Department of Neonatology, National Maternity Hospital, Dublin, Ireland.
School of Medicine, University College Dublin, Dublin, Ireland.
Cochrane Database Syst Rev. 2023 Oct 3;10(10):CD009102. doi: 10.1002/14651858.CD009102.pub2.
The Neonatal Task Force of the International Liaison Committee on Resuscitation (ILCOR) makes practice recommendations for the care of newborn infants in the delivery room (DR). ILCOR recommends that all infants who are gasping, apnoeic, or bradycardic (heart rate < 100 per minute) should be given positive pressure ventilation (PPV) with a manual ventilation device (T-piece, self-inflating bag, or flow-inflating bag) via an interface. The most commonly used interface is a face mask that encircles the infant's nose and mouth. However, gas leak and airway obstruction are common during face mask PPV. Nasal interfaces (single and binasal prongs (long or short), or nasal masks) and laryngeal mask airways (LMAs) may also be used to deliver PPV to newborns in the DR, and may be more effective than face masks.
To determine whether newborn infants receiving PPV in the delivery room with a nasal interface compared to a face mask, laryngeal mask airway (LMA), or another type of nasal interface have reduced mortality and morbidity. To assess whether safety and efficacy of the nasal interface differs according to gestational age or ventilation device.
Searches were conducted in September 2022 in CENTRAL, MEDLINE, Embase, Epistemonikos, and two trial registries. We searched conference abstracts and checked the reference lists of included trials and related systematic reviews identified through the search.
We included randomised controlled trials (RCTs) and quasi-RCT's that compared the use of nasal interfaces to other interfaces (face masks, LMAs, or one nasal interface to another) to deliver PPV to newborn infants in the DR.
Each review author independently evaluated the search results against the selection criteria, screened retrieved records, extracted data, and appraised the risk of bias. If they were study authors, they did not participate in the selection, risk of bias assessment, or data extraction related to the study. In such instances, the study was independently assessed by other review authors. We contacted trial investigators to obtain additional information. We completed data analysis according to the standards of Cochrane Neonatal, using risk ratio (RR) and 95% confidence Intervals (CI) to measure the effect of the different interfaces. We used fixed-effect models and the GRADE approach to assess the certainty of the evidence.
We included five trials, in which 1406 infants participated. They were conducted in 13 neonatal centres across Europe and Australia. Each of these trials compared a nasal interface to a face mask for the delivery of respiratory support to newborn infants in the DR. Potential sources of bias were a lack of blinding to treatment allocation of the caregivers and investigators in all trials. The evidence suggests that resuscitation with a nasal interface in the DR, compared with a face mask, may have little to no effect on reducing death before discharge (typical risk ratio (RR) 0.72, 95% CI 0.47 to 1.13; 3 studies, 1124 infants; low-certainty evidence). Resuscitation with a nasal interface may reduce the rate of intubation in the DR, but the evidence is very uncertain (RR 0.68, 95% CI 0.54 to 0.85; 5 studies, 1406 infants; very low-certainty evidence). The evidence is very uncertain for the rate of intubation within 24 hours of birth (RR 0.97, 95% CI 0.85 to 1.09; 3 studies, 749 infants; very low-certainty evidence), endotracheal intubation outside the DR during hospitalisation (RR 1.15, 95% CI 0.93 to 1.42; 1 study, 144 infants; very low-certainty evidence) and cranial ultrasound abnormalities (intraventricular haemorrhage (IVH) grade ≥ 3, or periventricular leukomalacia; RR 0.94, 95% CI 0.55 to 1.61; 3 studies, 749 infants; very low-certainty evidence). Resuscitation with a nasal interface in the DR, compared with a face mask, may have little to no effect on the incidence of air leaks (RR 1.09, 95% CI 0.85 to 1.09; 2 studies, 507 infants; low-certainty evidence), or the need for supplemental oxygen at 36 weeks' corrected gestational age (RR 1.06, 95% CI 0.8 to 1.40; 2 studies, 507 infants; low-certainty evidence). We identified one ongoing study, which compares a nasal mask to a face mask to deliver PPV to infants in the DR. We did not identify any completed trials that compared nasal interfaces to LMAs or one nasal interface to another.
AUTHORS' CONCLUSIONS: Nasal interfaces were found to offer comparable efficacy to face masks (low- to very low-certainty evidence), supporting resuscitation guidelines that state that nasal interfaces are a comparable alternative to face masks for providing respiratory support in the DR. Resuscitation with a nasal interface may reduce the rate of intubation in the DR when compared with a face mask. However, the evidence is very uncertain. This uncertainty is attributed to the use of a new ventilation system in the nasal interface group in two of the five trials. As such, it is not possible to differentiate separate, specific effects related to the ventilation device or to the interface in these studies.
