A Randomized, Prospective Study to Compare the Video Miller Device to Direct Laryngoscopy Using a Standard Pediatric Miller Blade for Tracheal Intubation of Children < 3 Years of Age Undergoing General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Time to Obtain Glottic View
研究概览
简要总结
The purpose of this study is to compare:
the standard pediatric intubation instrument (Miller blade) used as direct laryngoscopy during tracheal intubation to the VideoMiller device (the standard pediatric blade with a camera attached, giving indirect view of the vocal cords in the screen). This intubation device is used to place the tube in the trachea to keep the patient breathing during the surgery procedure.
The anesthesiologist obtains a better view of the vocal cords looking at the screen provided by the VideoMiller.
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 (Participant)
入排标准
- 年龄范围
- — 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 3 years or younger undergoing anesthesia requiring endotracheal intubation.
- •Obtaining signed the informed consent by their parents or legal guardian.
- •American Society of Anaesthesiologists (ASA) physical status classification I - II or III
排除标准
- •Patients deemed to be at significant airway risk necessitating an awake fiber optic intubation
- •Patients with facial abnormalities, and/or oral-pharyngeal malformation.
- •Emergency operation
结局指标
主要结局
Time to Obtain Glottic View
时间窗: Times following initial insertion of laryngoscope blade to obtain glottic view
Time to obtain glottic view (from initial insertion of laryngoscope blade to obtain glottic view)
Intubation Time
时间窗: Times from insertion of laryngoscope blade to placement of tracheal tube
Times following initial insertion of laryngoscope blade to placement of tracheal tube
Time From Insertion of Laryngoscope Blade to Confirm w/ CO2 Waveform
时间窗: Time from initial insertion of laryngoscope blade to confirm w/ CO2 waveform
Time following initial insertion of laryngoscope blade to confirm w/ CO2 waveform
次要结局
- Number of Participants Intubated With 1 and > 1 Intubation Attempts(During intubation procedure, up to 3 minutes)
- Glottis Visualization Using Cormack Lehane(During intubation procedure, up to 3 minutes)
- Glottis Visualization Using POGO Score(During intubation procedure, up to 3 minutes)
研究者
Roya Yumul, M.D.,PhD.
Residency program director, Department of anesthesiology
Cedars-Sinai Medical Center