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BACKGROUND: The influence of high positive end-expiratory pressure (PEEP) with recruitment maneuvers on the occurrence of postoperative pulmonary complications after surgery is still not definitively established. Bayesian analysis can help to gain further insights from the available data and provide a probabilistic framework that is easier to interpret. Our objective was to estimate the posterior probability that the use of high PEEP with recruitment maneuvers is associated with reduced postoperative pulmonary complications in patients with intermediate-to-high risk under neutral, pessimistic, and optimistic expectations regarding the treatment effect. METHODS: Multilevel Bayesian logistic regression analysis on individual patient data from three randomized clinical trials carried out on surgical patients at Intermediate-to-High Risk for postoperative pulmonary complications. The main outcome was the occurrence of postoperative pulmonary complications in the early postoperative period. We studied the effect of high PEEP with recruitment maneuvers versus Low PEEP Ventilation. Priors were chosen to reflect neutral, pessimistic, and optimistic expectations of the treatment effect. RESULTS: Using a neutral, pessimistic, or optimistic prior, the posterior mean odds ratio (OR) for High PEEP with recruitment maneuvers compared to Low PEEP was 0.85 (95% Credible Interval [CrI] 0.71 to 1.02), 0.87 (0.72 to 1.04), and 0.86 (0.71 to 1.02), respectively. Regardless of prior beliefs, the posterior probability of experiencing a beneficial effect exceeded 90%. Subgroup analysis indicated a more pronounced effect in patients who underwent laparoscopy (OR: 0.67 [0.50 to 0.87]) and those at high risk for PPCs (OR: 0.80 [0.53 to 1.13]). Sensitivity analysis, considering severe postoperative pulmonary complications only or applying a different heterogeneity prior, yielded consistent results. CONCLUSION: High PEEP with recruitment maneuvers demonstrated a moderate reduction in the probability of PPC occurrence, with a high posterior probability of benefit observed consistently across various prior beliefs, particularly among patients who underwent laparoscopy.
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BACKGROUND: The incidence of anesthesia-induced atelectasis in children is high and closely related to episodes of hypoxemia. The Air-Test is a simple maneuver to detect lung collapse. By a step-reduction in FiO
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Atelectasia Pulmonar , Humanos , Atelectasia Pulmonar/diagnóstico por imagen , Atelectasia Pulmonar/diagnóstico , Preescolar , Niño , Femenino , Masculino , Lactante , Estudios Retrospectivos , Adolescente , Estudios Prospectivos , UltrasonografíaRESUMEN
PURPOSE: Invasive ventilation is a fundamental treatment in intensive care but its precise timing is difficult to determine. This study aims at assessing the effect of initiating invasive ventilation versus waiting, in patients with hypoxemic respiratory failure without immediate reason for intubation on one-year mortality. METHODS: Emulation of a target trial to estimate the benefit of immediately initiating invasive ventilation in hypoxemic respiratory failure, versus waiting, among patients within the first 48-h of hypoxemia. The eligible population included non-intubated patients with SpO2/FiO2 ≤ 200 and SpO2 ≤ 97%. The target trial was emulated using a single-center database (MIMIC-IV) which contains granular information about clinical status. The hourly probability to receive mechanical ventilation was continuously estimated. The hazard ratios for the primary outcome, one-year mortality, and the secondary outcome, 30-day mortality, were estimated using weighted Cox models with stabilized inverse probability weights used to adjust for measured confounding. RESULTS: 2996 Patients fulfilled the inclusion criteria of whom 792 were intubated within 48 h. Among the non-invasive support devices, the use of oxygen through facemask was the most common (75%). Compared to patients with the same probability of intubation but who were not intubated, intubation decreased the hazard of dying for the first year after ICU admission HR 0.81 (95% CI 0.68-0.96, p = 0.018). Intubation was associated with a 30-day mortality HR of 0.80 (95% CI 0.64-0.99, p = 0.046). CONCLUSION: The initiation of mechanical ventilation in patients with acute hypoxemic respiratory failure reduced the hazard of dying in this emulation of a target trial.
