To compare the arterial PCO2 level after brief ventilation using self inflating bag versus T- piece resuscitator post surfactant instillation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Mean change in arterial CO2 pre and post surfactant administration in SIB (Self inflating bag) versus TPR (T-Piece Resuscitator) group
研究概览
简要总结
AIM: To evaluate the effect of manual ventilation with T piece resuscitator or self-inflating bag during surfactant administration by measuring the mean change in arterial carbon dioxide levels following administration.
METHODS: Preterm neonates requiring first dose of surfactant within 24 hours of life were randomized to receive positive pressure ventilation with either self inflating bag or T piece
resuscitator during surfactant administration. Arterial blood gases were obtained at baseline and one hour after the surfactant dose. Primary outcome was change in PaCO 2 levels one hour after the intervention estimated as difference between baseline and PaCO 2 levels after brief manual ventilation.
RESULTS: A total of 80 neonates were enrolled in the study (40 in each group). The drop in PaCO 2 at one hour was significantly higher in the group ventilated with the self inflating bag as compared to the T-piece resuscitator group (10.01 mmHg Vs 0.89 mmHg, Mean difference=9.13 mmHg, [95% confidence interval: 5.03-13.22; P <; 0.001]). This difference was also significant at six hours after the intervention. The PaCO 2 change was also evident in the subgroup of infants that required only non invasive ventilation (10.8 mmHg Vs 0.75 mmHg,Mean difference= 10.04, [95% confidence interval: 5.35-14.74; P< 0.001]). The need for seconddose of surfactant was lower in the T piece group (55% Vs 77%, P=0.03)
CONCLUSIONS: Use of T-piece resuscitator results in lesser reduction in PaCO 2 levels compared tothe self inflating bag, when used for brief manual ventilation during surfactant administration.
Keywords: T – Piece Resuscitator, Self – Inflating Bag, Surfactant
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 0.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
入选标准
- •preterm infants with respiratory distress requiring 1st dose of surfactant.
排除标准
- •Antenatally diagnosed congenital heart disease such as complex cyanotic heart disease Infants who have received first dose of surfactant prior to transfer to the hospital.
结局指标
主要结局
Mean change in arterial CO2 pre and post surfactant administration in SIB (Self inflating bag) versus TPR (T-Piece Resuscitator) group
时间窗: 30 minutes
次要结局
- Mean PaCO2 six hours post surfactant administration (mm Hg)(6 hours)
- Requirement of assisted ventilation (%)(1st week of life)
- Type of respiratory support required (%)(1st week of life)
- Mean PaO2 six hours post surfactant administration (mm Hg)(6 hours)
- Duration of oxygen therapy (days)(28 days)
- Duration of respiratory support (days)(28 days)
- Duration of hospital stay (days)(at the time of discharge from NICU)
- Incidence of air leak/Pneumothorax (%)(28 days)
- Incidence of Intraventricular Hemorrhage -IVH and Periventricular leucomalacia PVL (%)(28 days)
- Incidence of Retinopathy of prematurity ROP (%)(at the time of discharge from NICU)
- Incidence of Necrotising Enterocolitis -NEC (%)(28 days)
- Incidence of Bronchopulmonary Dysplasia BPD (%)(at 36 weeks of post conceptional age)