Driving pressure, as opposed to tidal volume based on predicted body weight, is associated with mortality: results from a prospective cohort of COVID-19 acute respiratory distress syndrome patients.

OBJECTIVE: To evaluate the association between driving pressure and tidal volume based on predicted body weight and mortality in a cohort of patients with acute respiratory distress syndrome caused by COVID-19. METHODS: This was a prospective, observational study that included patients with acute respiratory distress syndrome due to COVID-19 admitted to two intensive care units. We performed multivariable analyses to determine whether driving pressure and tidal volume/kg predicted body weight on the first day of mechanical ventilation, as independent variables, are associated with hospital mortality. RESULTS: We included 231 patients. The mean age was 64 (53 - 74) years, and the mean Simplified Acute and Physiology Score 3 score was 45 (39 - 54). The hospital mortality rate was 51.9%. Driving pressure was independently associated with hospital mortality (odds ratio 1.21, 95%CI 1.04 - 1.41 for each cm H2O increase in driving pressure, p = 0.01). Based on a double stratification analysis, we found that for the same level of tidal volume/kg predicted body weight, the risk of hospital death increased with increasing driving pressure. However, changes in tidal volume/kg predicted body weight were not associated with mortality when they did not lead to an increase in driving pressure. CONCLUSION: In patients with acute respiratory distress syndrome caused by COVID-19, exposure to higher driving pressure, as opposed to higher tidal volume/kg predicted body weight, is associated with greater mortality. These results suggest that driving pressure might be a primary target for lung-protective mechanical ventilation in these patients.

Effects of atelectatic areas on the surrounding lung tissue during mechanical ventilation in an experimental model of acute lung injury induced by lipopolysaccharide / Efeitos das áreas atelectásicas no tecido pulmonar circundante durante a ventilação mecânica em um modelo experimental de lesão pulmonar aguda induzida por lipopolissacarídeo

ABSTRACT Objective: To assess the effect of atelectasis during mechanical ventilation on the periatelectatic and normal lung regions in a model of atelectasis in rats with acute lung injury induced by lipopolysaccharide. Methods: Twenty-four rats were randomized into the following four groups, each with 6 animals: the Saline-Control Group, Lipopolysaccharide Control Group, Saline-Atelectasis Group, and Lipopolysaccharide Atelectasis Group. Acute lung injury was induced by intraperitoneal injection of lipopolysaccharide. After 24 hours, atelectasis was induced by bronchial blocking. The animals underwent mechanical ventilation for two hours with protective parameters, and respiratory mechanics were monitored during this period. Thereafter, histologic analyses of two regions of interest, periatelectatic areas and the normally-aerated lung contralateral to the atelectatic areas, were performed. Results: The lung injury score was significantly higher in the Lipopolysaccharide Control Group (0.41 ± 0.13) than in the Saline Control Group (0.15 ± 0.51), p < 0.05. Periatelectatic regions showed higher lung injury scores than normally-aerated regions in both the Saline-Atelectasis (0.44 ± 0.06 x 0.27 ± 0.74 p < 0.05) and Lipopolysaccharide Atelectasis (0.56 ± 0.09 x 0.35 ± 0.04 p < 0.05) Groups. The lung injury score in the periatelectatic regions was higher in the Lipopolysaccharide Atelectasis Group (0.56 ± 0.09) than in the periatelectatic region of the Saline-Atelectasis Group (0.44 ± 0.06), p < 0.05. Conclusion: Atelectasis may cause injury to the surrounding tissue after a period of mechanical ventilation with protective parameters. Its effect was more significant in previously injured lungs.

