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BACKGROUND: One single-center randomized clinical trial showed that INTELLiVENT-adaptive support ventilation (ASV) is superior to conventional ventilation with respect to the quality of ventilation in post-cardiac surgery patients. Other studies showed that this automated ventilation mode reduces the number of manual interventions at the ventilator in various types of critically ill patients. In this multicenter study in patients post-cardiac surgery, we test the hypothesis that INTELLiVENT-ASV is superior to conventional ventilation with respect to the quality of ventilation. METHODS: "POStoperative INTELLiVENT-adaptive support VEntilation in cardiac surgery patients II (POSITiVE II)" is an international, multicenter, two-group randomized clinical superiority trial. In total, 328 cardiac surgery patients will be randomized. Investigators screen patients aged > 18 years of age, scheduled for elective cardiac surgery, and expected to receive postoperative ventilation in the ICU for longer than 2 h. Patients either receive automated ventilation by means of INTELLiVENT-ASV or ventilation that is not automated by means of a conventional ventilation mode. The primary endpoint is quality of ventilation, defined as the proportion of postoperative ventilation time characterized by exposure to predefined optimal, acceptable, and critical (injurious) ventilatory parameters in the first two postoperative hours. One major secondary endpoint is ICU team staff workload, captured by the ventilator software collecting manual settings on alarms. Patient-centered endpoints include duration of postoperative ventilation and length of stay in ICU. DISCUSSION: POSITiVE II is the first international, multicenter, randomized clinical trial designed to confirm that POStoperative INTELLiVENT-ASV is superior to non-automated conventional ventilation and secondary to determine if this closed-loop ventilation mode reduces ICU team staff workload. The results of POSITiVE II will support intensive care teams in their choices regarding the use of automated ventilation in postoperative care of uncomplicated cardiac surgery patients. TRIAL REGISTRATION: Clinicaltrials.gov NCT06178510 . Registered on December 4, 2023.
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Procedimentos Cirúrgicos Cardíacos , Estudos Multicêntricos como Assunto , Humanos , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Respiração Artificial/métodos , Resultado do Tratamento , Cuidados Pós-Operatórios/métodos , Fatores de Tempo , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos de Equivalência como Asunto , Unidades de Terapia IntensivaRESUMO
RATIONALE: The positive end-expiratory pressure (PEEP) strategy in patients with coronavirus 2019 (COVID-19) acute respiratory distress syndrome (ARDS) remains debated. Most studies originate from the initial waves of the pandemic. Here we aimed to assess the impact of high PEEP/low FiO2 ventilation on outcomes during the second wave in the Netherlands. METHODS: Retrospective observational study of invasively ventilated COVID-19 patients during the second wave. Patients were categorized based on whether they received high PEEP or low PEEP ventilation according to the ARDS Network tables. The primary outcome was ICU mortality, and secondary outcomes included hospital and 90-day mortality, duration of ventilation and length of stay, and the occurrence of kidney injury. Propensity matching was performed to correct for factors with a known relationship to ICU mortality. RESULTS: This analysis included 790 COVID-ARDS patients. At ICU discharge, 32 (22.5%) out of 142 high PEEP patients and 254 (39.2%) out of 848 low PEEP patients had died (HR 0.66 [0.46-0.96]; P = 0.03). High PEEP was linked to improved secondary outcomes. Matched analysis did not change findings. CONCLUSIONS: High PEEP ventilation was associated with improved ICU survival in patients with COVID-ARDS.
