The Design of Future Pediatric Mechanical Ventilation Trials for Acute Lung Injury

Abstract

Pediatric practitioners face unique challenges when attempting to translate or adapt adult-derived evidence regarding ventilation practices for acute lung injury or acute respiratory distress syndrome into pediatric practice. Fortunately or unfortunately, there appears to be selective adoption of adult practices for pediatric mechanical ventilation, many of which pose considerable challenges or uncertainty when translated to pediatrics. These differences, combined with heterogeneous management strategies within pediatric critical care, can complicate clinical practice and make designing robust clinical trials in pediatric acute respiratory failure particularly difficult. These issues surround the lack of explicit ventilator protocols in pediatrics, either computer or paper based; differences in modes of conventional ventilation and perceived marked differences in the approach to high-frequency oscillatory ventilation; challenges with patient recruitment; the shortcomings of the definition of acute lung injury and acute respiratory distress syndrome; the more reliable yet still somewhat unpredictable relationship between lung injury severity and outcome; and the reliance on potentially biased surrogate outcome measures, such as ventilator-free days, for all pediatric trials. The purpose of this review is to highlight these challenges, discuss pertinent work that has begun to address them, and propose potential solutions or future investigations that may help facilitate comprehensive trials on pediatric mechanical ventilation and define clinical practice standards.

The use of the Berlin definition for acute respiratory distress syndrome during infancy and early childhood: multicenter evaluation and expert consensus

“…This is the case with BD, because it improves the classification of ARDS in early childhood, describing its clinical picture [20]. This project was needed because, despite the original ARDS description included children [21], ARDS definitions have never been evaluated in multicenter pediatric populations.…”

Assistance extracorporelle au cours du syndrome de détresse respiratoire aiguë (chez l’adulte et l’enfant, à l’exclusion du nouveau-né). Conférence de consensus organisée par la Société de réanimation de langue française

“…Chez l'enfant de moins de 20 kg, l'optimisation de la ventilation mécanique peut nécessiter l'utilisation de la ventilation en oscillation à haute fréquence [33].…”

Pediatric Acute Respiratory Distress Syndrome

“…27 Specific concerns included heterogeneous management strategies, a lack of explicit ventilation protocols for pediatric patients, an unpredictable relationship between lung injury severity and outcome, and the reliance on potentially biased surrogate outcome measures such as ventilator-free days. Given the hurdles in studying pediatric ALI/ARDS, clinicians involved with the care of critically ill infants and children are left with extrapolation of data from the adult population, reliance on the limited available pediatric data, careful assessment of applicable principles of physiology and pathophysiology, and/or reliance on clinical experience.…”