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Respiración Artificial , Insuficiencia Respiratoria , Humanos , Masculino , Femenino , Insuficiencia Respiratoria/terapia , Insuficiencia Respiratoria/mortalidad , Persona de Mediana Edad , Anciano , Respiración Artificial/métodos , Respiración Artificial/estadística & datos numéricos , Hipoxia/terapia , Hipoxia/mortalidad , Modelos de Riesgos Proporcionales , Factores de Tiempo , Unidades de Cuidados Intensivos/organización & administración , Unidades de Cuidados Intensivos/estadística & datos numéricosRESUMEN
Objective To determine the prevalence of elevated mechanical power (MP) values (>17J/min) used in routine clinical practice. Design Observational, descriptive, cross-sectional, analytical, multicenter, international study conducted on November 21, 2019, from 8:00 AM to 3:00 PM. NCT03936231. Setting One hundred thirty-three Critical Care Units. Patients Patients receiving invasive mechanical ventilation for any cause. Interventions None. Main variables of interest Mechanical power. Results A population of 372 patients was analyzed. PM was significantly higher in patients under pressure-controlled ventilation (PC) compared to volume-controlled ventilation (VC) (19.20±8.44J/min vs. 16.01±6.88J/min; p<0.001), but the percentage of patients with PM>17J/min was not different (41% vs. 35%, respectively; p=0.382). The best models according to AICcw expressing PM for patients in VC are described as follows: Surrogate Strain (Driving Pressure) + PEEP+Surrogate Strain Rate (PEEP/Flow Ratio) + Respiratory Rate. For patients in PC, it is defined as: Surrogate Strain (Expiratory Tidal Volume/PEEP) + PEEP+Surrogate Strain Rate (Surrogate Strain/Ti) + Respiratory Rate+Expiratory Tidal Volume+Ti. Conclusions A substantial proportion of mechanically ventilated patients may be at risk of experiencing elevated levels of mechanical power. Despite observed differences in mechanical power values between VC and PC ventilation, they did not result in a significant disparity in the prevalence of high mechanical power values. (AU)
Objetivo Determinar la prevalencia de valores elevados de potencia mecánica (PM) (>17J/min) utilizados en la práctica clínica habitual. Diseño estudio observacional, descriptivo de corte transversal, analítico, multicéntrico e internacional, realizado el 21 de noviembre de 2019 en horario de 8 a 15 horas. NCT03936231. Ámbito Ciento treinta y tres Unidad de Cuidados Críticos. Pacientes pacientes que recibirán ventilación mecánica por cualquier causa. Intervenciones ninguna Variables de interés principales Potencia mecánica. Resultados se analizaron 372 enfermos. La PM fue significativamente mayor en pacientes en ventilación controlada por presión (PC) que en ventilación controlada por volumen (VC) (19,20+8,44J/min frente a 16,01+6,88J/min; p<0,001), pero el porcentaje de pacientes con PM>17J/min no fue diferente (41% frente a 35% respectivamente; p=0,382). Los mejores modelos según AICcw que expresan la PM para los enfermos en VC se decribe como: Strain subrogante (Presión de conducción) + PEEP+Strain Rate subrogante (PEEP/cociente de flujo) + Frecuencia respiratoria. Para los enfermos en PC se define como: Strain subrogante (Volumen tidal expiratorio/PEEP) + PEEP+Strain Rate subrogante (Strain subrogante/Ti) + Frecuencia respiratoria+Expiratory Tidal Volumen+Ti. Conclusiones Gran parte de los pacientes en ventilación mecánica en condiciones de práctica clínica habitual reciben niveles de potencia mecánica peligrosos. A pesar de las diferencias observadas en los valores de potencia mecánica entre la ventilación VC y PC, este porcentaje de riesgo fue similar en PC y VC. (AU)
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Humanos , Masculino , Femenino , Adulto , Respiración Artificial , Mecánica Respiratoria , Unidades de Cuidados Intensivos , Epidemiología Descriptiva , Estudios Transversales , InternacionalidadRESUMEN
Background: The ability to predict a long duration of mechanical ventilation (MV) by clinicians is very limited. We assessed the value of machine learning (ML) for early prediction of the duration of MV > 14 days in patients with moderate-to-severe acute respiratory distress syndrome (ARDS). Methods: This is a development, testing, and external validation study using data from 1173 patients on MV ≥ 3 days with moderate-to-severe ARDS. We first developed and tested prediction models in 920 ARDS patients using relevant features captured at the time of moderate/severe ARDS diagnosis, at 24 h and 72 h after diagnosis with logistic regression, and Multilayer Perceptron, Support Vector Machine, and Random Forest ML techniques. For external validation, we used an independent cohort of 253 patients on MV ≥ 3 days with moderate/severe ARDS. Results: A total of 441 patients (48%) from the derivation cohort (n = 920) and 100 patients (40%) from the validation cohort (n = 253) were mechanically ventilated for >14 days [median 14 days (IQR 8-25) vs. 13 days (IQR 7-21), respectively]. The best early prediction model was obtained with data collected at 72 h after moderate/severe ARDS diagnosis. Multilayer Perceptron risk modeling identified major prognostic factors for the duration of MV > 14 days, including PaO2/FiO2, PaCO2, pH, and positive end-expiratory pressure. Predictions of the duration of MV > 14 days showed modest discrimination [AUC 0.71 (95%CI 0.65-0.76)]. Conclusions: Prolonged MV duration in moderate/severe ARDS patients remains difficult to predict early even with ML techniques such as Multilayer Perceptron and using data at 72 h of diagnosis. More research is needed to identify markers for predicting the length of MV. This study was registered on 14 August 2023 at ClinicalTrials.gov (NCT NCT05993377).