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COVID-19 , Mortalidade Hospitalar , Respiração com Pressão Positiva , Síndrome do Desconforto Respiratório , Humanos , COVID-19/mortalidade , COVID-19/terapia , Estudos Retrospectivos , Respiração com Pressão Positiva/métodos , Masculino , Feminino , Pessoa de Meia-Idade , Países Baixos/epidemiologia , Idoso , Síndrome do Desconforto Respiratório/terapia , Síndrome do Desconforto Respiratório/mortalidade , Unidades de Terapia Intensiva , SARS-CoV-2 , Tempo de Internação/estatística & dados numéricos , Respiração Artificial/métodos , Respiração Artificial/estatística & dados numéricosRESUMO
INTRODUCTION: Mechanical power of ventilation, a summary parameter reflecting the energy transferred from the ventilator to the respiratory system, has associations with outcomes. INTELLiVENT-Adaptive Support Ventilation is an automated ventilation mode that changes ventilator settings according to algorithms that target a low work-and force of breathing. The study aims to compare mechanical power between automated ventilation by means of INTELLiVENT-Adaptive Support Ventilation and conventional ventilation in critically ill patients. MATERIALS AND METHODS: International, multicenter, randomized crossover clinical trial in patients that were expected to need invasive ventilation > 24 hours. Patients were randomly assigned to start with a 3-hour period of automated ventilation or conventional ventilation after which the alternate ventilation mode was selected. The primary outcome was mechanical power in passive and active patients; secondary outcomes included key ventilator settings and ventilatory parameters that affect mechanical power. RESULTS: A total of 96 patients were randomized. Median mechanical power was not different between automated and conventional ventilation (15.8 [11.5-21.0] versus 16.1 [10.9-22.6] J/min; mean difference -0.44 (95%-CI -1.17 to 0.29) J/min; P = 0.24). Subgroup analyses showed that mechanical power was lower with automated ventilation in passive patients, 16.9 [12.5-22.1] versus 19.0 [14.1-25.0] J/min; mean difference -1.76 (95%-CI -2.47 to -10.34J/min; P < 0.01), and not in active patients (14.6 [11.0-20.3] vs 14.1 [10.1-21.3] J/min; mean difference 0.81 (95%-CI -2.13 to 0.49) J/min; P = 0.23). CONCLUSIONS: In this cohort of unselected critically ill invasively ventilated patients, automated ventilation by means of INTELLiVENT-Adaptive Support Ventilation did not reduce mechanical power. A reduction in mechanical power was only seen in passive patients. STUDY REGISTRATION: Clinicaltrials.gov (study identifier NCT04827927), April 1, 2021. URL OF TRIAL REGISTRY RECORD: https://clinicaltrials.gov/study/NCT04827927?term=intellipower&rank=1.
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Estado Terminal , Estudos Cross-Over , Respiração Artificial , Humanos , Masculino , Feminino , Respiração Artificial/métodos , Pessoa de Meia-Idade , Idoso , Estado Terminal/terapia , Ventiladores Mecânicos , Adulto , AutomaçãoRESUMO
Patients with acute exacerbation of lung fibrosis with usual interstitial pneumonia (EUIP) pattern are at increased risk for ventilator-induced lung injury (VILI) and mortality when exposed to mechanical ventilation (MV). Yet, lack of a mechanical model describing UIP-lung deformation during MV represents a research gap. Aim of this study was to develop a constitutive mathematical model for UIP-lung deformation during lung protective MV based on the stress-strain behavior and the specific elastance of patients with EUIP as compared to that of acute respiratory distress syndrome (ARDS) and healthy lung. Partitioned lung and chest wall mechanics were assessed for patients with EUIP and primary ARDS (1:1 matched based on body mass index and PaO2/FiO2 ratio) during a PEEP trial performed within 24 h from intubation. Patient's stress-strain curve and the lung specific elastance were computed and compared with those of healthy lungs, derived from literature. Respiratory mechanics were used to fit a novel mathematical model of the lung describing mechanical-inflation-induced lung parenchyma deformation, differentiating the contributions of elastin and collagen, the main components of lung extracellular matrix. Five patients with EUIP and 5 matched with primary ARDS were included and analyzed. Global strain was not different at low PEEP between the groups. Overall specific elastance was significantly higher in EUIP as compared to ARDS (28.9 [22.8-33.2] cmH2O versus 11.4 [10.3-14.6] cmH2O, respectively). Compared to ARDS and healthy lung, the stress/strain curve of EUIP showed a steeper increase, crossing the VILI threshold stress risk for strain values greater than 0.55. The contribution of elastin was prevalent at lower strains, while the contribution of collagen was prevalent at large strains. The stress/strain curve for collagen showed an upward shift passing from ARDS and healthy lungs to EUIP lungs. During MV, patients with EUIP showed different respiratory mechanics, stress-strain curve and specific elastance as compared to ARDS patients and healthy subjects and may experience VILI even when protective MV is applied. According to our mathematical model of lung deformation during mechanical inflation, the elastic response of UIP-lung is peculiar and different from ARDS. Our data suggest that patients with EUIP experience VILI with ventilatory setting that are lung-protective for patients with ARDS.
