Effects of Intraoperative High PEEP with Recruitment Maneuvers vs. Low PEEP on Postoperative Pulmonary Complications a patientlevel metaanalysis of three randomized clinical trials

Permanece incerto se a estratégia de ventilação intraoperatória com alta pressão positiva ao final da expiração (PEEP) associada a manobras de recrutamento alveolar melhora os desfechos clínicos de pacientes submetidos a cirurgia geral. Três ensaios clínicos randomizados multicêntrios (PROVHILO, iPROVE e PROBESE) falharam em demonstrar benefício estatisticamente significativo da PEEP alta com manobras de recrutamento alveolar com relação à ocorrência de complicações pulmonares pós-operatórias. Uma metanálise de dados individuais de pacientes dos três ensaios clínicos foi realizada para avaliar se a PEEP alta com manobras de recrutamento alveolar reduz a ocorrência de complicações pulmonares pós-operatórias em pacientes submetidos a cirurgia geral. Os dados de pacientes adultos com risco aumentado para complicações pulmonares pós-operatórias que foram submetidos a cirurgia não cardiotorácica e não neurológica sob anestesia geral incluídos nos três estudos foram agrupados. Os três ensaios envolveram pacientes de 128 hospitais, em um total de 24 países, de fevereiro de 2011 a fevereiro de 2018. Os grupos estudados foram PEEP alta com manobras de recrutamento alveolar (n = 1913) vs PEEP baixa (n = 1924). Todos os pacientes receberam ventilação controlada a volume com volume corrente alvo 8 ml/kg de peso corporal previsto. O desfecho primário foi um composto de complicações pulmonares na primeira semana de pós-operatório, incluindo insuficiência respiratória leve e grave, síndrome do desconforto respiratório agudo, broncoespasmo, infecção pulmonar, derrame pleural, atelectasia e pneumotórax. Os desfechos secundários incluíram eventos adversos intraoperatórios, um composto de complicações pulmonares pós-operatórias graves em que a insuficiência respiratória leve foi ignorada, um composto de complicações pós-operatórias graves, complicações extrapulmonares, admissão em unidade de terapia intensiva não planejada, tempo de internação hospitalar e mortalidade. Foram testadas as interações entre tratamento e subgrupos criados de acordo com características dos pacientes, procedimentos e cuidados realizados. Dos 3.925 pacientes randomizados, 3.837 (97,7%) completaram os ensaios (idade média de 56,3 anos; 2.104 [55%] mulheres; 3.640 [95%] foram submetidos a cirurgia abdominal). O desfecho primário ocorreu em 562 pacientes (29,5%) no grupo de PEEP alta e em 620 (32,3%) pacientes no grupo de PEEP baixa (razão de chances não ajustada, 0,87 (intervalo de confiança [IC] de 95%, 0,75 a 1,01; p = 0,06). Menos pacientes do grupo de PEEP alta precisaram de resgate intraoperatório para dessaturação (4,5% vs. 11,2%; razão de chances não ajustada, 0,34 [IC 95%, 0,26 a 0,45]; p < 0,001) e mais pacientes no grupo de PEEP alta tiveram hipotensão intraoperatória (41,0% vs. 30,1%; razão de chances não ajustada, 1,87 [IC 95%, 1,60 a 2,17]; p < 0,001). Dos 14 desfechos secundários pré-especificados, 11 não foram significativamente diferentes entre os grupos e três foram significativamente diferentes, incluindo menos pacientes precisando de resgate para dessaturação no grupo de PEEP alta e menos pacientes desenvolvendo hipotensão e precisando de drogas vasoativas no grupo PEEP baixa. Nesta metanálise de dados de pacientes de três ensaios clínicos randomizados de ventilação em pacientes submetidos a cirurgias não cardiotorácicas e não neurológicas, durante ventilação com volume corrente protetor, o uso intraoperatório de PEEP alta associado a manobras de recrutamento alveolar não reduziu de forma estatisticamente significativa as complicações pulmonares pós-operatóriasIt remains uncertain if an intraoperative ventilation strategy that uses high positive endexpiratory pressure (PEEP) with recruitment maneuvers improves clinical outcomes. Three multicenter randomized clinical trials (PROVHILO, iPROVE, and PROBESE) failed to show statistically significant benefit of high PEEP with recruitment maneuvers with respect to occurrence of postoperative pulmonary complications. A patientlevel metaanalysis of the three clinical trials was performed to assess whether high PEEP with recruitment maneuvers reduces the occurrence of postoperative pulmonary complications in patients undergoing major nonthoracic operations. Data from adult patients at increased risk for postoperative pulmonary complications who underwent noncardiothoracic and nonneurological surgery under general anesthesia included in the three trials were pooled. The three trials enrolled patients at 128 hospitals in 24 countries from February 2011February 2018. The groups studied were high PEEP with recruitment maneuvers (n=1913) vs low PEEP (n=1924). All patients received volumecontrolled ventilation with a target tidal volume 8 mL/kg of predicted body weight. The primary outcome was a composite of pulmonary complications within the first postoperative week, including mild and severe respiratory failure, acute respiratory distress syndrome, bronchospasm, pulmonary infection, pleural effusion, atelectasis, and pneumothorax. Secondary outcomes included intraoperative adverse events, a composite of severe postoperative pulmonary complications in which mild respiratory failure was ignored, a composite of major postoperative complications, extrapulmonary complications, unplanned intensive care unit admission, hospital length of stay and mortality. Treatmentbysubgroup interactions for patient characteristics, and procedure and caredelivery characteristics were tested. Among 3925 randomized patients, 3837 (97.7%) completed the trials (mean age 56.3 years; 2104 [55%] women; 3640 [95%] underwent a major abdominal operation). The primary outcome occurred in 562 patients (29.5%) in the high PEEP group and in 620 (32.3%) patients in the low PEEP group (unadjusted odds ratio, 0.87 (95%confidence interval [CI], 0.75 to 1.01; p = 0.06). Fewer patients in the high PEEP group needed an intraoperative rescue for desaturation (4.5% vs 11.2%; unadjusted odds ratio, 0.34 [95%CI, 0.26 to 0.45]; p < 0.001); more patients in the high PEEP group had intraoperative hypotension (41.0% vs. 30.1%; unadjusted odds ratio, 1.87 [95%CI, 1.60 to 2.17]; p < 0.001). Among the 14 prespecified secondary outcomes, 11 were not significantly different between the groups, and three were significantly different, including fewer patients needing rescue for desaturation in the high PEEP group and fewer patients developing hypotension and needing vasoactive drugs in the low PEEP group. In this patientlevel metaanalysis of three randomized clinical trials of ventilation in patients undergoing major nonthoracic operations, during protective tidal volume intraoperative use of high PEEP with recruitment maneuvers did not significantly reduce postoperative pulmonary complication

