OBJECTIVE:To analyze the relationship between the characteristics of respiratory support (RS) for patients with stroke and clinical factors with the number and structure of complications, deaths, and length of stay in the intensive care unit (ICU) and duration of artificial pulmonary ventilation (ALV). MATERIAL AND METHODS:The Russian multicenter observational clinical study «Respiratory Therapy for Acute Stroke» (RETAS) that enrolled 1289 patients with stroke requiring RS was conducted under the auspices of the All-Russian public organization «Federation of Anesthesiologists and Resuscitators». Indications for ALV, the use of hyperventilation, the maximum level of positive end-expiratory pressure, starting modes of mechanical ventilation, timing of tracheostomy, the incidence of protein-energy malnutrition (PEM) and infectious complications were analyzed. The following scales were used to assess the severity of the condition: the National Institutes of Health Stroke Severity Scale (NIHSS), the Glasgow Coma Scale, the Glasgow Outcome Scale (GOS). RESULTS:For the group of patients with a stroke severity of more than 20 NIHSS points, the mortality increase was associated with initial hypoxia (p=0.004), hyperventilation used to relieve intracranial hypertension (p=0.034), and starting ventilation with volume control (VC) compared with starting pressure-controlled ventilation (PC) (p<0.001). We found that the use of the instrumental monitoring of intracranial pressure was associated with a decrease in mortality (p<0.001). The absence of PEM in patients with stroke is associated with a higher probability of a positive outcome (GOS 4 and 5) for the group with NIHSS less than 14 points (p<0.001). Ventilator-associated tracheobronchitis and ventilator-associated pneumonia were associated with an increase in the duration of ALV, the duration of weaning from the ventilator (for ventilator-associated tracheobronchitis) and the duration of stay in the ICU, and also reduced the chances of favorable outcomes (p<0.05). CONCLUSION:The factors associated with increased mortality in acute stroke are: hypoxemia at the start of ALV, hyperventilation, starting ventilation with VC in comparison with starting ventilation with PC, the use of only clinical methods of monitoring intracranial pressure in comparison with instrumental monitoring. The adverse effect of PEM and infectious complications on the outcome in patients with acute stroke has been proven.

АКТУАЛЬНОСТЬ: Острое нарушение мозгового кровообращения (ОНМК) характеризует высокая распространенность и летальность. Белково-энергетическая недостаточность является распространенным синдромом у данной категории пациентов, влияющим на течение и исходы церебрального инсульта. ЦЕЛЬ ИССЛЕДОВАНИЯ: Провести анализ распространенности и влияния на осложнения и исход тяжелого церебрального инсульта белково-энергетической недостаточности. МАТЕРИАЛЫ И МЕТОДЫ: Под эгидой Федерации анестезиологов и реаниматологов России проведено многоцентровое обсервационное клиническое исследование «Регистр респираторной терапии у пациентов с ОНМК (RETAS)». В исследовании участвовало 14 центров, включено 1289 пациентов с ОНМК, которым проводили респираторную поддержку. РЕЗУЛЬТАТЫ: Белково-энергетическая недостаточность у пациентов с ОНМК при осуществлении искусственной вентиляции легких (ИВЛ) ассоциировалась с тенденцией к большему риску развития летального исхода (р = 0,0003). Отсутствие белково-энергетической недостаточности у пациентов с ОНМК с тяжестью по Шкале тяжести инсульта Национальных институтов здоровья (National Institutes of Health Stroke Scale, NIHSS) менее 14 баллов при осуществлении ИВЛ ассоциировалось с большей вероятностью позитивного клинического исхода (по Шкале исходов Глазго [Glasgow Outcome Scale, GOS] 4 и 5) в сравнении с пациентами, имеющими признаки недостаточности питания (р = 0,000002). Белково-энергетическая недостаточность ассоциируется с более длительным пребыванием пациентов с ОНМК на ИВЛ (р < 0,0001). При этом для группы пациентов с длительной ИВЛ были характерны большая распространенность пролежней (р < 0,0001), гипопротеинемии, гипоальбуминемии (р = 0,0001) и снижение массы тела на 10 и более процентов (р < 0,0001). Наличие белково-энергетической недостаточности сопровождалось повышенным риском развития вентилятор-ассоциированного трахеобронхита у пациентов с ОНМК (р < 0,0001). ВЫВОДЫ: Белково-энергетическая недостаточность оказывает существенное влияние на течение и основные показатели клинического исхода тяжелого церебрального инсульта у пациентов при проведении искусственной вентиляции легких (ИВЛ).