RESUMO Objetivo: Avaliar o efeito da atelectasia durante a ventilação mecânica nas regiões periatelectáticas e pulmonares normais em um modelo de atelectasia em ratos com lesão pulmonar aguda induzida por lipopolissacarídeo. Métodos: Foram distribuídos aleatoriamente 24 ratos em quatro grupos, cada um com 6 animais: Grupo Salina-Controle, Grupo Lipopolissacarídeo-Controle, Grupo Salina-Atelectasia e Grupo Lipopolissacarídeo-Atelectasia. A lesão pulmonar aguda foi induzida por injeção intraperitoneal de lipopolissacarídeo. Após 24 horas, a atelectasia foi induzida por bloqueio brônquico. Os animais foram submetidos à ventilação mecânica por 2 horas com parâmetros ventilatórios protetores, e a mecânica respiratória foi monitorada durante esse período. Em seguida, foram realizadas análises histológicas de duas regiões de interesse: as áreas periatelectásicas e o pulmão normalmente aerado contralateral às áreas atelectásicas. Resultados: O escore de lesão pulmonar foi significativamente maior no Grupo Controle-Lipopolissacarídeo (0,41 ± 0,13) do que no Grupo Controle-Solução Salina (0,15 ± 0,51), com p < 0,05. As regiões periatelectásicas apresentaram escores maiores de lesão pulmonar do que as regiões normalmente aeradas nos Grupos Atelectasia-Solução Salina (0,44 ± 0,06 versus 0,27 ± 0,74, p < 0,05) e Atelectasia-Lipopolissacarídeo (0,56 ± 0,09 versus 0,35 ± 0,04, p < 0,05). O escore de lesão pulmonar nas regiões periatelectásicas foi maior no Grupo Atelectasia-Lipopolissacarídeo (0,56 ± 0,09) do que na região periatelectásica do Grupo Atelectasia-Solução Salina (0,44 ± 0,06), p < 0,05. Conclusão: A atelectasia pode causar lesão no tecido circundante após um período de ventilação mecânica com parâmetros ventilatórios protetores. Seu efeito foi mais significativo em pulmões previamente lesionados.

Effect of a structured early mobilization protocol on the level of mobilization and muscle strength in critical care patients: A randomized clinical trial.

BACKGROUND: Few studies have evaluated the effects of structured early mobilization (EM) protocols on the level of mobilization in critical care patients. OBJECTIVE: To evaluate the impact of a structured EM protocol on the level of mobilization, muscle strength, and the level of activities of daily living (LADL) after intensive care unit (ICU) and hospital discharge. METHODS: This randomized clinical trial (U1111-1245-4840) included adults patients who were randomized into two groups: intervention (n = 40) and control (n = 45). The intervention group underwent conventional physiotherapy and structured EM protocols, and the control group underwent conventional physiotherapy. The level of mobilization from 0 (no mobilization) to 5 (walking), muscle strength (Medical Research Council scale), LADL (Katz Index), and incidence of complications were evaluated. RESULTS: The level of mobilization from day 1 to day 7 increased in the intervention group compared with the control group (p < .05). Muscle strength did not change during the protocol in the intervention and control groups {day 1 [effect size (r) = 0.15, p = .161], at ICU discharge [r = 0.16, p = .145], and after ICU discharge [r = 0.16, p = .191]}. The LADL did not differ between the intervention and control groups after ICU discharge [4 (1-6) vs. 3 (1-5), p = .702] or 30 days after hospital discharge [6 (5-6) vs. 6 (5-6), p = .945]. The structured EM protocol was safe, and no severe complications were observed during the protocol. CONCLUSION: A structured EM protocol increased the level of mobilization without improving muscle strength and the LADL compared with conventional physiotherapy.

Effects of atelectatic areas on the surrounding lung tissue during mechanical ventilation in an experimental model of acute lung injury induced by lipopolysaccharide.

OBJECTIVE: To assess the effect of atelectasis during mechanical ventilation on the periatelectatic and normal lung regions in a model of atelectasis in rats with acute lung injury induced by lipopolysaccharide. METHODS: Twenty-four rats were randomized into the following four groups, each with 6 animals: the Saline-Control Group, Lipopolysaccharide Control Group, Saline-Atelectasis Group, and Lipopolysaccharide Atelectasis Group. Acute lung injury was induced by intraperitoneal injection of lipopolysaccharide. After 24 hours, atelectasis was induced by bronchial blocking. The animals underwent mechanical ventilation for two hours with protective parameters, and respiratory mechanics were monitored during this period. Thereafter, histologic analyses of two regions of interest, periatelectatic areas and the normally-aerated lung contralateral to the atelectatic areas, were performed. RESULTS: The lung injury score was significantly higher in the Lipopolysaccharide Control Group (0.41 ± 0.13) than in the Saline Control Group (0.15 ± 0.51), p < 0.05. Periatelectatic regions showed higher lung injury scores than normally-aerated regions in both the Saline-Atelectasis (0.44 ± 0.06 x 0.27 ± 0.74 p < 0.05) and Lipopolysaccharide Atelectasis (0.56 ± 0.09 x 0.35 ± 0.04 p < 0.05) Groups. The lung injury score in the periatelectatic regions was higher in the Lipopolysaccharide Atelectasis Group (0.56 ± 0.09) than in the periatelectatic region of the Saline-Atelectasis Group (0.44 ± 0.06), p < 0.05. CONCLUSION: Atelectasis may cause injury to the surrounding tissue after a period of mechanical ventilation with protective parameters. Its effect was more significant in previously injured lungs.

