Key Laboratory of Birth Defects and Related Diseases of Women and Children, Ministry of Education, West China Second University Hospital, Sichuan University, Renmin South Road #16, Wuhou District, Chengdu, China.
West China Second University Hospital, Sichuan University, Renmin South Road #20, Wuhou District, Chengdu, China.
Trials. 2023 Aug 16;24(1):536. doi: 10.1186/s13063-023-07564-x.
Mechanical ventilation (MV) is essential in the management of critically ill neonates, especially preterm infants. However, inappropriate or prolonged use of invasive MV may result in ventilator-associated lung injury. A systemic review comparing pressure control ventilation (PCV) with volume-targeted ventilation mode (VTV) approved that VTV reduces the incidence of death or bronchopulmonary dysplasia (BPD) in neonates; however, this study did not analyze subgroups of very low birthweight (VLBW) infants. Therefore, the aim of this study was to compare the use of VTV and PCV in VLBW infants and to provide clinical evidence for reducing mortality and complications of MV in VLBW infants.
A single-center randomized controlled trial will be performed. All eligible infants will be randomized and assigned to either VTV or PCV group with 1:1 ratio using sealed envelopes. Death or BPD at 36 weeks' postmenstrual age will be used as the primary outcome. Secondary outcomes include BPD, death, length of invasive MV, noninvasive mechanical ventilation, and oxygen use, length of hospital stay, failure of conventional MV, rate of using high-frequency oscillatory ventilation (HFOV) as rescue therapy, rate of reintubation within 48 h, and hospital expenses.
Systemic review suggested that VTV decreases the incidence of death or BPD in neonates compared to PLV; however, this study did not specifically analyze subgroups of VLBW infants. We designed this single-center randomized controlled trials (RCT) to add a significant contribution regarding the benefits of VTV for VLBW patients.
机械通气(MV)是危重新生儿,尤其是早产儿管理的重要手段。然而,不适当或长时间使用有创 MV 可能导致呼吸机相关性肺损伤。一项比较压力控制通气(PCV)与容量目标通气模式(VTV)的系统评价证实,VTV 可降低新生儿死亡率或支气管肺发育不良(BPD)的发生率;然而,该研究并未对极低出生体重(VLBW)婴儿进行亚组分析。因此,本研究旨在比较 VLBW 婴儿使用 VTV 和 PCV 的情况,并为降低 VLBW 婴儿 MV 死亡率和并发症提供临床证据。
将进行单中心随机对照试验。所有符合条件的婴儿将使用密封信封以 1:1 的比例随机分配到 VTV 或 PCV 组。36 周校正胎龄时的死亡或 BPD 将作为主要结局。次要结局包括 BPD、死亡、有创 MV 时间、无创机械通气和吸氧时间、住院时间、常规 MV 失败率、高频振荡通气(HFOV)作为抢救治疗的使用率、48 小时内再插管率和住院费用。
系统评价表明,与 PLV 相比,VTV 可降低新生儿死亡率或 BPD 的发生率;然而,该研究并未专门分析 VLBW 婴儿的亚组。我们设计了这项单中心随机对照试验(RCT),以增加关于 VTV 对 VLBW 患者益处的重要贡献。