NCT04866472招募中不适用
Comparison of Video Laryngoscope (VLS) With GlideRite Ridge Stylet vs Video Laryngoscope With the TCI Articulating Indroducer for Endotracheal Intubation in Predicted Difficult Airways. A Prospective Randomized Control Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 4
- 主要终点
- Time to successful intubation using a combination of video-laryngoscope and TCI Articulating Device will be equilivant to intubation success usinging a combination of video-laryngoscope and GlideRite Rigid Stylet
研究概览
简要总结
This study will assess the feasibility of using the TCI Articulating Device with video-laryngoscope in predictive, difficult airway, endotracheal intubation cases. It is meant to show the use of this device is equivalent to using the GlideRite Rigid Stylet with video-laryngoscope.
详细描述
Multi-Centered, Prospective, Randomized, Control Trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients requiring oral endotracheal intubation
- •Age 18 years or older
- •Group A Criteria (need only one of the following criteria)
- •History of difficult intubation
- •History of head/neck radiation and prior oral cavity, pharyngeal, or laryngeal surgery
- •Group B Criteria (need three or more of the following)
- •Thyromental distance <6 cm (Defined as distance measured from the thyroid notch to the tip of the jaw with the head extended and the mouth closed)
- •Sternomental distance < 12 cm (Defined as distance measured as the straight line between the upper border of the manubrium sterni and the bony point of the mentum with the head in full extension and the mouth closed
- •Oropharyngeal view: modified Mallampati scale of 3 or 4
- •Mouth opening < 4 cm
- •Protruding upper teeth (severe overbite)
- •History of radiation to the neck
- •Limited neck movement: inability to extend and flex neck >90° from full extension to full flexion or presence of cervical spine pathologies and fractures (e.g., C-collar in place)
- •Body Mass Index (BMI) >35 kg/m2
- •Neck circumference .> 40 cm in females and 43 cm in males measured at the thyroid cartilage
- •Obstructive sleep apnea diagnoses or a STOP BANG score 6 and above
排除标准
- •Any patient under the age of 18 Full stomach, Untreated hiatal hernia Uncontrolled gastroesophageal reflux disease Known tracheal narrowing
结局指标
主要结局
Time to successful intubation using a combination of video-laryngoscope and TCI Articulating Device will be equilivant to intubation success usinging a combination of video-laryngoscope and GlideRite Rigid Stylet
时间窗: time measured in seconds with an estimated time of 30 to 120 seconds from the start of intubation to endotracheal tube placement verified by CO2
successful intubation
次要结局
- Ease of intubation using TCI Articulating Device as compaired to GlideRite Rigid Stylet as rated by provider(completed immediately after subject intubation)
- Blood in airway(Period in seconds with an estimated time of 30 to 120 seconds between start of use of TCI Articulating Device to placement of ETT tube or failure to place)
- Time to intubate using either control or intervention(Time measured in seconds, with an estimated time of 30 to 120 seconds, from time of first view of glottis to time ETT placement or failure to place)
- Need to use a maneuver called "corkscrew" ETT to pass glottis(Period in seconds with an estimated time of 30 to 120 seconds between start of intubation procedure to ETT placement or failure to place)
研究者
Rainer Lenhardt
Professor, University of Louisville, School of Medicine
University of Louisville
研究点 (4)
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