Protective mechanical ventilation in patients with risk factors for ARDS: prospective cohort study.

OBJECTIVE: To evaluate the association that protective mechanical ventilation (MV), based on VT and maximum distending pressure (MDP), has with mortality in patients at risk for ARDS. METHODS: This was a prospective cohort study conducted in an ICU and including 116 patients on MV who had at least one risk factor for the development of ARDS. Ventilatory parameters were collected twice a day for seven days, and patients were divided into two groups (protective MV and nonprotective MV) based on the MDP (difference between maximum airway pressure and PEEP) or VT. The outcome measures were 28-day mortality, ICU mortality, and in-hospital mortality. The risk factors associated with the adoption of nonprotective MV were also assessed. RESULTS: Nonprotective MV based on VT and MDP was applied in 49 (42.2%) and 38 (32.8%) of the patients, respectively. Multivariate Cox regression showed that protective MV based on MDP was associated with lower in-hospital mortality (hazard ratio = 0.37; 95% CI: 0.19-0.73) and lower ICU mortality (hazard ratio = 0.40; 95% CI: 0.19-0.85), after adjustment for age, Simplified Acute Physiology Score 3, and vasopressor use, as well as the baseline values for PaO2/FiO2 ratio, PEEP, pH, and PaCO2. These associations were not observed when nonprotective MV was based on the VT. CONCLUSIONS: The MDP seems to be a useful tool, better than VT, for adjusting MV in patients at risk for ARDS.

Protective mechanical ventilation in patients with risk factors for ARDS: prospective cohort study / Ventilação mecânica protetora em pacientes com fator de risco para SDRA: estudo de coorte prospectiva

ABSTRACT Objective: To evaluate the association that protective mechanical ventilation (MV), based on VT and maximum distending pressure (MDP), has with mortality in patients at risk for ARDS. Methods: This was a prospective cohort study conducted in an ICU and including 116 patients on MV who had at least one risk factor for the development of ARDS. Ventilatory parameters were collected twice a day for seven days, and patients were divided into two groups (protective MV and nonprotective MV) based on the MDP (difference between maximum airway pressure and PEEP) or VT. The outcome measures were 28-day mortality, ICU mortality, and in-hospital mortality. The risk factors associated with the adoption of nonprotective MV were also assessed. Results: Nonprotective MV based on VT and MDP was applied in 49 (42.2%) and 38 (32.8%) of the patients, respectively. Multivariate Cox regression showed that protective MV based on MDP was associated with lower in-hospital mortality (hazard ratio = 0.37; 95% CI: 0.19-0.73) and lower ICU mortality (hazard ratio = 0.40; 95% CI: 0.19-0.85), after adjustment for age, Simplified Acute Physiology Score 3, and vasopressor use, as well as the baseline values for PaO2/FiO2 ratio, PEEP, pH, and PaCO2. These associations were not observed when nonprotective MV was based on the VT. Conclusions: The MDP seems to be a useful tool, better than VT, for adjusting MV in patients at risk for ARDS.

RESUMO Objetivo: Avaliar a associação da ventilação mecânica (VM) protetora, com base no VT e na pressão de distensão máxima (PDM), com a mortalidade em pacientes com fator de risco para SDRA. Métodos: Este estudo de coorte prospectivo foi conduzido em uma UTI e incluiu 116 pacientes em VM que apresentavam pelo menos um fator de risco para o desenvolvimento de SDRA. Os parâmetros ventilatórios foram coletados duas vezes ao dia durante sete dias, e os pacientes foram divididos em dois grupos (VM protetora e VM não protetora) com base na PDM (diferença entre pressão máxima de vias aéreas e PEEP) ou no VT. Os desfechos foram mortalidade em 28 dias, mortalidade na UTI e mortalidade hospitalar. Os fatores de risco associados com a adoção da VM não protetora também foram avaliados. Resultados: A VM não protetora com base no VT e na PDM ocorreu em 49 (42,2%) e em 38 (32,8%) dos pacientes, respectivamente. A regressão multivariada de Cox mostrou que a VM protetora com base na PDM associou-se a menor mortalidade hospitalar (hazard ratio = 0,37; IC95%: 0,19-0,73) e em UTI (hazard ratio = 0,40; IC95%, 0,19-0,85), após ajuste para idade, Simplified Acute Physiology Score 3, uso de vasopressor e valores basais de PaO2/FiO2, PEEP, pH e PaCO2. Essas associações não foram observadas quando a VM não protetora foi baseada no VT. Conclusões: A PDM parece ser uma ferramenta útil, melhor do que o VT, para o ajuste da VM em pacientes sob risco para SDRA.

