Individualised, perioperative open-lung ventilation strategy during one-lung ventilation (iPROVE-OLV): a multicentre, randomised, controlled clinical trial.

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.

Evaluation of an enhanced recovery after lung surgery (ERALS) program in lung cancer lobectomy: An eight-year experience.

INTRODUCTION: Enhanced recovery after lung surgery (ERALS) protocols have proven useful in reducing postoperative stay (POS) and postoperative complications (POC). We studied the performance of an ERALS program for lung cancer lobectomy in our institution, aiming to identify which factors are associated with a reduction of POC and POS. METHODS: Analytic retrospective observational study conducted in a tertiary care teaching hospital involving patients submitted to lobectomy for lung cancer and included in an ERALS program. Univariable and multivariable analysis were employed to identify factors associated with increased risk of POC and prolonged POS. RESULTS: A total 624 patients were enrolled in the ERALS program. The median POS was 4 days (range 1-63), with 2.9% of ICU postoperative admission. A videothoracoscopic approach was used in 66.6% of cases, and 174 patients (27.9%) experienced at least one POC. Perioperative mortality rate was 0.8% (5 cases). Mobilization to chair in the first 24h after surgery was achieved in 82.5% of cases, with 46.5% of patients achieving ambulation in the first 24h. Absence of mobilization to chair and preoperative FEV1% less than 60% predicted, were identified as independent risk factors for POC, while thoracotomy approach and the presence of POC predicted prolonged POS. CONCLUSIONS: We observed a reduction in ICU admissions and POS contemporaneous with the use of an ERALS program in our institution. We demonstrated that early mobilization and videothoracoscopic approach are modifiable independent predictors of reduced POC and POS, respectively.

Evaluation of an enhanced recovery after lung surgery (ERALS) program in lung cancer lobectomy: An eight-year experience / Evaluación de un programa de rehabilitación multimodal en lobectomía por cáncer de pulmón: experiencia de 8 años

Introduction: Enhanced recovery after lung surgery (ERALS) protocols have proven useful in reducing postoperative stay (POS) and postoperative complications (POC). We studied the performance of an ERALS program for lung cancer lobectomy in our institution, aiming to identify which factors are associated with a reduction of POC and POS. Methods: Analytic retrospective observational study conducted in a tertiary care teaching hospital involving patients submitted to lobectomy for lung cancer and included in an ERALS program. Univariable and multivariable analysis were employed to identify factors associated with increased risk of POC and prolonged POS. Results: A total 624 patients were enrolled in the ERALS program. The median POS was 4 days (range 1–63), with 2.9% of ICU postoperative admission. A videothoracoscopic approach was used in 66.6% of cases, and 174 patients (27.9%) experienced at least one POC. Perioperative mortality rate was 0.8% (5 cases). Mobilization to chair in the first 24h after surgery was achieved in 82.5% of cases, with 46.5% of patients achieving ambulation in the first 24h. Absence of mobilization to chair and preoperative FEV1% less than 60% predicted, were identified as independent risk factors for POC, while thoracotomy approach and the presence of POC predicted prolonged POS. Conclusions: We observed a reduction in ICU admissions and POS contemporaneous with the use of an ERALS program in our institution. We demonstrated that early mobilization and videothoracoscopic approach are modifiable independent predictors of reduced POC and POS, respectively. (AU)

Introducción: Los programas de recuperación intensificada en cirugía de pulmón (por sus siglas en inglés, ERALS) han demostrado ser útiles para reducir la estancia hospitalaria y las complicaciones postoperatorias. Estudiamos los resultados de la aplicación de un programa ERALS para lobectomía por cáncer en nuestro centro con la intención de identificar aquellos factores que se relacionan con la reducción de las complicaciones y la estancia. Métodos: Estudio observacional retrospectivo en pacientes sometidos a lobectomía por cáncer de pulmón e incluidos en un programa ERALS. Se empleó análisis univariable y multivariable para identificar los factores de riesgo de complicaciones y estancia prolongada. Resultados: Un total de 624 pacientes se inscribieron en el programa ERALS. La estancia postoperatoria mediana fue de 4 días (1-63), con una tasa de ingreso en la UCI del 2,9%. El abordaje videotoracoscópico fue empleado en el 66,6% de los casos, y la tasa de complicaciones postoperatorias fue del 27,9%, con una tasa de mortalidad del 0,8% (5 casos). La no movilización en las primeras 24h, y el FEV1% inferior al 60% del previsto, se identificaron como factores de riesgo de complicaciones; mientras que el abordaje mediante toracotomía y la presencia de complicaciones predijeron la estancia prolongada. Conclusiones: Observamos una reducción en la estancia hospitalaria y en los ingresos postoperatorios en la UCI concomitante a la puesta en marcha de un programa ERALS en nuestro centro. La movilización precoz y el abordaje quirúrgico videotoracoscópico demostraron ser predictores independientes y modificables para la reducción de las complicaciones y para la duración de la estancia, respectivamente. (AU)

Influence of the end inspiratory pause on respiratory mechanics and tidal gas distribution of surgical patients ventilated under a tailored open lung approach strategy: A randomised, crossover trial.