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Pulmão , Respiração Artificial , Síndrome do Desconforto Respiratório , Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Respiração Artificial/efeitos adversos , Síndrome do Desconforto Respiratório/fisiopatologia , Idoso , Pulmão/fisiopatologia , Pulmão/patologia , Elasticidade , Lesão Pulmonar Induzida por Ventilação Mecânica/fisiopatologia , Fibrose Pulmonar/fisiopatologia , Fibrose Pulmonar/metabolismo , Mecânica Respiratória/fisiologia , Estresse Mecânico , Doenças Pulmonares Intersticiais/fisiopatologia , Modelos TeóricosRESUMO
BACKGROUND: Acute respiratory distress syndrome (ARDS) is a frequent cause of hypoxemic respiratory failure with a mortality rate of approximately 30%. Identifying ARDS subphenotypes based on "focal" or "non-focal" lung morphology has the potential to better target mechanical ventilation strategies of individual patients. However, classifying morphology through chest radiography or computed tomography is either inaccurate or impractical. Lung ultrasound (LUS) is a non-invasive bedside tool that can accurately distinguish "focal" from "non-focal" lung morphology. We hypothesize that LUS-guided personalized mechanical ventilation in ARDS patients leads to a reduction in 90-day mortality compared to conventional mechanical ventilation. METHODS: The Personalized Mechanical Ventilation Guided by UltraSound in Patients with Acute Respiratory Distress Syndrome (PEGASUS) study is an investigator-initiated, international, randomized clinical trial (RCT) that plans to enroll 538 invasively ventilated adult intensive care unit (ICU) patients with moderate to severe ARDS. Eligible patients will receive a LUS exam to classify lung morphology as "focal" or "non-focal". Thereafter, patients will be randomized within 12 h after ARDS diagnosis to receive standard care or personalized ventilation where the ventilation strategy is adjusted to the morphology subphenotype, i.e., higher positive end-expiratory pressure (PEEP) and recruitment maneuvers for "non-focal" ARDS and lower PEEP and prone positioning for "focal" ARDS. The primary endpoint is all-cause mortality at day 90. Secondary outcomes are mortality at day 28, ventilator-free days at day 28, ICU length of stay, ICU mortality, hospital length of stay, hospital mortality, and number of complications (ventilator-associated pneumonia, pneumothorax, and need for rescue therapy). After a pilot phase of 80 patients, the correct interpretation of LUS images and correct application of the intervention within the safe limits of mechanical ventilation will be evaluated. DISCUSSION: PEGASUS is the first RCT that compares LUS-guided personalized mechanical ventilation with conventional ventilation in invasively ventilated patients with moderate and severe ARDS. If this study demonstrates that personalized ventilation guided by LUS can improve the outcomes of ARDS patients, it has the potential to shift the existing one-size-fits-all ventilation strategy towards a more individualized approach. TRIAL REGISTRATION: The PEGASUS trial was registered before the inclusion of the first patient, https://clinicaltrials.gov/ (ID: NCT05492344).
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Pulmão , Ensaios Clínicos Controlados Aleatórios como Assunto , Respiração Artificial , Síndrome do Desconforto Respiratório , Ultrassonografia de Intervenção , Humanos , Síndrome do Desconforto Respiratório/terapia , Síndrome do Desconforto Respiratório/diagnóstico por imagem , Síndrome do Desconforto Respiratório/mortalidade , Respiração Artificial/métodos , Pulmão/diagnóstico por imagem , Pulmão/fisiopatologia , Resultado do Tratamento , Ultrassonografia de Intervenção/métodos , Fatores de Tempo , Estudos Multicêntricos como Assunto , Valor Preditivo dos Testes , Medicina de Precisão/métodosRESUMO
Background: Airway care interventions and prone positioning are used in critically ill patients with coronavirus disease 2019 (COVID-19) admitted to the intensive care unit (ICU) to improve oxygenation and facilitate mucus removal. At the onset of the COVID-19 pandemic, the decision-making process regarding the practice of airway care interventions and prone positioning was challenging. Objective: To provide an overview of the practice of airway care interventions and prone positioning during the second wave of the pandemic in the Netherlands. Method: Web-based survey design. Seventy ICU nurses, each representing one intensive care in the Netherlands, were contacted for participation. Potential items were generated based on a literature search and formulated by a multidisciplinary team. Questions were pilot tested for face and construct validity by four intensive care nurses from four different hospitals. Results: The response rate was 53/77 (69%). This survey revealed widespread use of airway care interventions in the Netherlands in COVID-19 patients, despite questionable benefits. Additionally, prone positioning was used in invasively and non-invasively ventilated patients. Conclusions: The use of airway care interventions and prone positioning is time consuming and comes with the production of waste. Further research is needed to assess the effectiveness, workload, and environmental impact of airway care interventions and prone positioning.
