Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
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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