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临床试验/NCT03053583
NCT03053583已完成不适用

Comparison of the Vocal Cord Views Using the Classical Miller, Wis-Hipple and C-MAC Straight Size 1 Blades in Young Children

State University of New York at Buffalo0 个研究点目标入组 96 人开始时间: 2016年4月1日最近更新:

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jerrold Lerman

Clinical Professor of Anesthesia

State University of New York at Buffalo

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