Comparison of Placement of Double-lumen Endobronchial Tube Using GlideScope With 2 Different Stylet Configurations vs Standard Macintosh Laryngoscopy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 4
- 主要终点
- Mean Time to Place the Double-lumen Endobronchial Tube
研究概览
简要总结
The purpose of this study is to compare three different standard of care methods of double-lumen endobronchial tube (DLT) placement in patients who are scheduled to have thoracic surgery in which lung isolation is required.
详细描述
The purpose of this study is to compare three different standard of care methods of double-lumen endobronchial tube (DLT) placement in patients who are scheduled to have thoracic surgery in which lung isolation is required. The investigators want to evaluate the technique of placement of the double-lumen endobronchial tube (DLT) using an included stylet that has been radically bent (ZU-bend) as compared to a commercial GlideRite stylet with the GlideScope and direct laryngoscopy using the Macintosh laryngoscope. A double-lumen endobronchial tube (DLT) is a breathing tube utilized to manage the airway when lung separation is needed for a surgical procedure. The investigator wants to evaluate how long it takes for successful placement of the double-lumen endobronchial tube (DLT) and assess the difficulty of the procedure experienced by the physician performing the intubation.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients requiring a double-lumen endobronchial tube placement for surgery at Emory University Hospital or Emory University Hospital Midtown
- •Patients willing and able to provide written informed consent
排除标准
- •Patients in whom a previously difficult airway manipulation was recorded on an anesthetic record
- •Lung transplantation procedures, as underlying pulmonary disorder that will confound the SpO2 (peripheral capillary oxygen saturation) metric
- •Any patient who is receiving anticoagulants in excess of a daily aspirin, patients with an International Normalized Ratio or INR >1
- •Patients in whom one lung ventilation or placement of a double-lumen endobronchial tube is contraindicated
- •Patients who require a rapid-sequence intubation
- •Patients undergoing emergency procedures
研究组 & 干预措施
ZU-bend stylet with GlideScope technique
Subjects scheduled for thoracic surgery in which the surgeon requests lung isolation will undergo laryngoscopy and intubation using the ZU-bend with the GlideScope technique of a double lumen endobronchial tube (DLT) placement as part of the anesthesia procedure prior to surgery.
干预措施: ZU-bend stylet (Device)
ZU-bend stylet with GlideScope technique
Subjects scheduled for thoracic surgery in which the surgeon requests lung isolation will undergo laryngoscopy and intubation using the ZU-bend with the GlideScope technique of a double lumen endobronchial tube (DLT) placement as part of the anesthesia procedure prior to surgery.
干预措施: GlideScope (Device)
GlideScope with the GlideRite stylet
Subjects scheduled for thoracic surgery in which the surgeon requests lung isolation will undergo laryngoscopy and intubation using the GlideScope with the GlideRite stylet for placement of a double lumen endobronchial tube (DLT) as part of the anesthesia procedure prior to surgery.
干预措施: GlideScope (Device)
GlideScope with the GlideRite stylet
Subjects scheduled for thoracic surgery in which the surgeon requests lung isolation will undergo laryngoscopy and intubation using the GlideScope with the GlideRite stylet for placement of a double lumen endobronchial tube (DLT) as part of the anesthesia procedure prior to surgery.
干预措施: GlideRite stylet (Device)
Macintosh blade and a regular DLT stylet
Subjects scheduled for thoracic surgery in which the surgeon requests lung isolation will undergo laryngoscopy and intubation using the direct laryngoscopy technique with the Macintosh blade and a regular double lumen endobronchial tube (DLT) stylet as part of the anesthesia procedure prior to surgery.
干预措施: Macintosh blade (Device)
Macintosh blade and a regular DLT stylet
Subjects scheduled for thoracic surgery in which the surgeon requests lung isolation will undergo laryngoscopy and intubation using the direct laryngoscopy technique with the Macintosh blade and a regular double lumen endobronchial tube (DLT) stylet as part of the anesthesia procedure prior to surgery.
干预措施: Regular Double-lumen endobronchial tube (DLT) Stylet (Device)
结局指标
主要结局
Mean Time to Place the Double-lumen Endobronchial Tube
时间窗: during laryngoscope placement, up to 120 seconds
The time taken for successful intubation will be recorded by the anesthetist. The total duration from the time the laryngoscope is placed at the patient's lips to the first detection of End-tidal CO2 (EtCO2), an average of 120 seconds, will be recorded in seconds. A higher duration noted is indicative of a longer time taken for successful intubation. 0 seconds (laryngoscope at patient's lips), (first End-tidal CO2 (EtCO2) detection)
次要结局
- Success Rate of First Endobronchial Intubation Attempt(during laryngoscope placement, up to 120 seconds)
- Number of Cases With Complications(during laryngoscope placement, up to 120 seconds)
- Throat Pain(Up to 60 minutes after extubation)
- Number of Cases of Voice Change(Up to 60 minutes after extubation)
- Assessment of Difficulty of Intubation(during laryngoscope placement, up to 120 seconds)
研究者
Igor Zhukov
Assistant Professor
Emory University