INTRODUCTION: The number of criminal cases brought against doctors — anesthesiologists and resuscitators in the Russian Federation is not decreasing. However, a detailed analysis has not been carried out in recent years, and this was primarily due to the pandemic of the new coronavirus infection COVID-19 and the restrictions that were associated with it. OBJECTIVE: To analyze criminal cases against anesthesiologists and resuscitators initiated under various articles of the Criminal Code of the Russian Federation over the past four years, from 2019 to 2022. MATERIALS AND METHODS: The search for criminal cases was carried out in the following electronic databases: “Court decisions of the Russian Federation” and the State Automated System of the Russian Federation “Justice”. Based on the search results, 66 criminal cases against anesthesiologists and resuscitators were considered. RESULTS: The main articles of the Criminal Code of the Russian Federation were identified, under which anesthesiologists and resuscitators are most often held accountable. The gender and territorial distribution of criminal cases by region of the Russian Federation is presented. The most significant and frequently committed defects in the provision of medical care have been identified. Examples of the most complex criminal cases are given. CONCLUSIONS: It seems that the number of criminal cases against anesthesiologists and resuscitators has decreased slightly after 2019, however, we believe that this is due to the pandemic of the new coronavirus infection, and for this reason many court cases are still under investigation and have not been completed on time.

АКТУАЛЬНОСТЬ: Количество уголовных дел, возбуждаемых против врачей — анестезиологов-реаниматологов в Российской Федерации, не уменьшается. Однако подробный анализ за последние годы не проводился, и в первую очередь это было обусловлено пандемией новой коронавирусной инфекции COVID-19 и теми ограничениями, которые были с ней связаны. ЦЕЛЬ ИССЛЕДОВАНИЯ: Провести анализ уголовных дел в отношении врачей — анестезиологов-реаниматологов, возбужденных по различным статьям Уголовного кодекса Российской Федерации (УК РФ) за последние четыре года — с 2019 по 2022 г. МАТЕРИАЛЫ И МЕТОДЫ: Поиск уголовных дел был выполнен в следующих электронных базах данных: «Судебные решения РФ» и «Государственная автоматизированная система Российской Федерации ”Правосудие”». По результатам поиска было рассмотрено 66 уголовных дел против врачей — анестезиологов-реаниматологов. РЕЗУЛЬТАТЫ: Выявлены основные статьи УК РФ, по которым наиболее часто привлекают к ответственности врачей — анестезиологов-реаниматологов. Представлены гендерные и территориальные распределения уголовных дел по регионам Российской Федерации. Определены наиболее значимые и часто совершаемые дефекты оказания медицинской помощи. Приведены примеры наиболее громких и сложных уголовных дел. ВЫВОДЫ: Создается впечатление, что количество уголовных дел против врачей — анестезиологов-реаниматологов несколько уменьшилось после 2019 г., однако мы считаем, что это связано с пандемией новой коронавирусной инфекции, по этой причине множество судебных дел еще находится на стадии расследования и не были завершены в срок.

INTRODUCTION: Stroke is characterized by high prevalence and mortality. Protein-energy deficiency is a common syndrome in this category of patients, affecting the course and outcomes of cerebral stroke. OBJECTIVE: The purpose of the study was to analyze the prevalence and impact on the course and outcome of stroke of protein-energy deficiency in patients with mechanical ventilation. MATERIALS AND METHODS: A multicenter observational clinical study “Register of respiratory therapy in patients with stroke (RETAS)” was conducted under the auspices of the Russian Federation of Anesthesiologists and Reanimatologists. The study involved 14 centers, included 1289 acute stroke patients received respiratory support. RESULTS: Protein-energy deficiency in patients with stroke on mechanical ventilation was associated with a tendency to a greater risk of a lethal outcome (p = 0.0003). The absence of protein-energy malnutrition in patients with stroke severity less than 14 points during mechanical ventilation was associated with a greater likelihood of a positive outcome (Glasgow Outcome Scale, GOS 4 and 5) compared with patients with signs of malnutrition (p = 0.000002). Protein-energy malnutrition is associated with prolonged stay in ICU of patients with stroke on mechanical ventilation (p < 0.0001). At the same time, the group of patients with prolonged mechanical ventilation was characterized by a high prevalence of bedsores (p < 0.0001), hypoproteinemia, hypoalbuminemia (р = 0.0001), and decreased body weight 10 percent or more (p < 0.0001). The presence of protein-energy malnutrition was accompanied by an increased risk of ventilator-associated tracheobronchitis in patients with stroke (p < 0.0001). CONCLUSIONS: Protein-energy malnutrition significantly influences on the course and clinical outcome parameters of severe cerebral stroke patients on mechanical ventilation.

