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Pediatric Acute Lung Injury Epidemiology and Natural History Study: Incidence and outcome of the acute respiratory distress syndrome in children*

López-Fernández, Yolanda MD; Martínez-de Azagra, Amelia MD; de la Oliva, Pedro MD, PhD; Modesto, Vicent MD, PhD; Sánchez, Juan I. MD, PhD; Parrilla, Julio MD; Arroyo, María José MD; Reyes, Susana Beatriz MD, PhD; Pons-ódena, Martí MD, PhD; López-Herce, Jesús MD, PhD; Fernández, Rosa Lidia MBA; Kacmarek, Robert M. PhD, RTT; Villar, Jesús MD, PhD

doi: 10.1097/CCM.0b013e318260caa3
Pediatric Critical Care

Objectives: The incidence and outcome of the acute respiratory distress syndrome in children are not well-known, especially under current ventilatory practices. The goal of this study was to determine the incidence, etiology, and outcome of acute respiratory distress syndrome in the pediatric population in the setting of lung protective ventilation.

Design: A 1-yr, prospective, multicenter, observational study in 12 geographical areas of Spain (serving a population of 3.77 million ≤15 yrs of age) covered by 21 pediatric intensive care units.

Subjects: All consecutive pediatric patients receiving invasive mechanical ventilation and meeting American-European Consensus Criteria for acute respiratory distress syndrome.

Interventions: None.

Measurements and Main Results: Data on ventilatory management, gas exchange, hemodynamics, and organ dysfunction were collected. A total of 146 mechanically ventilated patients fulfilled the acute respiratory distress syndrome definition, representing a incidence of 3.9/100,000 population ≤15 yrs of age/yr. Pneumonia and sepsis were the most common causes of acute respiratory distress syndrome. At the time of meeting acute respiratory distress syndrome criteria, mean PaO2/FIO2 was 99 mm Hg ± 41 mm Hg, mean tidal volume was 7.6 mL/kg ± 1.8 mL/kg predicted body weight, mean plateau pressure was 27 cm H2O ± 6 cm H2O, and mean positive end-expiratory pressure was 8.9 cm ± 2.9 cm H2O. Overall pediatric intensive care unit and hospital mortality were 26% (95% confidence interval 19.6–33.7) and 27.4% (95% confidence interval 20.8–35.1), respectively. At 24 hrs, after the assessment of oxygenation under standard ventilatory settings, 118 (80.8%) patients continued to meet acute respiratory distress syndrome criteria (PaO2/FIO2 104 mm Hg ± 36 mm Hg; pediatric intensive care units mortality 30.5%), whereas 28 patients (19.2%) had a PaO2/FIO2 >200 mm Hg (pediatric intensive care units mortality 7.1%) (p = .014).

Conclusions: This is the largest study to estimate prospectively the pediatric population-based acute respiratory distress syndrome incidence and the first incidence study performed during the routine application of lung protective ventilation in children. Our findings support a lower acute respiratory distress syndrome incidence and mortality than those reported for adults. PaO2/FIO2 ratios at acute respiratory distress syndrome onset and at 24 hrs after onset were helpful in defining groups at greater risk of dying (clinical trials registered with http://www.clinicaltrials.gov; NCT 01142544)

From the Pediatric Intensive Care Unit (YL-F), Hospital Universitario Cruces, Vizcaya, Spain; Pediatric Intensive Care Unit (AM-dA), Hospital Infantil Universitario Niño Jesús, Madrid, Spain; Pediatric Intensive Care Unit (PdlO), Hospital Universitario La Paz, Madrid, Spain; Pediatric Intensive Care Unit (VM), Hospital Universitari i Politecnic La Fé, Valencia, Spain; Pediatric Intensive Care Unit (JIS), Hospital Universitario 12 de Octubre, Madrid, Spain; Pediatric Intensive Care Unit (JP), Hospital Universitario Virgen del Rocío, Sevilla, Spain; Pediatric Intensive Care Unit (MJA), Hospital Universitario Reína Sofía, Còrdoba, Spain; Pediatric Intensive Care Unit (SBR), Hospital Virgen de la Arrixaca, Murcia, Spain; Pediatric Intensive Care Unit (MP-O), Hospital Sant Joan de Déu, Barcelona, Spain; Pediatric Intensive Care Unit (JL-H), Hospital General Universitario Gregorio Marañón, Madrid, Spain; CIBER de Enfermedades Respiratorias (RLF, JV), Instituto de Salud Carlos III, Spain; Research Unit (RLF, JV), Hospital Universitario Dr. Negrin, Las Palmas de Gran Canaria, Spain; Department of Respiratory Care (RMK), Massachusetts General Hospital, Boston, MA; and Department of Anesthesia (RMK), Harvard University, Boston, MA.

*See also p. 3325.

Members of the PED-ALIEN Network are listed in the Appendix.

Supported, in part, by Instituto de Salud Carlos III, Madrid, Spain (PI07/0113, PI10/0393), and Asociación Científica Pulmón y Ventilación Mecánica, Spain.

Drs. López-Fernández, and Martínez-de Azagra contributed equally to this work as main authors. Drs. Kacmarek and Villar contributed equally to this work as senior authors.

Dr. Kacmarek has received research grants from Hamilton Medical and Coviden, honorarium for lecturing from Hamilton Medical, Maquet, and Kimberly-Clark and is a consultant for Newport Medical, Bayer, and KCI. Drs. Villar and Fernández have received research grants from Maquet. The remaining authors have not disclosed any conflicts of interest.

J. Villar, R.M. Kacmarek, Y. López-Fernández, and A. Martínez-de Azagra contributed to the study concept and design. Y. López-Fernández, A. Martínez-de Azagra, P. de la Oliva, V. Modesto, J.I. Sánchez, J. Parrilla, M.J. Arroyo, S. Beatriz-Reyes, M. Pons-Ódena, J. López-Herce, and R.L. Fernández helped in acquisition of data. Y. López-Fernández, A. Martínez-de Azagra, R.L. Fernández, R.M. Kacmarek, and J. Villar analyzed and interpreted the data. Y. López-Fernández, A. Martínez-de Azagra, J. Villar, R.L. Fernández, and R.M. Kacmarek were involved in drafting of the first manuscript. Y. López-Fernández, A. Martínez-de Azagra, P. de la Oliva, V. Modesto, J.I. Sánchez, J. Parrilla, M.J. Arroyo, S. Beatriz-Reyes, M. Pons-ódena, J. López-Herce, R.L. Fernández, J. Villar, and R.M. Kacmarek contributed to critical revision of the manuscript for important intellectual content. J. Villar, R.L. Fernández, Y. López-Fernández, and A. Martínez-de Azagra helped in statistical analysis. Y. López-Fernández, A. Martínez-de Azagra, P. de la Oliva, V. Modesto, J.I. Sánchez, J. Parrilla, M.J. Arroyo, S. Beatriz-Reyes, M. Pons-Ódena, J. López-Herce, R.L. Fernández, R.M. Kacmarek, and J. Villar contributed to administrative, technical, or material support and study supervision. J. Villar obtained funding. All authors saw and approved the final draft.

The funding agencies of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. The corresponding authors had full access to all the data of the study and had final responsibility for the decision to submit for publication.

For information regarding this article, E-mail: jesus.villar54@gmail.com

© 2012 by the Society of Critical Care Medicine and Lippincott Williams & Wilkins