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临床试验/NCT07391969
NCT07391969
尚未招募
不适用

Evaluation of New Supraglottic Airway Device - SaCo VLMA for General Anesthesia for Laparoscopic Procedures

Medical University of Lodz0 个研究点目标入组 20 人开始时间: 2026年2月1日最近更新:

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

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

Experimental

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

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tomasz Gaszynski

prof. dr hab.

Medical University of Lodz

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