Endotracheal Tube-mounted Camera Assisted Intubation Versus Videolaryngoscopic Intubation in Patients With Expected Difficult Airway - a Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- first-pass success
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) videolaryngoscopy or b) an endotracheal tube-mounted camera.
详细描述
Endotracheal intubation is required for different surgical procedures for mechanical ventilation and to prevent aspiration of secretions. Endotracheal intubation is usually performed by direct laryngoscopy (DL), but this technique may fail in patients with a difficult airway, i.e. during otorhinolaryngologic or oral and maxillofacial surgery. Besides fiberoptic intubation that is regarded as gold standard, videolaryngoscopy (VL) has evolved as a valuable alternative technique in patients with a difficult airway. However, VL has its limitations and may also fail due to insufficient visualization of the larynx. An endotracheal tube with an integrated camera (VST, VivaSight-SL, Ambu A/S, Ballerup, Denmark) may allow for direct guidance of the tube and may aid in endotracheal intubation in difficult airway patients. This tube has been evaluated in intensive care patients and in patients with morbid adiposity compared to DL, but there is a paucity of data in difficult airway patients, so far.
Therefore, we aim to test the VST in difficult airway patients compared to VL 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 in accordance with standard operating procedure of the Department of Anesthesiology, University Medical Center Hamburg-Eppendorf using the implemented in-house algorithm for the prediction of difficult airway management and the Simplified Airway Risk Index (SARI).
Patients randomized to the intervention group will be intubated with a VST. Depending on gender and patient's size, tubes with inner diameters of 7.0, 7.5, and 8.0 are available. The tubes camera is connected to an Ambu aView monitor (Ambu A/S, Ballerup, Denmark). Patients randomized to the control group are intubated with a C-MAC videolaryngoscope (Karl Storz SE & Co. KG, Tuttlingen, Germany) with a Macintosh type blade size 3 or 4 blade.
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
first-pass success
时间窗: 15 minutes
percentage of successful intubations with one attempt
end-tidal oxygen fraction
时间窗: 15 minutes
the lowest end-tidal oxygen fraction within two minutes after successful intubation after a standardized preoxygenation
次要结局
- time to successful intubation with one attempt(15 minutes)
- hypotension(15 minutes)
- time to successful intubation(15 minutes)
- esophageal intubation(15 minutes)
- number of attempts(15 minutes)
- aspiration(15 minutes)
- hypoxia(15 minutes)
- intubation difficulty(15 minutes)
- end-tidal carbondioxide fraction(15 minutes)
- intubating conditions(15 minutes)
- overall success rate(15 minutes)
