Permissive hypercapnia in extremely low birthweight C ossMark infants (PHELBI): a randomised controlled multicentre trial
Permissive hypercapnia in extremely low birthweight C ossMark infants (PHELBI): a randomised controlled multicentre trial
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DOI：
10.1016/s2213-2600(15)00204-0
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发表时间：
2015-07-01
影响因子：
76.2
通讯作者：
Hummler, Helmut D.
中科院分区：
文献类型：
--
作者：
Thome, Ulrich H.;Genzel-Boroviczeny, Orsolya;Hummler, Helmut D.
在机械通气的极低出生体重儿中，耐受较高的二氧化碳分压（pCO 2）可能会减少呼吸机诱导的肺损伤和支气管肺发育不良。我们的目的是测试的假设，较高的二氧化碳分压的目标范围降低支气管肺发育不良或death.Methods在这个随机多中心试验中，我们招募了婴儿从16个三级保健围产期中心在德国与出生体重400克和1000克之间，胎龄23-28周加6天，谁需要气管插管和机械通气出生后24小时内。婴儿被随机分配到高目标组或对照组。高目标组在出生后第1-3天的pCO 2值为55-65 mmHg，第4-6天为60-70 mmHg，第7-14天为65-75 mmHg，对照组在出生后第1-3天的pCO 2值为40-50 mmHg，第4-6天为45-55 mmHg，第7-14天为50-60 mmHg。主要结局是死亡或中度至重度支气管肺发育不良，定义为在月经后36周需要机械压力支持或补充氧气。由设盲的儿科放射科医生集中评估颅骨超声图像。结果2008年3月1日至2012年7月31日，共纳入362例患者，其中3例退出，高靶组179例，对照组180例。在中期分析后停止试验（n=359）。高靶组的支气管肺发育不良或死亡率（65/179 [36%]）与对照组（54/180 [30%]; p=0.18）无显著差异。高目标组的死亡率为25（14%），（11%; p=0.32）在对照组中，3-4级脑室内出血分别为26例（15%）和21例（10%）。（12%; p=0.30），记录的严重视网膜病变发生率分别为20（11%）和26（14%; p=0.36）。解释以较高的pCO 2为目标并没有降低通气早产儿的支气管肺发育不良率或死亡率。各组之间的死亡率、脑室内出血和视网膜病变发生率没有差异。这些结果表明，比轻度高碳酸血症对照组更高的pCO 2目标并不能增加肺保护等益处。
Background Tolerating higher partial pressure of carbon dioxide (pCO2) in mechanically ventilated, extremely low birthweight infants might reduce ventilator-induced lung injury and bronchopulmonary dysplasia. We aimed to test the hypothesis that higher target ranges for pCO2 decrease the rate of bronchopulmonary dysplasia or death.Methods In this randomised multicentre trial, we recruited infants from 16 tertiary care perinatal centres in Germany with birthweight between 400 g and 1000 g and gestational age 23-28 weeks plus 6 days, who needed endotracheal intubation and mechanical ventilation within 24 h of birth. Infants were randomly assigned to either a high target or control group. The high target group aimed at pCO2 values of 55-65 mm Hg on postnatal days 1-3, 60-70 mm Hg on days 4-6, and 65-75 mm Hg on days 7-14, and the control target at pCO2 40-50 mmHg on days 1-3, 45-55 mm Hg on days 4-6, and 50-60 mm Hg on days 7-14. The primary outcome was death or moderate to severe bronchopulmonary dysplasia, defined as need for mechanical pressure support or supplemental oxygen at 36 weeks postmenstrual age. Cranial ultrasonograms were assessed centrally by a masked paediatric radiologist. This trial is registered with the IS RCTN registry, number IS RCTN56143743.Results Between March 1, 2008, and July 31, 2012, we recruited 362 patients of whom three dropped out, leaving 179 patients in the high target and 180 in the control group. The trial was stopped after an interim analysis (n=359). The rate of bronchopulmonary dysplasia or death in the high target group (65/179 [36%]) did not differ significantly from the control group (54/180 [30%]; p=0.18). Mortality was 25 (14%) in the high target group and 19 (11%; p=0.32) in the control group, grade 3-4 intraventricular haemorrhage was 26 (15%) and 21 (12%; p=0.30), and the rate of severe retinopathy recorded was 20 (11%) and 26 (14%; p=0.36).Interpretation Targeting a higher pCO2 did not decrease the rate of bronchopulmonary dysplasia or death in ventilated preterm infants. The rates of mortality, intraventricular haemorrhage, and retinopathy did not differ between groups. These results suggest that higher pCO2 targets than in the slightly hypercapnic control group do not confer increased benefits such as lung protection.