Parker Flex-it Directional Stylet Versus Conventional Malleable Stylet in Elective Orotracheal Intubation Using a Fiber-optic Laryngoscope
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Mean and Standard deviation of Time required for orotracheal intubation (seconds) (mean±SD)
研究概览
简要总结
Objectives: To compare the safety and efficacy of Parker flex-it directional stylet (PFDS) versus conventional malleable stylet (CMS) in orotracheal intubation (OTI) using fiber-optic Macintosh laryngoscope.
Background: OTI is used in general anesthesia for anesthetic delivery and ventilation of patients. OTI delay or failure may adversely affect patient outcomes, therefore, anesthetists with sufficient clinical experience and skill should perform OTI. However, in emergency situations, experienced anesthetists may not be available, and the patient may have a high Cormack-Lehane grade. A stylet is commonly used in the emergency department to aid insertion of the endotracheal tube during direct laryngoscopy.
Patients and Methods: This was a prospective, randomized, double-blind clinical trial; carried out on 80 patients requiring OTI under general anesthesia at our hospital. Patients were randomly allocated into two equal groups; group DS, intubated using PFDS, and group MS, intubated using CMS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status ≤ II
- •Age from 21 to 60 years
- •Body Mass Index (BMI) < 35
- •Mallampati classification ≤ II
排除标准
- •American Society of Anesthesiologists (ASA) physical status > II
- •Age < 21 years or > 60 years
- •Body Mass Index (BMI) ≥ 35
- •Mallampati classification > II
- •Pregnant women
- •Anticipated difficult airway
- •Need for rapid sequence induction
- •Increased risk of gastric aspiration such as gastroesophageal reflux
- •Edentulous patients, Loose teeth
- •Known pathology, trauma, or previous surgery to the mouth, pharynx, larynx, or cervical spine
- •History of; Dysrhythmia, Hypertension, Ischemic heart disease, Hyperthyroidism, DM
研究组 & 干预措施
Group DS (n=40)
Parker Flex-it Directional Stylet group
干预措施: Parker Flex-it Directional Stylet (Device)
Group MS (n=40)
Conventional Malleable Stylet group
干预措施: Conventional Malleable Stylet (Device)
结局指标
主要结局
Mean and Standard deviation of Time required for orotracheal intubation (seconds) (mean±SD)
时间窗: 2 minutes after inserting the blade of the laryngoscope in the mouth
Time interval from holding the endotracheal tube by the anesthetist till removal of the stylet from the endotracheal tube by the anesthetist
次要结局
- Mean and Standard deviation of Heart rate (beat/min.)(mean±SD)(2 minutes after inserting the blade of the laryngoscope in the mouth)
- Mean and Standard deviation of Blood Pressure (mmHg)(mean±SD)(2 minutes after inserting the blade of the laryngoscope in the mouth)
- Number of participants and Rate of Successful intubation from the first-attempt(2 minutes after inserting the blade of the laryngoscope in the mouth)
- Number of participants and Rate of Use of external laryngeal manipulation(2 minutes after inserting the blade of the laryngoscope in the mouth)
- Mean and Standard deviation of Oxygen Saturation (%)(mean±SD)(2 minutes after inserting the blade of the laryngoscope in the mouth)
- Mean and Standard deviation of Total time required for orotracheal intubation (seconds) (mean±SD)(2 minutes after inserting the blade of the laryngoscope in the mouth)
- Mean and Standard deviation of Number of intubation attempts (mean±SD)(2 minutes after inserting the blade of the laryngoscope in the mouth)
- Number of participants and Rate of Procedure-related complications(5 minutes after the end of the procedure)