Supraglottic Jet Oxygenation and Ventilation Via Nasal Approach During Laser Microlaryngeal Surgery for Vocal Polyps Resection
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Numerical rating scale (NRS) rated by surgeon
研究概览
简要总结
The key to a successful microlaryngoscopy is adequate operative field exposure and illumination. A variety of airway control procedures has been developed to improve operative exposure. A small size endotracheal tube is commonly used. However, some surgeon may suggest a 'no-tube' technique to optimize the surgical field. This study aims to investigate effectiveness and safety of a novel technique by supraglottic jet oxygenation and ventilation (SJOV) via nasal approach to facilitate optimal visualization in laser microlaryngeal surgery for small vocal polyps resection.
详细描述
The allocation sequence is generated by computer random number generation, and the allocation is placed in sequentially numbered opaque sealed envelopes by a non-investigator. Enrolment and data collection are performed by trained research staff who are not involved in the care of the patients. The treating clinicians are not possible to be blinded to the assignment group, but all other staff involved in both the collection and collation of data, and administration of neurocognitive testing, are blinded to group allocation.
The primary measurement is numerical rating scale (NRS) rated by surgeon according to surgical exposure and visualization. The secondary measurements are operation duration, and Intraoperative pulse oximetry (SpO2), PetCO2.
The continuous variables were expressed as means ± standard deviation (SD) whereas categorical variables were expressed as frequency and percentage for data description.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for laser laryngeal surgery under general anesthesia
排除标准
- •Patients with cardiac, pulmonary, hepatic, or renal dysfunction. Patients with nasal disease. Patients with anticipated difficult airway.
研究组 & 干预措施
Group J
Jet ventilation was achieved via supraglottic jet oxygenation and ventilation with WEI NASAL JET (WNJ).
干预措施: WEI NASAL JET (WNJ) (Device)
Group I
Patients were ventilated with a small size endotracheal tube.
结局指标
主要结局
Numerical rating scale (NRS) rated by surgeon
时间窗: Immediately after surgery, the surgeons rated surgical exposure and visualization with NRS only once.
The surgeons rated surgical exposure and visualization on a numerical rating scale (NRS), ranging from 0 to 10, with 0 defined as the best condition and 10 as the worst.
次要结局
- Operation duration(Immediately after surgery, the duration of the operation was recorded by the investigator.)
研究者
Hui Qiao
Attending Anesthesiologist
Eye & ENT Hospital of Fudan University