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Acute respiratory failure due to COVID-19 pneumonia often requires a comprehensive approach that includes non-pharmacological strategies such as non-invasive support (including positive pressure modes, high flow therapy or awake proning) in addition to oxygen therapy, with the primary goal of avoiding endotracheal intubation. Clinical issues such as determining the optimal time to initiate non-invasive support, choosing the most appropriate modality (based not only on the acute clinical picture but also on comorbidities), establishing criteria for recognition of treatment failure and strategies to follow in this setting (including palliative care), or implementing de-escalation procedures when improvement occurs are of paramount importance in the ongoing management of severe COVID-19 cases. Organizational issues, such as the most appropriate setting for management and monitoring of the severe COVID-19 patient or protective measures to prevent virus spread to healthcare workers in the presence of aerosol-generating procedures, should also be considered. While many early clinical guidelines during the pandemic were based on previous experience with acute respiratory distress syndrome, the landscape has evolved since then. Today, we have a wealth of high-quality studies that support evidence-based recommendations to address these complex issues. This document, the result of a collaborative effort between four leading scientific societies (SEDAR, SEMES, SEMICYUC, SEPAR), draws on the experience of 25 experts in the field to synthesize knowledge to address pertinent clinical questions and refine the approach to patient care in the face of the challenges posed by severe COVID-19 infection.
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COVID-19 , Ventilación no Invasiva , Humanos , COVID-19/complicaciones , COVID-19/terapia , Insuficiencia Respiratoria/terapia , Insuficiencia Respiratoria/etiología , Terapia por Inhalación de Oxígeno , Consenso , SARS-CoV-2 , Pandemias , Comunicación Interdisciplinaria , Respiración con Presión PositivaRESUMEN
OBJECTIVE: To determine the prevalence of elevated mechanical power (MP) values (>17J/min) used in routine clinical practice. DESIGN: Observational, descriptive, cross-sectional, analytical, multicenter, international study conducted on November 21, 2019, from 8:00 AM to 3:00 PM. NCT03936231. SETTING: One hundred thirty-three Critical Care Units. PATIENTS: Patients receiving invasive mechanical ventilation for any cause. INTERVENTIONS: None. MAIN VARIABLES OF INTEREST: Mechanical power. RESULTS: A population of 372 patients was analyzed. PM was significantly higher in patients under pressure-controlled ventilation (PC) compared to volume-controlled ventilation (VC) (19.20±8.44J/min vs. 16.01±6.88J/min; p<0.001), but the percentage of patients with PM>17J/min was not different (41% vs. 35%, respectively; p=0.382). The best models according to AICcw expressing PM for patients in VC are described as follows: Surrogate Strain (Driving Pressure) + PEEP+Surrogate Strain Rate (PEEP/Flow Ratio) + Respiratory Rate. For patients in PC, it is defined as: Surrogate Strain (Expiratory Tidal Volume/PEEP) + PEEP+Surrogate Strain Rate (Surrogate Strain/Ti) + Respiratory Rate+Expiratory Tidal Volume+Ti. CONCLUSIONS: A substantial proportion of mechanically ventilated patients may be at risk of experiencing elevated levels of mechanical power. Despite observed differences in mechanical power values between VC and PC ventilation, they did not result in a significant disparity in the prevalence of high mechanical power values.
