Comparison of C-MAC Miller Size 0 Blade and C-MAC Macintosh Size 0 Blade for Intubation in Preterm Infants & Neonates: A Randomised Controlled Study
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Time to Intubation (TTI): Time from insertion of the blade in the mouth to the passage of the endotracheal tube through the vocal cords.
研究概览
简要总结
Neonatal airway management presents unique challenges due to the anatomical and physiological differences in preterm infants and neonates, such as a proportionally larger tongue, anterior larynx, and narrower airway. These features make intubation technically demanding and necessitate specialized tools. The C-MAC video laryngoscope, with its Miller and Macintosh blades, has been extensively used in adult and pediatric airway management. However, there is limited evidence comparing these blades for intubation in preterm infants and neonates. This randomised controlled study aims to evaluate and compare the effectiveness of the C-MAC Miller size 0 blade with the C-MAC Macintosh size 0 blade for endotracheal intubation in this population. After performing a pre-anesthetic check-up and obtaining consent, eligible participants will be randomised into two groups: Group Miller: Intubation with the C-MAC Miller size 0 blade and Group Macintosh: Intubation with the C-MAC Macintosh size 0 blade. In the operation theatre, routine monitors (ECG, SpOâ‚‚, NIBP) will be applied, and general anesthesia will be induced with sevoflurane. After adequate depth of anesthesia is achieved, atracurium (0.5 mg/kg) will be administered, and manual ventilation will be provided. Intubation will then be performed using the allocated blade by an experienced paediatric anaesthesiologist, following standardized techniques. The primary outcome will be the time to intubation (TTI) and secondary outcomes will include: Total time for the procedure (TTP), Glottic visualization quality (POGO score), Intubation attempts, Ease of blade, and ETT insertion and adverse events, such as desaturation (SpOâ‚‚ < 90%) or bradycardia. All intubations will be video-recorded to ensure objectivity during outcome analysis. If intubation fails after two attempts, an alternative blade will be used, and the event will be documented as a failure. This study aims to identify the optimal blade design for preterm neonatal intubation by analysing efficiency, ease of use, and safety parameters, contributing to improved clinical practices in neonatal airway management.
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 1.00 Month(s)（—）
- 性别
- All
入选标准
- •Preterm infants & neonates [from birth till 60 weeks post conceptional age (PCA) or 1 month of age].
排除标准
- •Neonates with known craniofacial abnormalities or congenital airway malformations.
- •History of difficult intubation.
- •Hemodynamic instability or conditions contraindicating elective intubation.
结局指标
主要结局
Time to Intubation (TTI): Time from insertion of the blade in the mouth to the passage of the endotracheal tube through the vocal cords.
时间窗: From the time of induction of anaesthesia till endotracheal intubation is completed. (usually 5-10 minutes from start of anaesthesia induction)
次要结局
- 1.Time to Best Glottic View (TTGV): Time from insertion of the blade in the mouth to achieving the best possible glottic view.(2.Time to Procedure (TTP): Time from insertion of the blade in the mouth till square shaped etCO2 tracing is seen in the monitor.)
研究者
Renu Sinha
All India Institute of Medical Sciences, New Delhi