STUDY EVALUATING THE PARKER-FLEX ENDOTRACHEAL TUBE FOR FIBEROPTIC INTUBATION ON OBESE PATIENTS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Length of Time Required for Successful Advancement of Endotracheal Tube Into Trachea
研究概览
简要总结
A recent article examined the use of Parker Flex-Tip tubes to standard ETTs for oral fiberoptic intubation and concluded that there was a significant benefit in terms of difficulty encountered when using the Parker Flex-Tip. The Parker Flex-Tip tracheal tube has a flexible, curved, and tapered tip design different from traditional endotracheal tubes. The design allows the tube to lie closely against the fiberoptic scope that is often used to facilitate intubation, resulting in a smaller gap between the ETT and the fiberoptic scope. This may allow the ETT to clear anatomic obstructions more easily. The patients they examined had an average body mass index (BMI) categorized as normal weight. To our knowledge, there have not been any studies that have investigated the use of the Parker Flex-Tube for fiberoptic intubations in patients categorized as obese by BMI. Our hypothesis is that the Parker Flex-Tip ETT results in easier passage of the ETT over a fiberoptic scope during elective fiberoptic intubation of obese patients in comparison to a traditional ETT.
详细描述
This is a randomized, double-blinded study. Neither the patient nor the anesthesia practitioner advancing the ETT will know the group to which the patient has been assigned. On the day of surgery, participants will be randomized 1:1 to one of two groups. Both groups will be electively intubated with a fiberoptic scope. One group will be intubated using a Parker-Flex endotracheal tube and the second group of will be intubated with a standard endotracheal tube. There will be an equal probability of being assigned to either group. No placebo or control group will be used. Randomization will be computer-generated and assignments will be enclosed in sealed envelopes to provide allocation concealment. The anesthesiology technician involved in the case will open the envelope at the start of the case and will not be blinded to the study, due to the fact that the technician must prepare the endotracheal tube for the fiberoptic intubation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI of 30 or greater
- •American Society of Anesthesiologists (ASA) Physical Status Classification I- III
- •Patients scheduled for elective procedures requiring general anesthesia and endotracheal intubation.
排除标准
- •Predicted difficult airway based on physical exam and patient's history
- •Rapid sequence intubation indicated (patients who require to be intubated as quickly as possible)
- •Prior trauma or surgery in the oropharynx/larynx
- •Known abnormal laryngeal structures (tumors)
- •Infectious and toxic conditions
- •Cervical spine instability
- •Emergency surgery
结局指标
主要结局
Length of Time Required for Successful Advancement of Endotracheal Tube Into Trachea
时间窗: following successful intubation or lasting longer than 120 seconds
次要结局
- Percentage of Endotracheal Intubations Successful on First Attempt Attempts(following successful intubation or more than 5 attempts)
研究者
Lee Chang
Assistant Professor
Baylor College of Medicine