Comparison of Two Ventilation Systems in Laryngeal Surgery: High-flow Nasal Oxygen Therapy and Laryngeal Micro-catheter With the Ventinova Technique
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Hopital Foch
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Compare the percentage of patients having oxygen desaturation during the procedure or a PaCO2 > 65 mmHg at its end with both methods (high-flow nasal oxygen therapy and the use of FCV modality via a laryngeal tri-tube).
研究概览
简要总结
Single-center, randomized study, comparing two methods of oxygenation on 80 patients
详细描述
This study is a single-center, randomized study, comparing two methods of oxygenation during micro-laryngeal surgery performed under general anesthesia and myorelaxation: high-flow nasal oxygen therapy (HFNO) or Flow Controlled Ventilation (FCV) using a laryngeal tri-tube. The study population will be composed of 80 patients, aged over 18 and under 80.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient over the age of 18 and under the age of 80
- •Patient to benefit from micro-laryngeal ENT surgery under general anesthesia and myorelaxation with an estimated duration which does not exceed 30 minutes
- •Having signed a consent form
- •Being affiliated with a Health Insurance plan.
排除标准
- •Pregnant or lactating patient
- •Patient with a weight <40 kg
- •Obese patient (BMI> 30)
- •Patient with foreseeable intubation difficulty
- •Patient maintained under general anesthesia postoperatively
- •Surgery requiring time by surgical laser
- •Surgery involving the use of an active electrosurgical electrode in the immediate area of the electrosurgical device or electrode
- •Predictable surgery longer than 30 minutes
- •Being deprived of liberty or under guardianship.
研究组 & 干预措施
High-flow nasal oxygen therapy
Ventilation with High-flow nasal oxygen therapy
干预措施: High-flow nasal oxygen therapy using a specific nasal cannula (Device)
Flow Controlled Ventilation
Ventilation with laryngeal tri-tube with Flow Controlled Ventilation technique
干预措施: Flow Controlled Ventilation using a laryngeal tri-tube (Device)
结局指标
主要结局
Compare the percentage of patients having oxygen desaturation during the procedure or a PaCO2 > 65 mmHg at its end with both methods (high-flow nasal oxygen therapy and the use of FCV modality via a laryngeal tri-tube).
时间窗: 1 day (during surgery)
% of patients having an oxygen desaturation (SpO2\<92%) during the procedure OR a PaCO2 \> 65 mmHg at its end
次要结局
- Evaluate the duration of oxygen therapy before desaturation in the two groups(1 day (during surgery))
- Evaluate the incidence of atelectasis(1 day (during surgery))
- Evaluate the incidence of postoperative complications on day 1 in relation to the technique(1 day)
- Evaluate the quality of the visualization of the laryngeal region in the two groups(1 day (during surgery))
- Evaluate the time-PaCO2 (partial pressure of carbon dioxide) relationship according to the techniques(1 day (during surgery))
- Evaluate the time taken to resume spontaneous ventilation and wake up when the anesthetic agents are stopped(1 day (during surgery))
- Evaluate the possibility of a decrease in FiO2 (Fraction of inspired oxygen)(1 day (during surgery))
- Evaluate the incidence of postoperative complications on day 7 in relation to the technique(7 days)