BACKGROUND: The effect of modifying the end inspiratory pause (EIP) on respiratory mechanics and gas distribution of surgical patients ventilated with an open lung approach (OLA) has not been addressed before. METHODS: Prospective, randomised, crossover study carried out in a tertiary hospital. Subjects were assigned to receive an initial EIP of 10% or 30% of the total inspiratory time. We compared standard ventilation [time 0: tidal volume (VT) 7 mL × kg-1, respiratory rate (RR) 13, inspiratory:expiratory (I:E) rate 1:2, positive end-expiratory pressure (PEEP) 5 cm H2O and EIP 10% and 30% for groups 1 and 2, respectively) with tailored OLA (similar parameters except for a tailored PEEP after a stepwise recruitment manoeuvre), followed by a crossover assignment sequence between groups (times 2-4). RESULTS: We included 32 adult subjects undergoing major surgery. Tailored OLA strategy was associated with a significant increase in PEEP, plateau pressure (Pplat), PaO2, and compliance of the respiratory system (CRS) with a significant decrease in driving pressure (Pdriv) and PaCO2, and a more homogeneous gas distribution in both groups. A significantly lower PEEP (p < 0.001), Pdriv (5 [5-6] versus 6.5 [6-8] cmH2O; p < 0.001) and mean airway pressure (Pmean; p < 0.001) together with a higher CRS (77 [67-87] versus 58 [52-70] ml*cmH2O-1; p < 0.001) were observed when an EIP of 30% was applied as compared to an EIP of 10%. CONCLUSION: The use of a tailored OLA strategy combined with a longer EIP is associated with a higher CRS, and a lower Pdriv, Pmean and PEEP. Additional studies are necessary to assess if the improved ventilatory conditions observed with a longer EIP are associated with better patients' outcomes. Trial registration at clinicaltrials.gov with identifier: NCT03568786.

COVID-19 epidemiology in a Mexican tertiary care hospital.

INTRODUCTION: As a result of COVID-19, many hospitals underwent a conversion for the care for this disease. OBJECTIVE: To analyze COVID-19 hospital epidemiological behavior from March to August 2020. METHODS: Through a series of cases, COVID-19 epidemiological behavior at the hospital was analyzed, for which simple case rates, percentages and incidence of COVID-19 per 100 hospital discharges were estimated. RESULTS: Out of 491 subjects who tested positive for SARS-CoV-2, 156 (31.7 %) were hospitalized for clinical data of moderate to severe disease. Average age was 59.1 years; 121 cases (75 %) were discharged due to improvement, and 32 (20.5 %), due to death. Average age of those who died was 69.7 years, and the most affected age group was 60 to 80 years (45.4 %). Calculated lethality was 20.5 per 100 hospital discharges, while that calculated taking into account positive patients (outpatients and hospitalized patients) was 6.5. CONCLUSIONS: COVID-19 epidemiological behavior was similar to that described in other studies; however, lethality and mortality are above national average. The analysis of this and of the factors that favored it in our population is pending.

INTRODUCCIÓN: A consecuencia de COVID-19, numerosos hospitales sufrieron una reconversión para la atención de esta enfermedad. OBJETIVO: Analizar el comportamiento epidemiológico hospitalario de COVID-19 entre marzo y agosto de 2020. MÉTODOS: En una serie de casos se analizó el comportamiento epidemiológico de COVID-19 en un hospital de tercer nivel, para lo cual se estimaron frecuencias simples de casos, porcentajes e incidencia por cada 100 egresos hospitalarios. RESULTADOS: De 491 sujetos con prueba positiva para SARS-CoV-2, 156 (31.7 %) fueron hospitalizados por datos clínicos de enfermedad moderada a grave. La edad promedio fue de 59.1 años; 121 casos (75 %) egresaron por mejoría y 32 (20.5 %), por defunción. El promedio de edad de quienes fallecieron fue de 69.7 años y el grupo etario más afectado fue el de 60 a 80 años (45.4 %). La letalidad calculada fue de 20.5 por 100 egresos hospitalarios, mientras que la calculada tomando en cuenta los pacientes positivos (ambulatorios y hospitalizados) fue de 6.5. CONCLUSIONES: El comportamiento epidemiológico de COVID-19 fue similar al descrito en otros estudios; sin embargo, la letalidad y la mortalidad están por encima de la media nacional. Está pendiente el análisis de estas y de los factores que las favorecieron en nuestra población.