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Unidades de Cuidados Intensivos , Respiración Artificial , Humanos , Prevalencia , Estudios Transversales , RespiraciónRESUMEN
BACKGROUND: It is uncertain whether individualisation of the perioperative open-lung approach (OLA) to ventilation reduces postoperative pulmonary complications in patients undergoing lung resection. We compared a perioperative individualised OLA (iOLA) ventilation strategy with standard lung-protective ventilation in patients undergoing thoracic surgery with one-lung ventilation. METHODS: This multicentre, randomised controlled trial enrolled patients scheduled for open or video-assisted thoracic surgery using one-lung ventilation in 25 participating hospitals in Spain, Italy, Turkey, Egypt, and Ecuador. Eligible adult patients (age ≥18 years) were randomly assigned to receive iOLA or standard lung-protective ventilation. Eligible patients (stratified by centre) were randomly assigned online by local principal investigators, with an allocation ratio of 1:1. Treatment with iOLA included an alveolar recruitment manoeuvre to 40 cm H2O of end-inspiratory pressure followed by individualised positive end-expiratory pressure (PEEP) titrated to best respiratory system compliance, and individualised postoperative respiratory support with high-flow oxygen therapy. Participants allocated to standard lung-protective ventilation received combined intraoperative 4 cm H2O of PEEP and postoperative conventional oxygen therapy. The primary outcome was a composite of severe postoperative pulmonary complications within the first 7 postoperative days, including atelectasis requiring bronchoscopy, severe respiratory failure, contralateral pneumothorax, early extubation failure (rescue with continuous positive airway pressure, non-invasive ventilation, invasive mechanical ventilation, or reintubation), acute respiratory distress syndrome, pulmonary infection, bronchopleural fistula, and pleural empyema. Due to trial setting, data obtained in the operating and postoperative rooms for routine monitoring were not blinded. At 24 h, data were acquired by an investigator blinded to group allocation. All analyses were performed on an intention-to-treat basis. This trial is registered with ClinicalTrials.gov, NCT03182062, and is complete. FINDINGS: Between Sept 11, 2018, and June 14, 2022, we enrolled 1380 patients, of whom 1308 eligible patients (670 [434 male, 233 female, and three with missing data] assigned to iOLA and 638 [395 male, 237 female, and six with missing data] to standard lung-protective ventilation) were included in the final analysis. The proportion of patients with the composite outcome of severe postoperative pulmonary complications within the first 7 postoperative days was lower in the iOLA group compared with the standard lung-protective ventilation group (40 [6%] vs 97 [15%], relative risk 0·39 [95% CI 0·28 to 0·56]), with an absolute risk difference of -9·23 (95% CI -12·55 to -5·92). Recruitment manoeuvre-related adverse events were reported in five patients. INTERPRETATION: Among patients subjected to lung resection under one-lung ventilation, iOLA was associated with a reduced risk of severe postoperative pulmonary complications when compared with conventional lung-protective ventilation. FUNDING: Instituto de Salud Carlos III and the European Regional Development Funds.
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Ventilación Unipulmonar , Adulto , Humanos , Femenino , Masculino , Adolescente , Respiración , Presión de las Vías Aéreas Positiva Contínua , Pulmón/cirugía , OxígenoRESUMEN
INTRODUCTION: The use of high fraction of inspired oxygen (FiO2) intraoperatively for the prevention of surgical site infection (SSI) remains controversial. Promising results of early randomised controlled trials (RCT) have been replicated with varying success and subsequent meta-analysis are equivocal. Recent advancements in perioperative care, including the increased use of laparoscopic surgery and pneumoperitoneum and shifts in fluid and temperature management, can affect peripheral oxygen delivery and may explain the inconsistency in reproducibility. However, the published data provides insufficient detail on the participant level to test these hypotheses. The purpose of this individual participant data meta-analysis is to assess the described benefits and harms of intraoperative high FiO2compared with regular (0.21-0.40) FiO2 and its potential effect modifiers. METHODS AND ANALYSIS: Two reviewers will search medical databases and online trial registries, including MEDLINE, Embase, CENTRAL, CINAHL, ClinicalTrials.gov and WHO regional databases, for randomised and quasi-RCT comparing the effect of intraoperative high FiO2 (0.60-1.00) to regular FiO2 (0.21-0.40) on SSI within 90 days after surgery in adult patients. Secondary outcome will be all-cause mortality within the longest available follow-up. Investigators of the identified trials will be invited to collaborate. Data will be analysed with the one-step approach using the generalised linear mixed model framework and the statistical model appropriate for the type of outcome being analysed (logistic and cox regression, respectively), with a random treatment effect term to account for the clustering of patients within studies. The bias will be assessed using the Cochrane risk-of-bias tool for randomised trials V.2 and the certainty of evidence using Grading of Recommendations, Assessment, Development and Evaluation methodology. Prespecified subgroup analyses include use of mechanical ventilation, nitrous oxide, preoperative antibiotic prophylaxis, temperature (<35°C), fluid supplementation (<15 mL/kg/hour) and procedure duration (>2.5 hour). ETHICS AND DISSEMINATION: Ethics approval is not required. Investigators will deidentify individual participant data before it is shared. The results will be submitted to a peer-review journal. PROSPERO REGISTRATION NUMBER: CRD42018090261.
