Comparison of Laryngeal Mask Airway Versus Endotracheal Intubation in Pediatric Laparoscopic Inguinal Hernia Repair

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-10
SponsorSaglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Obesity (body weight >95th percentile),

symptomatic gastroesophageal reflux,

high risk of aspiration,

upper airway anomalies,

Trial design

Design model

Parallel

Treatments tested in this trial

  • General Aneasthesia

    Procedure/Surgery

    Laryngeal mask airway (LMA) or endotracheal intubation (ETT) in pediatric laparoscopic inguinal hernia repair

Treatment groups

266 Participants
are divided into 2 treatment groups
Group A: Patients received general anesthesia, with Laryngeal Mask Airway (LMA)Active comparator 1 intervention
Group B: Patients received general anesthesia, endotracheal entubationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Oxygen Saturation

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

Time frame
perioperative period
2

end-tidal carbondioxide levels

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

Time frame
perioperative period
3

airway safety

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

Time frame
perioperative period

Secondary outcomes

1

peak airway pressure

Time frame
perioperative period
2

PACU duration

Time frame
postoperative period

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Lead sponsor

Dicle University

Sponsor institution

Başakşehir Çam & Sakura City Hospital

Collaborator

Mardin Training and Research Hospital

Collaborator

Dicle University

Collaborator