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Original Investigation | Caring for the Critically Ill Patient

Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries

Giacomo Bellani, MD, PhD1,2; John G. Laffey, MD, MA3,4; Tài Pham, MD5,6,7; Eddy Fan, MD, PhD8,9; Laurent Brochard, MD, HDR10,11; Andres Esteban, MD, PhD12; Luciano Gattinoni, MD, FRCP13; Frank van Haren, MD, PhD14; Anders Larsson, MD, PhD15; Daniel F. McAuley, MD, PhD16,17,18; Marco Ranieri, MD19; Gordon Rubenfeld, MD, MSc20,21; B. Taylor Thompson, MD, PhD22; Hermann Wrigge, MD, PhD23; Arthur S. Slutsky, MD, MASc24; Antonio Pesenti, MD13 ; for the LUNG SAFE Investigators and the ESICM Trials Group
[+] Author Affiliations
1School of Medicine and Surgery, University of Milan-Bicocca, Monza, Italy
2Department of Emergency and Intensive Care, San Gerardo Hospital, Monza, Italy
3Departments of Anesthesia and Critical Care Medicine, Keenan Research Centre for Biomedical Science, St Michael’s Hospital
4Departments of Anesthesia, Physiology and Interdepartmental division of Critical Care Medicine, University of Toronto, Canada
5AP-HP, Hôpital Tenon, Unité de Réanimation médico-chirurgicale, Pôle Thorax Voies aériennes, Groupe hospitalier des Hôpitaux Universitaires de l’Est Parisien, Paris, France
6UMR 1153, Inserm, Sorbonne Paris Cité, ECSTRA Team, Université Paris Diderot, Paris, France
7UMR 915, Inserm, Université Paris Est Créteil, Créteil, France
8Department of Medicine, University Health Network and Mount Sinai Hospital
9Interdepartmental Division of Critical Care Medicine and Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada
10Keenan Research Centre, Li Ka Shing Knowledge Institute, St Michael’s Hospital, Toronto, Canada
11Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Canada
12Hospital Universitario de Getafe, CIBER de Enfermedades Respiratorias, Madrid, Spain
13Istituto di Anestesia e Rianimazione, Università degli Studi di Milano, Ospedale Maggiore, Istituto di Ricovero e Cura a Carattere Scientifico, Milan, Italy
14Intensive Care Unit, Canberra Hospital, and Australian National University, Canberra, Australia
15Section of Anesthesiology and Intensive Care, Department of Surgical Sciences, Uppsala University, Uppsala, Sweden
16Centre for Experimental Medicine, Queen's University of Belfast, Belfast, Northern Ireland
17Wellcome-Wolfson Institute for Experimental Medicine, Belfast, Northern Ireland
18Regional Intensive Care Unit, Royal Victoria Hospital, Grosvenor Road, Belfast, Northern Ireland
19SAPIENZA Università di ROMA, Dipartimento di Anestesia e Rianimazione, Policlinico Umberto I, Viale del Policlinico 155, 00161 Roma, Italy
20Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Canada
21Program in Trauma, Emergency and Critical Care, Sunnybrook Health Sciences Center, Toronto, Canada
22Division of Pulmonary and Critical Care Unit, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston
23Department of Anesthesiology and Intensive Care Medicine, University of Leipzig, Liebigstr. 20, D-04103 Leipzig, Germany
24Keenan Research Center at the Li Ka Shing Knowledge Institute of St Michael’s Hospital, the Interdepartmental Division of Critical Care Medicine, and the Department of Medicine, University of Toronto, Toronto, Canada
JAMA. 2016;315(8):788-800. doi:10.1001/jama.2016.0291.
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Importance  Limited information exists about the epidemiology, recognition, management, and outcomes of patients with the acute respiratory distress syndrome (ARDS).

Objectives  To evaluate intensive care unit (ICU) incidence and outcome of ARDS and to assess clinician recognition, ventilation management, and use of adjuncts—for example prone positioning—in routine clinical practice for patients fulfilling the ARDS Berlin Definition.

Design, Setting, and Participants  The Large Observational Study to Understand the Global Impact of Severe Acute Respiratory Failure (LUNG SAFE) was an international, multicenter, prospective cohort study of patients undergoing invasive or noninvasive ventilation, conducted during 4 consecutive weeks in the winter of 2014 in a convenience sample of 459 ICUs from 50 countries across 5 continents.

Exposures  Acute respiratory distress syndrome.

Main Outcomes and Measures  The primary outcome was ICU incidence of ARDS. Secondary outcomes included assessment of clinician recognition of ARDS, the application of ventilatory management, the use of adjunctive interventions in routine clinical practice, and clinical outcomes from ARDS.

