Feasibility of the RetrogradeTranscutaneous Infra-Red Illumination for Facilitation of Video Scope-tracheal Intubation
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- infrared red light on the performance of video-laryngoscopy intubation and its impact on first pass success
研究概览
简要总结
Airway securing through the placement of an endotracheal tube continues to be the definitive and the global standard management. The successful first attempt is aimed to avoid the consequences of multiple intubation trials as bleeding, tissue swelling, and airway contamination from gastric content that led to considerable morbidity and mortality. Visualization of the larynx and the glottic opening is the key to first-pass success requiring long-term training and availability of specific equipment concerned to that. For confirmation of the position endotracheal tube or its displacement, various clinical and equipment aids to that which are not valid or limited in different scenarios. Video laryngoscopes (VL) have been proposed to improve laryngeal visualization, hence a higher first-pass success rate accomplished. Despite that, there are limitations of video laryngoscope use in different circumstances that requiring adding of other aids to facilitate endotracheal intubation.
x
详细描述
Airway securing through the placement of an endotracheal tube continues to be the definitive and the global standard management. The successful first attempt is aimed to avoid the consequences of multiple intubation trials as bleeding, tissue swelling, and airway contamination from gastric content that led to considerable morbidity and mortality. Visualization of the larynx and the glottic opening is the key to first-pass success requiring long-term training and availability of specific equipment concerned to that. For confirmation of the position endotracheal tube or its displacement, various clinical and equipment aids to that which are not valid or limited in different scenarios. Video laryngoscopes (VL) have been proposed to improve laryngeal visualization, hence a higher first-pass success rate accomplished. Despite that, there are limitations of video laryngoscope use in different circumstances that requiring adding of other aids to facilitate endotracheal intubation.
The proposal of this study is to assess the feasibility and the impact of infrared/near-infrared (IRD) light on the performance of video-laryngoscopy and reduction of the time needed for endotracheal intubation and increase the credibility of the device.
Data-collection will be started after induction of the anesthesia and ended at the confirmation of endotracheal tube position
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Age above 18 years
- •General anesthesia that needs endotracheal intubation
- •All Mallampati score 1-3
- •ASA physical status 1-3
排除标准
- •Refuse or unable to sign the consent.
- •Pregnancy
- •Emergency cases
- •History of or expected difficult intubation
- •Maxillofacial abnormality or trauma
- •Age below 18 years
- •Rapid sequence induction
- •Skin disorders and skin light sensitivity (SLE, Lupus ....)
- •Impaired head and neck mobility
- •Scars or skin injuries at the neck
研究组 & 干预措施
Group A: control group (intubation without IRD/IRRIS device)
Group A = control group (intubation without IRD/IRRIS device) (15 subjects) The first operator experienced with video-laryngoscopy intubation will do the endotracheal intubation after induction of anesthesia.
Intervention group using Infrared (Active IRD/ IRRIS) device
Group B = intervention group using Infrared active IRD/IRRIS device (15 subjects) Before inducing anesthesia, the second operator will open the randomization envelope and adhere IRRIS/IRD device to the anterior skin of the neck above the sternal notch according to the group of patients. After confirming lack of discomfort during application of the IRRIS/IRD device, anesthesia will be induced
干预措施: Application of Infrared (Active IRD/ IRRIS) device (Device)
结局指标
主要结局
infrared red light on the performance of video-laryngoscopy intubation and its impact on first pass success
时间窗: During procedure time
The primary endpoint will be the feasibility of infrared/near-red light on the performance of video-laryngoscopy tracheal intubation and its impact on first pass success
次要结局
- Visibility of the glottic entrance(During procedure time)
- Time to recognize the illuminated laryngeal inlet.(one year)
- Correct intubation(one year)
- Number of intubation attempt.(During procedure time)
- Types of video laryngoscopy(During procedure time)
- Alternative techniques of intubation.(During procedure time)
- Safety of Infra Red(During procedure time)