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BACKGROUND: The application of hand hygiene (HH) and the use of non-sterile gloves (NSG) in daily care is highly intertwined. We aimed (1) to assess the combined application of HH and NSG among nurses and (2) to explore determinants that influence their ability to combine both measures in their care. METHODS: In a multi-methods study, we combined direct observations of care episodes with semi-structured interviews with nurses in two affiliated university hospitals. Topics were based on Flottorp's checklist of determinants of practice. RESULTS: In total, we observed 205 care episodes and interviewed 10 nurses. Observations revealed that the combination of NSG and HH was correctly applied in 19% of care episodes in which a single procedure was executed, and in 2% of care episodes in which multiple procedures were performed. From the interviews, we found determinants that influenced compliance, covered mainly by three out of seven of Flottorp's checklist domains. Nurses indicated that their knowledge of protocols was limited to HH and protocols were hardly ever actively consulted; visual reminders within their workplace were used as sources of information. Nurses' behavior was primarily influenced by their ability to operationalize this information and their ability to integrate both infection prevention measures into their care. The intention to apply and combine HH and NSG use was influenced by their risk assessment of cross-contamination, by the urge to self-protect and gut feeling. The feasibility to execute HH and NSG protocols is influenced by the urgency and the complexity of the care episode. CONCLUSIONS: The combined correct application with HH and NSG measures by nurses is low. Nurses are instructed in a fragmented way while in the day to day care HH and NSG use are highly intertwined. Operationalization and simplification of infection prevention protocols, in which instructions on both infection prevention measures are fused, should be considered. Strategies to improve practice should consider the power of habit and nurses urge to self-protect.
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Infecção Hospitalar , Higiene das Mãos , Humanos , Higiene das Mãos/métodos , Centros de Atenção Terciária , Infecção Hospitalar/prevenção & controle , Pessoal de Saúde , Encaminhamento e ConsultaRESUMO
Serum biomarkers and lung ultrasound are important measures for prognostication and treatment allocation in patients with COVID-19. Currently, there is a paucity of studies investigating relationships between serum biomarkers and ultrasonographic biomarkers derived from lung ultrasound. This study aims to assess correlations between serum biomarkers and lung ultrasound findings. This study is a secondary analysis of four prospective observational studies in adult patients with COVID-19. Serum biomarkers included markers of epithelial injury, endothelial dysfunction and immune activation. The primary outcome was the correlation between biomarker concentrations and lung ultrasound score assessed with Pearson's (r) or Spearman's (rs) correlations. Forty-four patients (67 [41-88] years old, 25% female, 52% ICU patients) were included. GAS6 (rs = 0.39), CRP (rs = 0.42) and SP-D (rs = 0.36) were correlated with lung ultrasound scores. ANG-1 (rs = -0.39) was inversely correlated with lung ultrasound scores. No correlations were found between lung ultrasound score and several other serum biomarkers. In patients with COVID-19, several serum biomarkers of epithelial injury, endothelial dysfunction and immune activation correlated with lung ultrasound findings. The lack of correlations with certain biomarkers could offer opportunities for precise prognostication and targeted therapeutic interventions by integrating these unlinked biomarkers.
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BACKGROUND: Lung protective ventilation is considered standard of care in the intensive care unit. However, modifying the ventilator settings can be challenging and is time consuming. Closed loop modes of ventilation are increasingly attractive for use in critically ill patients. With closed loop ventilation, settings that are typically managed by the ICU professionals are under control of the ventilator's algorithms. OBJECTIVES: To describe the effectiveness, safety, efficacy and workload with currently available closed loop ventilation modes. DESIGN: Systematic review of randomised clinical trials. DATA SOURCES: A comprehensive systematic search in PubMed, Embase and the Cochrane Central register of Controlled Trials search was performed in January 2023. ELIGIBILITY CRITERIA: Randomised clinical trials that compared closed loop ventilation with conventional ventilation modes and reported on effectiveness, safety, efficacy or workload. RESULTS: The search identified 51 studies that met the inclusion criteria. Closed loop ventilation, when compared with conventional ventilation, demonstrates enhanced management of crucial ventilator variables and parameters essential for lung protection across diverse patient cohorts. Adverse events were seldom reported. Several studies indicate potential improvements in patient outcomes with closed loop ventilation; however, it is worth noting that these studies might have been underpowered to conclusively demonstrate such benefits. Closed loop ventilation resulted in a reduction of various aspects associated with the workload of ICU professionals but there have been no studies that studied workload in sufficient detail. CONCLUSIONS: Closed loop ventilation modes are at least as effective in choosing correct ventilator settings as ventilation performed by ICU professionals and have the potential to reduce the workload related to ventilation. Nevertheless, there is a lack of sufficient research to comprehensively assess the overall impact of these modes on patient outcomes, and on the workload of ICU staff.
