LMA Protector vs I-Gel in Low-Flow Anesthesia for Laparoscopic Cholecystectomy
2026年7月11日 更新者：Ahmet Emre Akın、Fatih Sultan Mehmet Training and Research Hospital
Comparison of LMA Protector and I-Gel Use in Low-Flow Anesthesia for Laparoscopic Cholecystectomy: A Prospective Randomized Study
This prospective randomized study aims to compare two second-generation supraglottic airway devices (SGAs), the I-Gel and the laryngeal mask airway (LMA) Protector, in patients undergoing laparoscopic cholecystectomy under low-flow desflurane anesthesia.
The study evaluates the devices in terms of respiratory mechanics (dynamic compliance, peak inspiratory pressure, plateau pressure, and airway resistance), non-invasive perfusion parameters (oxygen reserve index, perfusion index, and pleth variability index), hemodynamic stability, ease of insertion, oropharyngeal leak pressure, and postoperative complication rates.
研究概览
详细说明
Sixty-two patients (ASA I-II, aged 18-65 years) scheduled for elective laparoscopic cholecystectomy were randomized into two groups: Group I (I-Gel) and Group P (LMA Protector).
General anesthesia induction was standardized, and maintenance was provided with desflurane at a fresh gas flow of 1 L/min to achieve low-flow anesthesia.
Peak inspiratory pressure (PIP), plateau pressure (Pplato), dynamic compliance (Cdyn), and airway resistance were recorded at six distinct intraoperative time points: 5 minutes after SGA insertion (T1), 1 minute after pneumoperitoneum insufflation (T2), 1 minute after the 30-degree reverse Trendelenburg position (T3), 10 minutes after insufflation (T4), 1 minute after desufflation (T5), and immediately before SGA removal (T6).
Oropharyngeal leak pressure (OLP) was measured after insertion and before removal.
Postoperative complications such as sore throat, cough, hoarseness, dysphagia, and nausea-vomiting were monitored postoperatively.
研究类型
介入性
注册 (实际的)
62
阶段
- 不适用
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。
学习地点
-
-
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Istanbul、土耳其（türkiye）、34752
- Fatih Sultan Mehmet Training and Research Hospital
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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
描述
Inclusion Criteria:
- Patients aged 18-65 years
- American Society of Anesthesiologists (ASA) physical status I or II
- Scheduled for elective laparoscopic cholecystectomy
Exclusion Criteria:
- Known or predicted difficult airway or history of difficult intubation
- Body Mass Index (BMI) greater than 35 kg/m²
- High risk of gastroesophageal reflux or aspiration
- Severe cardiac, respiratory, renal, or hepatic disease
- Pregnancy
- Patient refusal to participate
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
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Group I: I-Gel
Patients managed with the I-Gel supraglottic airway device during low-flow desflurane anesthesia for laparoscopic cholecystectomy.
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Placement of an appropriate size of i-gel supraglottic airway device for airway management during general anesthesia.
Anesthesia maintenance is provided with desflurane in a fresh gas flow of 1 L/min (low-flow anesthesia).
其他名称：
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实验性的：Group P: LMA Protector
Patients managed with the LMA Protector supraglottic airway device during low-flow desflurane anesthesia for laparoscopic cholecystectomy.
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Placement of an appropriate size of LMA Protector supraglottic airway device for airway management during general anesthesia.
Anesthesia maintenance is provided with desflurane in a fresh gas flow of 1 L/min (low-flow anesthesia).
其他名称：
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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 |
|---|---|---|
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Dynamic Lung Compliance (Cdyn)
大体时间：Measured intraoperatively at 6 specific time points from 5 minutes after device insertion until immediately before device removal.
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Dynamic compliance of the respiratory system, calculated automatically by the ventilator as tidal volume divided by (peak inspiratory pressure minus positive end-expiratory pressure).
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Measured intraoperatively at 6 specific time points from 5 minutes after device insertion until immediately before device removal.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Peak Inspiratory Pressure (PIP)
大体时间：Measured intraoperatively at 6 specific time points from 5 minutes after device insertion until immediately before device removal.
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Maximum airway pressure generated during the inspiratory phase, monitored to assess airway dynamics under general anesthesia.
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Measured intraoperatively at 6 specific time points from 5 minutes after device insertion until immediately before device removal.
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Plateau Pressure (Pplateau)
大体时间：Measured intraoperatively at 6 specific time points from 5 minutes after device insertion until immediately before device removal.
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Pressure applied to the small airways and alveoli during a period of zero gas flow, monitored to assess risk of barotrauma.
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Measured intraoperatively at 6 specific time points from 5 minutes after device insertion until immediately before device removal.
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Airway Resistance
大体时间：Measured intraoperatively at 6 specific time points from 5 minutes after device insertion until immediately before device removal.
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The resistance of the respiratory tract to airflow during mechanical ventilation, calculated using peak and plateau pressures.
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Measured intraoperatively at 6 specific time points from 5 minutes after device insertion until immediately before device removal.
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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。
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 (实际的)
2020年7月1日
初级完成 (实际的)
2020年10月31日
研究完成 (实际的)
2020年10月31日
研究注册日期
首次提交
2026年7月5日
首先提交符合 QC 标准的
2026年7月11日
首次发布 (实际的)
2026年7月16日
研究记录更新
最后更新发布 (实际的)
2026年7月16日
上次提交的符合 QC 标准的更新
2026年7月11日
最后验证
2026年7月1日
更多信息
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.