SEVERITAS: An externally validated mortality prediction for critically ill patients in low and middle-income countries

Objective: Severity of illness scores used in critical care for benchmarking, quality assurance and risk stratification have been mainly created in high-income countries. In low and middle-income countries (LMICs), they cannot be widely utilized due to the demand for large amounts of data that may not be available (e.g. laboratory results). We attempt to create a new severity prognostication model using fewer variables that are easier to collect in an LMIC. Setting: Two intensive care units, one private and one public, from São Paulo, Brazil Patients: An ICU for the first time. Interventions: None. Measurements and Mains results: The dataset from the private ICU was used as a training set for model development to predict in-hospital mortality. Three different machine learning models were applied to five different blocks of candidate variables. The resulting 15 models were then validated on a separate dataset from the public ICU, and discrimination and calibration compared to identify the best model. The best performing model used logistic regression on a small set of 10 variables: highest respiratory rate, lowest systolic blood pressure, highest body temperature and Glasgow Coma Scale during the first hour of ICU admission; age; prior functional capacity; type of ICU admission; source of ICU admission; and length of hospital stay prior to ICU admission. On the validation dataset, our new score, named SEVERITAS, had an area under the receiver operating curve of 0.84 (0.82 – 0.86) and standardized mortality ratio of 1.00 (0.91–1.08). Moreover, SEVERITAS had similar discrimination compared to SAPS-3 and better discrimination than the simplified TropICS and R-MPM. Conclusions: Our study proposes a new ICU mortality prediction model using simple logistic regression on a small set of easily collected variables may be better suited than currently available models for use in low and middle-income countries