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Unidades de Terapia Intensiva , Ensaios Clínicos Controlados Aleatórios como Assunto , Respiração Artificial , Ventiladores Mecânicos , Carga de Trabalho , Humanos , Respiração Artificial/métodos , Respiração Artificial/instrumentação , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Cuidados Críticos/métodos , Resultado do TratamentoRESUMO
BACKGROUND: Endotracheal suctioning causes discomfort, is associated with adverse effects, and is resource-demanding. An artificial secretion removal method, known as an automated cough, has been developed, which applies rapid, automated deflation, and inflation of the endotracheal tube cuff during the inspiratory phase of mechanical ventilation. This method has been evaluated in the hands of researchers but not when used by attending nurses. The aim of this study was to explore the efficacy of the method over the course of patient management as part of routine care. METHODS: This prospective, longitudinal, interventional study recruited 28 subjects who were intubated and mechanically ventilated. For a maximum of 7 d and on clinical need for endotracheal suctioning, the automatic cough procedure was applied. The subjects were placed in a pressure-regulated ventilation mode with elevated inspiratory pressure, and automated cuff deflation and inflation were performed 3 times, with this repeated if deemed necessary. Success was determined by resolution of the clinical need for suctioning as determined by the attending nurse. Adverse effects were recorded. RESULTS: A total of 84 procedures were performed. In 54% of the subjects, the artificial cough procedure was successful on > 70% of occasions, with 56% of all procedures considered successful. Ninety percent of all the procedures were performed in subjects who were spontaneously breathing and on pressure-support ventilation with peak inspiratory pressures of 20 cm H2O. Rates of adverse events were similar to those seen in the application of endotracheal suctioning. CONCLUSIONS: This study solely evaluated the efficacy of an automated artificial cough procedure, which illustrated the potential for reducing the need for endotracheal suctioning when applied by attending nurses in routine care.
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Tosse , Intubação Intratraqueal , Respiração Artificial , Humanos , Estudos Prospectivos , Sucção/métodos , Feminino , Masculino , Intubação Intratraqueal/métodos , Respiração Artificial/métodos , Estudos Longitudinais , Pessoa de Meia-Idade , Idoso , Tosse/etiologia , Adulto , Automação , Resultado do Tratamento , Idoso de 80 Anos ou maisRESUMO
OBJECTIVES: To assess the effect of incorporating bilateral abnormalities as detected by lung ultrasound (LUS) in the Kigali modification and the New Global definition of acute respiratory distress syndrome (ARDS) on the occurrence rate of ARDS. DESIGN: Post hoc analysis of a previously published prospective cohort study. SETTING: An academic mixed medical-surgical ICU. PATIENTS: The original study included critically ill adults with any opacity on chest radiography in whom subsequent LUS was performed. Patients with ARDS according to the Berlin definition, COVID-19 patients and patients with major thorax trauma were excluded. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: LUS was performed within 24 hours of chest radiography and the presence of unilateral and bilateral abnormalities on LUS and chest radiograph (opacities) was scored. Subsequently, the Kigali modification and the New Global definition of ARDS were applied by two independent researchers on the patients with newly found bilateral opacities. Of 120 patients, 116 were included in this post hoc analysis. Thirty-three patients had bilateral opacities on LUS and unilateral opacities on chest radiograph. Fourteen of these patients had ARDS according to the Kigali modification and 12 had ARDS according to the New Global definition. The detected LUS patterns were significantly different between patients with and without ARDS ( p = 0.004). An A-profile with a positive PosteroLateral Alveolar and/or Pleural Syndrome was most prevalent in patients without ARDS, whereas heterogeneous and mixed A, B, and C patterns were most prevalent in patients with ARDS. CONCLUSION: The addition of bilateral abnormalities as detected by LUS to the Kigali modification and the New Global definition increases the occurrence rate of the ARDS. The nomenclature for LUS needs to be better defined as LUS patterns differ between patients with and without ARDS. Incorporating well-defined LUS criteria can increase specificity and sensitivity of new ARDS definitions.
