Comparison of Intubation Time and Performance Between the ProVu Video Stylet With Versus Without the Fekry Airway in Adults With Normal Airway: A Single-Blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Time to successful intubation
研究概览
简要总结
This study aimed to compare assisted intubation using the ProVu video stylet device passing through Fekry airway versus intubation without the use of Fekry airway .
The investigators hypothesized that endotracheal intubation assisted by ProVu video stylet using the Fekry airway as a conduit for intubation would improve the glottic visualization and the higher first attempt success rate when compared to endotracheal intubation assisted by ProVu video stylet without using the Fekry airway.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• American Society of Anesthesiologists (ASA) physical status I, II.
- •Patients scheduled for elective surgery requiring general anesthesia and orotracheal intubation of less than 2 hours duration .
- •Ganzouri Airway score <3.
排除标准
- •Patient with Active cardiac condition.
- •Patient with airway congenital anomaly.
- •Mallampati score III or IV.
- •Body mass index (BMI) > 35 kg/m² (obesity).
- •Limited cervical spine mobility.
- •History of difficult intubation, upper airway surgery, or trauma.
- •Facial or oropharyngeal deformities.
- •Allergy or contraindication to study medications.
- •Refusal to participate.
研究组 & 干预措施
Group C (n=55): Intubation using the ProVu video stylet without the Fekry Airway.
The ProVu™ video stylet's novelty is a manoeuvrable tip controlled by a bidirectional wheel enabling flexion and retroflexion both of the stylet and tracheal tube with a 95° range of movement. It requires a specific tracheal tube where a softer polyvinyl chloride material is utilised in its distal section underneath the cuff enabling the tip to be flexed. Both the tracheal tube and video stylet are single-use and come with a range of high-resolution reusable video displays for a shared view of the airway
干预措施: ProVu video stylet and Fekry Airway (Device)
Group F (n =55): endotracheal Intubation assisted by the ProVu video stylet and using Fekry Airway
The ProVu™ video stylet's novelty is a manoeuvrable tip controlled by a bidirectional wheel enabling flexion and retroflexion both of the stylet and tracheal tube with a 95° range of movement. It requires a specific tracheal tube where a softer polyvinyl chloride material is utilised in its distal section underneath the cuff enabling the tip to be flexed. Both the tracheal tube and video stylet are single-use and come with a range of high-resolution reusable video displays for a shared view of the airway Size10 of the FEKRY airway will be selected.
干预措施: ProVu video stylet (Device)
结局指标
主要结局
Time to successful intubation
时间窗: up to 24 weeks
It is defined as time in seconds elapsing from touching assimply of ProVu video stylet to insisors (C group)or to Fekry Airway ( F group) till connecting the endotracheal tube to ventlatory circuate after removal of assimply
次要结局
未报告次要终点
研究者
Reham Ali Abdelhaleem Abdelrahman
Assistant Professor of Anesthesia, Surgical ICU and Pain Management-Faculty of Medicine-Cairo University
Cairo University