Effects of an unsupervised pedometer-based physical activity program on daily steps of adults with moderate to severe asthma: a randomized controlled trial.

Supervised exercise has shown benefits for subjects with asthma, but little is known about the effectiveness of unsupervised physical activity on this population. We investigated the effects of a 12-week unsupervised pedometer-based physical activity program on daily steps and on clinical and psychological parameters of adults with asthma. Clinically stable adults with moderate to severe asthma were encouraged to take daily 30-minute walks and were randomized to pedometer and control groups. The pedometer group received pedometers and individualized daily step targets. Changes in daily steps (average of steps taken during six consecutive days), six-minute walk test (6MWT), health-related quality of life, asthma control and anxiety and depression levels were assessed 12 weeks after intervention and 24-28 weeks after randomization. Thirty-seven participants were recruited and 30 completed the intervention. At 12 weeks, the groups differed significantly in daily steps (adjusted average difference, 2488 steps; 95% confidence interval [CI], 803 to 4172; p = 0.005) and in the 6MWT (adjusted average difference, 21.9 m; 95% CI, 6.6 to 37.3; p = 0.006). These differences were not significant 24-28 weeks after randomization. The program was effective in increasing daily steps of adults with moderate to severe asthma 12 weeks after intervention.

Objectively measured daily-life physical activity of moderate-to-severe Brazilian asthmatic women in comparison to healthy controls: A cross-sectional study.

Considering the complex relationship between asthma symptoms and exercise, asthmatics are usually believed to be less active in daily life than healthy subjects. However, few studies have objectively assessed daily-life physical activity (DLPA) of asthmatic adults. OBJECTIVE: To objectively assess DLPA of a sample of Brazilian asthmatic women in comparison to healthy controls, and to investigate the associations between DLPA and asthma control, health-related quality of life, anxiety and depression levels, and the Six-minute walk test (6MWT) in this population. METHODS: Sixty-six women were included, 36 in the asthma group (AG) and 30 in the control group (CG). The AG was composed by clinically stable moderate-to-severe asthmatics. The CG was composed by apparently healthy volunteers. All subjects underwent DLPA assessment (considered as the average of steps taken during six consecutive days measured by a pedometer) and performed the 6MWT. Additionally, participants in the AG were assessed using the Asthma Control Questionnaire, the Asthma Quality of Life Questionnaire (AQLQ), and the Hospital Anxiety and Depression Scale. RESULTS: There was no difference between the AG and the CG regarding DLPA (7490.3 ± 3330.2 vs 6876.4 ± 3242.1 steps respectively, p = 0.45), even after adjustment for covariates. DLPA was significantly correlated to the activity limitation domain of the AQLQ among asthmatics (r = 0.43, p < 0.01). CONCLUSION: Despite the association between self-perceived activity limitation and DLPA among asthmatics, there were no differences regarding DLPA between a sample of moderate-to-severe Brazilian asthmatic women and apparently healthy controls.

Physical Activity in Hemodialysis Patients Measured by Triaxial Accelerometer.

Different factors can contribute to a sedentary lifestyle among hemodialysis (HD) patients, including the period they spend on dialysis. The aim of this study was to evaluate characteristics of physical activities in daily life in this population by using an accurate triaxial accelerometer and to correlate these characteristics with physiological variables. Nineteen HD patients were evaluated using the DynaPort accelerometer and compared to nineteen control individuals, regarding the time spent in different activities and positions of daily life and the number of steps taken. HD patients were more sedentary than control individuals, spending less time walking or standing and spending more time lying down. The sedentary behavior was more pronounced on dialysis days. According to the number of steps taken per day, 47.4% of hemodialysis patients were classified as sedentary against 10.5% in control group. Hemoglobin level, lower extremity muscle strength, and physical functioning of SF-36 questionnaire correlated significantly with the walking time and active time. Looking accurately at the patterns of activity in daily life, HDs patients are more sedentary, especially on dialysis days. These patients should be motivated to enhance the physical activity.

