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1. Clinical relevance of timing of assessment of ICU mortality in patients with moderate-to-severe Acute Respiratory Distress Syndrome

Author

Jesús Villar, Jesús M. González-Martin, José M. Añón, Carlos Ferrando, Juan A. Soler, Fernando Mosteiro, Juan M. Mora-Ordoñez, Alfonso Ambrós, Lorena Fernández, Raquel Montiel, Anxela Vidal, Tomás Muñoz, Lina Pérez-Méndez, Pedro Rodríguez-Suárez, Cristina Fernández, Rosa L. Fernández, Tamas Szakmany, Karen E. A. Burns, Ewout W. Steyerberg, and Arthur S. Slutsky

Subjects
Medicine, Science
Abstract

Abstract 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

Published
2023
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2. The PANDORA Study: Prevalence and Outcome of Acute Hypoxemic Respiratory Failure in the Pre-COVID-19 Era

Author

Jesús Villar, MD, PhD, FCCM, Juan M. Mora-Ordoñez, MD, Juan A. Soler, MD, PhD, Fernando Mosteiro, MD, PhD, Anxela Vidal, MD, Alfonso Ambrós, MD, PhD, Lorena Fernández, MD, Isabel Murcia, MD, Belén Civantos, MD, Miguel A. Romera, MD, Adrián Mira, MD, Francisco J. Díaz-Domínguez, MD, Dácil Parrilla, MD, J. Francisco Martínez-Carmona, MD, Domingo Martínez, MD, Lidia Pita-García, MD, Denis Robaglia, MD, Ana Bueno-González, MD, Jesús Sánchez-Ballesteros, MD, Ángel E. Pereyra, MD, Mónica Hernández, MD, Carlos Chamorro-Jambrina, MD, Pilar Cobeta, MD, Raúl I. González-Luengo, MD, Raquel Montiel, MD, Leonor Nogales, MD, M. Mar Fernández, MD, PhD, Blanca Arocas, MD, Álvaro Valverde-Montoro, MD, Ana M. del Saz-Ortiz, MD, Victoria Olea-Jiménez, MD, José M. Añón, MD, PhD, Pedro Rodríguez-Suárez, MD, Rosa L. Fernández, MSc, Cristina Fernández, MSc, Tamas Szakmany, MD, PhD, Jesús M. González-Martín, PhD, Carlos Ferrando, MD, PhD, Robert M. Kacmarek, PhD, RTT, Arthur S. Slutsky, MD, for the Prevalence AND Outcome of acute hypoxemic Respiratory fAilure (PANDORA) Network, José M. Añón, Belén Civantos, Mónica Hernández, Elena González, Rosario Solano, F. Javier Díaz-Domínguez, Demetrio Carriedo, Raul I. González Luengo, Carlos Ferrando, Blanca Arocas, Javier Belda, Marina Soro, Gerardo Aguilar, Ernesto Pastor, Lorena Fernández, Jesús Sánchez-Ballesteros, Arturo Muriel, Pablo Blanco-Schweizer, José Ángel de Ayala, Jesús Blanco, César Aldecoa, Alba Pérez, Jesús Rico-Feijoo, Leonor Nogales, David Andaluz, Laura Parra, Juan A. Soler, Domingo Martínez, Ana M. del Saz-Ortiz, Alfonso Ambrós, Ana Bueno-González, Carmen Hornos-López, Raquel Montiel, Dácil Parrilla, Eduardo Peinado, Isidro Prieto, Mario Chico, Miguel A. Romera, Carlos Chamorro-Jambrina, Juan M. Mora-Ordoñez, J. Francisco Martínez-Carmona, Álvaro Valverde-Montoro, Victoria Olea-Jiménez, Paco Alba, Ruth Corpas, Fernando Mosteiro, Lidia Pita-García, Eleuterio Merayo, Chanel Martínez, Ángeles de Célis-Álvarez, Carmen Martín-Delgado, Adrián Mira, Pilar Cobeta, David Pestaña, María del Mar Fernández, Concepción Tarancón, Silvia Cortés-Díaz, Anxela Vidal, Denis Robaglia, César Pérez, Isabel Murcia, Ángel E. Pereyra-Pache, Tamas Szakmany, Jesús Villar, Rosa L. Fernández, Cristina Fernández, Pedro Rodríguez-Pérez, Jesús M. González-Martín, Robert M. Kacmarek, and Arthur S. Slutsky

Subjects
Medical emergencies. Critical care. Intensive care. First aid, RC86-88.9
Abstract

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.