OBJECTIVE: To describe the available evidence on indications, complications, care and alternative strategies in the use of physical restraint in adult patients in Intensive Care Units. MATERIALS AND METHODS: An integrative review conducted in the Cochrane, PubMed, Scopus, LILACS, Nursing Database and the eLibrary portal. The search was performed on the queries: “physical restriction”, “fixation devices in intensive care”, “patient safety”, “fixation of the patient”. RESULTS: The final selection was of 93 articles, from which the indications, complications, care and alternative strategies were extracted. CONCLUSIONS: The most common practices regarding physical restraints in Russia and foreign countries were described, and the need for the elaboration and implementation of protocols on intervention to support decision — making was observed.

Background . A significant proportion of patients infected with the SARS-CoV-2 virus had a severe course of the disease required hospitalization and intensive care The objective was to analyze the defects allowed during intensive care of patients with SARS-CoV-2, and to assess the causes of their occurrence. Materials and methods . An analytical study was made on the basis of expert opinions on 60 case histories of deceased patients in the intensive care unit with the main diagnosis: “COVID-19. Community-acquired bilateral polysegmental viral pneumonia ARDS”. To identify the reasons that led to defects in the diagnosis and treatment of patients with NCI COVID-19 in intensive care units, an anonymous survey of 92 anesthesiologists-resuscitators who worked in the “red zone” during the COVID-19 pandemic was conducted. Results . The defects identified by experts can be divided into two main groups: diagnostic defects and treatment defects. ARDS in 25%, PE in 8% of cases were not diagnosed. There was no ECG control and cardiac monitoring in 22%, lung CT in 6.7%, echocardiography in 10% of cases. Consultations of specialized specialists were not held in 11.7% of patients. There were defects in the correction of EBV and ABS in 30%, unreasonable prescribing of drugs in 58%, defects in vasopressor support in 10%, defects associated with mechanical ventilation in 40% of cases. The survey of physicians showed that the defects were based on insufficient knowledge of the governing documents and the limited capabilities of medical organizations to implement the necessary research. Conclusion . The obtained results made it possible to demonstrate the limitations and subjectivity of the existing assessment of the quality of medical care, which sometimes does not take into account the existing conditions for treating patients and the material and technical capabilities of a medical organization.

АКТУАЛЬНОСТЬ: Как известно, питание через гастральный зонд не всегда хорошо переносится тяжелобольными пациентами на искусственной вентиляции легких (ИВЛ). При возникновении проблем с усвоением энтерального кормления врачи отдают предпочтение парентеральному питанию. Транспилорический метод кормления является оптимальным методом для тяжелобольных недоношенных детей. ЦЕЛЬ ИССЛЕДОВАНИЯ: Оценить преимущества использования транспилорического метода кормления у недоношенных детей, находящихся на ИВЛ, в сравнении с гастральным кормлением (ГК). МАТЕРИАЛЫ И МЕТОДЫ: В исследование были включены 64 пациента, которые имели низкую толерантность к энтеральной нагрузке, а также нуждались в проведении ИВЛ. Гестационный возраст пациентов не превышал 34 (32–35) недель. Для энтерального кормления через питательный зонд, установленный за пределы привратника, использовали смесь NAN®Антирефлюкс. Объем энтерального кормления определяли из расчета необходимой потребности 120 ккал/кг/сут. РЕЗУЛЬТАТЫ: В результате проведенного исследования в группе больных с транспилорическим кормлением обращает на себя внимание меньший срок пребывания в стационаре — 54 (41–67) дня по сравнению с группой ГК — 86 (64–94) дней, р < 0,05. Прибавка массы тела в группе ГК была значительно ниже — 89 (55–200) г по сравнению с группой транспилорического кормления — 161,5 (110–218) г. Аналогичные изменения зафиксированы и в отношении снижения уровня общего белка на 10-й день исследования в группе ГК (36,5 [32–40] г/л) по сравнению с группой транспилорического кормления (47 [42–50] г/л), р < 0,05. ВЫВОДЫ: Использование транспилорического питания у недоношенных детей на ИВЛ в сравнении с ГК является более эффективным методом. Полученные данные свидетельствуют о таких положительных эффектах, как снижение срока госпитализации, предотвращение гипопротеинемии, большая прибавка массы тела.