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Pulmão , Síndrome do Desconforto Respiratório , Adulto , Humanos , Estudos Prospectivos , Ruanda , Pulmão/diagnóstico por imagem , Síndrome do Desconforto Respiratório/diagnóstico por imagem , Síndrome do Desconforto Respiratório/epidemiologia , Tórax , UltrassonografiaRESUMO
BACKGROUND: INTELLiVENT-adaptive support ventilation (ASV) is an automated closed-loop mode of invasive ventilation for use in critically ill patients. INTELLiVENT-ASV automatically adjusts, without the intervention of the caregiver, ventilator settings to achieve the lowest work and force of breathing. AIMS: The aim of this case series is to describe the specific adjustments of INTELLiVENT-ASV in patients with acute hypoxemic respiratory failure, who were intubated for invasive ventilation. STUDY DESIGN: We describe three patients with severe acute respiratory distress syndrome (ARDS) because of COVID-19 who received invasive ventilation in our intensive care unit (ICU) in the first year of the COVID-19 pandemic. RESULTS: INTELLiVENT-ASV could be used successfully, but only after certain adjustments in the settings of the ventilator. Specifically, the high oxygen targets that are automatically chosen by INTELLiVENT-ASV when the lung condition 'ARDS' is ticked had to be lowered, and the titration ranges for positive end expiratory pressure (PEEP) and inspired oxygen fraction (FiO2 ) had to be narrowed. CONCLUSIONS: The challenges taught us how to adjust the ventilator settings so that INTELLiVENT-ASV could be used in successive COVID-19 ARDS patients, and we experienced the benefits of this closed-loop ventilation in clinical practice. RELEVANCE TO CLINICAL PRACTICE: INTELLiVENT-ASV is attractive to use in clinical practice. It is safe and effective in providing lung-protective ventilation. A closely observing user always remains needed. INTELLiVENT-ASV has a strong potential to reduce the workload associated with ventilation because of the automated adjustments.
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COVID-19 , Síndrome do Desconforto Respiratório , Insuficiência Respiratória , Humanos , Pandemias , COVID-19/terapia , Pulmão , Respiração Artificial , Insuficiência Respiratória/terapia , Síndrome do Desconforto Respiratório/terapia , OxigênioRESUMO
Chronic obstructive pulmonary disease (COPD) is a risk factor for death in patients admitted to intensive care units (ICUs) for respiratory support. Previous reports suggested higher mortality in COPD patients with COVID-19. It is yet unknown whether patients with COPD were treated differently compared to non-COPD patients. We compared the ventilation management and outcomes of invasive ventilation for COVID-19 in COPD patients versus non-COPD patients. This was a post hoc analysis of a nation-wide, observational study in the Netherlands. COPD patients were compared to non-COPD patients with respect to key ventilation parameters. The secondary endpoints included adjunctive treatments for refractory hypoxemia, and 28-day mortality. Of a total of 1090 patients, 88 (8.1%) were classified as having COPD. The ventilation parameters were not different between COPD patients and non-COPD patients, except for FiO2, which was higher in COPD patients. Prone positioning was applied more often in COPD patients. COPD patients had higher 28-day mortality than non-COPD patients. COPD had an independent association with 28-day mortality. In this cohort of patients who received invasive ventilation for COVID-19, only FiO2 settings and the use of prone positioning were different between COPD patients and non-COPD patients. COPD patients had higher mortality than non-COPD patients.
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Rationale: Supplemental oxygen is widely administered to ICU patients, but appropriate oxygenation targets remain unclear. Objectives: This study aimed to determine whether a low-oxygenation strategy would lower 28-day mortality compared with a high-oxygenation strategy. Methods: This randomized multicenter trial included mechanically ventilated ICU patients with an expected ventilation duration of at least 24 hours. Patients were randomized 1:1 to a low-oxygenation (PaO2, 55-80 mm Hg; or oxygen saturation as measured by pulse oximetry, 91-94%) or high-oxygenation (PaO2, 110-150 mm Hg; or oxygen saturation as measured by pulse oximetry, 96-100%) target until ICU discharge or 28 days after randomization, whichever came first. The primary outcome was 28-day mortality. The study was stopped prematurely because of the COVID-19 pandemic when 664 of the planned 1,512 patients were included. Measurements and Main Results: Between November 2018 and November 2021, a total of 664 patients were included in the trial: 335 in the low-oxygenation group and 329 in the high-oxygenation group. The median achieved PaO2 was 75 mm Hg (interquartile range, 70-84) and 115 mm Hg (interquartile range, 100-129) in the low- and high-oxygenation groups, respectively. At Day 28, 129 (38.5%) and 114 (34.7%) patients had died in the low- and high-oxygenation groups, respectively (risk ratio, 1.11; 95% confidence interval, 0.9-1.4; P = 0.30). At least one serious adverse event was reported in 12 (3.6%) and 17 (5.2%) patients in the low- and high-oxygenation groups, respectively. Conclusions: Among mechanically ventilated ICU patients with an expected mechanical ventilation duration of at least 24 hours, using a low-oxygenation strategy did not result in a reduction of 28-day mortality compared with a high-oxygenation strategy. Clinical trial registered with the National Trial Register and the International Clinical Trials Registry Platform (NTR7376).
