The Efficacy of Transnasal Humidified Rapid-insufflation Ventilatory Exchange in Patients Undergoing Laryngeal Microsurgery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- lowest oxygen saturation
研究概览
简要总结
Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) was revealed to prolong apneic time with a slow increase in carbon dioxide; thus, has been used for preoxygenation in patients with difficult airways or requiring rapid sequence induction in general anesthesia.
However, in patients undergoing hypopharyngeal and laryngo-tracheal surgery, THRIVE during operation can be advantageous by allowing tubeless surgical field with sufficient oxygenation.
Therefore, the investigators conducted this study to evaluate the efficacy of THRIVE on prolonged apneic time with enhanced surgical conditions in patients with laryngeal microsurgery.
详细描述
Patients undergoing laryngeal microsurgery will be randomized into either intubation group or THRIVE group.
On arriving operating room, the patients will be preoxygenated by facemask or high flow nasal cannula with 100% oxygen for 3 minutes according to the allocated group. After inducing general anesthesia, patients in intubation group will be oxygenated by endotracheal tube, while patients in THRIVE group will be oxygenated by high flow nasal cannula with flow rate of 70L/min. During the surgery, the endotracheal tube can be removed and reintubated in intubation group patients to provide surgical field by a surgeon, respectively.
The monitored pulse oximetry, oxygen reserve index, and transcutaneous partial pressure of carbon dioxide will be recorded during surgery.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing laryngeal microsurgery
- •ASA class I-III
排除标准
- •patients scheduled for laryngeal microsurgery using CO2 laser
- •patients with increased intracranial pressure
- •patients with skull base defect
- •patients with chronic obstructive pulmonary disease
- •patients with pulmonary hypertension
- •patients requiring rapid sequence induction
研究组 & 干预措施
intubation group
The enrolled patients will be oxygenated by endotracheal tube during operation.
干预措施: endotracheal intubation (Procedure)
THRIVE group
The enrolled patients will be oxygenated by intubationless high flow nasal cannula during operation.
干预措施: high flow nasal cannula (Procedure)
结局指标
主要结局
lowest oxygen saturation
时间窗: from the time of starting laryngeal microsurgery till the end of the surgery
lowest oxygen saturation monitored by pulse oximetry during laryngeal microsurgery
次要结局
- highest transcutaneous partial pressure of carbon dioxide(from the time of starting laryngeal microsurgery till the end of the surgery)
- lowest oxygen reserve index(from the time of starting laryngeal microsurgery till the end of the surgery)
研究者
Youn Joung Cho, MD
Clinical assistant professor
Seoul National University Hospital