Intraprocedural nasal HHHFNC versus Free Flow Oxygen for the Successful Endotracheal Intubation in Neonates: A Randomized Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- successful endotracheal intubation in first attempt heart rate more than hundred beats per minute, fall in spo2 less than twenty percent from baseline.
研究概览
简要总结
Endotracheal intubation (ETI) is one of the most common emergency procedures performed in the neonatal intensive care unit (NICU). As a convention before endotracheal intubation, the baby is either preoxygenated with 100% oxygen through bag and mask ventilation or free flow oxygen is administered during the procedure. The use of heated humidified high flow nasal cannula (HHHFNC) therapy has been tried to improve the success of endotracheal intubation in neonates. Recently it has been shown to decrease the intraprocedural physiological instability i.e., oxygen desaturation to <20% from baseline and bradycardia in neonates. To evaluate this, we plan to conduct this randomized control trial, where the study participants will be divided into two groups (HHHFNC group and free flow oxygen group) enrolling 110 intubations in each group, consisting of neonates of all gestational ages admitted in NICU who will be requiring endotracheal intubation. The primary outcome will be the successful endotracheal intubation, defined as endotracheal intubation in the first attempt not associated with oxygen desaturation to <20% from baseline and bradycardia (heart rate <100 bpm). The secondary outcome measures will include cumulative durations of oxygen desaturation <20% from baseline and bradycardia (hear rate <100 bpm), median heart rate and spo2 during the procedure and number of intubation attempts. We expect that using high flow oxygen compared to free flow oxygen during the procedure will increase endotracheal intubation success rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 0.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
入选标准
- •Male and female neonates of all gestational ages.
排除标准
- •requirement for immediate endotracheal intubation as determined by treating clinician, insufficient time for the researcher to randomize and setup study equipment, unable to achieve spo2 more than ninety percent prior to intubation, heart rate less than hundred beats per minute prior to randomization, contraindications to HFNC like congenital upper airway anomaly, congenital diaphragmatic hernia, abdominal wall defect, congenital cyanotic heart disease, failure to obtain consent.
结局指标
主要结局
successful endotracheal intubation in first attempt heart rate more than hundred beats per minute, fall in spo2 less than twenty percent from baseline.
时间窗: Baseline
次要结局
- cumulative duration of oxygen desaturation more than twenty percent from baseline, cumulative duration of bradycardia heart rate less than hundred beats per minute, number of attempts for intubation, duration of intubation attempts, adverse events during intubation, severe like esophageal intubation with delayed recognition, airway trauma, hypotension, pneumothorax, pneumomediastinum, non severe esophageal intubation with immediate recognition, mainstem bronchial intubation, oral or airway bleeding, lip trauma.(Baseline)
研究者
Dr Arun Soni
Sir Ganga Ram Hospital