-label trial of watchful waiting versus antimicrobial therapy for ventilator-associated tracheobronchitis.","authors":"Bruno Martins Tomazini, Bruno Adler Maccagnan Pinheiro Besen, Camila Dietrich, Ana Paula Rossi Gandara, Debora Patrícia Silva, Carla Cristina Gomes Pinheiro, Mariane Nascimento Luz, Renata Rodrigues de Mattos, Luiz Fernando Lima Reis, Roberta Muriel Longo Roepke, Carlos Sérgio Luna Gomes Duarte, Antônio Paulo Nassar Júnior, Viviane Cordeiro Veiga, Beatriz Arns, Giovanna Marssola Nascimento, Adriano José Pereira, Alexandre Biasi Cavalcanti, Flávia Ribeiro Machado, Luciano Cesar Pontes Azevedo","doi":"10.62675/2965-2774.20240029-en","DOIUrl":"10.62675/2965-2774.20240029-en","url":null,"abstract":"<p><strong>Background: </strong>Ventilator-associated tracheobronchitis is a common condition among invasively ventilated patients in intensive care units, for which the best treatment strategy is currently unknown. We designed the VATICAN (Ventilator-Associated Tracheobronchitis Initiative to Conduct Antibiotic Evaluation) trial to assess whether a watchful waiting antibiotic treatment strategy is noninferior to routine antibiotic treatment for ventilator-associated tracheobronchitis regarding days free of mechanical ventilation.</p><p><strong>Methods: </strong>VATICAN is a randomized, controlled, open-label, multicenter noninferiority trial. Patients with suspected ventilator-associated tracheobronchitis without evidence of ventilator-associated pneumonia or hemodynamic instability due to probable infection will be assigned to either a watchful waiting strategy, without antimicrobial administration for ventilator-associated tracheobronchitis and prescription of antimicrobials only in cases of ventilator-associated pneumonia, sepsis or septic shock, or another infectious diagnosis, or to a routine antimicrobial treatment strategy for seven days. The primary outcome will be mechanical ventilation-free days at 28 days, and a key secondary outcome will be ventilator-associated pneumonia-free survival. Through an intention-to-treat framework with a per-protocol sensitivity analysis, the primary outcome analysis will address noninferiority with a 20% margin, which translates to a 1.5 difference in ventilator-free days. Other analyses will follow a superiority analysis framework.</p><p><strong>Conclusion: </strong>The VATICAN trial will follow all national and international ethical standards. We aim to publish the trial in a high-visibility general journal and present it at critical care and infectious disease conferences for dissemination. These results will likely be immediately applicable to the bedside upon trial completion and will provide information with a low risk of bias for guideline development.</p>","PeriodicalId":72721,"journal":{"name":"Critical care science","volume":"36 ","pages":"e20240029en"},"PeriodicalIF":0.0,"publicationDate":"2024-08-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11321716/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142082794","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}
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