A Randomized Prospective Study to Compare Tracheal Intubation With the CMAC Device to Fiberoptic Bronchoscopy in Patients With an Unstable Cervical Spine
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Time to Confirm the Placement of the Tracheal Tube
研究概览
简要总结
The purpose of this study is to evaluate whether tracheal intubation with the CMAC device decreases the time required for intubation as compared to intubation with the fiberoptic bronchoscope in patients with an unstable cervical spine. Both the CMAC device and the fiberoptic bronchoscope are currently commonly used in standard of care practices in the intubation of patients with cervical spine injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an unstable Cervical-spine as a result of C-spine injury.
- •Patients scheduled to undergo inpatient surgical procedures under general anesthesia.
- •Willingness and ability to sign an informed consent document.
- •18-80 years of age.
- •ASA Class I - III adults of either sex
排除标准
- •Patients deemed to be at significant airway risk to necessitate awake fiber optic intubation.
- •Patients with a history of oral-pharyngeal cancer or reconstructive surgery.
- •Emergency surgeries.
- •Any other conditions which may interfere with the conduct of the study.
研究组 & 干预措施
CMAC Device
CMAC Intubating device time to achieve successful tracheal intubation.
干预措施: CMAC (Device)
Fiberoptic bronchoscope
Fiberoptic bronchoscope Intubating device time to achieve successful tracheal intubation.
干预措施: Fiberoptic bronchoscope (Device)
结局指标
主要结局
Time to Confirm the Placement of the Tracheal Tube
时间窗: up tp 3 minutes
It is the time (in seconds) following initial insertion of laryngoscope blade to confirm with CO2 waveform
Intubation Time (Seconds)
时间窗: 3 minutes
Times (seconds) following initial insertion of laryngoscope blade to placement of tracheal tube
次要结局
- Time to Obtain Glottis Visualization (Seconds)(1 minute)
研究者
Roya Yumul, M.D.,PhD.
Residency program director, Department of anesthesiology
Cedars-Sinai Medical Center