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Oxígeno , Infección de la Herida Quirúrgica , Adulto , Humanos , Infección de la Herida Quirúrgica/prevención & control , Revisiones Sistemáticas como Asunto , Metaanálisis como Asunto , Respiración Artificial , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND: The efficacy of routine admission of high-risk patients to a critical care unit after surgery is not clear. The aim of our study was to investigate the association between critical care admission after scheduled colorectal surgery and postoperative complications, 30-day mortality, and length of stay in hospital. METHODS: A pre-defined secondary substudy of POWER study was performed. POWER study was a prospective multicenter observational study of patients undergoing elective primary colorectal surgery during a single period of two months of recruitment between September and December 2017. RESULTS: A total of 2084 patients from 80 Spanish hospitals were included, of which 722 (34.6%) were admitted to critical care unit (CCU) after elective surgery. After adjusting for confounding factors in the multivariate analysis, postoperative CCU admission was independently associated with a higher incidence of moderate-to-severe postoperative complications (adjusted OR 1.951, 95% CI 1.570, 2.425; p < 0.001). Regarding secondary outcomes, postoperative critical care admission was independently associated with higher 30-day mortality (adjusted OR 6.736; 95% CI 2.507, 18.101; p < 0.001) and independently associated with an increased hospital length of stay (adjusted OR 1.143, 95% CI 1.112, 1.175; p < 0.001). CONCLUSIONS: Direct admission to CCU after scheduled colorectal surgery was not associated with a reduction in moderate-to-severe postoperative complications.
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Cirugía Colorrectal , Humanos , Estudios Prospectivos , Hospitalización , Cuidados Críticos , Procedimientos Quirúrgicos Electivos/efectos adversos , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Tiempo de InternaciónRESUMEN
OBJECTIVES: To assess the value of machine learning approaches in the development of a multivariable model for early prediction of ICU death in patients with acute respiratory distress syndrome (ARDS). DESIGN: A development, testing, and external validation study using clinical data from four prospective, multicenter, observational cohorts. SETTING: A network of multidisciplinary ICUs. PATIENTS: A total of 1,303 patients with moderate-to-severe ARDS managed with lung-protective ventilation. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: We developed and tested prediction models in 1,000 ARDS patients. We performed logistic regression analysis following variable selection by a genetic algorithm, random forest and extreme gradient boosting machine learning techniques. Potential predictors included demographics, comorbidities, ventilatory and oxygenation descriptors, and extrapulmonary organ failures. Risk modeling identified some major prognostic factors for ICU mortality, including age, cancer, immunosuppression, Pa o2 /F io2 , inspiratory plateau pressure, and number of extrapulmonary organ failures. Together, these characteristics contained most of the prognostic information in the first 24 hours to predict ICU mortality. Performance with machine learning methods was similar to logistic regression (area under the receiver operating characteristic curve [AUC], 0.87; 95% CI, 0.82-0.91). External validation in an independent cohort of 303 ARDS patients confirmed that the performance of the model was similar to a logistic regression model (AUC, 0.91; 95% CI, 0.87-0.94). CONCLUSIONS: Both machine learning and traditional methods lead to promising models to predict ICU death in moderate/severe ARDS patients. More research is needed to identify markers for severity beyond clinical determinants, such as demographics, comorbidities, lung mechanics, oxygenation, and extrapulmonary organ failure to guide patient management.
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Síndrome de Dificultad Respiratoria , Humanos , Unidades de Cuidados Intensivos , Pulmón , Estudios Prospectivos , Respiración Artificial/métodos , Síndrome de Dificultad Respiratoria/terapiaRESUMEN
BACKGROUND: Animal models of acute respiratory distress syndrome (ARDS) do not completely resemble human ARDS, struggling translational research. We aimed to characterize a porcine model of ARDS induced by pneumonia-the most common risk factor in humans-and analyze the additional effect of ventilator-induced lung injury (VILI). METHODS: Bronchoscopy-guided instillation of a multidrug-resistant Pseudomonas aeruginosa strain was performed in ten healthy pigs. In six animals (pneumonia-with-VILI group), pulmonary damage was further increased by VILI applied 3 h before instillation and until ARDS was diagnosed by PaO2/FiO2 < 150 mmHg. Four animals (pneumonia-without-VILI group) were protectively ventilated 3 h before inoculum and thereafter. Gas exchange, respiratory mechanics, hemodynamics, microbiological studies and inflammatory markers were analyzed during the 96-h experiment. During necropsy, lobar samples were also analyzed. RESULTS: All animals from pneumonia-with-VILI group reached Berlin criteria for ARDS diagnosis until the end of experiment. The mean duration under ARDS diagnosis was 46.8 ± 7.7 h; the lowest PaO2/FiO2 was 83 ± 5.45 mmHg. The group of pigs that were not subjected to VILI did not meet ARDS criteria, even when presenting with bilateral pneumonia. Animals developing ARDS presented hemodynamic instability as well as severe hypercapnia despite high-minute ventilation. Unlike the pneumonia-without-VILI group, the ARDS animals presented lower static compliance (p = 0.011) and increased pulmonary permeability (p = 0.013). The highest burden of P. aeruginosa was found at pneumonia diagnosis in all animals, as well as a high inflammatory response shown by a release of interleukin (IL)-6 and IL-8. At histological examination, only animals comprising the pneumonia-with-VILI group presented signs consistent with diffuse alveolar damage. CONCLUSIONS: In conclusion, we established an accurate pulmonary sepsis-induced ARDS model.
