Forces Exerted on Upper and Lower Teeth During Intubation: a Randomized, Cross-over Trial Comparing Indirect Videolaryngoscopy to Direct Videolaryngoscopy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Measuring the frequency with which forces are applied to the upper and lower teeth.
研究概览
简要总结
In this randomized crossover trial the investigators test whether three different brands of videolaryngoscopes (VLS) exhibit reduced forces on both upper and lower teeth, and compare them with a classic Macintosh laryngoscope blade.
详细描述
During endotracheal intubation the anesthesiologist uses a laryngoscope blade to distract the tongue to achieve the best view of the glottis opening, thereby avoiding using the maxillary incisors as a fulcrum to lever the soft tissues upwards. Using the maxillary incisors as a fulcrum may otherwise result in dental trauma. It is obvious that contact with teeth and - even worse - the incidence of accidental dental trauma, is directly related to the difficulty of the intubation.
Indirect videolaryngoscopy has proven advantageous over direct laryngoscopy using a classic Macintosh blade, for improved viewing of the glottis, with subsequent more successful intubations, and a shorter effective airway time both in patients with normal and difficult airways. Previously, it has been demonstrated that the forces exerted by the anesthesiologist on the patient's maxillary incisors are reduced when using a VLS, compared with a classic Macintosh laryngoscope. However, only one type of VLS (V-MAC®, Karl Storz, Tuttlingen, Germany) was used or only forces applied to upper teeth were being registered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
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
- •Informed patient consent
- •ASA I -III
- •Age > 18 years
- •Elective surgery, other than head and/or throat surgery
- •Pre-operative Mallampati I -III
- •Fasted (≥6 hours)
排除标准
- •No informed patient consent
- •Age < 18 year
- •Emergency surgery, surgery of head and/of throat
- •Locoregional anaesthesia
- •Pre-operative Mallampati IV
- •Fasted < 6 hours
- •Pre-operative expected difficult airway
- •No teeth, bad dentition
- •Dental crowns and/or fixed partial denture
结局指标
主要结局
Measuring the frequency with which forces are applied to the upper and lower teeth.
时间窗: At intubation of the patient
One of the three videolaryngoscopes will be placed in the patient's mouth. The measurement of forces applied to the teeth will be performed using Flexiforce® sensors.
次要结局
- Measuring the magnitude of the forces being applied and registering the differences between (video)laryngoscopes.(At intubation of the patient)
研究者
Barbe Pieters
Principal Investigator
Catharina Ziekenhuis Eindhoven