Comparison of the Vocal Cord Views Using the Classical Miller, Wis-Hipple and C-MAC Straight Size 1 Blades in Young Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 主要终点
- Percentage of Vocal Cord Opening
研究概览
简要总结
The purpose of this study is to compare straight blades in obtaining best vocal cord view in children. The investigators will compare size 1 Classical Miller, size 1 Wis-Hipple, and size 1 C-MAC straight blades in young children.
详细描述
This will be a prospective, randomized, blinded study. The primary objective is to compare straight blades in obtaining best vocal cord view in children. The secondary objectives will be to determine the subjective ease of laryngoscopy and intubation, desaturation and complications with each blade and to compare the view of the CMAC with a photo of the direct view with the CMAC blade.
In this study, the investigators will compare three different straight blades used in pediatric anesthesia: Miller blade size 1, Wis-Hipple blade size 1, and C-MAC straight blade size 1.
The sample size was estimated in this equivalence study assuming an alpha two-tailed of 0.05, beta of 0.2, proportion with a POGO score > 80 with the Miller blade (based on the results of our previous study) of 0.64 and an estimated proportion of 0.74 with the Wis-Hipple blade in the present study. The hypothesized difference required to reject equivalence is ≥ 0.2. This requires 96 children in total or 32 children per group. To account for un-interpretable photos and dropouts, we enrolled 101 children.
One hundred and one children who were eligible to participate will be consented, randomized, and allocated to one of the three study groups after consent is obtained from the parents/ guardian during regular anesthesia pre-operative evaluation. According to randomization children will be assigned to one of three groups:
Group A- Laryngoscopy by classical Miller blade, size 1 Group B- Laryngoscopy by Wis-Hipple blade, size 1 Group C- Laryngoscopy by C-MAC Miller blade, size 1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 2 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children age ≤ 2 years
- •American Society of Anesthesiologists (ASA) class I-II
- •Scheduled for elective surgery under general anesthesia
排除标准
- •Refusal by parents
- •Airway surgery
- •Obstructive sleep apnea
- •Craniofacial abnormalities
- •Predicted difficult intubation
- •Prematurity < 37 gestational age
- •NICU stay for > 1 week after birth
- •Gastroesophageal reflux disease
- •Neuromuscular disease
结局指标
主要结局
Percentage of Vocal Cord Opening
时间窗: 10 minutes
The percentage of vocal cord opening (POGO) is the percent of the vocal cords that is visible during laryngoscopy. Minimum is obviously 0 and maximum 100 as in percents. The more visible the vocal cords the better the view or outcome. The mean or measure of central tendency was reported together with the 25th to 75th percentile as a measure of dispersion.
次要结局
- Subjective Ease of Laryngoscopy and Intubation(30 minutes from induction to tracheal intubation)
- Percent of Oxygen Saturation(post laryngoscopy)
研究者
Jerrold Lerman
Clinical Professor of Anesthesia
State University of New York at Buffalo
