Nasal Intermittent Positive Pressure Ventilation (NIPPV) During Neonatal Endotracheal Intubation: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 146
- 试验地点
- 4
- 主要终点
- Successful intubation without physiological instability during all intubation attempts
研究概览
简要总结
The study aims to determine whether the use of nasal intermittent positive pressure ventilation (NIPPV) during neonatal endotracheal intubation increases the rate of successful intubation without physiological instability during all intubation attempts.
The present study was designed as a prospective, multicenter, randomized, controlled study conducted with neonates undergoing endotracheal intubation. The infants were assigned randomly to either the NIPPV group or the standard care group.
详细描述
The present study was designed as a prospective, multicenter, randomized, controlled trial. The study was conducted at two tertiary Neonatal Intensive Care Units (Mugla Training and Research Hospital, Mugla, Turkey; Akdeniz University School of Medicine, Antalya, Turkey) between May 2023 and May 2024. Written informed consent was obtained from the parents of each neonatal patient prior to enrollment in the study.
Participants:
Infants of a gestational age of 22-41 weeks and undergoing oral endotracheal intubation in the neonatal intensive care unit within the first 28 days of life were eligible for inclusion in the present study. The infants who required urgent intubation, those intubated in the delivery room or the operating room, infants with a heart rate of <120/min prior to randomization, those with airway or lung anomalies, the ones with cyanotic congenital heart disease, and the ones for whom nasal intermittent positive pressure ventilation (NIPPV) treatment was contraindicated (congenital nasal anomaly, congenital diaphragmatic hernia, or abdominal wall defect) were excluded from the study.
Randomization:
Each infant was randomly assigned to either the intervention group or the standard-care group. Sequential numbers were generated in the neonatal intensive care unit's computer with an allocation ratio of 1:1. The numbers were concealed in opaque, sequentially numbered, sealed envelopes. The physician on call opened sequentially numbered sealed opaque envelopes and randomized infants to respective groups before procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants of a gestational age of 22-41 weeks and undergoing oral endotracheal intubation in the neonatal intensive care within the first 28 days of life
排除标准
- •The infants who required urgent intubation,
- •Infants intubated in the delivery room or the operating room,
- •Infants with a heart rate of <120/min prior to randomization,
- •Infants with airway or lung anomalies,
- •Infants with cyanotic congenital heart disease,
- •Infants NIPPV treatment was contraindicated (congenital nasal anomaly, congenital diaphragmatic hernia, or abdominal wall defect)
结局指标
主要结局
Successful intubation without physiological instability during all intubation attempts
时间窗: One year
Successful intubation was defined as the placement of an endotracheal tube in the trachea, confirmed based on chest elevation, auscultation, second independent laryngoscopy, carbon dioxide detection, and/or chest radiography. Physiological instability was defined as severe desaturation (a decrease of \>20% in oxygen saturation relative to that immediately prior to pre-laryngoscopy) or bradycardia (a heart rate of \<100 beats per minute) during the intubation attempts. All intubation attempts was defined as the requirement for single, two, or multiple attempts for successful intubation.
次要结局
- Lowest SpO2 level(One year)
- Lowest heart rate(One year)
- Bradycardia(One year)
- Severe desaturation(One year)
- Time to successful intubation(One year)
- Successful intubation on the first attempt without physiological instability(One year)
- Duration of severe desaturation(One year)
研究者
Ozkan Ilhan
Associate Professor
Muğla Sıtkı Koçman University