INTRODUCTION: Feeding critically ill patients on mechanical ventilation through a gastric tube can be challenging. Parenteral nutrition is often preferred when enteral feeding is problematic. Transpyloric feeding has been identified as an optimal method of nutrition for seriously ill premature infants. OBJECTIVE: This study aims to evaluate the advantages of transpyloric feeding combined with artificial ventilation compared to gastric feeding in premature neonatal patients. MATERIALS AND METHODS: The study included 64 patients with low tolerance to enteral feeding who required mechanical ventilation. The gestational age of the patients did not exceed 34 (32–35) weeks. Enteral feeding using a NAN® mixture was administered through a feeding tube placed outside the pylorus with an anti-reflux mechanism. The volume of enteral feeding was determined based on the requirement of 120 kcal/kg/day. RESULTS: The results of the study demonstrated that the group receiving transpyloric feeding had a significantly shorter hospital stay of 54 (41–67) days compared to the group receiving gastric feeding with 86 (64–94) days, p < 0.05. The weight gain in the group receiving gastric feeding was significantly lower at 89 (55–200) g compared to the group receiving transpyloric feeding with 161.5 (110–218) g. Similar findings were observed regarding a decrease in total protein levels on the 10th day of the study in the gastric feeding group with 36.5 (32–40) g/l compared to the transpyloric feeding group with 47 (42–50) g/l, p < 0.05. CONCLUSION: Transpyloric nutrition in premature infants on mechanical ventilation is a more efficient method compared to gastric feeding. The findings suggest positive effects including reduced hospitalization duration, prevention of hypoproteinemia, and significant increase in body weight.

INTRODUCTION: Approaches to sedation in the departments of anesthesiology, intensive care and intensive care have changed over the past 20 years. In 2020, the guidelines “Sedation of patients in the departments of anesthesiology, intensive care and intensive care” were placed in the rubric of clinical recommendations. OBJECTIVE: To contribute to improving the quality of planned updating of recommendations with the help of a modified Delphi analysis of the provisions and quality criteria of the current version of the document published in the rubricator of clinical recommendations of the Ministry of Health of the Russian Federation. MATERIALS AND METHODS: We used a modified Delphi method with two rounds of questionnaires to develop a consensus. The agreement of specialists was reached in three stages: preparatory, discussions and the development of a consensus conclusion. To conduct the assessment, a questionnaire was created consisting of 3 blocks: assessment of the provisions of the clinical recommendation; assessment of the quality criteria of the clinical recommendation and an overall assessment of the clinical recommendation. The assessment was made on the basis of the Likert scale. Median, fashion and weighted average score were calculated. If, when evaluating the provisions and quality criteria of a clinical recommendation, the median value or mode of any provision was less than 7, the weighted average score was less than 70 %; the median value or mode of quality criteria is less than 7.5, the weighted average score is less than 75 %, then this provision (quality criterion) should be recommended for processing. RESULTS: The assessment of the provisions and criteria was carried out in the first round of discussion. At the second round of discussion, comments and recommendations were finally developed for the developers of the methodological recommendation. Consensus was reached during two rounds of modified Delphi analysis. As a result of the analysis, 16 out of 21 provisions and 5 out of 6 quality criteria were agreed, the rest required processing. CONCLUSIONS: As a result of an independent assessment by experts, 5 provisions and 1 quality criterion were recommended for processing. Comments and recommendations on all these provisions and quality criteria of the methodological recommendation “Sedation of patients in the departments of anesthesiology, intensive care and intensive care” were also agreed.