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COVID-19 , Pandemias , Humanos , COVID-19/terapia , Cuidados Críticos , Oximetria , Unidades de Terapia Intensiva , Respiração ArtificialRESUMO
The aim of this analysis was to compare ventilation management and outcomes in invasively ventilated patients with acute hypoxemic respiratory failure due to coronavirus disease 2019 (COVID-19) between the first and second wave in the Netherlands. This is a post hoc analysis of two nationwide observational COVID-19 studies conducted in quick succession. The primary endpoint was ventilation management. Secondary endpoints were tracheostomy use, duration of ventilation, intensive care unit (ICU) and hospital length of stay (LOS), and mortality. We used propensity score matching to control for observed confounding factors. This analysis included 1122 patients from the first and 568 patients from the second wave. Patients in the second wave were sicker, had more comorbidities, and had worse oxygenation parameters. They were ventilated with lower positive end-expiratory pressure and higher fraction inspired oxygen, had a lower oxygen saturation, received neuromuscular blockade more often, and were less often tracheostomized. Duration of ventilation was shorter, but mortality rates were similar. After matching, the fraction of inspired oxygen was lower in the second wave. In patients with acute hypoxemic respiratory failure due to COVID-19, aspects of respiratory care and outcomes rapidly changed over the successive waves.
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INTRODUCTION: The driving pressure (ΔP) has an independent association with outcome in patients with acute respiratory distress syndrome (ARDS). INTELLiVENT-Adaptive Support Ventilation (ASV) is a closed-loop mode of ventilation that targets the lowest work and force of breathing. AIM: To compare transpulmonary and respiratory system ΔP between closed-loop ventilation and conventional pressure controlled ventilation in patients with moderate-to-severe ARDS. METHODS: Single-center randomized cross-over clinical trial in patients in the early phase of ARDS. Patients were randomly assigned to start with a 4-h period of closed-loop ventilation or conventional ventilation, after which the alternate ventilation mode was selected. The primary outcome was the transpulmonary ΔP; secondary outcomes included respiratory system ΔP, and other key parameters of ventilation. RESULTS: Thirteen patients were included, and all had fully analyzable data sets. Compared to conventional ventilation, with closed-loop ventilation the median transpulmonary ΔP with was lower (7.0 [5.0-10.0] vs. 10.0 [8.0-11.0] cmH2O, mean difference - 2.5 [95% CI - 2.6 to - 2.1] cmH2O; P = 0.0001). Inspiratory transpulmonary pressure and the respiratory rate were also lower. Tidal volume, however, was higher with closed-loop ventilation, but stayed below generally accepted safety cutoffs in the majority of patients. CONCLUSIONS: In this small physiological study, when compared to conventional pressure controlled ventilation INTELLiVENT-ASV reduced the transpulmonary ΔP in patients in the early phase of moderate-to-severe ARDS. This closed-loop ventilation mode also led to a lower inspiratory transpulmonary pressure and a lower respiratory rate, thereby reducing the intensity of ventilation. Trial registration Clinicaltrials.gov, NCT03211494, July 7, 2017. https://clinicaltrials.gov/ct2/show/NCT03211494?term=airdrop&draw=2&rank=1 .
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BACKGROUND: High-flow nasal oxygen (HFNO) is increasingly used in patients with acute hypoxemic respiratory failure. It is uncertain whether a broadened Berlin definition of acute respiratory distress syndrome (ARDS), in which ARDS can be diagnosed in patients who are not receiving ventilation, results in similar groups of patients receiving HFNO as in patients receiving ventilation. METHODS: We applied a broadened definition of ARDS in a multicenter, observational study in adult critically ill patients with acute hypoxemic respiratory failure due to coronavirus disease 2019 (COVID-19), wherein the requirement for a minimal level of 5 cm H2O PEEP with ventilation is replaced by a minimal level of airflow rate with HFNO, and compared baseline characteristics and outcomes between patients receiving HFNO and patients receiving ventilation. The primary endpoint was ICU mortality. We also compared outcomes in risk for death groups using the PaO2/FiO2 cutoffs as used successfully in the original definition of ARDS. Secondary endpoints were hospital mortality; mortality on days 28 and 90; need for ventilation within 7 days in patients that started with HFNO; the number of days free from HFNO or ventilation; and ICU and hospital length of stay. RESULTS: Of 728 included patients, 229 patients started with HFNO and 499 patients with ventilation. All patients fulfilled the broadened Berlin definition of ARDS. Patients receiving HFNO had lower disease severity scores and lower PaO2/FiO2 than patients receiving ventilation. ICU mortality was lower in receiving HFNO (22.7 vs 35.6%; p = 0.001). Using PaO2/FiO2 cutoffs for mild, moderate and severe arterial hypoxemia created groups with an ICU mortality of 16.7%, 22.0%, and 23.5% (p = 0.906) versus 19.1%, 37.9% and 41.4% (p = 0.002), in patients receiving HFNO versus patients receiving ventilation, respectively. CONCLUSIONS: Using a broadened definition of ARDS may facilitate an earlier diagnosis of ARDS in patients receiving HFNO; however, ARDS patients receiving HFNO and ARDS patients receiving ventilation have distinct baseline characteristics and mortality rates. TRIAL REGISTRATION: The study is registered at ClinicalTrials.gov (identifier NCT04719182).
