Newborn Research Centre, The Royal Women's Hospital, Melbourne, Australia; Department of Neonatology, University Children's Hospital of Tübingen, Tübingen, Germany.
Newborn Research Centre, The Royal Women's Hospital, Melbourne, Australia; Newborn Research, Department of Neonatology, University Hospital and University of Zürich, Zürich, Switzerland.
J Pediatr. 2018 Jul;198:181-186.e2. doi: 10.1016/j.jpeds.2018.03.013. Epub 2018 Apr 25.
To compare the suction mask, a new facemask that uses suction to create a seal between the mask and the infant's face, with a conventional soft, round silicone mask during positive pressure ventilation (PPV) in the delivery room in newborn infants >34 weeks of gestation.
Single-center randomized controlled trial in the delivery room. The primary outcome was mask leak.
Forty-five infants were studied at a median gestational age of 38.1 weeks (IQR, 36.4-39.0 weeks); 22 were randomized to the suction mask and 23 to the conventional mask. The suction mask did not reduce mask leak (49.9%; IQR, 11.0%-92.7%) compared with the conventional mask (30.5%; IQR, 10.6%-48.8%; P = .51). The suction mask delivered lower peak inspiratory pressure (27.2 cm HO [IQR, 25.0-28.7 cm HO] vs 30.4 cm HO [IQR, 29.4-32.5 cm HO]; P < .05) and lower positive end expiratory pressure (3.7 cm HO [IQR, 3.1-4.5 cm HO] vs 5.1 cm HO [IQR, 4.2-5.7 cm HO ]; P < .05). There was no difference in the duration of PPV or rates of intubation or admission to the neonatal intensive care unit. In 5 infants (23%), the clinician switched from the suction to the conventional mask, 2 owing to intermittently low peak inspiratory pressure, 2 owing to failure to respond to PPV, and 1 owing to marked facial bruising after 6 minutes of PPV.
The use of the suction mask to provide PPV in newborn infants did not reduce facemask leak. Adverse effects such as the inability to achieve the set pressures and transient skin discoloration are concerning.
Australian and New Zealand Clinical Trial Registry ACTRN12616000768493.
比较在>34 周胎龄的新生儿中，使用正压通气（PPV）时，一种新的使用吸力在面罩和婴儿面部之间形成密封的吸嘴面罩与传统的软圆形硅胶面罩的效果。
分娩室的单中心随机对照试验。主要结局为面罩泄漏。
45 名婴儿在中位胎龄 38.1 周（IQR，36.4-39.0 周）进行了研究；22 名随机分配至吸嘴面罩组，23 名随机分配至传统面罩组。与传统面罩（30.5%；IQR，10.6%-48.8%；P=0.51）相比，吸嘴面罩并未减少面罩泄漏（49.9%；IQR，11.0%-92.7%）。吸嘴面罩提供的吸气峰压较低（27.2 cm HO [IQR，25.0-28.7 cm HO] 与 30.4 cm HO [IQR，29.4-32.5 cm HO]；P<.05）和呼气末正压较低（3.7 cm HO [IQR，3.1-4.5 cm HO] 与 5.1 cm HO [IQR，4.2-5.7 cm HO]；P<.05）。PPV 持续时间、插管率或入住新生儿重症监护病房率无差异。在 5 名婴儿（23%）中，临床医生从吸嘴面罩切换到传统面罩，2 名是因为吸气峰压间歇性较低，2 名是因为对 PPV 无反应，1 名是因为在接受 6 分钟的 PPV 后出现明显的面部瘀伤。
使用吸嘴面罩为新生儿提供 PPV 并不能减少面罩泄漏。无法达到设定压力和短暂的皮肤变色等不良反应令人担忧。
澳大利亚和新西兰临床试验注册 ACTRN12616000768493。