Интратекальное введение антибактериальных препаратов показано при инфекциях центральной нервной системы, вызванных мультирезистентными возбудителями. Интратекальная терапия должна сопровождаться внутривенным введением антибактериальных препаратов. Антибиотики, легко преодолевающие гематоэнцефалический и гематоликворный барьеры и/или обладающие низкой токсичностью, позволяющей увеличить суточную дозу, не должны использоваться для интратекального введения. Антибактериальные препараты, применяемые для интратекальной терапии, это аминогликозиды, колистин, даптомицин, тигециклин и ванкомицин. Ограниченный опыт свидетельствует о полезности противогрибковых препаратов амфотерицина В и каспофунгина. Внутрижелудочковое введение обеспечивает равномерное распределение препарата в ликворе, тогда как интралюмбальное введение часто не позволяет достичь адекватных концентраций антибиотика в желудочках мозга. Индивидуальная доза определяется предполагаемым размером ликворного пространства и ожидаемым уровнем клиренса из спинномозговой жидкости. Вентрикулярный/интралюмбальный дренаж должен быть пережат на 15—120 мин, чтобы облегчить распространение антибактериального препарата в ликворном пространстве.

ЦЕЛЬ ИССЛЕДОВАНИЯ: Описать имеющиеся данные о показаниях, осложнениях, реализации и альтернативных стратегиях использования физического сдерживания у взрослых пациентов в отделениях реанимации и интенсивной терапии. МАТЕРИАЛЫ И МЕТОДЫ: Комплексный обзор, проведенный в базе данных Cochrane, PubMed, Scopus, LILACS, Nursing Database, научной электронной библиотеки eLibrary. Поиск производился по запросам: «физическое ограничение», «фиксирующие устройства в реанимации», «безопасность пациента», «фиксация пациента». РЕЗУЛЬТАТЫ: Окончательный выбор состоял из 93 статей, из которых были извлечены показания, осложнения, алгоритмы и альтернативные стратегии. ВЫВОДЫ: Описаны наиболее распространенные практики в отношении физических ограничений в России и за рубежом, отмечена необходимость разработки и внедрения протоколов использования физических ограничений в отделениях интенсивной терапии.

OBJECTIVE:To analyze the treatment of patients with severe stroke requiring respiratory support, and identify predictors of death.MATERIAL AND METHODS:A multicenter observational clinical study «REspiratory Therapy for Acute Stroke» (RETAS) was conducted under the aegis of the «Federation of Anaesthesiologists and Reanimatologists» (FAR). The study involved 14 clinical centers and included 1289 stroke patients with respiratory support.RESULTS:We found that initial hypoxemia in the 28-day period was associated with higher mortality than in absence of hypoxemia (in patients with 20 or more NIHSS scores) (76.22% versus 63.45%, p=0.004). Risk factors for lethal outcome: hyperventilation used to relieve intracranial hypertension compared with group of patients who were not treated with hyperventilation (in patients with 20 or more NIHSS scores) (79.55% versus 72.75%, p=0.0336); volume-controlled ventilation (VC) versus pressure-controlled ventilation (PC) (in patients with 20 or more NIHSS scores) (p<0.001); use of clinical methods for monitoring ICP in comparison with instrumental ones (87.64% versus 62.33%, p<0.001). It has been proved that the absence of nutritional insufficiency in patients with stroke is associated with a higher probability of a positive outcome (GOS 4 and 5) in comparison with patients with signs of nutritional insufficiency, for the group with NIHSS less than 14 points (p<0.001).CONCLUSIONS:A group of factors associated with a deterioration in the prognosis of outcomes in patients with stroke who are undergoing ventilation has been identified: hypoxemia at the start of respiratory support, lack of instrumental monitoring of ICP, the use of hyperventilation to correct ICP, ventilation with volume control (VC), as well as the presence of nutritional insufficiency.

