Actively Recruiting

Phase Not Applicable
Age: 1Year - 10Years
All Genders
ID07511764

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

Led by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital · Updated on 2026-04-06

266

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

Sponsors

S

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Lead Sponsor

B

Başakşehir Çam & Sakura City Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the use of two different airway management techniques—laryngeal mask airway (LMA) and endotracheal intubation (ETT)—in children undergoing laparoscopic surgery for inguinal hernia repair. This condition is common in childhood and requires surgical intervention, but there is limited evidence comparing these two methods in pediatric laparoscopic procedures. The study is a multicenter, prospective, randomized controlled clinical trial aiming to fill this knowledge gap and guide optimal airway management in this setting. The trial will include 266 pediatric patients aged 1 to 10 years classified as ASA I-II who are scheduled for elective laparoscopic inguinal hernia repair. Participants will be randomly assigned to receive general anesthesia either with LMA or with ETT. Anesthesia protocols will be standardized across centers. The study will monitor perioperative outcomes such as oxygen saturation, carbon dioxide levels, airway safety events, and secondary measures like peak airway pressure and recovery times. During the study, demographic and clinical information will be collected, and patients will be closely observed for airway safety and respiratory parameters throughout the perioperative period. Recovery times and postoperative airway symptoms will also be assessed. The study’s primary outcomes focus on oxygen saturation, end-tidal carbon dioxide levels, and airway safety events during the surgery. Participants will be followed throughout the anesthesia and immediate postoperative recovery phases to compare the two airway management methods.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 1Year - 10Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged between 1 and 10 years
  • Scheduled for elective laparoscopic inguinal hernia repair
  • Classified as American Society of Anesthesiologists (ASA) class I or II
  • Informed consent given by parent or guardian
Not Eligible

You will not qualify if you...

  • Obesity with body weight above the 95th percentile
  • Symptomatic gastroesophageal reflux
  • Conditions with a high risk of aspiration
  • Presence of upper airway anomalies
  • History of difficult intubation
  • Acute respiratory tract infection
  • Emergency surgical indication
  • Need for conversion from laparoscopic to open surgery
  • Additional systemic risks such as immunodeficiency or malignancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Surgical day

Participants undergo pediatric laparoscopic inguinal hernia repair under general anesthesia using either laryngeal mask airway (LMA) or endotracheal intubation (ETT). Anesthesia protocols are standardized, and perioperative monitoring includes oxygen saturation, end-tidal carbon dioxide levels, and airway safety.

1 visit (in-person during surgery and immediate recovery)

Post-operative Follow-up

Duration - Until discharge from PACU

Participants are monitored postoperatively for recovery time, duration in the post-anesthesia care unit (PACU), and any airway-related complications such as cough or stridor.

1 follow-up visit (in-person)

Trial Site Locations

Total: 1 location

1

Dicle University

Diyarbakır, Eyalet/Yerleşke, Turkey (Türkiye), 21070

Actively Recruiting

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Research Team

F

Fikret Salık, associate professor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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