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Comparison of I-gel and SaCoVLM in Laparoscopic Cholecystectomy

2026年7月17日 更新者：Samsun University

Comparison of Airway Performance Between I-gel and SaCoVLM in Patients Undergoing Elective Laparoscopic Cholecystectomy: A Prospective Observational Study

This prospective observational study aims to compare the ventilation performance and safety of the i-gel and SaCoVLM supraglottic airway devices in adult patients undergoing elective laparoscopic cholecystectomy. Ventilation-related parameters, airway sealing performance, insertion characteristics, and perioperative complications will be evaluated.

研究概览

地位

尚未招聘

条件

详细说明

Laparoscopic surgery requires the creation of pneumoperitoneum and frequently involves patient positioning changes, both of which can increase intrathoracic and airway pressures. These physiological changes may affect the performance of supraglottic airway devices and challenge effective ventilation.

Second-generation supraglottic airway devices are increasingly used as alternatives to endotracheal intubation in laparoscopic procedures because they provide effective ventilation while reducing airway-related complications. The i-gel is widely used due to its ease of insertion, integrated gastric drainage channel, and favorable safety profile. The SaCoVLM (Video Laryngeal Mask) is a novel supraglottic airway device that enables direct visualization of laryngeal structures during placement, allowing confirmation of optimal positioning and potentially improving airway management.

This prospective observational study will compare the i-gel and SaCoVLM in adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia. Ventilation performance, airway sealing pressure, insertion success, ease of placement, hemodynamic responses, and perioperative airway-related complications will be assessed. The findings may provide further evidence regarding the clinical performance and safety of these devices during laparoscopic surgery.

研究类型

观察性的

注册 (估计的)

80

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

The study population will consist of adult patients aged 18-70 years with American Society of Anesthesiologists (ASA) physical status I-III who are scheduled to undergo elective laparoscopic cholecystectomy under general anesthesia at Samsun City Hospital. Eligible patients who provide written informed consent and meet the study inclusion criteria will be consecutively enrolled during the study period.

描述

Inclusion Criteria:

  • Age between 18 and 70 years.
  • American Society of Anesthesiologists (ASA) physical status I-III.
  • Patients scheduled for elective laparoscopic cholecystectomy.
  • Patients undergoing general anesthesia.
  • Patients who provide written informed consent.

Exclusion Criteria:

-

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
Group I: i-gel group
Patients receiving airway management with the i-gel supraglottic airway device
Grup II: SaCoVLM
Patients receiving airway management with the SaCoVLM supraglottic airway device

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Oropharyngeal Leak Pressure (OLP)
大体时间：After device insertion and after pneumoperitoneum creation during surgery.
Oropharyngeal leak pressure (OLP) will be measured and compared between the i-gel and SaCoVLM groups to evaluate airway sealing performance during elective laparoscopic cholecystectomy..
After device insertion and after pneumoperitoneum creation during surgery.

次要结果测量

结果测量
措施说明
大体时间
First-Attempt Insertion Success Rate
大体时间：During device insertion procedure
The proportion of patients in whom the supraglottic airway device is successfully inserted on the first attempt.
During device insertion procedure
Device Insertion Time
大体时间：During device insertion procedure
The time required for successful placement of the supraglottic airway device, measured from device insertion into the oral cavity until effective ventilation is achieved.
During device insertion procedure
Gastric Tube Insertion Success Rate
大体时间：Immediately following successful placement of the supraglottic airway device before initiation of mechanical ventilation
The proportion of patients in whom the gastric tube is successfully inserted through the gastric drainage channel of the device.
Immediately following successful placement of the supraglottic airway device before initiation of mechanical ventilation
Peak Airway Pressure (PAP)
大体时间：5 minutes after pneumoperitoneum is established.
Peak airway pressure values measured during mechanical ventilation and compared between study groups
5 minutes after pneumoperitoneum is established.
End-Tidal Carbon Dioxide (EtCO₂)
大体时间：Throughout laparoscopic surgery.
End-tidal carbon dioxide values measured during surgery and compared between study groups.
Throughout laparoscopic surgery.
Postoperative Sore Throat
大体时间：Within 24 hours after surgery.
The incidence of postoperative sore throat following removal of the supraglottic airway device.Postoperative sore throat severity assessed using an 11-point Numeric Rating Scale (NRS)
Within 24 hours after surgery.
Hoarseness
大体时间：Within 24 hours after surgery.
The incidence of postoperative dysphagia following airway device use.
Within 24 hours after surgery.
Blood Staining and Mucosal Trauma
大体时间：Immediately after device removal.
The incidence of blood staining on the device and evidence of mucosal trauma after device removal.
Immediately after device removal.
Hemodynamic Parameters
大体时间：Baseline, immediately after device placement, 5 minutes after device placement, 5 minutes after pneumoperitoneum, 15 minutes after pneumoperitoneum, and at the end of surgery.
Heart rate (beats per minute [bpm]) will be recorded at baseline, immediately after supraglottic airway device placement, 5 minutes after device placement, 5 minutes after pneumoperitoneum, 15 minutes after pneumoperitoneum, and at the end of surgery. Mean heart rate values will be compared between the i-gel and SaCoVLM groups.Systolic blood pressure (millimeters of mercury [mmHg]) will be recorded at baseline, immediately after supraglottic airway device placement, 5 minutes after device placement, 5 minutes after pneumoperitoneum, 15 minutes after pneumoperitoneum, and at the end of surgery. Mean systolic blood pressure values will be compared between the i-gel and SaCoVLM groups.Mean arterial pressure (millimeters of mercury [mmHg]) will be recorded at baseline, immediately after supraglottic airway device placement, 5 minutes after device placement, 5 minutes after pneumoperitoneum, 15 minutes after pneumoperitoneum, and at the end of surgery. Mean arterial pressure values will be
Baseline, immediately after device placement, 5 minutes after device placement, 5 minutes after pneumoperitoneum, 15 minutes after pneumoperitoneum, and at the end of surgery.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Samsun University

调查人员

  • 研究主任：Hatice Selçuk Kuşderci、Samsun University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月24日

初级完成 (估计的)

2026年12月31日

研究完成 (估计的)

2026年12月31日

研究注册日期

首次提交

2026年6月24日

首先提交符合 QC 标准的

2026年7月2日

首次发布 (实际的)

2026年7月9日

研究记录更新

最后更新发布 (实际的)

2026年7月21日

上次提交的符合 QC 标准的更新

2026年7月17日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • GOKAEK 2026/11/18

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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