Flexible Scope Intubation vs.Flexible Scope Intubation and Video Laryngoscopy Combination: A Prospective Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- Difficult Endotracheal Tube (ETT) Placement
研究概览
简要总结
This trial studies how well flexible intubation scope with or without video laryngoscope works in supporting endotracheal tube placement in patients with head and neck cancer before surgery. Flexible intubation scope and video laryngoscope are devices that have a small camera to help the doctor see the patient's airway on a screen. Both devices may help the doctor who gives anesthesia prevent complications from placing the breathing tube (such as pain or mouth injury).
详细描述
PRIMARY OBJECTIVES:
I. To compare the rates of difficult endotracheal tube (ETT) placement using a flexible intubation scope (FIS) versus a combination of flexible intubation and video laryngoscopy in difficult airway management.
SECONDARY OBJECTIVES:
I. To compare the ease of using a flexible intubation scope (FIS) with and without the use of the video laryngoscope (VL).
II. Total time for securing the airway.
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
- None
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
- •Ages ≥ 18 years of age
- •All surgical patients with known or suspected difficult airways that meet at least three (3) of the Difficult Airway criteria [Mallampati III-IV, Neck circumference > 40 cm, Sternomental distance < 12 cm, Thyromental distance < 6 cm, Mouth opening < 4 cm, BMI ≥ 35 kg/m2, Upper Lip Bite Test - ULBT (class III)] or history of radiation to the head and neck area or oral pathology obstructing the glottic view
- •American Society of Anesthesiology (ASA) I-IV
- •Has provided written informed consent
排除标准
- •Active bleeding from nasopharynx or oropharynx
- •Oral pathology obstructing the glottic view
- •Planned awake or nasal intubation
- •Neuromuscular Blockade (NMB) contraindicated post-induction
- •Emergency endotracheal intubation and patients intubated pre and post-surgery
- •Surgical procedures such as Tracheostomy, Laryngectomy, Esophagectomy
- •Patient refusal or inability to consent for study participation
- •American Society of Anesthesiology (ASA) V
- •Pregnant females
研究组 & 干预措施
Arm A (flexible intubation scope)
Patients undergo flexible scope intubation up to 2 attempts following induction of general anesthesia and adequate manual ventilation. In case of failed 2 attempts, patients undergo a third attempt utilizing another technique or device.
干预措施: Tracheal Intubation (Procedure)
Arm B (flexible intubation scope,video laryngoscope)
Patients undergo flexible scope intubation and video laryngoscopy up to 2 attempts following induction of general anesthesia and adequate manual ventilation. In case of failed 2 attempts, patients undergo a third attempt utilizing another technique or device.
干预措施: Laryngoscopy (Device)
Arm B (flexible intubation scope,video laryngoscope)
Patients undergo flexible scope intubation and video laryngoscopy up to 2 attempts following induction of general anesthesia and adequate manual ventilation. In case of failed 2 attempts, patients undergo a third attempt utilizing another technique or device.
干预措施: Tracheal Intubation (Procedure)
结局指标
主要结局
Difficult Endotracheal Tube (ETT) Placement
时间窗: intubation time, up to 3 minutes
Defined as the number of participants with any of the following during initial intubation attempt.1 Intubation time exceeding 60 seconds, 2. Failure to intubate on the first attempt, 3. Provider assessment of intubation as difficult or unsuccessful.
次要结局
- Intubation Time(time captured when FIS passed the lips to CO2 confirmation)
- Number of Intubation Attempts(intubation time, up to 3 minutes)
- Rate of Failure at Intubation(during intubation process/attempt)
- Ease of Intubation (Provider Assessment)(duration of intubation attempt)