Protocol for a systematic review and individual patient data meta-analysis of benefit of so-called lung-protective ventilation settings in patients under general anesthesia for surgery

BACKGROUND: Almost all patients under general anesthesia for surgery need mechanical ventilation. The harmful effects of short-term intra-operative ventilation on pulmonary integrity are increasingly recognized. Recent investigations suggest protection against so-called ventilation-associated lung injury with the use of lower tidal volumes and/or the use of higher levels of positive end-expiratory pressure (PEEP). This review and meta-analysis will evaluate the effects of these protective measures on pulmonary and extra-pulmonary complications, and try to discriminate the effects of lower tidal volumes from those of higher levels of PEEP. METHODS/DESIGN: The Medline database will be searched for observational studies and randomized controlled trials of intra-operative ventilation. Individual patient data will be collected from databases obtained via direct contact with corresponding authors of original articles. The primary endpoint is development of postoperative acute respiratory distress syndrome, the most important postoperative pulmonary complication. Secondary endpoints include hospital length of stay and hospital mortality, and reported intra-operative and postoperative pulmonary and extra-pulmonary complications. Emphasis is put on separating the effects of lower tidal volumes from those of higher levels of PEEP. DISCUSSION: This will be the first meta-analysis of intra-operative ventilation using individual patient data from observational studies and randomized controlled trials. The large sample size could allow discrimination of the effect of the two most frequently used protective measures - that is, lower tidal volumes and higher levels of PEEP. The results of this review and meta-analysis can be used in designing future trials of ventilation

LEI DO FEMINICÍDIO: PARA QUEM E PARA QUÊ? UMA ABORDAGEM CONSTITUCIONAL

O presente trabalho tem como objeto discutir a eficácia da lei penal como política pública de redução da violência de gênero no Brasil. Para tal, trazemos à baila o novel diploma infraconstitucional 13.104/15, que incluí o homicídio praticado contra a mulher em razão da sua condição de gênero ou se ocasionado por violência domestica no rol de homicídios qualificados

Effect of a low versus intermediate tidal volume strategy on pulmonary complications in patients at risk of acute respiratory distress syndrome—a randomized clinical trial

IntroductionThere is no consensus on whether invasive ventilation should use low tidal volumes (VT) to prevent lung complications in patients at risk of acute respiratory distress syndrome (ARDS). The purpose of this study is to determine if a low VT strategy is more effective than an intermediate VT strategy in preventing pulmonary complications.MethodsA randomized clinical trial was conducted in invasively ventilated patients with a lung injury prediction score (LIPS) of >4 performed in the intensive care units of 10 hospitals in Spain and one in the United States of America (USA) from 3 November 2014 to 30 August 2016. Patients were randomized to invasive ventilation using low VT (≤ 6 mL/kg predicted body weight, PBW) (N = 50) or intermediate VT (> 8 mL/kg PBW) (N = 48). The primary endpoint was the development of ARDS during the first 7 days after the initiation of invasive ventilation. Secondary endpoints included the development of pneumonia and severe atelectases; the length of intensive care unit (ICU) and hospital stay; and ICU, hospital, 28– and 90–day mortality.ResultsIn total, 98 patients [67.3% male], with a median age of 65.5 years [interquartile range 55–73], were enrolled until the study was prematurely stopped because of slow recruitment and loss of equipoise caused by recent study reports. On day 7, five (11.9%) patients in the low VT group and four (9.1%) patients in the intermediate VT group had developed ARDS (risk ratio, 1.16 [95% CI, 0.62–2.17]; p = 0.735). The incidence of pneumonia and severe atelectasis was also not different between the two groups. The use of a low VT strategy did neither affect the length of ICU and hospital stay nor mortality rates.ConclusionsIn patients at risk for ARDS, a low VT strategy did not result in a lower incidence of ARDS than an intermediate VT strategy.Clinical Trial Registration: ClinicalTrials.gov, identifier NCT02070666

Associations of Body Mass Index with Ventilation Management and Clinical Outcomes in Invasively Ventilated Patients with ARDS Related to COVID-19-Insights from the PRoVENT-COVID Study