新生儿复苏国际联络委员会(ILCOR)的新生儿特别工作组针对产房(DR)中新生儿的护理制定了实践建议。ILCOR 建议所有出现喘息、无呼吸或心动过缓(心率<100 次/分钟)的婴儿都应使用手动通气设备(T 型件、自膨式气囊或流量膨式气囊)通过接口进行正压通气(PPV)。最常用的接口是环绕婴儿口鼻的面罩。然而,面罩通气时经常会出现气体泄漏和气道阻塞。鼻接口(单鼻和双鼻叉(长或短)或鼻罩)和喉罩气道(LMA)也可用于在 DR 中为新生儿提供 PPV,并且可能比面罩更有效。
确定与面罩、喉罩气道(LMA)或其他类型的鼻接口相比,DR 中接受 PPV 的新生儿使用鼻接口是否降低了死亡率和发病率。评估根据胎龄或通气设备,鼻接口的安全性和疗效是否存在差异。
2022 年 9 月在 CENTRAL、MEDLINE、Embase、Epistemonikos 和两个试验注册中心进行了搜索。我们还检索了会议摘要,并检查了纳入试验和相关系统评价的参考文献列表,这些研究是通过搜索确定的。
我们纳入了比较使用鼻接口与其他接口(面罩、LMA 或一种鼻接口与另一种鼻接口)在 DR 中提供 PPV 的随机对照试验(RCT)和准随机对照试验。
每位综述作者都独立根据选择标准评估搜索结果、筛选检索记录、提取数据并评估偏倚风险。如果他们是研究作者,他们不参与与研究相关的选择、偏倚风险评估或数据提取。在这种情况下,其他综述作者会独立评估研究。我们联系了试验研究人员以获取更多信息。我们根据 Cochrane 新生儿的标准完成了数据分析,使用风险比(RR)和 95%置信区间(CI)来衡量不同接口的效果。我们使用固定效应模型和 GRADE 方法来评估证据的确定性。
我们纳入了五项试验,其中有 1406 名婴儿参与。这些试验在欧洲和澳大利亚的 13 个新生儿中心进行。每项试验都将鼻接口与面罩进行比较,以比较在 DR 中为新生儿提供呼吸支持。每个试验中都存在潜在的偏倚来源,包括对治疗分配的照顾者和研究人员缺乏盲法。证据表明,与面罩相比,DR 中使用鼻接口复苏可能对降低出院前死亡率没有影响(典型风险比(RR)0.72,95%CI 0.47 至 1.13;3 项研究,1124 名婴儿;低确定性证据)。DR 中使用鼻接口复苏可能会降低 DR 内插管的发生率,但证据非常不确定(RR 0.68,95%CI 0.54 至 0.85;5 项研究,1406 名婴儿;非常低确定性证据)。DR 内插管的发生率(RR 0.97,95%CI 0.85 至 1.09;3 项研究,749 名婴儿;非常低确定性证据)和住院期间在 DR 外进行气管插管的发生率(RR 1.15,95%CI 0.93 至 1.42;1 项研究,144 名婴儿;非常低确定性证据)以及颅超声异常(脑室内出血(IVH)等级≥3 或脑室周围白质软化;RR 0.94,95%CI 0.55 至 1.61;3 项研究,749 名婴儿;非常低确定性证据)非常不确定。与面罩相比,DR 中使用鼻接口复苏可能对空气泄漏的发生率(RR 1.09,95%CI 0.85 至 1.09;2 项研究,507 名婴儿;低确定性证据)或在纠正胎龄 36 周时需要补充氧气的发生率(RR 1.06,95%CI 0.8 至 1.40;2 项研究,507 名婴儿;低确定性证据)没有影响。我们发现了一项正在进行的研究,该研究比较了鼻面罩和面罩在 DR 中为婴儿提供 PPV 的效果。我们没有发现任何已完成的试验比较了鼻接口与 LMA 或一种鼻接口与另一种鼻接口。
鼻接口与面罩相比提供了相当的疗效(低至非常低确定性证据),支持复苏指南指出,鼻接口是 DR 中提供呼吸支持的一种等效替代面罩。与面罩相比,鼻接口复苏可能会降低 DR 内的插管率。然而,证据非常不确定。这种不确定性归因于五项试验中的两项试验中在鼻接口组中使用了新的通气系统。因此,在这些研究中,无法区分与通气设备或接口相关的特定影响。