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BACKGROUND: Ventilation with lower positive end-expiratory pressure (PEEP) may cause loss of lung aeration in critically ill invasively ventilated patients. This study investigated whether a systematic lung ultrasound (LUS) scoring system can detect such changes in lung aeration in a study comparing lower versus higher PEEP in invasively ventilated patients without acute respiratory distress syndrome (ARDS). METHODS: Single center substudy of a national, multicenter, randomized clinical trial comparing lower versus higher PEEP ventilation strategy. Fifty-seven patients underwent a systematic 12-region LUS examination within 12 h and between 24 to 48 h after start of invasive ventilation, according to randomization. The primary endpoint was a change in the global LUS aeration score, where a higher value indicates a greater impairment in lung aeration. RESULTS: Thirty-three and twenty-four patients received ventilation with lower PEEP (median PEEP 1 (0-5) cm H2O) or higher PEEP (median PEEP 8 (8-8) cm H2O), respectively. Median global LUS aeration scores within 12 h and between 24 and 48 h were 8 (4 to 14) and 9 (4 to 12) (difference 1 (-2 to 3)) in the lower PEEP group, and 7 (2-11) and 6 (1-12) (difference 0 (-2 to 3)) in the higher PEEP group. Neither differences in changes over time nor differences in absolute scores reached statistical significance. CONCLUSIONS: In this substudy of a randomized clinical trial comparing lower PEEP versus higher PEEP in patients without ARDS, LUS was unable to detect changes in lung aeration.
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BACKGROUND: In hospitalized patients with COVID-19, the dosing and timing of corticosteroids vary widely. Low-dose dexamethasone therapy reduces mortality in patients requiring respiratory support, but it remains unclear how to treat patients when this therapy fails. In critically ill patients, high-dose corticosteroids are often administered as salvage late in the disease course, whereas earlier administration may be more beneficial in preventing disease progression. Previous research has revealed that increased levels of various biomarkers are associated with mortality, and whole blood transcriptome sequencing has the ability to identify host factors predisposing to critical illness in patients with COVID-19. OBJECTIVE: Our goal is to determine the most optimal dosing and timing of corticosteroid therapy and to provide a basis for personalized corticosteroid treatment regimens to reduce morbidity and mortality in hospitalized patients with COVID-19. METHODS: This is a retrospective, observational, multicenter study that includes adult patients who were hospitalized due to COVID-19 in the Netherlands. We will use the differences in therapeutic strategies between hospitals (per protocol high-dose corticosteroids or not) over time to determine whether high-dose corticosteroids have an effect on the following outcome measures: mechanical ventilation or high-flow nasal cannula therapy, in-hospital mortality, and 28-day survival. We will also explore biomarker profiles in serum and bronchoalveolar lavage fluid and use whole blood transcriptome analysis to determine factors that influence the relationship between high-dose corticosteroids and outcome. Existing databases that contain routinely collected electronic data during ward and intensive care admissions, as well as existing biobanks, will be used. We will apply longitudinal modeling appropriate for each data structure to answer the research questions at hand. RESULTS: As of April 2023, data have been collected for a total of 1500 patients, with data collection anticipated to be completed by December 2023. We expect the first results to be available in early 2024. CONCLUSIONS: This study protocol presents a strategy to investigate the effect of high-dose corticosteroids throughout the entire clinical course of hospitalized patients with COVID-19, from hospital admission to the ward or intensive care unit until hospital discharge. Moreover, our exploration of biomarker and gene expression profiles for targeted corticosteroid therapy represents a first step towards personalized COVID-19 corticosteroid treatment. TRIAL REGISTRATION: ClinicalTrials.gov NCT05403359; https://clinicaltrials.gov/ct2/show/NCT05403359. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/48183.