Tracheal Intubation With VieScope Versus Videolaryngoscopy in Patients for Elective Surgery With an Expected Difficult Airway - a Prospective Randomized Trial (VieScOP-II)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Percentage of Glottis Opening (POGO) scale
研究概览
简要总结
Patients requiring endotracheal intubation for elective surgery with an expected difficult airway are randomized to be intubated either by a) VieScope or b) videolaryngoscopy.
详细描述
Tracheal intubation is required for different surgical procedures for mechanical ventilation and to prevent aspiration of secretions. In patients with an expected difficult airway, tracheal intubation is often performed by videolaryngoscopy (VL). However, this technique has limitations and may fail due to insufficient visualization of the larynx. A new device has been introduced that consists of an illuminated straight plastic tube for laryngoscopy (VSC, Vie Scope, Adroit Surgical, Oklahoma City, OK, USA) that enables for indirect intubation over a stylet.
So far, the VSC has shown promising results in manikin studies for intubation in normal and difficult airways. We aim to test the VSC in patients compared to videolaryngoscopy in a prospective randomized non-inferiority trial.
Patients will be assessed for eligibility in the Anesthesiology Pre-assessment Clinic of the University Medical Center Hamburg-Eppendorf prior to elective surgery. All patients receive a structured preoperative airway assessment.
Patients are randomized 1:1 to either intervention or control group. Patients randomized to the intervention group will be intubated with the VSC. Patients randomized to the control group are intubated with a MacIntosh type videolaryngoscope (CMAC, Storz, Germany).
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
- Single (Participant)
盲法说明
device for intubation may not be blinded for provider or investigator
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
- •Patients requiring general anesthesia with transoral tracheal intubation for elective surgery
- •Preoperative airway assessment reveals an expected difficult airway (rated by the responsible anesthetist in the Pre-assessment Clinic based on the existing in-house algorithm)
排除标准
- •Pregnant or breastfeeding woman
- •Confirmed indications for awake fiberoptic intubation especially due to enoral, pharyngeal tumors, abscesses or other processes
- •Planned endotracheal intubation without deep anesthesia or neuromuscular blocking agents (e.g. awake videolaryngoscopy)
- •Required transnasal tracheal intubation (e.g. for surgical reasons)
- •Requirement of special endotracheal tubes such as laser or RAE tubes for surgical reasons
- •Patients at risk for pulmonary aspiration who qualify for rapid sequence induction
- •Loose teeth
- •Denial of consent
结局指标
主要结局
Percentage of Glottis Opening (POGO) scale
时间窗: 15 min
intubating conditions according to the percentage of glottis opening scale (POGO), range 0-100%, higher values better
次要结局
- time to intubation(15 min)
- first attempt success rate(15 min)
- Cormack-Lehane(15 min)
- overall success rate(15 min)
- hypotension(15 min)
- hypoxia(15 min)
- intubation difficulty(15 min)
- esophageal intubation(15 min)
- time to successful intubation with one attempt(15 min)
- number of attempts(15 min)
- aspiration(15 min)