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临床试验/NCT07511764
NCT07511764招募中不适用

Comparison of Laryngeal Mask Airway Versus Endotracheal Intubation in Pediatric Laparoscopic Inguinal Hernia Repair: A Multicenter, Prospective, Randomized Controlled Clinical Trial

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 266 人开始时间: 2025年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
266
试验地点
1
主要终点
Oxygen Saturation

研究概览

简要总结

Inguinal hernia is one of the most common conditions requiring surgical intervention in childhood, with a reported lifetime prevalence of 1-4%. With the increasing use of minimally invasive techniques such as PIRS (Percutaneous Internal Ring Suturing) among laparoscopic surgical procedures, perioperative anesthesia and airway management have become a critical area of clinical decision-making. The traditional approach in pediatric laparoscopic surgery is endotracheal intubation (ETT). Although ETT provides reliable airway control, it carries certain disadvantages. In contrast, the laryngeal mask airway (LMA) is less invasive and is associated with faster recovery. Systematic reviews and meta-analyses conducted in recent years have shown that the LMA may be safe for ventilation in pediatric laparoscopy, reduces peak airway pressure, and shortens recovery time. No well-designed, multicenter study with an adequate sample size comparing the LMA and ETT in pediatric laparoscopic inguinal hernia surgery has yet been conducted. This gap limits evidence-based decision-making in a clinical setting that directly impacts practice. Therefore, the aim of this study is to compare LMA and ETT in pediatric laparoscopic inguinal hernia repair. In this regard, the study is unique and necessary from both clinical and academic perspectives for determining the optimal airway strategy in pediatric laparoscopy.

详细描述

This study is designed as a multicenter, prospective, randomized controlled clinical trial to compare laryngeal mask airway (LMA) and endotracheal intubation (ETT) in pediatric laparoscopic inguinal hernia repair.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
1 Year 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • being between 1 and 10 years of age,
  • having a planned laparoscopic inguinal hernia repair,
  • being classified as ASA I-II,
  • having given informed consent from the parent.

排除标准

  • Obesity (body weight >95th percentile),
  • symptomatic gastroesophageal reflux,
  • high risk of aspiration,
  • upper airway anomalies,
  • history of difficult intubation,
  • acute respiratory tract infection,
  • emergency surgical indication,
  • need for conversion from laparoscopy to open surgery,
  • presence of additional systemic risks such as immunodeficiency/malignancy.

研究组 & 干预措施

Patients received general anesthesia, with Laryngeal Mask Airway (LMA)

Active Comparator

Patient group in whom mechanical ventilation is provided via LMA during general anesthesia.

干预措施: General Aneasthesia (Procedure)

Patients received general anesthesia, endotracheal entubation

Active Comparator

Patient group in whom mechanical ventilation is provided via endotracheal entubation during general anesthesia.

干预措施: General Aneasthesia (Procedure)

结局指标

主要结局

Oxygen Saturation

时间窗: perioperative period

Patients' oxygen saturation levels will be monitored using peripheral spO2.

end-tidal carbondioxide levels

时间窗: perioperative period

Patients' end-tidal CO2 levels will be monitored using capnography.

airway safety

时间窗: perioperative period

The development and management of complications related to airway safety (such as laryngospasm, bronchospasm, desaturation, and aspiration) in patients will be monitored.

次要结局

  • peak airway pressure(perioperative period)
  • PACU duration(postoperative period)

研究者

发起方
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fikret Salık

Medicine Doctor Associate Professor in Anesthesiology

Dicle University

研究点 (1)

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