RAM Cannula Versus Bi-Nasal Prongs as Respiratory Device Interfaces in Neonates of Thirty-Two or More Weeks of Gestation With Respiratory Distress: The First "ProRAM" Randomized Trial Report.

IF 1.6 Q2 MEDICINE, GENERAL & INTERNAL Journal of clinical medicine research Pub Date : 2024-01-01 Epub Date: 2024-01-10 DOI:10.14740/jocmr5077
Manar Al-Lawama, Bayan Alaraj, Mahmoud Abu Zahra, Ibtehal AlHasanat, Heba Habash, AbdelKareem Alhyari, Leen Alshajrawi, Sallam Jaafreh
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Abstract

Background: Using bilateral short nasal prongs as an interface for noninvasive respiratory support is challenging, and it is associated with nasal injury. We aimed to compare RAM cannula with nasal prongs in delivering noninvasive ventilation to newborn infants.

Methods: This is a single-center randomized trial (trial registry: ISRCTN10561691). The setting involves a tertiary neonatal unit with a capacity of 30 beds and more than 13 years of experience in neonatal noninvasive ventilation. We included 50 infants born at ≥ 32 weeks of gestation, who had respiratory distress at birth. We excluded those with major congenital anomalies and those who required intubation in the delivery room. Primary outcomes were intubation rate and use of noninvasive positive-pressure ventilation (NIPPV); other outcomes included air leak and nasal injury rate. The infants were assigned using randomly generated numbers into bi-nasal prong and RAM canula groups in a 1:1 ratio.

Results: Two and four babies in the RAM and prong groups, respectively, were upgraded to NIPPV (P = 0.600). One versus no baby in the RAM vs. prong groups was intubated (P = 1.000). Newborns in the prong group required oxygen support for a longer period (mean duration: 154.6 ± 255.2 h) than those in the RAM group (40.7 ± 72.6 h, P = 0.030). None of the patients in the RAM group had traumatic nasal injury compared to five babies in the prong group (P = 0.050). Four babies in our study developed air leaks, with two in each group.

Conclusions: The use of RAM cannula in delivering noninvasive ventilation to newborns ≥ 32 weeks of age did not affect the noninvasive ventilation failure rate or incidence of air leak. The use was associated with a shorter duration of respiratory support and a reduced risk of nasal septal injury.

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在妊娠 32 周或以上、出现呼吸困难的新生儿中,RAM 套管与双鼻孔插管作为呼吸设备接口的对比:首份 "ProRAM "随机试验报告。
背景:使用双侧短鼻插管作为无创呼吸支持的接口具有挑战性,而且会造成鼻部损伤。我们的目的是比较 RAM 插管和鼻插管在为新生儿提供无创通气方面的效果:这是一项单中心随机试验(试验登记:ISRCTN10561691)。试验地点位于一家拥有 30 张病床、在新生儿无创通气方面拥有超过 13 年经验的三级新生儿科。我们纳入了 50 名妊娠≥ 32 周、出生时出现呼吸窘迫的婴儿。我们排除了有重大先天性畸形和需要在产房插管的婴儿。主要结果是插管率和无创正压通气(NIPPV)的使用率;其他结果包括漏气率和鼻损伤率。婴儿按随机生成的号码以 1:1 的比例分配到双鼻插管组和 RAM 插管组:结果:RAM 组和刺管组分别有 2 名和 4 名婴儿升级为 NIPPV(P = 0.600)。RAM组和prong组分别有1名和4名新生儿升级为NIPPV(P = 0.600),RAM组和prong组分别有1名和4名新生儿插管(P = 1.000)。与 RAM 组(40.7 ± 72.6 小时,P = 0.030)相比,prong 组新生儿需要氧气支持的时间更长(平均时间:154.6 ± 255.2 小时)。RAM 组中没有一名患者出现鼻外伤,而棱形支撑组中有五名婴儿出现鼻外伤(P = 0.050)。我们的研究中有四名婴儿出现漏气,每组各有两名:结论:使用 RAM 插管为年龄≥ 32 周的新生儿进行无创通气不会影响无创通气失败率或漏气发生率。使用 RAM 插管与缩短呼吸支持时间和降低鼻中隔损伤风险有关。
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