Published ahead of print on June 21, 2007, doi:10.1164/rccm.200610-1534OC
Am. J. Respir. Crit. Care Med., Volume 176, Number 8, October 2007, 795-804
A more recent version of this article appeared on October 15, 2007
Submitted on October 24, 2006
Accepted on June 21, 2007
An Early PEEP/FiO2 Trial IdentifiesDifferent Degrees of Lung Injury in ARDS patients
Jesus Villar1, Lina Mendez-Perez2, Jose Lopez3, Javier Belda4, Jesus Blanco5, Inaki Saralegui6, Fernando Suarez-Sipmann7, Julia Lopez8, Santiago Lubillo9, and Robert M Kacmarek10*
1 Division of Organ Dysfunction, Institute for Biomedical Research, Canary Islands, Hospital Universitario Dr. Negrin, Las Palmas, Spain,
2 Division of Organ Dysfunction, Institute for Biomedical Research, Canary Islands, Hospital Universitario Dr. Negrin, Las Palmas, Spain; Division of Clinical and Genetic Epidemiology, Hospital Universitario NS de Candelaria, Tenerife, Spain,
3 Intensive Care Unit, Hospital General de Leon, Leon, Spain,
4 Department of Anesthesia, Hospital Clinico de Valencia, Valencia, Spain,
5 Intensive Care Unit, Hospital Universitario Rio Hortega, Valladolid, Spain,
6 Hospital Santiago Apostol, Vitoria, Spain,
7 Intensive Care Unit, Fundacion Jimenez Diaz, Madrid, Spain,
8 Intensive Care Unit, Hospital Universitario La Paz, Madrid, Spain,
9 Division of Organ Dysfunction, Institute for Biomedical Research, Canary Islands, Hospital Universitario Dr. Negrin, Las Palmas, Spain; Intensive Care Unit, Hospital Universitario NS de Candelaria, Santa Cruz de Tenerife, Spain,
10 Respiratory Care, Massachusetts General Hospital, Harvard University, Boston, USA
* To whom correspondence should be addressed. E-mail: rkacmarek{at}partners.org.
Rationale and Objective: Current American-European Consensus Conference (AECC) definitions for ALI and ARDS are inadequate for inclusion into clinical trials due to the lack of standardization for measuring the oxygenation defect. We questioned whether an early assessment of oxygenation on specific ventilator settings would identify patients with established ARDS (persisting over 24h).
Methods. At the time of meeting ARDS criteria (Day 0) and 24 hours later (Day 1), arterial blood gases were obtained on standard ventilator settings, VT7 mL/kg PBW plus the following PEEP and FiO2 settings in sequence: (1) PEEP 5 cmH2O and FiO20.5, (2) PEEP5 cmH2O and FiO2 1.0, (3) PEEP10 cmH2O and FiO20.5, and (4) PEEP10 cmH2O and FiO21.0.
Measurements and Main Results: 170 patients meeting ARDS criteria (PaO2/FiO2 128±33 mmHg) were enrolled. Overall hospital mortality was 34.1%. The standard ventilator settings that best identified established ARDS patients and predicted differences in ICU mortality were PEEP10 cmH2O and FiO20.5 at Day 1 (p=0.0001). Only 99 (58.2%) patients continued to meet ARDS criteria (PaO2/FiO2 155.8 ± 29.8 mmHg, ICU mortality 45.5%) while 55 patients were reclassified as ALI (PaO2/FiO2 246.5 ± 25.6 mmHg, ICU mortality 20%) and 16 patients as acute respiratory failure (ARF) (PaO2/FiO2 370 ± 54 mmHg, ICU mortality 6.3%) (p=0.0001) on these settings.
Conclusions: Patients meeting current AECC ARDS criteria may have highly variable levels of lung injury and outcomes. A systematic method of assessing severity of lung injury is required for enrollment of ARDS patients into randomized controlled trials.
www.clinicaltrials.gov NCT00435110
Key words: acute respiratory distress syndrome, acute lung injury, positive-end expiratory pressure, standard ventilator settings, definitions
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