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临床试验/NCT07361042
NCT07361042尚未招募不适用

Comparison of Video and Classic Laryngeal Mask Airways: A Prospective Randomized Trial

Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.0 个研究点目标入组 417 人开始时间: 2026年4月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
417
主要终点
Sealing pressure

研究概览

简要总结

The goal of this study is to evaluate the performance of the new video laryngeal masks for securing airway in patients undergoing general anaesthesia. Main goal is to evaluate the first insertion attempt success rate, time to adequate ventilation, sealing pressures and adverse events.

详细描述

First, informed consent for study participation will be obtained from the patient. The consent will be collected during the preoperative evaluation by the anesthesiologist responsible for providing anesthesia care during the surgical procedure, in the preoperative holding area.After obtaining informed consent, a routine preoperative assessment will be conducted by the anesthesiologist, including standard preparation procedures (e.g., establishing peripheral venous access, evaluation of airway management risk, etc.). Randomization will be performed using a computerized online tool (studyrandomizer.com).The patient will then be transferred to the operating room, where standard monitoring will be initiated in accordance with the principles of safe anesthesia care.Induction of anesthesia will follow, during which propofol and sufentanil will be administered in doses determined by the attending anesthesiologist. A muscle relaxant will not be used to facilitate insertion of the laryngeal mask airway (LMA). Once an adequate depth of anesthesia is achieved-defined by an entropy value of SE < 60-airway management will proceed according to the patient's assigned group (Group A - SaCoVLM; Group B - Supreme; Group C - Ambu).In both groups, the back of the LMA will be lubricated with a water-based gel. Group A will receive airway management using the SaCoVLM™ video laryngeal mask. Group B will receive airway management using the Supreme™ laryngeal mask and Group C will recieve airway management using the Ambu Aura Gain.The following data will be recorded: successful first attempt with adequate ventilation, time to initiation of ventilation, number of attempts required, SpO₂ at the time of ventilation onset, and EtCO₂ after initiation. Additionally, the fraction of oxygen in the exhaled gas mixture will be measured before the first insertion attempt and after achieving adequate ventilation. A gastric tube will be inserted via the drainage port in both groups.Surgery will then proceed. During the procedure, oropharyngeal leak pressure will be measured at the 10th and 20th minute following LMA insertion. Ventilation will continue using the inserted LMA throughout the procedure. At the end of surgery, anesthesia will be discontinued, and the LMA will be removed. Upon removal, the presence of blood-tinged secretions on the LMA will be noted.One hour after LMA removal, the patient will be assessed for oropharyngeal discomfort (e.g., sore throat, pain, cough irritation, or blood-streaked sputum). The need for oxygen therapy will also be recorded at 10 minutes and 1 hour following LMA removal. After this, the patient's participation in the study will conclude.

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
None

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

  • Patient without predicted difficult airway (MACOCHA score ≤ 2), undergoing a planned surgical procedure under general anesthesia with an indication for airway management using a laryngeal mask.
  • Patient aged 18 years or older.

排除标准

  • Patient younger than 18 years.
  • Patient with predicted difficult airway (MACOCHA score > 2).
  • Patient with a history of difficult airway.
  • Patient requiring airway management with a method other than a laryngeal mask.
  • Refusal or failure to sign the informed consent for study participation. • Patient undergoing emergency surgery.
  • Administration of muscle relaxants for LMA insertion.
  • State Entropy value below 30 during LMA insertion.
  • State Entropy value above 60 during LMA insertion.

研究组 & 干预措施

Video Laryngeal Mask

Experimental

This arm will have airway secured with SaCo video laryngeal mask.

干预措施: Video Laryngeal Mask SaCo VLM (Device)

Laryngeal Mask Supreme

Active Comparator

This group will have airway secured with traditional Supreme laryngeal mask.

干预措施: Laryngeal Mask Supreme (Device)

Laryngeal Mask Ambu

Active Comparator

Laryngeal Mask Ambu Aura Gain

干预措施: Laryngeal Mask Ambu Aura Gain (Device)

结局指标

主要结局

Sealing pressure

时间窗: After achieving adequate ventilation, and at 10 and 20 minutes thereafter.

The maximum sealing pressure that can be reach after insertion and optimal alignment of the laryngeal mask. The APL ventilator will be set to 70 mbar and after there will be plateau on the pressure curve the sealing pressure will be measured.

次要结局

  • Time to adequate ventilation(From initiation of the first insertion attempt through the end of general anesthesia, up to 6 hours.)

研究者

发起方
Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michal Kalina

Deputy for science and research

Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.

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