Resuscitation Research and the Final Rule: Is There an Impasse?

Cardiopulmonary arrest with apnea and loss of palpable pulse (CA) in childhood is a tragic event that often results in either death or poor-quality neurologic survival. This is especially true of CAs occurring in the out-of-hospital setting, where devastating neurologic injury is very common. Until very recently, no therapy had been established to improve neurologic outcome in humans. Two randomized, clinical trials (RCTs) in highly selected adult populations with out-of-hospital CAs reported increased survival and, most importantly, improved neurologic outcomes.1,2 An expert committee concluded that generalization of these findings to all adult or to pediatric CA events should not occur without additional study.3 Unfortunately, major advances in resuscitation of humans have been quite limited over the past 4 decades. The need for RCTs to advance resuscitation science is entering an important period. Promising therapies such as mild hypothermia and vasopressin have been reported recently to improve outcomes in very select adult CA populations.1,2,4 However, many critical questions remain that need urgent study. For example, concerning hypothermia: 1) What is the optimal temperature for therapeutic hypothermia? Does it vary by age group or etiology of CA? 2) What is the duration of the therapeutic window? Are there factors that affect this? 3) What is the optimal duration of hypothermia? No …