We describe the practice of ventilation and mortality rates in invasively ventilated normal-weight (18.5 ≤ BMI ≤ 24.9 kg/m2), overweight (25.0 ≤ BMI ≤ 29.9 kg/m2), and obese (BMI > 30 kg/m2) COVID-19 ARDS patients in a national, multicenter observational study, performed at 22 intensive care units in the Netherlands. The primary outcome was a combination of ventilation variables and parameters over the first four calendar days of ventilation, including tidal volume, positive end-expiratory pressure (PEEP), respiratory system compliance, and driving pressure in normal-weight, overweight, and obese patients. Secondary outcomes included the use of adjunctive treatments for refractory hypoxaemia and mortality rates. Between 1 March 2020 and 1 June 2020, 1122 patients were included in the study: 244 (21.3%) normal-weight patients, 531 (47.3%) overweight patients, and 324 (28.8%) obese patients. Most patients received a tidal volume < 8 mL/kg PBW; only on the first day was the tidal volume higher in obese patients. PEEP and driving pressure were higher, and compliance of the respiratory system was lower in obese patients on all four days. Adjunctive therapies for refractory hypoxemia were used equally in the three BMI groups. Adjusted mortality rates were not different between BMI categories. The findings of this study suggest that lung-protective ventilation with a lower tidal volume and prone positioning is similarly feasible in normal-weight, overweight, and obese patients with ARDS related to COVID-19. A patient's BMI should not be used in decisions to forgo or proceed with invasive ventilation

Practice of ventilation in middle-Income countries (PRoVENT-iMIC): Rationale and protocol for a prospective international multicentre observational study in intensive care units in Asia

Introduction: Current evidence on epidemiology and outcomes of invasively mechanically ventilated intensive care unit (ICU) patients is predominantly gathered in resource-rich settings. Patient casemix and patterns of critical illnesses, and probably also ventilation practices are likely to be different in resource-limited settings. We aim to investigate the epidemiological characteristics, ventilation practices and clinical outcomes of patients receiving mechanical ventilation in ICUs in Asia.Methods and Analysis: PRoVENT-iMIC (study of PRactice of VENTilation in Middle-Income Countries) is an international multicentre observational study to be undertaken in approximately 60 ICUs in 11 Asian countries. Consecutive patients aged 18 years or older who are receiving invasive ventilation in participating ICUs during a predefined 28-day period are to be enrolled, with a daily follow-up of 7 days. The primary outcome is ventilatory management (including tidal volume expressed as mL/kg predicted body weight and positive end-expiratory pressure expressed as cm H2O) during the first 3 days of mechanical ventilation-compared between patients at no risk for acute respiratory distress syndrome (ARDS), patients at risk for ARDS and in patients with ARDS (in case the diagnosis of ARDS can be made on admission). Secondary outcomes include occurrence of pulmonary complications and all-cause ICU mortality.Ethics and Dissemination: PRoVENT-iMIC will be the first international study that prospectively assesses ventilation practices, outcomes and epidemiology of invasively ventilated patients in ICUs in Asia. The results of this large study, to be disseminated through conference presentations and publications in international peer-reviewed journals, are of ultimate importance when designing trials of invasive ventilation in resource-limited ICUs. Access to source data will be made available through national or international anonymised datasets on request and after agreement of the PRoVENT-iMIC steering committee

Antipyretic therapy in critically ill septic patients: A systematic review and meta-analysis

OBJECTIVE: This meta-analysis aimed to examine the impact of antipyretic therapy on mortality in critically ill septic adults. DATA SOURCES: Literature searches were implemented in Ovid Medline, Embase, Scopus, Cumulative Index of Nursing and Allied Health Literature, Cochrane Central Register of Controlled Trials, NHS Economic Evaluation Database, and ClinicalTrials.gov through February 2016. STUDY SELECTION: Inclusion criteria were observational or randomized studies of septic patients, evaluation of antipyretic treatment, mortality reported, and English-language version available. Studies were excluded if they enrolled pediatric patients, patients with neurologic injury, or healthy volunteers. Criteria were applied by two independent reviewers. DATA EXTRACTION: Two reviewers independently extracted data and evaluated methodologic quality. Outcomes included mortality, frequency of shock reversal, acquisition of nosocomial infections, and changes in body temperature, heart rate, and minute ventilation. Randomized and observational studies were analyzed separately. DATA SYNTHESIS: Eight randomized studies (1,507 patients) and eight observational studies (17,432 patients) were analyzed. Antipyretic therapy did not reduce 28-day/hospital mortality in the randomized studies (relative risk, 0.93; 95% CI, 0.77–1.13; I(2) = 0.0%) or observational studies (odds ratio, 0.90; 95% CI, 0.54–1.51; I(2) = 76.1%). Shock reversal (relative risk, 1.13; 95% CI, 0.68–1.90; I(2) = 51.6%) and acquisition of nosocomial infections (relative risk, 1.13; 95% CI, 0.61–2.09; I(2) = 61.0%) were also unchanged. Antipyretic therapy decreased body temperature (mean difference, –0.38°C; 95% CI, –0.63 to –0.13; I(2) = 84.0%), but not heart rate or minute ventilation. CONCLUSIONS: Antipyretic treatment does not significantly improve 28-day/hospital mortality in adult patients with sepsis