The literature review reflects the existing approaches to the structural organization of medical care in Russia and its provision with regulatory legal acts. A critical analysis of the list of medical services in the profile of anesthesiology and intensive care is being carried out, which requires significant adjustments and optimization. A variant of the formation and structuring of medical services as a purposeful concretized process of medical care is proposed. Various options for the development of the classification of complications of anesthesia and intensive care are presented. The paper substantiates the urgent need to form a database of various complications and adverse reactions of anesthesia and intensive care, which currently does not exist, as there are no official documents regulating and obliging to conduct this monitoring, and some documents on this issue are related exclusively to the undesirable effects of drugs.

В процессе разработки рекомендаций были проанализированы публикации официальных сайтов Российской Федерации, электронных баз данных РИНЦ, PubMed, MEDLINE, EMBASE и Cochrane Central Register of Controlled Trials (CENTRAL) разработчиками независимо друг от друга. Дата последнего поискового запроса — 1 ноября 2021 г. Для разработки положений рекомендаций были использованы документы непосредственно описывающие особенности ведения пациентов с новой коронавирусной инфекцией (НКИ) COVID-19 (руководства и гайдлайны — 35; рандомизированные клинические исследования и Кокрейновские обзоры — 23; наблюдательные и сравнительные исследования — 134; прочие документы, заметки и комментарии — 72). По сравнению с предыдущей, 5-й, версией рекомендаций скорригированы 35 положений в 10 разделах. Положения текущей версии рекомендаций освещают особенности проведения анестезии, интенсивной терапии, реабилитации, реанимационных мероприятий, проведения манипуляций, транспортировки, предупреждения распространения НКИ COVID-19 при осуществлении данных видов деятельности. Рассмотрены методы защиты персонала от заражения НКИ COVID-19 при проведении манипуляций, анестезии и интенсивной терапии. Описаны особенности респираторной поддержки, экстракорпоральной детоксикации, экстракорпоральной мембранной оксигенации, тромбопрофилактики, лекарственных взаимодействий. Рассмотрены особенности ведения беременных, детей разных возрастных групп, пациентов с сопутствующими заболеваниями, принципы формирования запасов лекарственных препаратов и расходных материалов. Применительно к НКИ CОVID-19 уточнены и дополнены: 1) показания и противопоказания к назначению препаратов (ацетоминофена, глюкокортикостероидов, ремдесевира, тоцилизумаба, барицитинаба, статинов, плазмы реконвалесцентов) в зависимости от тяжести течения заболевания; 2) особенности интенсивной терапии при сопутствующих заболеваниях (сердечно-сосудистой системы, воспалительные заболевания кишечника, онкологические заболевания, нарушения ритма сердца); 3) срок проведения плановых операций у пациентов, перенесших НКИ CОVID-19, и после вакцинации; 4) вопросы тромбопрофилактики и лечения расстройств системы гемостаза; 5) нормативно-правовые документы, касающиеся деятельности медработников в связи с распространением НКИ CОVID-19.

The objective . Analysis of the course of the postoperative period and number of complications in patients with ovarian cancer during cytoreductive operations with hyperthermic intraoperative intra-abdominal chemotherapy. Subjects and Methods . We assessed the number of bed-days, the volume of infusion-transfusion therapy, diuresis, the volume of enteral feeding, the level of leukocytes, urea, creatinine, and lipocalin associated with gel in 45 patients with ovarian cancer after cytoreductive surgery with hyperthermic intraoperative intra-abdominal chemotherapy. Results . All patients developed polyuria while reference parameters of urea and creatinine were stable. Due to these changes, additional markers of acute renal damage were searched for. 15.9% of cases developed leukopenia on days 7–10. The number of complications and deaths does not exceed the world level. Conclusion . A multicomponent and versatile approach to the postoperative management of patients allows minimizing the level of complications and deaths. A search for a more sensitive marker of acute kidney injury is needed.