Epidemiología de COVID-19 en un hospital de tercer nivel mexicano / COVID-19 epidemiology in a Mexican tertiary care hospital

Resumen Introducción: A consecuencia de COVID-19, numerosos hospitales sufrieron una reconversión para la atención de esta enfermedad. Objetivo: Analizar el comportamiento epidemiológico hospitalario de COVID-19 entre marzo y agosto de 2020. Métodos: En una serie de casos se analizó el comportamiento epidemiológico de COVID-19 en un hospital de tercer nivel, para lo cual se estimaron frecuencias simples de casos, porcentajes e incidencia por cada 100 egresos hospitalarios. Resultados: De 491 sujetos con prueba positiva para SARS-CoV-2, 156 (31.7 %) fueron hospitalizados por datos clínicos de enfermedad moderada a grave. La edad promedio fue de 59.1 años; 121 casos (75 %) egresaron por mejoría y 32 (20.5 %), por defunción. El promedio de edad de quienes fallecieron fue de 69.7 años y el grupo etario más afectado fue el de 60 a 80 años (45.4 %). La letalidad calculada fue de 20.5 por 100 egresos hospitalarios, mientras que la calculada tomando en cuenta los pacientes positivos (ambulatorios y hospitalizados) fue de 6.5. Conclusiones: El comportamiento epidemiológico de COVID-19 fue similar al descrito en otros estudios; sin embargo, la letalidad y la mortalidad están por encima de la media nacional. Está pendiente el análisis de estas y de los factores que las favorecieron en nuestra población.

Abstract Introduction: As a result of COVID-19, many hospitals underwent a conversion for the care for this disease Objective: To analyze COVID-19 hospital epidemiological behavior from March to August 2020. Methods: Through a series of cases, COVID-19 epidemiological behavior at the hospital was analyzed, for which simple case rates, percentages and incidence of COVID-19 per 100 hospital discharges were estimated. Results: Out of 491 subjects who tested positive for SARS-CoV-2, 156 (31.7 %) were hospitalized for clinical data of moderate to severe disease. Average age was 59.1 years; 121 cases (75 %) were discharged due to improvement, and 32 (20.5 %), due to death. Average age of those who died was 69.7 years, and the most affected age group was 60 to 80 years (45.4 %). Calculated lethality was 20.5 per 100 hospital discharges, while that calculated taking into account positive patients (outpatients and hospitalized patients) was 6.5. Conclusions: COVID-19 epidemiological behavior was similar to that described in other studies; however, lethality and mortality are above national average. The analysis of this and of the factors that favored it in our population is pending.

Rationale and Study Design for an Individualized Perioperative Open Lung Ventilatory Strategy in Patients on One-Lung Ventilation (iPROVE-OLV).

OBJECTIVE: The aim of this clinical trial is to examine whether it is possible to reduce postoperative complications using an individualized perioperative ventilatory strategy versus using a standard lung-protective ventilation strategy in patients scheduled for thoracic surgery requiring one-lung ventilation. DESIGN: International, multicenter, prospective, randomized controlled clinical trial. SETTING: A network of university hospitals. PARTICIPANTS: The study comprises 1,380 patients scheduled for thoracic surgery. INTERVENTIONS: The individualized group will receive intraoperative recruitment maneuvers followed by individualized positive end-expiratory pressure (open lung approach) during the intraoperative period plus postoperative ventilatory support with high-flow nasal cannula, whereas the control group will be managed with conventional lung-protective ventilation. MEASUREMENTS AND MAIN RESULTS: Individual and total number of postoperative complications, including atelectasis, pneumothorax, pleural effusion, pneumonia, acute lung injury; unplanned readmission and reintubation; length of stay and death in the critical care unit and in the hospital will be analyzed for both groups. The authors hypothesize that the intraoperative application of an open lung approach followed by an individual indication of high-flow nasal cannula in the postoperative period will reduce pulmonary complications and length of hospital stay in high-risk surgical patients.