Background: When designing multicenter clinical trials, it is important to understand the characteristics of children who have received ventilation in PICUs.
Methods: This study involved the secondary analysis of an existing data set of all children intubated and mechanically ventilated from 16 US PICUs who were initially screened for a multicenter clinical trial on pediatric acute lung injury (ALI).
Results: A total of 12,213 children between 2 weeks and 18 years of age who were intubated and mechanically ventilated were included, representing 30% of PICU admissions (center range, 20 to 64%). Of the children who received ventilation, 22% had cyanotic congenital heart disease; 26% had respiratory failure but not bilateral pulmonary infiltrates on chest radiograph; 8% had chronic respiratory disease; 7% had upper airway obstruction; and 5% had reactive airway disease. At least 1,457 patients (15%) with respiratory failure lacked an arterial line. Of these patients, 97% had a positive end-expiratory pressure <or= 8 cm H(2)O, and 80% were supported on an Fio(2) of <or= 0.40. Moreover, 104 of 904 patients (12%) with pulse oximetric saturation (Spo(2)) and Fio(2) measurements available would have met the oxygenation criteria for ALI according to Spo(2)/Fio(2) ratio criteria.
Conclusions: At least 30% of children in a cross-section of US PICUs are endotracheally intubated, and 25% of those with respiratory failure do not fulfill the radiographic criteria for ALI. Although few patients without an indwelling arterial line require more than modest ventilator support, many may still meet the oxygenation criteria for ALI. These findings will facilitate sample size calculations and help to determine feasibility for future trials on pediatric mechanical ventilation.