Published
2022
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3. Dexamethasone treatment for the acute respiratory distress syndrome: a multicentre, randomised controlled trial

Author

Jesús Villar, Carlos Ferrando, Domingo Martínez, Alfonso Ambrós, Tomás Muñoz, Juan A Soler, Gerardo Aguilar, Francisco Alba, Elena González-Higueras, Luís A Conesa, Carmen Martín-Rodríguez, Francisco J Díaz-Domínguez, Pablo Serna-Grande, Rosana Rivas, José Ferreres, Javier Belda, Lucía Capilla, Alec Tallet, José M Añón, Rosa L Fernández, Jesús M González-Martín, Julián Álvarez, José M. Añón, María J. Asensio, Jesús Blanco, Marisa Blasco, Lucia Cachafeiro, Rafael del Campo, José A. Carbonell, Nieves Carbonell, Agustín Cariñena, Demetrio Carriedo, Mario Chico, Luís A. Conesa, Ruth Corpas, Javier Cuervo, Francisco J. Díaz-Domínguez, Cristina Domínguez-Antelo, Lorena Fernández, Rosa L. Fernández, Eneritz Gamboa, Raúl I. González-Luengo, Jesús M. González-Martín, Ramón Ortiz Díaz-Miguel, Raquel Pérez-González, Ana M. Prieto, Isidro Prieto, Leticia Rojas-Viguera, Miguel A. Romera, Jesús Sánchez-Ballesteros, José M. Segura, Ainhoa Serrano, Rosario Solano, Juan A. Soler, and Marina Soro

Subjects
Pulmonary and Respiratory Medicine, Adult, Male, ARDS, medicine.medical_treatment, Severity of Illness Index, Dexamethasone, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Fraction of inspired oxygen, Intensive care, Severity of illness, medicine, Data monitoring committee, Humans, 030212 general & internal medicine, Glucocorticoids, Aged, Mechanical ventilation, Respiratory Distress Syndrome, business.industry, Middle Aged, medicine.disease, Respiration, Artificial, Intensive Care Units, Treatment Outcome, 030228 respiratory system, Anesthesia, Administration, Intravenous, Female, business, medicine.drug
Abstract

Background There is no proven specific pharmacological treatment for patients with the acute respiratory distress syndrome (ARDS). The efficacy of corticosteroids in ARDS remains controversial. We aimed to assess the effects of dexamethasone in ARDS, which might change pulmonary and systemic inflammation and result in a decrease in duration of mechanical ventilation and mortality. Methods We did a multicentre, randomised controlled trial in a network of 17 intensive care units (ICUs) in teaching hospitals across Spain in patients with established moderate-to-severe ARDS (defined by a ratio of partial pressure of arterial oxygen to the fraction of inspired oxygen of 200 mm Hg or less assessed with a positive end-expiratory pressure of 10 cm H2O or more and FiO(2) of 0.5 or more at 24 h after ARDS onset). Patients with brain death, terminal-stage disease, or receiving corticosteroids or immunosuppressive drugs were excluded. Eligible patients were randomly assigned based on balanced treatment assignments with a computerised randomisation allocation sequence using blocks of 10 opaque, sealed envelopes to receive immediate treatment with dexamethasone or continued routine intensive care (control group). Patients in the dexamethasone group received an intravenous dose of 20 mg once daily from day 1 to day 5, which was reduced to 10 mg once daily from day 6 to day 10. Patients in both groups were ventilated with lung-protective mechanical ventilation. Allocation concealment was maintained at all sites during the trial. Primary outcome was the number of ventilator-free days at 28 days, defined as the number of days alive and free from mechanical ventilation from day of randomisation to day 28. Secondary outcome was all-cause mortality 60 days after randomisation. All analyses were done according to the intention-to-treat principle. This study is registered with ClinicalTrials.gov, NCT01731795. Findings Between March 28, 2013, and Dec 31, 2018, we enrolled 277 patients and randomly assigned 139 patients to the dexamethasone group and 138 to the control group. The trial was stopped by the data safety monitoring board due to low enrolment rate after enrolling more than 88% (277/314) of the planned sample size. The mean number of ventilator-free days was higher in the dexamethasone group than in the control group (between-group difference 4.8 days [95% CI 2.57 to 7.03]; p

