International randomised controlled trial of patient triggered ventilation in neonatal respiratory distress syndrome

新生儿呼吸窘迫综合征患者触发通气的国际随机对照试验

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Abstract

AIM: To compare the effects of patient triggered ventilation (PTV) with conventional ventilation (IMV) in preterm infants ventilated for respiratory distress syndrome (RDS). METHODS: Nine hundred and twenty four babies from 22 neonatal intensive care units were assessed. They were under 32 weeks of gestation and had been ventilated for respiratory distress syndrome (RDS) for less than 6 hours within 72 hours of birth. The infants were randomly allocated to receive either PTV or IMV. Analysis was on an "intention to treat" basis. Death before discharge home or oxygen therapy at 36 weeks of gestation; pneumothorax while ventilated; cerebral ultrasound abnormality nearest to 6 weeks; and duration of ventilation in survivors were the main outcome measures. RESULTS: There was no significant difference in outcome between the two groups. Unadjusted rates for death or oxygen dependency at 36 weeks of gestation were 47.4% and 48.7%, for PTV and IMV, respectively; for pneumothorax these were 13.4% and 10.3%; and for cerebral ultrasound abnormality nearest to 6 weeks these were 35.4% and 36.9%. Median duration of ventilation for survivors in both groups was 6 days. Overall, 79% of babies received only their assigned ventilation. PTV babies were more likely to depart from their intended ventilation (27% vs 15%). The trend towards higher pneumothorax rates with PTV occurred only in infants below 28 weeks of gestation (18.8% vs 11.8%). CONCLUSIONS: There was no observed benefit from the use of PTV, with a trend towards a higher rate of pneumothorax under 28 weeks of gestation. Although PTV has a similar outcome to IMV for treatment of RDS in infants of 28 weeks or more gestation, within 72 hours of birth, it was abandoned more often. It cannot be recommended for infants of less than 28 weeks' gestation with the ventilators used in this study.

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