Efficacy and safety of two dry-powder inhalers for the administration of mometasone furoate in asthma patients.

OBJECTIVE: Mometasone furoate (MF) is a new, potent synthetic inhaled corticosteroid. Worldwide, MF is administered via a dry-powder inhaler that contains multiple doses. As a preparation that would be more cost-effective, single-dose MF capsules were developed in Brazil. The objective of the present study was to evaluate the efficacy and safety of the two inhalers for MF administration in patients with asthma. METHODS: A randomized, multicenter, open-label, parallel-group clinical trial involving 74 adult patients with moderate, persistent asthma who were randomized into two groups to receive approximately 400 µg of MF once a day for 60 days, either via the multiple-dose inhaler or via the newly developed single-dose inhaler. RESULTS: No significant differences were observed between the two groups regarding the primary endpoints (FEV1 and rescue medication use) or the secondary endpoints (morning PEF, tolerability, and safety, the last as assessed on the basis of hypothalamic-pituitary-adrenal axis function). CONCLUSIONS: The use of the single-dose inhaler developed in Brazil for MF administration is as effective and safe as is that of a standard inhaler in the treatment of patients with asthma.

Eficácia e segurança de dois inaladores de pó seco usados para a aplicação de furoato de mometasona em pacientes com asma / Efficacy and safety of two dry-powder inhalers for the administration of mometasone furoate in asthma patients

OBJETIVO: O furoato de mometasona (FM) é um novo corticosteroide inalatório sintético potente. Internacionalmente, o FM é fornecido em um inalador de pó seco que permite sua administração em múltiplas doses. Para se obter uma preparação com melhor relação custo-eficácia, foram desenvolvidas no Brasil formulações de FM em cápsulas de pó seco para serem administradas em dose única. O presente estudo teve como objetivo avaliar a eficácia e a segurança dos dois inaladores usados para a administração de FM em pacientes asmáticos. MÉTODOS: Estudo clínico, aberto, comparativo, paralelo e multicêntrico com 74 adultos portadores de asma persistente e moderada, randomizados em dois grupos para receber FM em uma dose de aproximadamente 400 µg, fornecida por um inalador de dose múltipla ou pelo novo inalador de dose única, uma vez ao dia durante 60 dias. RESULTADOS: Não foram observadas diferenças significantes entre os dois grupos estudados nos desfechos primários (VEF1 e frequência do uso de medicação de resgate) ou nos desfechos secundários (PFE matinal, tolerabilidade e segurança, essa última avaliada pelo estudo do eixo hipotálamo-hipófise-adrenal). CONCLUSÕES: A administração de FM com o novo inalador de dose única desenvolvido no Brasil tem eficácia e segurança comparáveis à administração com o inalador de dose múltipla no tratamento de pacientes asmáticos.

OBJECTIVE: Mometasone furoate (MF) is a new, potent synthetic inhaled corticosteroid. Worldwide, MF is administered via a dry-powder inhaler that contains multiple doses. As a preparation that would be more cost-effective, single-dose MF capsules were developed in Brazil. The objective of the present study was to evaluate the efficacy and safety of the two inhalers for MF administration in patients with asthma. METHODS: A randomized, multicenter, open-label, parallel-group clinical trial involving 74 adult patients with moderate, persistent asthma who were randomized into two groups to receive approximately 400 µg of MF once a day for 60 days, either via the multiple-dose inhaler or via the newly developed single-dose inhaler. RESULTS: No significant differences were observed between the two groups regarding the primary endpoints (FEV1 and rescue medication use) or the secondary endpoints (morning PEF, tolerability, and safety, the last as assessed on the basis of hypothalamic-pituitary-adrenal axis function). CONCLUSIONS: The use of the single-dose inhaler developed in Brazil for MF administration is as effective and safe as is that of a standard inhaler in the treatment of patients with asthma.

Early versus late tracheostomy in patients with acute severe brain injury.