Intensive care unit patients' opinion on enrollment in clinical research: A multicenter survey

BACKGROUND: In most emergency situations or severe illness, patients are unable to consent for clinical trial enrollment. In such circumstances, the decision about whether to participate in a scientific study or not is made by a legally designated representative. OBJECTIVE: To address the willingness of patients admitted to the intensive care unit (ICU) to be enrolled in a scientific study as volunteers, and to assess the agreement between patients' and their legal representatives' opinion concerning enrollment in a scientific study. METHODS: This survey was conducted in two hospitals in São Paulo, Brazil. Patients (≥18 years) with preserved cognitive functions accompanied by a surrogate admitted to the ICU were eligible for this study. A survey containing 28 questions for patients and 8 questions for surrogates was applied within the first 48h from ICU admission. The survey for patients comprised three sections: demographic characteristics, opinion about participation in clinical research and knowledge about the importance of research. The survey for legal representatives contained two sections: demographic characteristics and assessment of legal representatives' opinion in authorizing patients to be enrolled in research. RESULTS: Between January 2017 and May 2018, 208 pairs of ICU patients and their respective legal representatives answered the survey. Out of 208 ICU patients answering the survey, 73.6% (153/208) were willing to be enrolled in the study as volunteers. Of those patients, 65.1% (97/149) would continue participating in a research even if their legal representative did not support their enrollment. Agreement between patients' and surrogates' opinion concerning participation was poor [Kappa = 0.11 (IC95% -0.02 to 0.25)]. If a consent for study participation had been obtained, 69.1% (103/149) of patients would continue participating in the study until its conclusion, and 23.5% (35/149) would allow researchers to use data collected to date, but would withdraw from the study on that occasion. CONCLUSION: The majority of patients admitted to the ICU were willing to be enrolled in a scientific study as volunteers, also after a deferred informed consent procedure has been used. Nevertheless, contradictory opinions between patients and their and their legal representatives' concerning enrollment in a scientific study were often observed

Assessment of mortality due to severe SARS-CoV-2 infection in public and private intensive care units in Brazil: a multicenter retrospective cohort study

ABSTRACT Objective To compare the clinical characteristics, use of organ support, and outcomes of critically ill patients with COVID-19 admitted to public and private intensive care units. Methods This multicenter retrospective cohort study included patients admitted to four intensive care units from March 1, 2020, to December 31, 2021. Patients with COVID-19 admitted to public and private intensive care units were compared. The primary outcome of interest, in-hospital mortality, was assessed using a hierarchical logistic regression (multilevel) model adjusted for study site and patient characteristics. Results A total of 5,790 patients with COVID-19 were admitted to the participating intensive care units, with 3,321 (57.3%) admitted to private hospitals and 2,469 (42.6%) admitted to public hospitals. Patients in public intensive care units were less likely to be male and had higher median SAPS III scores, Charlson Comorbidity Index values, and SOFA scores. They also required mechanical ventilation (53.1% versus 40.0%, p<0.001), vasopressors (43.1% versus 33.9%, p<0.001), and renal replacement therapy (20.3% versus. 14.5%, p<0.001) more frequently than those in private intensive care units. In contrast, patients in private intensive care units were more frequently managed with non-invasive ventilation (38.0% versus 66.8%; p<0.001) and high-flow nasal cannulas (18.3% versus 48.1%; p<0.001). The in-hospital mortality rate was significantly higher in public intensive care units (40.3%) compared to private intensive care units (16.4%) (adjusted OR=2.96; 95%CI=1.94-4.51; p<0.001). Conclusion We observed significant differences in resource utilization and mortality rates between patients with COVID-19 admitted to public and private intensive care units. Patients with COVID-19 in public care units face a higher risk of in-hospital mortality compared to those in private care units