After discharge from the Intensive Care Unit (ICU), more than 50 % of patients experience pathological symptoms that are not related to the primary emergency but reduce the quality of life and require rehabilitation. Post Intensive Care Syndrome (PIСS) include only those conditions that do not have a direct causal relationship with the emergency condition that gave rise to hospitalization in the ICU. The pathophysiological basis of the PICS is the phenomenon of “learned non-use”: a state of artificial limitation of the patient’s motor and cognitive activity as a result of the use of analgosedation, bed rest and immobilization. The clinical picture of PICS is determined by the severity of its individual components, detailed using a package of clinimetric scales. Based on the results of dynamic testing, the PICS severity index is calculated. The sum of the scores in the range from 0 to 10 reflects the severity and effectiveness of rehabilitation measures. For the prevention of PICS, the Union of Rehabilitologists of Russia together with the Federation of Anesthesiologists and Resuscitators of Russia has developed the rehabilitation complex “ReabICU”. In the English-language literature, such a complex is called “Awakening and Breathing Coordination, Delirium monitoring/management, and Early exercise/mobility” bundle. ReabICU is a complex of technologically therapeutic and diagnostic modules “positioning and mobilization”, “prevention of dysphagia and nutritional deficiency”, “prevention of emotional and cognitive impairment and delirium”, “prevention of loss of self-care skills”. The basis of the multidisciplinary rehabilitation team, which includes a doctor for medical rehabilitation, 2 specialists in physical rehabilitation, a specialist in occupation therapy, a medical psychologist, a medical speech therapist, a nurse for medical rehabilitation. The activity of multidisciplinary rehabilitation team is evaluated on the basis of quality criteria and the achievement of the main goal of ReabICU — the preservation of the premorbid status of the patient’s socialization.

AIM OF THE STUDY:To investigate the efficacy and safety of non-immunogenic staphylokinase (NS) compared with alteplase (A) in patients with acute ischemic stroke (AIS) within 4.5 h after symptom onset.MATERIAL AND METHODS:336 patients with IS within 4.5 h after symptom onset were included in a randomized, open-label, multicenter, parallel-group, non-inferiority comparative trial of NS vs A (168 patients in each group). NS was administered as an intravenous bolus in a dose of 10 mg, regardless of body weight, over 10 s, A was administered as a bolus infusion in a dose of 0.9 mg/kg, maximum 90 mg over 1 hour. The primary efficacy endpoint was a favorable outcome, defined as a modified Rankin scale (mRS) score of 0-1 on day 90. Safety endpoints included all-cause mortality on day 90, symptomatic intracranial haemorrhage, and other serious adverse events (SAEs).RESULTS:At day 90, 84 (50%) patients reached the primary endpoint (mRS 0-1) in the NS group, 68 (41%) patients - in the A group (p=0.10, OR=1.47, 95% CI=0.93-2.32). The difference between groups NS and A was 9.5% (95% CI= -1.7-20.7) and the lower limit of the 95% CI did not cross the margin of non-inferiority (pnon-inferiority<0.0001). There were no significant differences in the frequency of deaths between the groups: on day 90, 17 (10%) patients in the NS group and 24 (14%) in the A group had died (p=0.32). There was a trend towards significant differences in the frequency of symptomatic intracranial haemorrhage: NS group - 5 (3%) patients, A group - 13 (8%) patients (p=0.087, OR=0.37, 95% CI=0.1-1.13). There were significant differences in the number of patients with SAEs: in the NS group - 22 (13%) patients, in the A group - 37 (22%) patients (p=0.044, OR=0.53, 95% CI=0.28-0.98).CONCLUSION:The presented results of the FRIDA trial are the first in the world to use a drug based on NS in patients with IS. It has been shown that a single bolus (within 10 s) administration of NS at a standard dose of 10 mg, regardless of body weight, allows to conduct fast, effective and safe thrombolytic therapy in patients with IS within 4.5 h after symptom onset. In further clinical tials of NS, it is planned to expand the therapeutic window beyond 4.5 h after symptom onset in patients with IS.

Заключение эксперта фактически служит основным доказательством по гражданским и уголовным делам, связанным с неблагоприятным исходом заболевания и неблагоприятным результатом оказания медицинской помощи. Отсутствие единого понятийного аппарата приводит к субъективности выводов эксперта и к разной экспертной оценке однотипных клинических ситуаций, что не соответствует принципам правосудия. Для решения этой проблемы авторы предлагают использовать при экспертной оценке неблагоприятного исхода заболевания и неблагоприятного результата оказания медицинской помощи по специальности «анестезиология-реаниматология» единообразные основные понятия.