OBJECTIVE: To compare the effects of early tracheostomy and of late tracheostomy in patients with acute severe brain injury. METHODS: A retrospective study involving 28 patients admitted to the ICU of the Federal University of Juiz de Fora University Hospital in Juiz de Fora, Brazil, diagnosed with acute severe brain injury and presenting with a Glasgow coma scale (GCS) score < 8 within the first 48 h of hospitalization. The patients were divided into two groups: early tracheostomy (ET), performed within the first 8 days after admission; and late tracheostomy (LT), performed after postadmission day 8. At admission, we collected demographic data and determined the following scores: Acute Physiology and Chronic Health Evaluation (APACHE) II, GCS and Sequential Organ Failure Assessment (SOFA). RESULTS: There were no significant differences between the groups (ET vs. LT) regarding the demographic data or the scores: APACHE II (26 +/- 6 vs. 28 +/- 8; p = 0.37), SOFA (6.3 +/- 2.7 vs. 7.2 +/- 3.0; p = 0.43) and GCS (5.4 +/- 1.7 vs. 5.5 +/- 1.7; p = 0.87). The 28-day mortality rate was lower in the ET group (9% vs. 47%; p = 0.04). Nosocomial pneumonia occurring within the first 7 days was less common in the ET group, although the difference was not significant (0% vs. 23%; p = 0.13). There were no differences regarding the occurrence of late pneumonia or in the duration of mechanical ventilation between the groups. CONCLUSIONS: On the basis of these findings, early tracheostomy should be considered in patients with acute severe brain injury.

Traqueostomia precoce versus traqueostomia tardia em pacientes com lesão cerebral aguda grave / Early versus late tracheostomy in patients with acute severe brain injury

OBJETIVO: Comparar os efeitos da traqueostomia precoce e da traqueostomia tardia em pacientes com lesão cerebral aguda grave. MÉTODOS: Estudo retrospectivo com 28 pacientes admitidos na UTI do Hospital Universitário da Universidade Federal de Juiz de Fora com diagnóstico de lesão cerebral aguda grave e apresentando escore na escala de coma de Glasgow (ECG) < 8 nas primeiras 48 h de internação. Os pacientes foram divididos em dois grupos: traqueostomia precoce (TP), realizada em até 8 dias; e traqueostomia tardia (TT), realizada após 8 dias. Dados demográficos e os escores Acute Physiology and Chronic Health Evaluation (APACHE) II, ECG e Sequential Organ Failure Assessment (SOFA) do dia da admissão foram coletados. RESULTADOS: Não houve diferenças significativas em relação aos dados demográficos ou aos escores coletados nos grupos TP e TT: APACHE II (26 ± 6 vs. 28 ± 8; p = 0,37), SOFA (6,3 ± 2,7 vs. 7,2 ± 3,0; p = 0,43) e ECG (5,4 ± 1,7 vs. 5,5 ± 1,7; p = 0,87). A mortalidade em 28 dias foi menor no grupo TP (9 por cento vs. 47 por cento; p = 0,04). Pneumonia nosocomial precoce (até 7 dias) foi menos frequente no grupo TP, mas essa diferença não foi significativa (0 por cento vs. 23 por cento, p = 0,13). Não houve diferenças em relação à ocorrência de pneumonia tardia ou ao tempo de ventilação mecânica entre os grupos. CONCLUSÕES: Baseado nesses achados, a traqueostomia precoce deve ser considerada em pacientes com lesão cerebral aguda grave.

OBJECTIVE: To compare the effects of early tracheostomy and of late tracheostomy in patients with acute severe brain injury. METHODS: A retrospective study involving 28 patients admitted to the ICU of the Federal University of Juiz de Fora University Hospital in Juiz de Fora, Brazil, diagnosed with acute severe brain injury and presenting with a Glasgow coma scale (GCS) score < 8 within the first 48 h of hospitalization. The patients were divided into two groups: early tracheostomy (ET), performed within the first 8 days after admission; and late tracheostomy (LT), performed after postadmission day 8. At admission, we collected demographic data and determined the following scores: Acute Physiology and Chronic Health Evaluation (APACHE) II, GCS and Sequential Organ Failure Assessment (SOFA). RESULTS: There were no significant differences between the groups (ET vs. LT) regarding the demographic data or the scores: APACHE II (26 ± 6 vs. 28 ± 8; p = 0.37), SOFA (6.3 ± 2.7 vs. 7.2 ± 3.0; p = 0.43) and GCS (5.4 ± 1.7 vs. 5.5 ± 1.7; p = 0.87). The 28-day mortality rate was lower in the ET group (9 percent vs. 47 percent; p = 0.04). Nosocomial pneumonia occurring within the first 7 days was less common in the ET group, although the difference was not significant (0 percent vs. 23 percent; p = 0.13). There were no differences regarding the occurrence of late pneumonia or in the duration of mechanical ventilation between the groups. CONCLUSIONS: On the basis of these findings, early tracheostomy should be considered in patients with acute severe brain injury.