Randomised controlled trial of respiratory system compliance measurements in mechanically ventilated neonates

Abstract

Aim: To determine whether outcomes of neonatal mechanical ventilation could be improved by regular pulmonary function testing.

Methods: Two hundred and forty five neonates, without immediately life threatening congenital malformations, were mechanically ventilated in the newborn period. Infants were randomly allocated to conventional clinical management (control group) or conventional management supplemented by regular measurements of static respiratory system compliance, using the single breath technique, with standardised management advice based on the results.

Results: Fifty five (45%) infants in each group experienced one or more adverse outcomes. The median (quartile) durations of ventilation and oxygen supplementation were 5 (2-12) and 6 (2-34) days for the control group, and 4 (2-9) and 6 (3-36) days for the experimental group (not significant). On post-hoc secondary analysis, control group survivors were ventilated for 1269 days with a median (quartile) of 5 (2-13) days, and experimental group survivors were ventilated for 775 days with a median (quartile) duration of 3 (2-8) days (p = 0.03).

Conclusions: Although primary analysis did not show any substantial benefit associated with regular measurement of static respiratory system compliance, this may reflect a type II error, and a moderate benefit has not been excluded. Larger studies are required to establish the value of on-line monitoring techniques now available with neonatal ventilators.