Published
2020

4. A Quantile Analysis of Plateau and Driving Pressures: Effects on Mortality in Patients With Acute Respiratory Distress Syndrome Receiving Lung-Protective Ventilation

Author

Jesús, Villar, Carmen, Martín-Rodríguez, Ana M, Domínguez-Berrot, Lorena, Fernández, Carlos, Ferrando, Juan A, Soler, Ana M, Díaz-Lamas, Elena, González-Higueras, Leonor, Nogales, Alfonso, Ambrós, Demetrio, Carriedo, Mónica, Hernández, Domingo, Martínez, Jesús, Blanco, Javier, Belda, Dácil, Parrilla, Fernando, Suárez-Sipmann, Concepción, Tarancón, Juan M, Mora-Ordoñez, Lluís, Blanch, Lina, Pérez-Méndez, Rosa L, Fernández, and Robert M, Kacmarek

Subjects
Adult, Male, medicine.medical_specialty, Vital Capacity, Acute respiratory distress, Critical Care and Intensive Care Medicine, Plateau (mathematics), Severity of Illness Index, 03 medical and health sciences, Plateau pressure, 0302 clinical medicine, Internal medicine, Severity of illness, medicine, Humans, In patient, Intensive care medicine, Aged, Respiratory Distress Syndrome, business.industry, 030208 emergency & critical care medicine, Lung protective ventilation, Middle Aged, Respiration, Artificial, Beyond the Blue: What Fellows Are Reading in Other Journals, Intensive Care Units, Observational Studies as Topic, 030228 respiratory system, Breathing, Cardiology, Female, business, Quantile
Abstract

The driving pressure (plateau pressure minus positive end-expiratory pressure) has been suggested as the major determinant for the beneficial effects of lung-protective ventilation. We tested whether driving pressure was superior to the variables that define it in predicting outcome in patients with acute respiratory distress syndrome.A secondary analysis of existing data from previously reported observational studies.A network of ICUs.We studied 778 patients with moderate to severe acute respiratory distress syndrome.None.We assessed the risk of hospital death based on quantiles of tidal volume, positive end-expiratory pressure, plateau pressure, and driving pressure evaluated at 24 hours after acute respiratory distress syndrome diagnosis while ventilated with standardized lung-protective ventilation. We derived our model using individual data from 478 acute respiratory distress syndrome patients and assessed its replicability in a separate cohort of 300 acute respiratory distress syndrome patients. Tidal volume and positive end-expiratory pressure had no impact on mortality. We identified a plateau pressure cut-off value of 29 cm H2O, above which an ordinal increment was accompanied by an increment of risk of death. We identified a driving pressure cut-off value of 19 cm H2O where an ordinal increment was accompanied by an increment of risk of death. When we cross tabulated patients with plateau pressure less than 30 and plateau pressure greater than or equal to 30 with those with driving pressure less than 19 and driving pressure greater than or equal to 19, plateau pressure provided a slightly better prediction of outcome than driving pressure in both the derivation and validation cohorts (p0.0000001).Plateau pressure was slightly better than driving pressure in predicting hospital death in patients managed with lung-protective ventilation evaluated on standardized ventilator settings 24 hours after acute respiratory distress syndrome onset.

Published
2017

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