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Neumonía , Síndrome de Dificultad Respiratoria , Lesión Pulmonar Inducida por Ventilación Mecánica , Humanos , Porcinos , Animales , Síndrome de Dificultad Respiratoria/diagnóstico , Pulmón/patología , Neumonía/complicaciones , Lesión Pulmonar Inducida por Ventilación Mecánica/complicaciones , Lesión Pulmonar Inducida por Ventilación Mecánica/patología , Mecánica Respiratoria , Respiración Artificial/efectos adversosRESUMEN
BACKGROUND: Postoperative pulmonary complications (PPCs) are a major cause of morbidity and mortality after open abdominal surgery. Optimized perioperative lung expansion may minimize the synergistic factors responsible for the multiple-hit perioperative pulmonary dysfunction. This ongoing study will assess whether an anesthesia-centered bundle focused on perioperative lung expansion results in decreased incidence and severity of PPCs after open abdominal surgery. METHODS: Prospective multicenter randomized controlled pragmatic trial in 750 adult patients with at least moderate risk for PPCs undergoing prolonged (≥2 hour) open abdominal surgery. Participants are randomized to receive either a bundle intervention focused on perioperative lung expansion or usual care. The bundle intervention includes preoperative patient education, intraoperative protective ventilation with individualized positive end-expiratory pressure to maximize respiratory system compliance, optimized neuromuscular blockade and reversal management, and postoperative incentive spirometry and early mobilization. Primary outcome is the distribution of the highest PPC severity by postoperative day 7. Secondary outcomes include the proportion of participants with: PPC grades 1-2 through POD 7; PPC grades 3-4 through POD 7, 30 and 90; intraoperative hypoxemia, rescue recruitment maneuvers, or cardiovascular events; and any major extrapulmonary postoperative complications. Additional secondary and exploratory outcomes include individual PPCs by POD 7, length of postoperative oxygen therapy or other respiratory support, hospital resource use parameters, Patient-Reported Outcomes Measurements (PROMIS®) questionnaires for dyspnea and fatigue collected before and at days 7, 30 and 90 after surgery, and plasma concentrations of lung injury biomarkers (IL6, IL-8, RAGE, CC16, Ang-2) analyzed from samples obtained before, end of, and 24 hours after surgery. DISCUSSION: Participant recruitment for this study started January 2020; results are expected in 2024. At the conclusion of this trial, we will determine if this anesthesia-centered strategy focused on perioperative lung expansion reduces lung morbidity and healthcare utilization after open abdominal surgery. TRIAL REGISTRATION: ClinicalTrial.gov NCT04108130.
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Anestesia , Enfermedades Pulmonares , Adulto , Humanos , Anestesia/efectos adversos , Pulmón/cirugía , Enfermedades Pulmonares/etiología , Enfermedades Pulmonares/prevención & control , Enfermedades Pulmonares/epidemiología , Estudios Multicéntricos como Asunto , Respiración con Presión Positiva/métodos , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/prevención & control , Complicaciones Posoperatorias/epidemiología , Estudios Prospectivos , Ensayos Clínicos Controlados Aleatorios como Asunto , Ensayos Clínicos Pragmáticos como AsuntoRESUMEN
Mortality is a frequently reported outcome in clinical studies of acute respiratory distress syndrome (ARDS). However, timing of mortality assessment has not been well characterized. We aimed to identify a crossing-point between cumulative survival and death in the intensive care unit (ICU) of patients with moderate-to-severe ARDS, beyond which the number of survivors would exceed the number of deaths. We hypothesized that this intersection would occur earlier in a successful clinical trial vs. observational studies of moderate/severe ARDS and predict treatment response. We conducted an ancillary study of 1580 patients with moderate-to-severe ARDS managed with lung-protective ventilation to assess the relevance and timing of measuring ICU mortality rates at different time-points during ICU stay. First, we analyzed 1303 patients from four multicenter, observational cohorts enrolling consecutive patients with moderate/severe ARDS. We assessed cumulative ICU survival from the time of moderate/severe ARDS diagnosis to ventilatory support discontinuation within 7-days, 28-days, 60-days, and at ICU discharge. Then, we compared these findings to those of a successful randomized trial of 277 moderate/severe ARDS patients. In the observational cohorts, ICU mortality (487/1303, 37.4%) and 28-day mortality (425/1102, 38.6%) were similar (p = 0.549). Cumulative proportion of ICU survivors and non-survivors crossed at day-7; after day-7, the number of ICU survivors was progressively higher compared to non-survivors. Measures of oxygenation, lung mechanics, and severity scores were different between survivors and non-survivors at each point-in-time (p < 0.001). In the trial cohort, the cumulative proportion of survivors and non-survivors in the treatment group crossed before day-3 after diagnosis of moderate/severe ARDS. In clinical ARDS studies, 28-day mortality closely approximates and may be used as a surrogate for ICU mortality. For patients with moderate-to-severe ARDS, ICU mortality assessment within the first week of a trial might be an early predictor of treatment response.
