Evaluation of New Supraglottic Airway Device - SaCo VLMA for General Anesthesia for Laparoscopic Procedures
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- effectiveness of use
概览
简要总结
Evaluation of new supraglottic device SaCo VLMA for laparoscopic procedures under general anesthesia in comparison with other airway management methods including other supraglottic devices. The parameters noted will be: demographic data, time for placement of SGA counted from moment of grabbing device by operator to correct placement, subjective evaluation of ease of insertion of SGA in 5 step Borg scale, peak pressure, lung compliance, achieved tidal volume before creating pneumoperitoneum, after creating pneumoperitoneum, visualization of glottis on monitor of camera or fiberoptic scope.
详细描述
Evaluation of new supraglottic device SaCo VLMA for laparoscopic procedures under general anesthesia in comparison of other supraglottic devices and other methods of airway management for such procedures.
The airway management for laparoscopic surgery can be achieved by either endotracheal intubation (ET) or use of supraglottic devices (SGA). However, many anesthesiologist still prefer ET over use of SGA because of possible problems with adequate ventilation during pneumoperitoneum.
New SGA devices as video laryngeal mask offer important advantage which is continuous control of proper placement of SGA during anesthesia. In case of ventilation difficulties like leak, high peak pressure, low tidal volume SGA VLM allow to check if the problem is related to malposition or changed of position of SGA and allow for correction under control of vision.
The aim of this study is to evaluate the characteristics of the SaCo VLMA video laryngeal mask in the hands of experienced anesthesiologists.
All patients will be anesthetized following the same protocol: Intravenous induction with propofol, FNT, midazolam, rocuronium in standard doses. After achieving proper muscle relaxation SaCo VLMA was inserted following manufacturer recommendations. For maintaining anesthesia sevoflurane was used.
After induction for anesthesia the airway of the patient will be secured by one randomly chosen device: SaCo VLMA or other SGA or ET.
The parameters noted will be: demographic data, time for placement of SGA counted from moment of grabbing device by operator to correct placement, subjective evaluation of ease of insertion of SGA in 5 step Borg scale, peak pressure, lung compliance, achieved tidal volume before creating pneumoperitoneum, after creating pneumoperitoneum, visualization of glottis on monitor of camera or fiberoptic scope.
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
- Single (Outcomes Assessor)
盲法说明
the collected data will be anonymized regarding used for airway control device
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 undergoing elective surgery under general anesthesia for laparoscopic surgery of predicting lasting no longer than about 1 hour.
- •Age \>18 years.
- •ASA I-III.
- •Present ordinary airway
排除标准
- •Not meeting the above criteria
- •Presenting 3 predictors of a difficult airway (Mallampatti class III or IV; thyromental distance \<6 cm, sternomental distance \<12.5 cm, distance between incisors \<4.0 cm, bite test II or III, cervical mobility \<90o).
- •Gestation
- •Allergy to any drug included in the protocol.
- •Present risk factors for bronchial aspiration
- •\- Presenting with preoperative sore throat
- •Present severe respiratory, coronary or cerebral vascular pathology.
研究组 & 干预措施
SaCo VLMA airway management
SaCo VLMA Supraglottic Airway Device for airway control in anesthetized patient for general anesthesia for laparoscopic surgery
干预措施: SaCo VLM or SAD or ET for airway control for laparoscopy (Device)
Other device for airway management
Other Airway Device for airway control in anesthetized patient for general anesthesia for laparoscopic surgery
干预措施: SaCo VLM or SAD or ET for airway control for laparoscopy (Device)
结局指标
主要结局
effectiveness of use
时间窗: immediately after the intervention
success ratio of insertion of SGA or ET in % of success insertion
effectiveness of mechanical ventilation
时间窗: perioperatively
adequate ventilation described as maintaining adequate minute ventilation with acceptable leak in Tidal Volume in ml
safety of mechanical ventilation
时间窗: perioperatively
providing adequate ventilation parameters - peak pressure in mmHg
parameters of mechanical ventilation
时间窗: perioperatively
measurement of lung compliance in ml/mmHg
次要结局
- safety of use of SaCo VLM(immediately after the surgery)
研究者
Tomasz Gaszynski
prof. dr hab.
Medical University of Lodz