Results  Of 29 144 patients admitted to participating ICUs, 3022 (10.4%) fulfilled ARDS criteria. Of these, 2377 patients developed ARDS in the first 48 hours and whose respiratory failure was managed with invasive mechanical ventilation. The period prevalence of mild ARDS was 30.0% (95% CI, 28.2%-31.9%); of moderate ARDS, 46.6% (95% CI, 44.5%-48.6%); and of severe ARDS, 23.4% (95% CI, 21.7%-25.2%). ARDS represented 0.42 cases per ICU bed over 4 weeks and represented 10.4% (95% CI, 10.0%-10.7%) of ICU admissions and 23.4% of patients requiring mechanical ventilation. Clinical recognition of ARDS ranged from 51.3% (95% CI, 47.5%-55.0%) in mild to 78.5% (95% CI, 74.8%-81.8%) in severe ARDS. Less than two-thirds of patients with ARDS received a tidal volume 8 of mL/kg or less of predicted body weight. Plateau pressure was measured in 40.1% (95% CI, 38.2-42.1), whereas 82.6% (95% CI, 81.0%-84.1%) received a positive end-expository pressure (PEEP) of less than 12 cm H2O. Prone positioning was used in 16.3% (95% CI, 13.7%-19.2%) of patients with severe ARDS. Clinician recognition of ARDS was associated with higher PEEP, greater use of neuromuscular blockade, and prone positioning. Hospital mortality was 34.9% (95% CI, 31.4%-38.5%) for those with mild, 40.3% (95% CI, 37.4%-43.3%) for those with moderate, and 46.1% (95% CI, 41.9%-50.4%) for those with severe ARDS.

Conclusions and Relevance  Among ICUs in 50 countries, the period prevalence of ARDS was 10.4% of ICU admissions. This syndrome appeared to be underrecognized and undertreated and associated with a high mortality rate. These findings indicate the potential for improvement in the management of patients with ARDS.

Trial Registration  clinicaltrials.gov Identifier: NCT02010073

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Figure 1.
Flow of Patient Screening and Enrollment

aProjected from data provided by 360 intensive care units (ICUs [78%]). Data specifying other reasons were not collected during the study.

bPatient electronic case report forms that were not fully complete were excluded.

cNumber included in the primary analysis.

dPatients could have more than one cause for acute hypoxic respiratory failure.

eFor unclassified patients it was not possible to determine whether they fulfilled the criteria for acute respiratory distress syndrome (ARDS) due to incomplete data.

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Figure 2.
Ventilation Parameters in Patients With ARDS

A, Cumulative frequency distribution of tidal volume was similar in patients in each severity category, with 65% of patients with acute respiratory distress syndrome (ARDS) receiving a tidal volume of 8 mL/kg of predicted body weight or less. B, In contrast, a right shift of the cumulative frequency distribution curves of plateau pressures was seen for increasing ARDS severity category, with plateau pressure of more than 30 cm H2o in 8.5% of patients for which these data are available. C, Represents the distribution of day-1 tidal volume vs plateau pressure for each patient for which these data are available. Two-thirds of the patients fell within the limits for protective ventilation, defined as plateau pressure less than or equal to 30 cm H2o and tidal volume of less than or equal to 8 mL/kg of predicted body weight. Data refer to the first day of ARDS.

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Figure 3.
Mechanical Ventilation Settings in Early Acute Respiratory Distress Syndrome

A, Tidal volume remained relatively constant across the range of peak inspiratory pressures. B, Positive end-expiratory pressure (PEEP) progressively increased in patients requiring higher inspired fraction of oxygen (Fio2). C, There was a stepwise increase in Fio2 at lower arterial oxygen saturations, with Fio2 steeply increasing at atrial oxygen saturation (Sao2) values lower than 91%. Data refer to the first day of ARDS.

For each box plot, the middle line represents the median, the lower hinge represents the first quartile, the upper hinge represents the third quartile, the whiskers extend to 1.5 times interquartile range, and the outliers are values outside the whiskers’ range. The boxes are drawn with widths proportional to the square root of the number of observations in the groups. The numbers below each box plot represent the total number of patients in each group.

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Figure 4.
Outcome From Acute Respiratory Distress Syndrome

A, There was a lower likelihood of unassisted breathing with increasing severity of acute respiratory distress syndrome. B, There was a lower likelihood of survival to day 28 with increasing severity of acute respiratory distress syndrome (ARDS) at day 1. C, Patients with a driving pressure of greater than 14 cm H2o on day 1 of ARDS criteria had a higher mortality.

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Figure 5.
Driving Pressure and Plateau Pressure and Outcome From ARDS

A, Mortality increased with increasing quintiles of driving pressure on first day of ARDS. B, The relationship between mortality and quintiles of plateau pressure is provided for comparison. Error bars indicate 95% confidence interval.

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