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Relevancia Clínica , Síndrome de Dificultad Respiratoria , Humanos , Unidades de Cuidados Intensivos , Respiración Artificial , PulmónRESUMEN
BACKGROUND: The primary aim of our study was to investigate the association between intubation timing and hospital mortality in critically ill patients with coronavirus disease 2019 (COVID-19)-associated respiratory failure. We also analysed both the impact of such timing throughout the first four pandemic waves and the influence of prior noninvasive respiratory support on outcomes. METHODS: This is a secondary analysis of a multicentre, observational and prospective cohort study that included all consecutive patients undergoing invasive mechanical ventilation due to COVID-19 from across 58 Spanish intensive care units (ICUs) participating in the CIBERESUCICOVID project. The study period was between 29 February 2020 and 31 August 2021. Early intubation was defined as that occurring within the first 24â h of ICU admission. Propensity score matching was used to achieve a balance across baseline variables between the early intubation cohort and those patients who were intubated after the first 24â h of ICU admission. Differences in outcomes between early and delayed intubation were also assessed. We performed sensitivity analyses to consider a different time-point (48â h from ICU admission) for early and delayed intubation. RESULTS: Of the 2725 patients who received invasive mechanical ventilation, a total of 614 matched patients were included in the analysis (307 for each group). In the unmatched population, there were no differences in mortality between the early and delayed groups. After propensity score matching, patients with delayed intubation presented higher hospital mortality (27.3% versus 37.1%; p=0.01), ICU mortality (25.7% versus 36.1%; p=0.007) and 90-day mortality (30.9% versus 40.2%; p=0.02) compared with the early intubation group. Very similar findings were observed when we used a 48-h time-point for early or delayed intubation. The use of early intubation decreased after the first wave of the pandemic (72%, 49%, 46% and 45% in the first, second, third and fourth waves, respectively; first versus second, third and fourth waves p<0.001). In both the main and sensitivity analyses, hospital mortality was lower in patients receiving high-flow nasal cannula (HFNC) (n=294) who were intubated earlier. The subgroup of patients undergoing noninvasive ventilation (n=214) before intubation showed higher mortality when delayed intubation was set as that occurring after 48â h from ICU admission, but not when after 24â h. CONCLUSIONS: In patients with COVID-19 requiring invasive mechanical ventilation, delayed intubation was associated with a higher risk of hospital mortality. The use of early intubation significantly decreased throughout the course of the pandemic. Benefits of such an approach occurred more notably in patients who had received HFNC.
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COVID-19 , Ventilación no Invasiva , Insuficiencia Respiratoria , Humanos , Estudios Prospectivos , Pandemias , Intubación Intratraqueal/efectos adversos , Respiración Artificial/efectos adversos , Insuficiencia Respiratoria/terapia , Insuficiencia Respiratoria/etiología , Unidades de Cuidados IntensivosRESUMEN
Introduction: In patients with acute respiratory distress syndrome (ARDS), the PaO2/FiO2 ratio at the time of ARDS diagnosis is weakly associated with mortality. We hypothesized that setting a PaO2/FiO2 threshold in 150 mm Hg at 24 h from moderate/severe ARDS diagnosis would improve predictions of death in the intensive care unit (ICU). Methods: We conducted an ancillary study in 1303 patients with moderate to severe ARDS managed with lung-protective ventilation enrolled consecutively in four prospective multicenter cohorts in a network of ICUs. The first three cohorts were pooled (n = 1000) as a testing cohort; the fourth cohort (n = 303) served as a confirmatory cohort. Based on the thresholds for PaO2/FiO2 (150 mm Hg) and positive end-expiratory pressure (PEEP) (10 cm H2O), the patients were classified into four possible subsets at baseline and at 24 h using a standardized PEEP-FiO2 approach: (I) PaO2/FiO2 ≥ 150 at PEEP < 10, (II) PaO2/FiO2 ≥ 150 at PEEP ≥ 10, (III) PaO2/FiO2 < 150 at PEEP < 10, and (IV) PaO2/FiO2 < 150 at PEEP ≥ 10. Primary outcome was death in the ICU. Results: ICU mortalities were similar in the testing and confirmatory cohorts (375/1000, 37.5% vs. 112/303, 37.0%, respectively). At baseline, most patients from the testing cohort (n = 792/1000, 79.2%) had a PaO2/FiO2 < 150, with similar mortality among the four subsets (p = 0.23). When assessed at 24 h, ICU mortality increased with an advance in the subset: 17.9%, 22.8%, 40.0%, and 49.3% (p < 0.0001). The findings were replicated in the confirmatory cohort (p < 0.0001). However, independent of the PEEP levels, patients with PaO2/FiO2 < 150 at 24 h followed a distinct 30-day ICU survival compared with patients with PaO2/FiO2 ≥ 150 (hazard ratio 2.8, 95% CI 2.2−3.5, p < 0.0001). Conclusions: Subsets based on PaO2/FiO2 thresholds of 150 mm Hg assessed after 24 h of moderate/severe ARDS diagnosis are clinically relevant for establishing prognosis, and are helpful for selecting adjunctive therapies for hypoxemia and for enrolling patients into therapeutic trials.
