A Randomized Comparison Between the Flexible Tip Bougie Vs Tube with Stylet for First-attempt Intubation Success with a Videolaryngoscopy in ICU Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Difference in the first attempt success rate (percentage)
研究概览
简要总结
Tracheal intubation in the intensive care unit (ICU) is associated with high incidence of difficult intubation and complications . Videolaryngoscopes (VLs) devices have been proposed to improve airway management, and the use of VLs are recommended as first-line or after a first-attempt failure using direct laryngoscopy in ICU airway management algorithms. Although two meta-analysis showed that videolaryngoscopy improves visualization of the glottis and the first-attempt success, other two meta-analysis reported that videolaryngoscopy didn´t improve first-attempt success rate. The reason may be that although VLs improve glottic visualization, on many occasions it may not be accompanied by intubation at the first attempt, because the endotracheal tube has to pass a sharp angle to enter the trachea. To avoid this limitation, a new flexible tip bougie is designed to flexibly navigate the distal tip and help facilitate precise insertion of the endotracheal tube in the trachea .
详细描述
Although VLs improve glottic visualization, on many occasions it may not be accompanied by intubation at the first attempt, because the endotracheal tube has to pass a sharp angle to enter the trachea. To avoid this limitation, a new flexible tip bougie is designed to flexibly navigate the distal tip and help facilitate precise insertion of the endotracheal tube in the trachea. The flexible tip bougie has an integrated slider along the surface which moves the tip anterior and posterior while the pre-curved distal portion of shaft allows the angulation to provide anterior flexion. This new flexible tip bougie could be used as a rescue when first intubation failure using the videolaryngoscopy, or as a first option to improve the percentage of patients intubated at the first attempt.
The purpose of this prospective randomized study is to compare successful intubation on the first attempt wuth the new flexible tip bougie versus endotracheal tube with stylet during intubation with videolaryngoscopy of critically ill adults in ICU.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted in the intensive care unit (ICU) and require mechanical ventilation through a tracheal tube.
- •Adult (age ≥ 18 years)
- •Written informed consent from the patient or proxy (if present) before inclusion or once possible when patient has been included in a context of emergency.
排除标准
- •Refusal of study participation or to pursue the study by the patient
- •Pregnancy
结局指标
主要结局
Difference in the first attempt success rate (percentage)
时间窗: during intubation
To compare the difference in the first attempt success rate (percentage) of different techniques for tracheal intubation.
次要结局
- Difference in the overall success rate (percentage)(during intubation)
- Additional airway equipment(during intubation)
- Difficulty of intubation(during intubation)
- Difference in the incidence of complications related to intubation(Participants will be followed from the beginning of the intervention to 30 minutes after the intervention)
- Modified Cormack-Lehane grade of glottic view(during intubation)
- Number of intubation attempts(during intubation)
研究者
Manuel Taboada Muñiz
Professor
Hospital Clinico Universitario de Santiago