RESUMEN
PURPOSE: Despite the benefits of mechanical ventilation, its use in critically ill patients is associated with complications and had led to the growth of noninvasive techniques. We assessed the effect of early intubation (first 8 h after vasopressor start) in septic shock patients, as compared to non-early intubated subjects (unexposed), regarding in-hospital mortality, intensive care and hospital length of stay. METHODS: This study involves secondary analysis of a multicenter prospective study. To adjust for baseline differences in potential confounders, propensity score matching was carried out. In-hospital mortality was analyzed in a time-to-event fashion, while length of stay was assessed as a median difference using bootstrapping. RESULTS: A total of 735 patients (137 intubated in the first 8 h) were evaluated. Propensity score matching identified 78 pairs with similar severity and characteristics on admission. Intubation was used in all patients in the early intubation group and in 27 (35%) subjects beyond 8 h in the unexposed group. Mortality occurred in 35 (45%) and in 26 (33%) subjects in the early intubation and unexposed groups (hazard ratio 1.44 95% CI 0.86-2.39, p = 0.16). ICU and hospital length of stay were not different among groups [9 vs. 5 (95% CI 1 to 7) and 14 vs. 16 (95% CI - 7 to 8) days]. All sensitivity analyses confirmed the robustness of our findings. CONCLUSIONS: An early approach to invasive mechanical ventilation did not improve outcomes in this matched cohort of patients. The limited number of patients included in these analyses out the total number included in the study may limit generalizability of these findings. Trial registration NCT02780466. Registered on May 19, 2016.
Asunto(s)
Choque Séptico , Humanos , Unidades de Cuidados Intensivos , Intubación Intratraqueal/efectos adversos , Tiempo de Internación , Atención Dirigida al Paciente , Estudios ProspectivosRESUMEN
OBJECTIVES: To establish the epidemiological characteristics, ventilator management, and outcomes in patients with acute hypoxemic respiratory failure (AHRF), with or without acute respiratory distress syndrome (ARDS), in the era of lung-protective mechanical ventilation (MV). DESIGN: A 6-month prospective, epidemiological, observational study. SETTING: A network of 22 multidisciplinary ICUs in Spain. PATIENTS: Consecutive mechanically ventilated patients with AHRF (defined as Pao2/Fio2 ≤ 300 mm Hg on positive end-expiratory pressure [PEEP] ≥ 5 cm H2O and Fio2 ≥ 0.3) and followed-up until hospital discharge. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Primary outcomes were prevalence of AHRF and ICU mortality. Secondary outcomes included prevalence of ARDS, ventilatory management, and use of adjunctive therapies. During the study period, 9,803 patients were admitted: 4,456 (45.5%) received MV, 1,271 (13%) met AHRF criteria (1,241 were included into the study: 333 [26.8%] met Berlin ARDS criteria and 908 [73.2%] did not). At baseline, tidal volume was 6.9 ± 1.1 mL/kg predicted body weight, PEEP 8.4 ± 3.1 cm H2O, Fio2 0.63 ± 0.22, and plateau pressure 21.5 ± 5.4 cm H2O. ARDS patients received higher Fio2 and PEEP than non-ARDS (0.75 ± 0.22 vs 0.59 ± 0.20 cm H2O and 10.3 ± 3.4 vs 7.7 ± 2.6 cm H2O, respectively [p < 0.0001]). Adjunctive therapies were rarely used in non-ARDS patients. Patients without ARDS had higher ventilator-free days than ARDS (12.2 ± 11.6 vs 9.3 ± 9.7 d; p < 0.001). All-cause ICU mortality was similar in AHRF with or without ARDS (34.8% [95% CI, 29.7-40.2] vs 35.5% [95% CI, 32.3-38.7]; p = 0.837). CONCLUSIONS: AHRF without ARDS is a very common syndrome in the ICU with a high mortality that requires specific studies into its epidemiology and ventilatory management. We found that the prevalence of ARDS was much lower than reported in recent observational studies.